Ex Parte Jung et alDownload PDFPatent Trial and Appeal BoardJul 30, 201411471289 (P.T.A.B. Jul. 30, 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. 11/471,289 06/19/2006 Edward K.Y. Jung SE1-0969-US 1811 80118 7590 07/30/2014 Constellation Law Group, PLLC P.O. Box 580 Tracyton, WA 98393 EXAMINER CLOW, LORI A ART UNIT PAPER NUMBER 1631 MAIL DATE DELIVERY MODE 07/30/2014 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, ROBERT W. LORD, and LOWELL L. WOOD, JR.1 __________ Appeal 2012-004205 Application 11/471,289 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 relating to a treatment system, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part and enter a new ground of rejection. 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 2012-004205 Application 11/471,289 2 STATEMENT OF THE CASE The Specification states that “[c]ertain properties of the endothelial layer . . . may enable the targeted delivery of one or more treatment agents to a vicinity of the diseased tissue” (Spec. 8, ¶ 40). For example, the diseased tissue 114 may include a tumor that has grown over a period of time. During that period of time, a corresponding growth or development of a site on the endothelial layer 118 may reflect, or otherwise be correlated with and/or affected by, the growth of the diseased tissue (tumor) 114. This correlation between the history or ancestry of the site on the endothelial layer 118 in the vicinity of the diseased tissue 114 may result in unique, or almost unique, properties of the tissue ancestry-correlated site, such as, for example, a display of specific and identifiable proteins. (Id. at 8, ¶ 41.) “[S]uch tissue ancestry-correlated sites may be used to direct treatment agents” (id. at 8, ¶ 42). The Specification’s Figure 5 shows an example of treatment data, including “Treatment Parameter Direct End Target” and “Target-Related Tissue Ancestry-Correlated Binding Site” (Spec. 21-22, ¶ 86; Fig. 5). The figure shows, for example, that the direct end target “Diseased Lung Tissue” is associated with the target-related tissue ancestry-correlated binding site of “15 differentially expressed proteins associated with Endothelial Tissue” (id. at Fig. 5, row 506). Claims 1, 2, 4-9, 11, 12, 14, 15, 18, 19, 22-25, 27-32, 34-36, 50, 51, 53-57, and 59-62 are on appeal. Claims 1 and 62 are illustrative and read as follows: 1. A treatment system comprising: means for defining an association between at least two instances of at least one treatment parameter and at least one instance of at least one treatment characteristic, Appeal 2012-004205 Application 11/471,289 3 the at least one treatment parameter including at least one target- related tissue ancestry-correlated binding site, and the at least one treatment characteristic including at least one target- related tissue ancestry-correlated binding agent, at least one direct end target, at least one discriminated end target, at least one direct intermediate target, at least one discriminated intermediate target, at least one treatment agent delivery mechanism relative to the at least one target-related tissue ancestry-correlated binding agent, at least one treatment agent, or at least one treatment agent precursor; and means for assigning the association to at least one memory including an object-oriented database. 62. A computer program product comprising: a non-transitory signal-bearing medium bearing at least one of ( a) one or more instructions for defining an association between at least two instances of at least one treatment parameter and at least one instance of at least one treatment characteristic, the at least one treatment parameter including at least one target- related tissue ancestry-correlated binding agent, and the at least one treatment characteristic including at least one target- related tissue ancestry-correlated binding site, at least one direct end target, at least one discriminated end target, at least one direct intermediate target, at least one discriminated intermediate target, at least one treatment agent delivery mechanism relative to the at least one target-related tissue ancestry- correlated binding agent, at least one treatment agent, or at least one treatment agent precursor, and (b) one or more instructions for assigning the association to at least one memory including an object-oriented database. DISCUSSION Issue The Examiner has rejected claims 1, 2, 4, 5, 7-9, 11, 12, 14, 15, 18, 19, 22-25, 27-29, 31, 32, 34-36, 50, 51, 53-57, and 60-62 under 35 U.S.C. Appeal 2012-004205 Application 11/471,289 4 § 103(a) as obvious based on Oh2 and Arnaud3 (Ans. 5-6). The Examiner has rejected claims 1, 6, 30, 50, and 59 under 35 U.S.C. § 103(a) as obvious based on Oh, Arnaud, and Hood4 (Ans. 23). The same issue is dispositive for both rejections. The Examiner finds that Oh teaches “defining an association between at least two instances of a treatment parameter and at least one instance of a treatment characteristic and assigning the association to a memory” (Ans. 6). More specifically, the Examiner finds that Oh teaches “target related tissue ancestry binding sites [including] aminopeptidase P (APP) and OX-45” (id.), as well as “target related binding agents, such as APP and OX-45 monoclonal antibodies” (id.). The Examiner