Ex Parte Jung et alDownload PDFPatent Trial and Appeal BoardOct 15, 201411586349 (P.T.A.B. Oct. 15, 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. 11/586,349 10/24/2006 Edward K.Y. Jung SE1-1038-US 8195 80118 7590 10/15/2014 Constellation Law Group, PLLC P.O. Box 580 Tracyton, WA 98393 EXAMINER CLOW, LORI A ART UNIT PAPER NUMBER 1631 MAIL DATE DELIVERY MODE 10/15/2014 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. JUN, ROYCE A. LEVIEN, ROBERT W. LORD, MARK A. MALMUD, JOHN D. RINALDO, JR. and LOWELL L. WOOD, JR.1 __________ Appeal 2012-003837 Application 11/586,349 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC B. GRIMES, and LORA M. GREEN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a system for providing a treatment option based on a treatment parameter, 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 2012-003837 Application11/586,349 2 STATEMENT OF THE CASE Claims 1–36, 48, and 49 are on appeal. Claims 1 and 48 are illustrative and read as follows: 1. A system comprising: means for receiving a request for a treatment option, the request associated with at least one symptomatic query parameter, the symptomatic query parameter including at least one consequence of treatment on an end target; means for determining at least one treatment parameter, based on the request, the at least one treatment parameter including at least one target-related tissue ancestry-correlated binding site and/or at least one target-related tissue ancestry-correlated binding agent; and means for providing the treatment option, based on the at least one treatment parameter and the at least one symptomatic query parameter. 48. A computer program product comprising: a non-transitory signal-bearing medium bearing (a) one or more instructions for receiving a request for a treatment option, the request associated with at least one symptomatic query parameter, the symptomatic query parameter including at least one consequence of treatment on an end target; (b) one or more instructions for determining at least one treatment parameter by accessing treatment data, based on the request, the at least one treatment parameter including at least one target- related tissue ancestry-correlated binding site and/or at least one target-related tissue ancestry-correlated binding agent; and (c) one or more instructions for providing the treatment option, based on the at least one treatment parameter and the at least one symptomatic query parameter. Appeal 2012-003837 Application11/586,349 3 I. The Examiner has rejected claims 1–36, 48, and 49 under 35 U.S.C. § 103(a) as obvious based on Oh2 and McIlroy3 (Ans. 5–6). The Examiner finds that Oh discloses tissue-specific therapy and symptomatic parameters, as well as a target-related tissue ancestry-correlated binding site and a target- related tissue ancestry-correlated binding agent (id. at 6), but does not teach “a system that includes providing a treatment option wherein queries are generated and treatments are given” (id. at 7). The Examiner finds that McIlroy teaches such a system and concludes that it would have been obvious to have used the healthcare management system for treatment assessment as taught by McIlroy et al. with the treatment parameters and agents and binding sites elucidated by Oh et al. One would have been motivated to do so because McIlroy et al. specifically teach that the system is a flexible one [ ] which [is] adaptable to a myriad of treatment methods. (Id.) Appellants argue that the Examiner has not set out a prima facie case of obviousness (App. Br. 31–51). With respect to claims 1 and dependent claims 2–36, 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. Claim 1 is directed to a system having three structural elements: (1) “means for receiving a request for a treatment option,” (2) 2 Oh et al., Subtractive proteomic mapping of the endothelial surface in lung and solid tumours for tissue-specific therapy, 429 NATURE 629-635 (2004). 3 McIlroy et al., U.S. Patent 5,953,704, issued Sept. 14, 1999. Appeal 2012-003837 Application11/586,349 4 “means for determining at least one treatment parameter,” and (3) “means for providing the treatment option.” “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., 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 claim 1 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 Oh of a method that uses tissue-specific endothelial cell surface proteins for targeting a treatment agent to a specific organ or tissue (Ans. 6), combined with McIlroy’s healthcare management system (id. at 7). The Examiner has not explained how Oh’s steps, even combined with McIlroy’s healthcare management system, would have made obvious the structures disclosed in the Specification as corresponding to the “means for receiving a request,” “means for determining at least one treatment parameter,” and “means for providing the treatment option” that are required by claim 1, and claims dependent on it. “In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a Appeal 2012-003837 Application11/586,349 5 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 1–36. We are therefore constrained to reverse the rejection of those claims. Claims 48 and 49 are not written in means-plus-function format. Claim 49 will stand or fall with claim 48 because it was not argued separately. 