Ex Parte 7138275 et alDownload PDFBoard of Patent Appeals and InterferencesMar 23, 201295001158 (B.P.A.I. Mar. 23, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 95/001,158 05/01/2009 7138275 674528-5002 8993 28381 7590 04/02/2012 ARNOLD & PORTER LLP ATTN: IP DOCKETING DEPT. 555 TWELFTH STREET, N.W. WASHINGTON, DC 20004-1206 EXAMINER PONNALURI, PADMASHRI ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 04/02/2012 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 ____________ GHAZI JASWINDER DHOOT Requester & Appellant v. BLASTICON BIOTECHNOLOGISCHE FORSCHUNG GMBH Patent Owner & Respondent ____________ Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and DANIEL S. SONG, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 2 This is a decision1 on the appeal by the Third Party Requester of the Examiner’s decision confirming the patentability of originally issued claims 1-14 and setting forth the patentability of newly added claims 15-23 of US Patent No. 7,138,275 (“the ‘275 patent”). The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134(c), and 306. We affirm-in-part and reverse-in-part. STATEMENT OF CASE U.S. Patent No. 7,138,275 issued November 21, 2006. A “Request for Inter Partes Reexamination” of issued claims 1-14 of the ‘275 patent was filed by Thomas J. Kowalski of Frommer, Lawrence, & Haug LLP on May 1, 2009 pursuant to 35 U.S.C. §§ 311-318 and 37 C.F.R. § 1.913. Reexamination was ordered. Claims 15-23 were added during the proceeding. The reexamination proceeding culminated in the Examiner confirming the patentability of claims 1-14 and determining that new claims 15-23 are patentable, all over prior art cited by the Third Party Requester (Right of Appeal Notice (“RAN”) 34). The Third Party Requester, Ghazi Jaswinder Dhoot, appeals the Examiner’s decision favorable to the patentability of claims 1-23 (App. Br. 3). An oral hearing was held on December 21, 2011 in which oral arguments were presented by the Requester’s counsel. The Patent Owner of the ‘275 patent did not participate. A transcript of the hearing has been entered into the record. 1 The decision mailed March 26, 2012 contained errors on page 1 and page 13 (claim numbers) which have now been corrected. The decision of March 26, 2012 is thus withdrawn and replaced by this new decision. Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 3 Claims 1, 5, and 15 are representative of the appeal claims and read as follows: 1. A dedifferentiated, programmable cell of human monocytic origin, wherein said dedifferentiated, programmable cell of human monocytic origin expresses a CD14 antigen, a CD90 antigen, and a CD123 antigen. 5. A dedifferentiated, programmable cell of human monocytic origin, wherein said dedifferentiated, programmable cell of human monocytic origin expresses a CD14 antigen, a CD123 antigen, a CD90 antigen, and a CD135 antigen. 15. The dedifferentiated, programmable cell of human monocytic origin according to claim 1, wherein said dedifferentiated, programmable cell of human monocytic origin does not express a CD34 antigen. The Requester contends that the Examiner improperly withdrew prior art rejections under 35 U.S.C §§ 102 and 103. The rejections are summarized on pages 7-9 of the Requester’s Appeal Brief and will not be repeated here. The primary prior art publications cited in all the rejections are the ‘625 patent,2 the ‘826 published patent application,3 the ‘947 published patent application,4 and the ‘503 published patent application.5 All four publications are in the same family of patent publications and have related and overlapping disclosures. The Requester referred to all four patent publications as the “Primary References” and addressed their teachings together. Thus, in reviewing the Examiner’s determination to 2 U.S. Patent 6,090,625 (filed Jan. 31, 1996) (issued July 18, 2000). 3 U.S. Patent Application Publication 2001/0024826 (filed Dec. 20, 2000) (published Sept. 27, 2001). 4 U.S. Patent Application Publication 2003/0138947 (filed May 8, 2002) (published July 24, 2003). 5 U.S. Patent Application Publication 2003/0064503 (filed May 9, 2001) (published Apr. 3, 2003). Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 4 withdraw the anticipation and obviousness rejections, we shall consider the cited four publications together, making reference to only the disclosure in the ‘625 patent. We shall refer to the “Primary References” as “Abuljadayel,” who is the sole named inventor of all four related patent publications. ISSUE There are multiple independent claims in this appeal, all of which are directed to a “dedifferentiated, programmable cell of human monocytic origin.” The dedifferentiated cell is recited in the claims to express different combinations of the CD14, CD90, CD123, and CD135 antigens (compare, e.g., claims 1 and 5). According to the ‘275 patent, the term “dedifferentiated” “. . . signifies the regression of an adult, already specialized (differentiated) body cell to the status of a stem cell, i.e., of a cell, which in turn can be transferred (programmed) into a number of cell types.” (‘275 patent, col. 8, ll. 13-16.) Thus, the claimed cell is a “stem cell” which has the ability to be reprogrammed into any body cell (‘275 patent, col. 8, ll. 33-41). The ‘275 patent describes a process in which a human monocyte, a cell isolated from human blood, is dedifferentiated which includes: (a) providing human monocytes; (b) propagating the monocytes in a culture medium, which contains cellular growth factor M- CSF; (c) simultaneously cultivating the monocytes with or subsequently to step (b) in a culture medium comprising IL-3; and (d) obtaining human adult dedifferentiated programmable stem cells by separating from culture medium. (‘275 patent, col. 2, ll. 56-62.) Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 5 The key issue in the rejections is whether the Abuljadayel patent publications describe a “dedifferentiated, programmable cell of human monocytic origin” as claimed. The controversy stems from the fact that the claims require a specific set of antigens to be present on the dedifferentiated cells (e.g., CD14, CD90, CD123, and CD135 antigens), where Abuljadayel does not describe these antigens on its monocytic dedifferentiated cells, but rather describes different antigens. Abuljadayel’s method of dedifferentiating the monocytes is also different from the method used in the ‘275 patent. Thus, the issue is whether there is a reasonable basis to believe that Abuljadayel’s dedifferentiated cells are the same as those which are claimed, despite these differences. LEGAL PRINCIPLES “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). When the limitations of a claim are not expressly described in the prior art, the PTO must show “sound basis for believing” that despite the failure of the prior art to describe them, the limitations are inherently there and “the products of the applicant and the prior art are the same.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). With these guiding principles, we turn to the Abuljadayel disclosure. FINDINGS OF FACT (“FF”) FROM ABULJADAYEL Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 6 [FF1] Abuljadayel describes “a method of preparing an undifferentiated cell from a more committed cell” and the undifferentiated cells produced as a result (‘625 patent, col. 1, ll. 8-10). [FF2] In discussing the concept of retrodifferentiation, Abuljadayel states: “‘While preserving the entire information encoded on its genome, cells undergoing retrodifferentiation lose morphological and functional complexity by virtue of a process of self-deletion of cytoplasmic structures and the transition to a more juvenile pattern of gene expression.’” (‘625, col. 2, ll. 41-46, quoting Jose Uriel (Cancer Research 36, 4269-4275, Nov. 1976.) [FF3] The method for retrodifferentiation described in Abuljadayel comprises “contacting a more committed cell with an agent that causes the more committed cell to retrodifferentiate into an undifferentiated cell.” (‘625 patent, col. 4, ll. 5-9.) [FF4] “In another preferred embodiment, the more committed cell is a differentiated cell, such as . . . a monocyte . . . .” (‘625 patent, col. 6, l. 66 to col. 7, l. 4.) [FF5] Abuljadayel describes an example in which blood cells obtained from patients were treated with various agents to produce undifferentiated cells (‘625 patent, col. 10, ll. 37-61). [FF6] Treated blood cells were tested for the expression of antigens. According to Abuljadayel, the treatments were found to change the antigen expression on the cells, e.g., CD14 and CD34 (‘625 patent, cols. 11-21). [FF7] “The CD34 antigen is present on immature haematopoietic precursor cells and all haematopoietic