Ex Parte Jung et alDownload PDFPatent Trial and Appeal BoardOct 30, 201411541478 (P.T.A.B. Oct. 30, 2014) 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. 11/541,478 09/29/2006 Edward K.Y. Jung SE1-0976-US 9534 80118 7590 10/30/2014 Constellation Law Group, PLLC P.O. Box 580 Tracyton, WA 98393 EXAMINER LIN, JERRY ART UNIT PAPER NUMBER 1631 MAIL DATE DELIVERY MODE 10/30/2014 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 __________ Ex parte EDWARD K. Y. JUNG, ROYCE A. LEVIEN, ROBERT W. LORD, and LOWELL L. WOOD, JR. __________ Appeal 2012-006107 Application 11/541,478 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC B. GRIMES, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. PAULRAJ, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a system, computer program product, and method for providing a medical treatment agent to a particular subpopulation, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part and enter a new rejection based on indefiniteness. 1 According to Appellants, the Real Party in Interest is Searete LLC, which is wholly owned by Intellectual Ventures Management, LLC (App. Br. 5). Appeal 2012-006107 Application 11/541,478 2 STATEMENT OF THE CASE Claims 30–35, 39–42, and 55–64 are on appeal. Independent claims 30 and 58 are illustrative and read as follows: 30. A system comprising: means for accepting an input defining at least one medical condition; means for identifying within one or more sets of study data at least one agent having a defined level of efficacy in treating the at least one medical condition; means for identifying at least one subpopulation having a defined tolerance for at least one adverse event associated with administration of the at least one agent, the at least one subpopulation exhibiting at least some defined level of efficacy upon administration of the at least one agent to the subpopulation, including a suitably programmed microprocessor; and means for presenting the at least one agent responsive to said means for identifying at least one subpopulation. 58. A computer program product comprising: a non-transitory signal-bearing medium bearing (a) one or more instructions for accepting an input defining at least one medical condition; (b) one or more instructions for identifying within one or more sets of study data at least one agent having a defined level of efficacy in treating the at least one medical condition; (c) one or more instructions for identifying at least one subpopulation having a defined tolerance for at least one adverse event associated with administration of the at least one Appeal 2012-006107 Application 11/541,478 3 agent, the at least one subpopulation exhibiting at least some defined level of efficacy upon administration of the at least one agent to the subpopulation; and (d) one or more instructions for presenting the at least one agent in response to said identifying at least one subpopulation. I. The Examiner has rejected claims 30–34, 39, 41, 42, and 55–64 under 35 U.S.C. § 103(a) as obvious based on Mohanlal2 and Filvaroff3 (Ans. 5–7). The Examiner rejected claims 35 and 40 under 35 U.S.C. § 103(a) as obvious based on Mohanlal and Filvaroff, and further in view of Speier4 (id. at 7–8). The Examiner finds that Mohanlal teaches a method that includes accepting an input of a medical condition or treatment goal (i.e., subjects with a particular disease) (column 4, lines 2-6); identifying in a study set one agent with a level of efficacy in treating the medical condition (i.e., identifying agents and their level of efficacy) (column 4, lines 10-12); identifying an [sic] subpopulation with tolerance for the agent and efficacy upon administration of the agent (column 11, lines 19-67; column 12, line 55-column 13, line 45); and presenting the agent (page 13, lines 45-49). (Id. at 5–6). The Examiner acknowledges that “Mohanal [sic] does not explicitly teach using a computer,” but relies upon Filvaroff to make up for this deficiency (id. at 6). The Examiner further relies upon Filvaroff’s 2 Mohanlal, US 7,198,895 B2, issued Apr. 3, 2007. 3 Filvaroff, US 2006/0015952 A1, published Jan. 19, 2006. 