37 C.F.R. § 41.37(c)(1)(vii). Claim 48 is directed to a computer program product bearing instructions for (a) receiving a request for a treatment option, where the request is associated with a consequence of treatment on an end target; (b) determine a target-related tissue ancestry- correlated binding site or a target-related tissue ancestry-correlated binding agent based on the request; and (c) provide the treatment option. We agree with the Examiner that the combined teachings of Oh and Arnaud would have rendered obvious a computer program product meeting the limitations of claim 48. The Examiner found that Oh discloses target- related tissue ancestry-correlated binding sites and agents (i.e., tissue-specific proteins such as APP and monoclonal antibodies that bind to it) (Ans. 6), as well as using them “for targeting single organs or solid tumors, thus teaching a consequence of a treatment parameter (treatment of the target)” (id. at 6-7). The Examiner found that McIlroy discloses a healthcare management system in which queries can be made and treatment options are identified (id. at 7). The Examiner concludes that it would have been obvious to use McIlroy’s healthcare management system with the treatment sites and agents taught by Oh because McIlroy teaches that its system if adaptable to different treatment Appeal 2012-003837 Application11/586,349 6 methods and its system could easily be adapted to work with databases of different information (id.). We agree with the Examiner’s fact-finding and conclusion. Oh discloses tissue-specific proteins (e.g., APP; Oh 631, bridging paragraph) and tumor-specific proteins (e.g., annexin-A1; id. at 629, abstract), and a database containing such proteins (id. at 634, left col.). Oh also discloses radiolabeled antibodies that specifically target these proteins (id. at 629, abstract; 631, right col.) and states that it expects that such targeting “will benefit both drug and gene delivery in the treatment of many diseases” (id. at 634, right col.). McIlroy discloses “a health care management data processing system” (McIlroy 2:56–57). McIlroy’s system includes application software that permits a user to exchange information with the system (id. at 4:57–60) and a set of diagnosis-based guidelines associated with different health care conditions (id. at 4:62–66). McIlroy’s system includes a treatment component that presents treatment options and highlights option(s) based on user input (id. at 5:58–60). McIlroy states that “[b]ecause [its] invention implements the guidelines as data base parameters, the system is flexible; it can be readily adapted to changes in and evolution of health care professional knowledge and treatment methods” (id. at 10:4–7). We agree with the Examiner that, based on these teachings, it would have been obvious to modify Oh’s system to include instructions that direct a computing device to receive a request for a treatment option, the request including a consequence of treatment on an end target (e.g., causing the death of lung tumor cells); to determine based on the request a target-related tissue ancestry-correlated binding site or a target-related tissue ancestry- Appeal 2012-003837 Application11/586,349 7 correlated binding agent (e.g., a tumor antigen expressed by the specified tumor, or a monoclonal antibody that binds to it); and to provide the determined treatment option (e.g., treatment with a radiolabeled antibody that binds to a relevant tumor antigen). Oh provides a reason to combine its disclosure of tissue- or tumor-specific proteins and antibodies that bind to them with McIlroy’s system for identifying treatment options because Oh teaches that tissue- or tumor-specific targeting “will benefit both drug and gene delivery in the treatment of many diseases” (id. at 634, right col.). Appellants argue4 that “the PTO has overlooked several express recitations of Independent Claim 1” and the Examiner “has not provided any objectively verifiable evidence” to show that the references teach what is recited in claim 1 (App. Br. 31). Appellants conclude that “the USPTO- identified portions of Oh do not recite the text of . . . Independent Claim 1” (id. at 41). According to Appellants, “insofar as that Oh does not recite the text of . . . Independent Claim 1, . . . the USPTO-cited technical material does not a establish a prima facie case of the unpatentability of Independent Claim 1” (id. at 42). Appellants make a similar argument with respect to McIlroy (id. at 44–51). 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 4 Appellants’ argument with respect to claim 48 is that it “contain[s] similar recitations as Independent Claim 1, and is not obvious in view of Oh and McIlroy for at least the same reasons” (App. Br. 61). Appeal 2012-003837 Application11/586,349 8 § 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) (Ans. 5–6) and cited specific passages in Oh and McIlroy, by page and column or column and line, that were the basis for the conclusion of obviousness (id. at 6–7). 