colony-forming cells in bone marrow, Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 7 including unipotent (CFU-GM, BFU-E) and pluripotent progenitors (CFU- GEMM, CFU-Mix and CFU-blast).” (‘625 patent, col. 19, ll. 31-35.) [FF8] “Normal peripheral blood lymphocytes, monocytes, granulocytes and platelets do not express the CD34 antigen. CD34 antigen density is highest on early haematopoietic progenitor cells and decreases as the cells mature. The antigen is absent on fully differentiated haematopoietic cells.” (‘625 patent, col. 19, ll. 43-48.) ANALYSIS We agree with the Requester that there is sufficient evidence to have provided a reasonable basis to believe that the dedifferentiated monocytic cells described in Abuljadayel are the same as those which are claimed. Abuljadayel describes applying its treatment to monocytes in order to retrodifferentiate the cells (FF4). In addition to this, Abuljadayel applied the treatment to blood cells obtained from patients (FF5), which contain monocytes. Thus, treating the blood sample with a treatment protocol said to produce retrodifferentiation (FF3) would have inherently retrodifferentiated monocytes in the sample to produce an undifferentiated monocytic cell. In both cases, the same cell type as claimed is retrodifferentiated to produce an undifferentiated cell. The undifferentiated cell is taught by Abuljadayel as having a “more juvenile pattern of gene expression.” (FF2.) The ‘275 patent similarly characterizes its dedifferentiation process as causing “regression of an adult, already specialized (differentiated) body cell to the status of a stem cell.” (‘275 patent, col. 8, ll. 13-14). In other words, both Abuljadayel and the Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 8 ‘275 patent “take” an adult differentiated cell of the same cell type and revert it back to an undifferentiated “juvenile” state. In simple terms, if the same cell type is regressed, it stands to reason that the same “juvenile” stem cell would result because the cell is tracing its steps backwards from an adult cell. The Examiner seemed to presume that there were different juvenile states possible for the same adult monocyte, depending upon the treatment protocol utilized to retrodifferentiate the adult cell. As a consequence, even though both Abuljadayel and the ‘275 patent described dedifferentiated monocytes, the Examiner concluded that the dedifferentiated cells were not necessarily the same. The only evidence for different dedifferentiated states is in the ’275 patent with respect to the CD34 antigen status of the cell. CD34 is an antigen which is expressed on certain cells. According to the ‘275 patent: “Less than 3%, preferably less than 1% of the stem cells according to the invention express the CD34 antigen. Most preferably, none of the stem cells of the invention express the CD34 antigen.” (‘275 patent, col. 8, ll. 35-38.) The ’275 patent therefore teaches that its dedifferentiated monocytes can be either CD34 positive or CD34 negative for the CD34 antigen. Claim 1 does not limit the CD34 status of the cell and therefore covers dedifferentiated, programmable cells of human monocytic origin which are CD34 positive and CD34 negative. Dependent claims 15-23 are narrower and limit the dedifferentiated cells to cells which lack CD34. In contrast to the cells of claims 15-23, Abuljadayel teaches that CD34 is present on dedifferentiated cells. Abuljadayel states that the “CD34 Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 9 antigen is present on immature haematopoietic precursor cells.” (‘625 patent, col. 19, ll. 31-32 (FF7).) “Normal . . . monocytes . . . do not express the CD34 antigen. CD34 antigen density is highest on early haematopoietic progenitor cells and decreases as the cells mature. The antigen is absent on fully differentiated haematopoietic cells.” (‘625 patent, col. 19, ll. 43-48 (FF8).) Thus, based on Abuljadayel, the skilled worker would have reasonably expected a dedifferentiated monocyte to be CD34 positive, a juvenile stem cell type which, as discussed above, is covered by claim 1. In sum, there is evidence of two different undifferentiated monocytes: a CD34 positive and a CD34 negative cell type. Each arises from dedifferentiating the same adult cell. While there may be differences in the treatment protocols utilized to dedifferentiate