4 Speier, US 2007/0288256 A1, published Dec. 13, 2007. Appeal 2012-006107 Application 11/541,478 4 teaching of “studying a cancer condition (paragraphs 0142 and 0158) and identifying at least one anti-cancer drug (paragraph 0223)” (id.) The Examiner concludes that “[i]t would have been obvious to one [of] ordinary skill in the art at the time of the invention to combine the teachings of Mohanlal and Filvaroff to gain the benefit of ensuring that the agents have efficacy” (id. at 7). Appellants argue that the Examiner has not set out a prima facie case of obviousness (App. Br. 40–77). With respect to claims 30–35, 39–42, 55–57, 61, and 62, which are in means-plus-function format, we agree with Appellants that the Examiner has not shown that the claimed invention would have been obvious based on the cited references. Independent Claim 30 is directed to a system having four structural elements: (1) “means for accepting an input defining at least one medical condition;” (2) “means for identifying within one or more sets of study data at least one agent having a defined level of efficacy in treating the at least one medical condition;” (3) “means for identifying at least one subpopulation having a defined tolerance for at least one adverse event associated with administration of the at least one agent, the at least one subpopulation exhibiting at least some defined level of efficacy upon administration of the at least one agent to the subpopulation, including a suitably programmed microprocessor;” and (4) “means for presenting the at least one agent responsive to said means for identifying at least one subpopulation” (Cl. 30). Independent claim 61 recites similar limitations, except it is directed towards addressing a “treatment goal” rather than a Appeal 2012-006107 Application 11/541,478 5 “medical condition” (Cl. 61). Additional means-plus-function limitations are recited in dependent claims 31–35, 39–42, 55, 57, and 62. “Section 112, paragraph 6 provides that a patentee [or applicant] may define the structure for performing a particular function generically through the use of a means expression, provided that it discloses specific structure(s) corresponding to that means in the patent specification.” Kemco Sales, Inc. v. Control Papers Co., Inc., 208 F.3d 1352, 1360 (Fed. Cir. 2000). “A computer-implemented means-plus-function term is limited to the corresponding structure disclosed in the specification and equivalents thereof, and the corresponding structure is the algorithm.” Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1253 (Fed. Cir. 2005). Here, the Examiner has not addressed the scope of the means-plus- function limitations of claims 30 and 61 or their dependent claims based on their description in the Specification. The Examiner’s rejection, in fact, does not address the means-plus-function limitations at all, but is based on the disclosure in Mohanlal of a method of screening chemical entities for their efficacy in treating a disease (Mohanlal, col. 4, ll. 1–12), combined with Filvaroff’s computer-implemented method for screening candidate molecules for the treatment of a tumor (Filvaroff, ¶¶ 117, 142, 158). The Examiner has not explained how the combined teachings of Mohanlal and Filvaroff would have made obvious any structures disclosed in the Specification that correspond to means-plus-function limitations recited in claims 30 and 61 and their dependent claims. The Examiner’s rejection of claims 35 and 40 based on the further teachings of Speier suffers from the same deficiency. “In proceedings before the Patent and Trademark Appeal 2012-006107 Application 11/541,478 6 Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). That burden has not been carried with respect to claims 30–35, 39–42, 55–57, 61, and 62. We are therefore constrained to reverse the rejection of those claims. Claims 58–60, 63, and 64 are not written in means-plus-function format. Appellants only argue that these claims are not obvious for the same reasons they presented for independent claim 30, and do not otherwise separately argue the limitations recited in these claims. We choose claim 58 to be representative for this grouping of claims. 37 C.F.R. § 41.37(c)(1)(vii). Claim 58 is directed to a computer program product bearing instructions for (a) accepting an input defining at least one medical condition; (b) identifying within one or more sets of study data at least one agent having a defined level of efficacy in treating the at least one medical condition; (c) identifying at least one subpopulation having a defined tolerance for at least one adverse event associated with administration of the at least one agent, the at least one subpopulation exhibiting at least some defined level of efficacy upon administration of the at least one agent to the subpopulation; and (d) presenting the at least one agent in response to said identifying at least one subpopulation. We agree with the Examiner that the combined teachings of Mohanlal and Filvaroff would have rendered obvious a computer program product meeting the limitations of claim 58. Mohanlal discloses a method of screening chemical entities for their efficacy in treating a disease by performing gene expression analysis on Appeal 2012-006107 Application 11/541,478 7 peripheral blood mononuclear cells (“PBMCs”) of subjects diagnosed with a particular disease who have been treated with known chemical entities (Mohanlal, col. 4, ll. 1–6). These expression analysis results are used to create “cellular