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 has attempted to support the present rejection based on a ‘mere conclusory statement[ ]’” (App. Br. 54, quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). This argument is unpersuasive because the Examiner provided a reasoned basis for the conclusion of obviousness (Ans. 6 (Oh teaches cell surface proteins that can act as targets for targeting specific organs or tumors) and 7 (it would have been obvious to combine McIlroy’s system with Oh’s binding agents/targets based on McIlroy’s teaching that its system is adaptable to different treatment methods). The Examiner’s conclusion is Appeal 2012-003837 Application11/586,349 9 supported by the evidence (see Oh 634, right col. (“We expect that site- directed vascular and caveolar targeting will benefit both drug and gene delivery in the treatment of many diseases.”)). Appellants also argue that combining Oh and McIlroy as proposed by the Examiner would change Oh’s principle of operation (App. Br. 55–58) and “the suggested modifications/combinations would render the technologies of Oh and/or McIlroy unsatisfactory for their intended purposes” (id. at 61). These arguments are also unpersuasive. Appellants have not persuasively shown that combining Oh’s database with McIlroy’s health care management system would change Oh’s principle of operation or render it unsatisfactory for its intended purpose. The fact that the system made obvious by the cited references would include tissue-specific or tumor- specific proteins and antibodies that bind to them does not show any incompatibility between the teachings of Oh and McIlroy. Finally, Appellants argue that “[w]hether or not the Patent Office has carried 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 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 Appeal 2012-003837 Application11/586,349 10 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 48 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. We therefore affirm the rejection of claim 48 as obvious based on Oh and McIlroy. Claim 49 falls with claim 48. 37 C.F.R. § 41.37(c)(1)(vii). II. Under the provisions of 37 C.F.R. § 41.50(b), we enter the following new ground of rejection: Claims 1–36 are rejected under 35 U.S.C. § 112, second paragraph, as indefinite because the Specification does not disclose structures that correspond to the “means for receiving a request for a treatment option,” “means for determining at least one treatment parameter,” Appeal 2012-003837 Application11/586,349 11 and “means for providing the treatment option” that are recited in independent claim 1 in a way that allows a person of ordinary skill in the art to ascertain the scope of the 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, Inc. v. Control Papers Co., 208 F.3d 1352, 1361 (Fed. Cir. 2000). In this case, claim 1 uses the term “means” and recite no structures to perform the claimed functions. 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 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. Id. 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.” Medical Instrumentation and 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 Appeal 2012-003837 Application11/586,349 12 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 three of the “means” recited in claim 1 are described at “page 60, ll. 3-11 of specification (Independent Claim 1); and/or para [0003] of specification” (Appeal Br. 8). Original claim 1 is directed to a method, not a system, and does not include any recitation of structure for carrying out the method defined in that claim. Original claim 1 therefore does not disclose structures corresponding to the “means” recited in claim 1 on appeal. Paragraph 3 of the Specification describes a computer program product that includes a signal-bearing medium bearing instructions for carrying out the functions recited in claim 1 (Spec. 4, ¶ 3). It does not, however, describe any structures, such as algorithms, that correspond to the means-plus-function limitations of claim 1. Thus, Appellants have not identified any description in the Specification of structures corresponding to the means-plus-function limitations of claim 1. Our review of the Specification for a disclosure of Appeal 2012-003837 Application11/586,349 13 such structures included word searches for the phrase “means for” and the word “means.” The search for the phrase “means for” in the Specification did not identify any use of that phrase. The search for the word “means” identified only a single use, in an unrelated context.5 In summary, the Specification does not disclose any structures that correspond to the means-plus-function limitations of claim 1. Claims 2–36 depend from claim 1. Claims 1–36 are therefore unpatentable under 35 U.S.C. § 112, second paragraph, because they are indefinite. SUMMARY We reverse the rejection of claims 1–36 under 35 U.S.C. § 103(a) based on Oh and McIlroy, but we affirm the same rejection with respect to claims 48 and 49. We enter a new ground of rejection of claims 1–36 for indefiniteness under 35 U.S.C. § 112, second paragraph. TIME PERIOD FOR RESPONSE Regarding the affirmed rejection(s), 37 CFR § 41.52(a)(1) provides that “Appellant may file a single request for rehearing within two months from the date of the original decision of the Board.” In addition to affirming the Examiner’s rejection(s) of one or more claims, this decision contains a new ground of rejection pursuant to 37 CFR § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 5 The word “means” appears only in a sentence reading, in part: “the bare recitation of ‘two recitations,’ without other modifiers, typically means at least two recitations” (Spec. 59, ¶ 185). Appeal 2012-003837 Application11/586,349 14 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR § 41.50(b) provides: “A new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 CFR § 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 CFR § 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 Appellant elects 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 action on the affirmed rejection, including any timely request for rehearing thereof. AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b) lp Copy with citationCopy as parenthetical citation