also finds that Oh teaches the use of relational database management systems (id.). The Examiner finds that “the use of monoclonal antibodies to target aminopeptidase and OX-45 are two targets and target-related binding agents. These are parameters a clinician can assess for the treatment of epithelial cells.” (Id. at 7.) The Examiner finds that Oh does not teach a computer program product or a system but that Arnaud teaches “a program and system for building a medical database which uses data tags (also known as attributes) and metadata which are various characteristics of the particular datapoints” (id. at 22). The Examiner concludes that it would have been obvious to 2 Oh, et al., Substractive proteomic mapping of the endothelial surface in lung and solid tumours for tissue-specific therapy, 429 NATURE 629-635 (2004). 3 Arnaud et al., US 2002/0186818 A1, patented Dec. 12, 2002 4 Hood et al., Tumor Regression by Targeted Gene Delivery to the Neovasculature, 296 SCIENCE 2402-2407 (2002). Appeal 2012-004205 Application 11/471,289 5 “automate[ ] the methods of Oh et al. by using the formats as taught by Arnaud et al. to further optimize defining associations amongst tissue- ancestry correlated binding sites and agents for the purpose of targeted cancer therapies” (id.). Appellants contend that the Examiner has not presented a prima facie case of obviousness (App. Br. 35-41). We agree with Appellants that the Examiner has not shown that the inventions defined by claims 1 and 50 would have been obvious based on the cited references. Claim 1 is directed to a system having two structural elements: (1) “means for defining an association” between a treatment parameter that includes a target-related tissue ancestry-correlated binding site and a treatment characteristic such as a target-related tissue ancestry- correlated binding agent, and (2) “means for assigning the association to at least one memory.” Claim 50 is similar but requires means for defining an association between a treatment parameter that includes a target-related tissue ancestry-correlated binding agent (rather than site) and a treatment characteristic such as a target-related tissue ancestry-correlated binding site (rather than agent), together with a means for assigning the association to memory. “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 Appeal 2012-004205 Application 11/471,289 6 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 1 and 50 based on the description of them in the Specification. The Examiner’s rejections, in fact, do not address the means-plus-function limitations at all, but are based on the disclosure in Oh of a method that defines an association between treatment parameters and a treatment characteristic, and assigns the association to memory (see Ans. 6-7, 23), combined with Arnaud’s database system and method (id. at 22) and Hood’s integrin avB3-targeting ligand (id. at 24). The Examiner has not explained how Oh’s steps, even combined with Arnaud’s system and Hood’s ligand, would have made obvious the structures disclosed in the Specification as corresponding to the “means for defining” and “means for assigning” required by claims 1 and 50, and claims dependent on them. “In proceedings before the Patent and Trademark 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 here. We are therefore constrained to reverse the rejections of 1, 2, 4-9, 11, 12, 14, 15, 18, 19, 22-25, 27-32, 34- 36, 50, 51, 53-57, and 59-61 based on 35 U.S.C. § 103(a). Claim 62 is not written in means-plus-function language, but is directed to a computer program product having at least one of (a) “instructions for defining an association between at least two instances of at least one treatment parameter and at least one instance of at least one Appeal 2012-004205 Application 11/471,289 7 treatment characteristic,” where the treatment parameter includes a target- related tissue ancestry-correlated binding agent and the treatment characteristic can be a target-related tissue ancestry-correlated binding site, and (b) instructions for assigning the association to a memory that includes an object-oriented database. We interpret the “at least one of” language of claim 62 to require only one of the recited instructions, not both. The Examiner again cited Oh’s teaching of “defining an association” between treatment parameters and a treatment characteristic (Ans. 21) and Arnaud’s teaching of “a program . . . for building a medical database which uses data tags (also known as attributes) and metadata which are various characteristics of the particular datapoints” (id. at 22). The Examiner concludes that the combined teachings would have made it obvious to automate Oh’s methods “by using the formats as taught by Arnaud et al. to further optimize defining associations amongst tissue-ancestry correlated binding sites and agents for the purpose of targeted cancer therapies” (id.). 