response profiles” that “can then be used as markers for other chemical entities to predict their efficacy and/or adverse event profile in treating the disease” (id. at col. 4, ll. 6–12). “[T]he clinical indication may pertain to efficacy, adverse effect, or safety of the chemical entity” (id. at col. 4, ll. 13–14). We find that this teaching satisfies the claim requirements for “accepting an input defining at least one medical condition” and “identifying within one or more sets of study data at least one agent having a defined level of efficacy in treating the at least one medical condition.” Mohanlal further describes a process by which subjects treated with a drug (drug A) are classified either as “in vivo responders” or “non- responders,” and whereby “[i]n the group of the clinical in vivo responders to drug A, profiles of in vitro gene expression that all or the majority individual responders have in common are identified, along with which profiles are not or hardly present in the non-responders to drug A” (id. at col. 11, ll. 19–30). “This common in vitro cellular response gene expression profile therefore has a high predictive value for in vivo subject response to drug A (predictive expression profile A)” (id. at col. 11, ll. 30–33). The gene expression profile can be used for predicting both the drug’s efficacy and adverse effects associated with the drug in patients (id. at col. 11, ll. 36–67). We find that this teaching satisfies the claim requirements for “identifying at least one subpopulation having a defined tolerance for at least one adverse event associated with administration of the at least one agent, the at least one Appeal 2012-006107 Application 11/541,478 8 subpopulation exhibiting at least some defined level of efficacy upon administration of the at least one agent to the subpopulation” and “presenting the at least one agent in response to said identifying at least one subpopulation.” We also agree with the Examiner’s rationale that “one of ordinary skill in the art seeking to ensure that that drugs taught by Filvaroff also have efficacy would have been motivated to incorporate the teachings of Mohanlal with Filvaroff” (Ans. 7). Furthermore, to the extent that Mohanlal does not explicitly disclose the use of a computer for the screening method, we find that the implementation of that method on a computer would have been obvious to a skilled artisan. See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed. Cir. 2007) (“Applying modern electronics to older mechanical devices has been commonplace in recent years.”). Appellants argue5 that the “PTO has put forth no evidence supporting its characterization that Mohanlal ‘teaches’ recitations of independent claim 30” (App. Br. 45 (capitalization omitted)). According to Appellants, “insofar as Mohanlal does not recite the text of . . . Independent Claim 30, . . . the PTO-cited technical material does not a establish a prima facie case of the unpatentability of Independent Claim 30” (id. at 50). Appellants make a similar argument with respect to Filvaroff (id. at 52–57). 5 Appellants’ argument with respect to claim 58 is that it “contain[s] similar recitations as Independent Claim 30, and is not obvious in view of Filvaroff for at least the same reasons” (App. Br. 76). We therefore take the arguments presented with respect to claim 30 to be applicable to the other independent claims. Appeal 2012-006107 Application 11/541,478 9 These arguments are unpersuasive. “[A]ll that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of § 132.” In re Jung, 637 F.3d 1356, 1363 (Fed. Cir. 2011). Section 132, in turn, requires notice to the applicant sufficient to inform him of the reasons for rejection, “together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application.” 35 U.S.C. § 132. Here, the Examiner notified Appellants that the claims were being rejected as unpatentable under 35 U.S.C. § 103(a) and cited specific passages in Mohanlal and Filvaroff, by paragraph or column and line that were the basis for the conclusion of obviousness (Ans. 5–7). The Examiner’s rejection satisfies the notice requirement of § 132, and therefore meets the burden of establishing a prima facie case of unpatentability. Cf. Jung, 637 F.3d at 1363 (“[T]he examiner’s discussion of the theory of invalidity . . . , the prior art basis for the rejection . . . , and the identification of where each limitation of the rejected claims is shown in the prior art reference by specific column and line number was more than sufficient to meet this burden.”). Appellants also argue that “the USPTO assertions regarding a teaching to modify/combine to meet the recitations of independent Claim 30 are based on ‘mere conclusory statements’ without evidentiary support” (App. Br. 59–60 (capitalization omitted), citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). Appeal 