the monocyte, because the treatments have the same purpose and same result in regressing the adult cell back to an earlier, more “juvenile” state (‘275 patent, col. 8, ll. 13-16; ‘625 patent, col. 2, ll. 41-46 (FF2)), it would have been reasonably expected that the same dedifferentiated CD34 positive cell type would be arrived at, regardless of the retrodifferentiation method used. To reiterate, dedifferentiating an adult monocyte cell would be expected to result in the same “juvenile” stem cell because the adult cell is tracing its steps backwards to an earlier juvenile state. As there was reasonable basis to believe that the CD34 positive cell in Abuljadayel is the same CD34 positive cell described in the ‘275 patent, the burden shifted to the Patent Owner to prove that it was not. Spada, 911 F.2d at 708. Patent Owner did not file a brief in this appeal to present countervailing evidence. Consequently, we conclude that this burden was Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 10 not met and we reverse the Examiner’s determination that claims 1-14 are not anticipated nor rendered obvious by the Abuljadayel patent publications alone or combination with the additional prior art cited by the Requester (App. Br. 7-9). In reaching this determination, we recognize that the different sets of antigens were utilized to characterize the cells in Abuljadayel and the ‘275 patent. However, it is well known that cells express many different antigens. For example, a cell identified by two of the six antigens expressed by it is no different from the same cell identified by a different two antigens of the same six antigens. Thus, the fact that different antigens were used to characterize the cells is not sufficient to distinguish the cells from each other. The Examiner also argued that the claimed cells were different than those described in Abuljadayel because the cells in the Abuljadayel patent publications “do not exhibit adherence to a culture vessel,” while those in the ‘275 patent do. (RAN 6.) However, the Examiner did not provide adequate support in the RAN for the conclusion that the adhesion properties of the cells described in Abuljadayel were different. Nor did the Examiner adequately address the Requester’s argument, which was backed by factual evidence, that the adhesion properties represent the growth status of the cells and do not reflect actual differences in the cell types (App. Br. 14-15.) With respect to the Examiner’s arguments about differences in the “starting” cells which were retrodifferentiated (RAN 10-11), as noted by the Requester, Abuljadayel has express disclosure on retrodifferentiating adult Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 11 monocytes (FF4), the same cell population recited in the claims and used in the ‘275 patent. Claims 15-23 are directed to a dedifferentiated, programmable cell of human monocytic origin which “does not express a CD34 antigen.” We interpret these claims to cover cells which lack CD34. As discussed above, Abuljadayel teaches that CD34 is present on its dedifferentiated cells. Thus, with respect to claims 15-24, we conclude that there was not a reasonable basis to believe that Abuljadayel’s CD34 positive cells were the same as the claimed cells which lack CD34. SUMMARY We reverse the Examiner’s conclusion confirming the patentability of claims 1-14 over the cited prior art in the rejections on pages 7-9 of the Requester’s Appeal Brief. We affirm the Examiner’s determination that claims 15-23 are not anticipated by, or obvious in view of, the cited prior art set forth in the rejections listed on pages 7-9 of the Requester’s Appeal Brief. SECTION 112 REJECTIONS The Requester contends that the newly added claims 15-23, each of which recites that the “dedifferentiated, programmable cell of human monocytic origin does not express a CD34 antigen,” fail to meet the enablement and written description requirements of 35 U.S.C. § 112, first paragraph, and lack clarity as required by 35 U.S.C. § 112, second paragraph. Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 12 In the comments filed by Requester under 37 C.F.R. § 1.947 after Patent Owner added claims 15-23 (“Comments”),6 Requester argued that the newly added claims were not enabled (Comments 48), but Requester did not argue that they lacked written description or were indefinite. Such arguments appear not to have been made until the filing of the Appeal Brief. To be appealable, such rejections need to have been listed in in the statement of the non-adopted rejections in the Right of Appeal Notice (35 U.S.C. § 134 and 37 C.F.R. §§ 41.61(a)(2) and (d)). However, none of the § 112 rejections were listed in the RAN. Thus, the proposed written description and indefinite rejections have not been properly presented for our review. As to the enablement issue under § 112 because Requester timely raised this issue in their Comments, we use our discretion to address the same. The Requester contends: the ‘275 patent fails to enable how to prepare a cell product that has "none of the stem cells of the invention express the CD34 antigen". Simply, no product in the '275 patent is reported has [sic – “as”] having "none of the stem cells ... express[ing] the CD34 antigen." And nowhere does the '275 patent teach how to obtain a product that has "none of the stem cells ... express[ing] the CD34 antigen." (App. Br. 28.) This argument is not persuasive. The ‘275 patent expressly discloses that cells can be eliminated on the basis of surface antigen markers (col. 12, ll. 38-43.) The ‘275 discloses “[i]mmuno magnetic bead sorting” as an example of a method to isolate one cell type from another (col. 12, ll. 43- 45). The CD34 antibody used to deplete the dedifferentiated cells of CD34 6 Comments by Third Party Requester to Patent Owner’s Response in Inter Partes Reexamination under 37 C.F.R. § 1.947 (entered Oct. 30, 2009). Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 13 cells was known in the art, as evidenced by Abuljadayel, which discloses monoclonal antibodies to CD34 (‘625 patent, col. 11, l. 6). Requester has not demonstrated that, armed with such tools, it would have required undue experimentation to isolate cells which lack CD34 as claimed. NEW GROUNDS OF REJECTION 37 C.F.R. § 41.77(a) states that “[t]he reversal of the examiner’s determination not to make a rejection proposed by the third party requester constitutes a decision adverse to the patentability of the claims which are subject to that proposed rejection which will be set forth in the decision of the Board of Patent Appeals and Interferences as a new ground of rejection . . . .” As we have reversed the Examiner’s determination that claims 1-14 are patentable over the prior art cited on pages 7-9 of the Requester’s Appeal Brief, we are compelled to enter a new grounds of rejection. 37 C.F.R. § 41.77(b) states: (b) Should the Board reverse the examiner’s determination not to make a rejection proposed by a requester, the Board shall set forth in the opinion in support of its decision a new ground of rejection; or should the Board have knowledge of any grounds not raised in the appeal for rejecting any pending claim, it may include in its opinion a statement to that effect with its reasons for so holding, which statement shall constitute a new ground of rejection of the claim. Any decision which includes a new ground of rejection pursuant to this paragraph shall not be considered final for judicial review. When the Board makes a new ground of rejection, the owner, within one month from the date of the decision, must exercise one of the following two Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 14 options with respect to the new ground of rejection to avoid termination of the appeal proceeding as to the rejected claim: (1) Reopen prosecution. The owner may file a response requesting reopening of prosecution before the examiner. Such a response must be either an amendment of the claims so rejected or new evidence relating to the claims so rejected, or both. (2) Request rehearing. The owner may request that the proceeding be reheard under § 41.79 by the Board upon the same record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Requests for extensions of time in this inter partes reexamination proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79. AFFIRMED-IN-PART; REVERSED-IN-PART; 37 C.F.R. § 41.77(b) KMF Appeal 2011-010757 Application 95/001,158 Patent 7,138,275 15 Patent Owner ARNOLD & PORTER LLP ATTN: IP Docketing Department 555 Twelfth Street, N.W. Washington, DC 20004-1206 Third Party Requester VEDDER PRICE PC 1633 Broadway, 47th Floor New York, NY 10019 Copy with citationCopy as parenthetical citation