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 62. Oh teaches that the protein aminopeptidase P (APP) was detected in endothelial tissue from the lung but not from other tissues (Oh 631, bridging paragraph). Oh teaches that antibodies to APP rapidly and specifically targeted lung tissue (id. at 632, right col.). As the Examiner has pointed out (Ans. 26), Appellants’ Specification admits that the lung tissue described by Oh is a “direct end target” (Spec. 23, ¶ 91), the APP protein described by Oh is a “target-related tissue ancestry-correlated binding site” (id.), and the anti- Appeal 2012-004205 Application 11/471,289 8 APP antibody is a “target-related tissue ancestry-correlated binding agent” (id.). Thus, Oh teaches defining an association between a treatment parameter that is a target-related tissue ancestry-correlated binding agent (anti-APP antibody) and the treatment characteristics of a target-related tissue ancestry-correlated binding site (APP) and a direct end target (lung tissue), as those terms are defined in claim 62. Oh also describes “the creation of a database of vascular endothelial cell surface proteins containing accessible proteins apparently modulated by the tissue” (Oh 634, left col.). Oh does not describe a computer program having instructions for defining an association between target-related tissue ancestry-correlated binding agents (e.g., antibodies that bind to proteins expressed in a tissue- specific or tumor-specific manner) and target-related tissue ancestry- correlated binding sites (e.g., proteins expressed in a tissue-specific or tumor-specific manner). However, Arnaud teaches a method for building a database to aid in diagnosing diseases (Arnaud, abstract). Arnaud’s method includes formulating data points and associating those data points with relevant data point attributes (id. at 12-13, ¶ 192). Arnaud’s database can be an object-oriented database (id. at 14, ¶ 208). Based on these teachings, we agree with the Examiner that it would have been obvious to use Arnaud’s teachings to create a computer program to automate the process of defining data points and their attributes, including the associations that are described by Oh, in order to store them in a database, as described by Oh, because Oh states that “[w]e expect that site- Appeal 2012-004205 Application 11/471,289 9 directed vascular and caveolar targeting will benefit both drug and gene delivery in the treatment of many diseases” (Oh 634, right col.). Appellants argue5 that “the USPTO-cited material fails to recite several express recitations of 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. 47). Appellants conclude that “the PTO- identified portions of Oh do not recite the text of . . . Independent Claim 1” (id. at 54). According to Appellants, “insofar as that Oh does not recite the text of . . . Independent Claim 1, . . . the PTO-cited technical material does not a establish a prima facie case of the unpatentability of Independent Claim 1” (id. at 55). Appellants make a similar argument with respect to Arnaud (id. at 56-61). 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. 5 Appellants’ argument with respect to claim 62 is that it “contain[s] similar recitations as Independent Claim 1, and is not obvious in view of Oh and Arnaud for at least the same reasons” (App. Br. 78). Appeal 2012-004205 Application 11/471,289 10 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 Arnaud, by page and column or paragraph, that were the basis for the conclusion of obviousness (id. at 6, 22). 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 Examiner has attempted to support the present rejection based on [a] ‘mere conclusory statement[ ]’” (App. Br. 65, citing 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. 22: “[T]o further optimize defining associations amongst tissue-ancestry correlated binding sites and agents for the purpose of targeted cancer therapies.”). The Examiner’s conclusion is supported by the evidence (see Oh 634, right col.). Appellants also argue that combining Oh and Arnaud as proposed by the Examiner would change Oh’s principle of operation (App. Br. 65-69) and “would render the technologies of Oh and/or Arnaud unsatisfactory for their intended purposes” (id. at 72). These arguments are also unpersuasive. Appellants have not persuasively shown that combining Oh’s database with Arnaud’s program Appeal 2012-004205 Application 11/471,289 11 for building a database would change Oh’s principle of operation or render it unsatisfactory for its intended purpose. The fact that the database would not contain medical images, as intended by Arnaud, is immaterial to the basis of the rejection. In summary, the Examiner has made a prima facie case that claim 62 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 62 as obvious based on Oh and Arnaud. II. Under the provisions of 37 C.F.R. § 41.50(b), we enter the following new ground of rejection: Claims 1, 2, 4-9, 11, 12, 14, 15, 18, 19, 22-25, 27- 32, 34-36, 50, 51, 53-57, and 59-61 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 defining” and “means for assigning” that are recited in independent claims 1 and 50 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, 208 F.3d at 1361. In this case, claims 1 and 50 use 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. Appeal 2012-004205 Application 11/471,289 12 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 requiring 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 thereof, and the corresponding structure is the algorithm.” Harris Corp., 417 F.3d at 1253. 