2012-006107 Application 11/541,478 10 This argument is unpersuasive because the Examiner provided a reasoned basis for the conclusion of obviousness (Ans. 7 (“Mohanlal teaches that his method ensures offers the ability to determine if drugs have efficacy”)). The Examiner’s conclusion is supported by the evidence (see id., citing Mohanlal, col. 1, ll. 24–45 and col. 18, ll. 15–35). Appellants also argue that combining Mohanlal and Filvaroff in the manner proposed by the Examiner would change Mohanlal’s principle of operation (App. Br. 60–64) and “render Mohanlal unsatisfactory for its intended purpose” (id. at 64–68). These arguments are also unpersuasive. Appellants have not persuasively shown that combining Mohanlal’s screening methods with Filvaroff’s screening assays would change either Mohanlal’s or Filvaroff’s principle of operation or render it unsatisfactory for its intended purpose. Appellants do not explain why “Filvaroff would no longer have screening of candidate molecules for the treatment of tumor metastasis, and treatment methods using such molecules” when combined with the screening method taught by Mohanlal (id. at 62). Nor do Appellants explain why the intended purpose of such a screening method would be rendered unsatisfactory by the combination (id. at 67). Finally, Appellants argue that “[w]hether or not the Patent Office has met its burden in establishing a prima facie case of unpatentability is a question of law, not fact” (Reply Br. 7). Appellants argue that “[s]ince the resolution of this question controls whether or not Appellant must produce evidence in rebuttal of the prima facie case, Appellant asserts that it would be premature/improper for the Board to decide this appeal on the issue of the Appeal 2012-006107 Application 11/541,478 11 Patent Office fact finding” (id. at 7–8). Appellants request that, for those claims where we conclude that the Examiner has made out a prima facie case, “the Board should remand with instructions to the Patent Office to reopen prosecution for the purpose of receiving evidence/argument in rebuttal of the prima facie case” (id. at 8). The Court of Appeals for the Federal Circuit has specifically rejected this argument. See In re Jung, 637 F.3d at 1363: Jung, without any basis, would have this court impose additional prima facie procedural requirements and give applicants the right first to procedurally challenge and appeal the prima facie procedural showing before having to substantively respond to the merits of the rejection. Such a process is both manifestly inefficient and entirely unnecessary. Appellants have had the opportunity to provide “evidence/argument in rebuttal of the prima facie case” (Reply Br. 8) throughout the prosecution of this Application. That they have chosen not to do so reflects their choice of prosecution strategy and does not merit a remand of this application to the Examiner. In summary, the Examiner has made a prima facie case that claim 58 would have been obvious to a person of ordinary skill in the art, and Appellants have not provided persuasive evidence or reasoning to support a contrary conclusion. Appellants acknowledge that claims 59, 60, 63, and 64 recite similar limitations (App. Br. 76), and we therefore also affirm the rejection of those claims as obvious based on Mohanlal and Filvaroff for the same reasons. Appeal 2012-006107 Application 11/541,478 12 II. Under the provisions of 37 C.F.R. § 41.50(b), we enter the following new ground of rejection: Claims 30–35, 39–42, 55–57, 61, and 62 are rejected under 35 U.S.C. § 112, second paragraph, as indefinite because the Specification does not disclose structures that correspond to each of the “means-plus-function” limitations recited in those claims. “Use of the term ‘means’ in a claim limitation creates a presumption that section 112, paragraph 6 has been invoked, but that presumption may be rebutted if the properly construed claim limitation itself recites sufficiently definite structure to perform the claimed function.” Kemco Sales, 208 F.3d at 1361. In this case, claims 30–35, 39–42, 55–57, 61, and 62 each use the term “means” but recite no particular structures to perform the claimed functions. At most, claims 30 and 61 recite that the “means for identifying at least one subpopulation” includes “a suitably programmed microprocessor” (Cls. 30, 61). However, “[f]or a patentee to claim a means for performing a particular function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming.” Aristocrat Techs. Austl. Pty Ltd. v. Int'l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir. 2008). We therefore conclude that the claims invoke 35 U.S.C. § 112, sixth paragraph. Section 112, paragraph 6 provides that a patentee [or applicant] may define the structure for performing a particular