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 both the “means for defining an association” Appeal 2012-004205 Application 11/471,289 13 and “means for assigning” to memory recited in claim 1 are described at “page 121, ll. 3-14 of specification (Independent Claim 1); and/or page 77, ll. 10-20 of specification” (Appeal Br. 86). Appellants stated that the “means for defining an association” and “means for assigning” to memory recited in claim 50 are described at “page 131, ll. 6-17 of specification (Independent Claim 50); and/or page 113, l. 3 and ll. 20-30 of specification; and/or FIG 18 and 20” (id. at 17). Original claims 1 and 50 were both directed to methods, not systems, although they were amended in a preliminary amendment to define a treatment system instead. The claims, after amendment, recite the “means for defining an association” and “means for assigning” to memory recited in the claims as they read on appeal. However, claims 1 and 50, before or after entry of the preliminary amendment, do not include any recitation of structure corresponding to the recited means. Claims 1 and 50 therefore do not disclose structures corresponding to the “means for defining an association” and “means for assigning” to memory recited in claims 1 and 50 on appeal. The passage of the Specification at page 77, lines 10-20, states that “the present application constitutes a continuation-in-part of United States Patent Application No. 11/362,545, . . . filed 24 February 2006” and refers to a USPTO requirement regarding computer programs (Spec. 77, ll. 10-20). Page 113, line 3, refers to a treatment agent that delivers radio-immunotherapy (id. 6 The originally filed Specification included pages 1-46. On Aug. 28, 2006, Appellants filed a substitute Specification with pages numbered 75-122. We assume that the Appeal Brief refers to pages of the substitute Specification. Appeal 2012-004205 Application 11/471,289 14 at 113, l. 3). The passage of the Specification at page 113, lines 20-30, refers to assigning an association to a relational database or an object-oriented database (id. at 113, ll. 20-26) and states that Figure 18 shows a computer program product that can be provided using a signal-bearing medium (id. at 113, ll. 27-30). Figure 18 shows a computer program product 1800 that includes instructions for “defining an association between at least two instances of at least one treatment parameter and at least one instance of at least one treatment characteristic” and instructions for assigning the association to memory, where the treatment parameter and treatment characteristic are as defined in claim 1 (see Fig. 18). Figure 20 shows a flowchart that includes the single step of “[d]efining an association between at least two instances of at least one treatment parameter and at least one instance of at least one treatment characteristic,” where the treatment parameter and treatment characteristic are as defined in claim 1 (see Fig. 20). Neither of the figures, however, discloses structures that define an association or that assign an association to memory. In summary, the passages or figures cited by Appellants do not disclose structures corresponding to the “means for defining an association” and “means for assigning” to memory recited in claims 1 and 50. Thus, Appellants have not identified any description in the Specification of structures corresponding to the means-plus-function limitations of claims 1 and 50. Our review of the Specification for a disclosure of such structures included word searches for the phrase “means for” and the word “means.” Appeal 2012-004205 Application 11/471,289 15 The search for the phrase “means for” did not identify any use of that phrase in either the original Specification or the substitute Specification. The search for the word “means” identified only a single use, in an unrelated context.7 In summary, the Specification does not identify any structures that correspond to the means-plus-function limitations of claims 1 and 50. Those claims, and the claims that depend from them, are therefore unpatentable under 35 U.S.C. § 112, second paragraph, because they are indefinite. SUMMARY We reverse the rejection of claims 1, 2, 4, 5, 7-9, 11, 12, 14, 15, 18, 19, 22-25, 27-29, 31, 32, 34-36, 50, 51, 53-57, and 60-62 under 35 U.S.C. § 103(a) based on Oh and Arnaud. We affirm the rejection of claim 62 under 35 U.S.C. § 103(a) based on Oh and Arnaud. We reverse the rejection of claims 1, 6, 30, 50, and 59 under 35 U.S.C. § 103(a) based on Oh, Arnaud, and Hood. We enter a new ground of rejection of claims 1, 2, 4-9, 11, 12, 14, 15, 18, 19, 22-25, 27-32, 34-36, 50, 51, 53-57, and 59-61 under 35 U.S.C. § 112, second paragraph. TIME PERIOD FOR RESPONSE Regarding the affirmed rejection, 37 CFR § 41.52(a)(1) provides that “Appellant may file a single request for rehearing within two months from 7 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” (original Spec. 44, ¶ 179; substitute Spec. 121, ¶ 193). Appeal 2012-004205 Application 11/471,289 16 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 CFR § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 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 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. . . . AFFIRMED-IN-PART, 37 C.F.R. § 41.50(b) lp Copy with citationCopy as parenthetical citation