function generically through the use of a means expression, provided that it discloses specific structure(s) corresponding to that means in the patent specification. . . . As such, [the court has] referred to section 112, paragraph 6 as embodying a Appeal 2012-006107 Application 11/541,478 13 statutory quid pro quo. . . . If a patentee [or applicant] fails to satisfy the bargain because of a failure to disclose adequate structure, the claim will be rendered . . . indefinite under section 112, paragraph 2. Kemco Sales, 208 F.3d at 1360–61. The rules that “structure corresponding to the claimed function must be disclosed in the specification with clear linkage between the structure and the claimed function serve worthy goals. Such rules are intended to produce certainty in result.” Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1220 (Fed. Cir. 2003). “A computer-implemented means-plus-function term is limited to the corresponding structure disclosed in the specification and equivalents thereof, and the corresponding structure is the algorithm.” Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1253 (Fed. Cir. 2005). An Appeal Brief must include a summary of the claimed subject matter, and [f]or each independent claim involved in the appeal . . . every means plus function and step plus function as permitted by 35 U.S.C. 112, sixth paragraph, must be identified and the structure, material, or acts described in the specification as corresponding to each claimed function must be set forth with reference to the specification by page and line number, and to the drawing, if any, by reference characters. 37 C.F.R. § 41.37(c)(1)(v) (2004). In the Summary of Claimed Subject Matter section of the Appeal Brief, Appellants stated that all four of the “means” recited in claim 30 are described at “page 66, ll. 1-14 of specification (Independent Claim 30); and/or para [0003] of specification” (Appeal Br. 8). Similarly, Appellants point to “page 77, ll. 1-14 of specification (Independent Claim 61); and/or Appeal 2012-006107 Application 11/541,478 14 para. [00200] of specification; and/or FIG 19” as support for claim 61 (id. at 13). Original claims 30 and 61 do not include any recitation of structures for carrying out particular functions recited in those claims. Likewise, Paragraphs 3 and 200 and Figure 19 of the Specification do not describe any particular structures or algorithms that correspond to the means-plus- function limitations of claims 30 and 61 or their dependent claims. Thus, Appellants have not identified any description in the Specification of structures corresponding to the means-plus-function limitations of claims 30–35, 39–42, 55–57, 61, and 62. Our review of the Specification failed to reveal any other structures corresponding to those functional limitations. Claims 30–35, 39–42, 55–57, 61, and 62 are therefore unpatentable under 35 U.S.C. § 112, second paragraph, because they are indefinite. SUMMARY We reverse the rejection of claims 30–34, 39, 41, 42, 55–57, 61, and 62 under 35 U.S.C. § 103(a) based on Mohanlal and Filvaroff, but we affirm the same rejection with respect to claims 58–60, 63, and 64. We reverse the rejection of 35 and 40 under 35 U.S.C. § 103(a) as based on Mohanlal and Filvaroff, and further in view of Speier. We enter a new ground of rejection of claims 30–35, 39–42, 55–57, 61, and 62 for indefiniteness under 35 U.S.C. § 112, second paragraph. TIME PERIOD FOR RESPONSE Regarding the affirmed rejection, 37 C.F.R. § 41.52(a)(1) provides that “Appellant may file a single request for rehearing within two months Appeal 2012-006107 Application 11/541,478 15 from the date of the original decision of the Board.” In addition to affirming the Examiner’s rejection of one or more claims, this decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 C.F.R. § 41.50(b) provides: “A new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the Examiner, in which event the proceeding will be remanded to the Examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. . . . Should the Appellants elect to prosecute further before the Examiner pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection, the effective date of the affirmance is deferred until conclusion of the prosecution before the Examiner unless, as a mere incident to the limited prosecution, the affirmed rejection is overcome. If the Appellants elect prosecution before the Examiner and this does not result in allowance of the application, abandonment, or a second appeal, this case should be returned to the Patent Trial and Appeal Board for final Appeal 2012-006107 Application 11/541,478 16 action on the affirmed rejection, including any timely request for rehearing thereof. AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b) bar Copy with citationCopy as parenthetical citation