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  • Continuation and divisional applications are simply re-filings of the original application in order to claim additional inventions that are disclosed in the application. For example, the USPTO typically considers methods and apparatuses to be separate inventions. They can be filed as long as the prior application is still pending – basically the concept of a family tree. As long as the parent is alive, another child can be filed.The priority date for prior art purposes is 2001.The priority date for calculating the term of the patent is 2002 + 20 years – 2022.
  • Request Information: Request information - received request for information and GNO number - See Col. 26, lines 30-37. Object: Object - a medicament. See Col. 33, lines 35-41. See also Col. 40, lines 12-23 for broad definition of object.Does Not Include Genetic Information:  Negative limitation introduced to overcome prior art (Holden) which includes genetic information. information. "Indeed, an advantage of the claimed invention is that genetic information 28 is not transmitted to the shared computer 2 with the request information, but rather is transmitted later, and then only in a limited amount." OA response February 6, 2009.Positional Information: Positional information = polymorphism address - a position in a nucleotide sequence where a polymorphism is present. See Col. 22, lines 18-20. See also Col. 22, lines 27-34.Corresponding: "Corresponding is defined as the ordinary dictionary definition in an OA response August 21, 2006Classification of the Object or Service: classification of the object or service - see Col. 26, lines 38-51.Semantic Information: "Semantic Information" - expressly defined as: The term "semantic information" used herein refers to information associated with the "polymorphism pattern," for example, information including responsiveness to medicaments, side-effect caused by medicaments, a risk against diseases and disorders, diatheses and properties, interaction among proteins, and various phenotypes caused by differences in polymorphism patterns. "Semantic information" is a type of information which is corrected and increases in the numbers of types accompanied by progress in research on genome and genetics, and constant updating is preferred. In other words, "semantic information" becomes more accurate through increases and decreases in the amount of information accumulated by updating a database using the results of research on genome and genetics. See Col. 23, lines 15-30.Information Corresponding to the Semantic Information: is information associated with the semantic information, although not directly associated with the polymorphism pattern. See Col 23, lines 30-40.
  • "communication network" - "The use of the communication network, among other things, is a critical aspect of the claimed invention. Indeed, communicating via network is what raises the concerns about privacy, capacity, and standardization mentioned on page 49 of the present application. (Page 9 of OA Response filed February 5, 20009)."request information' - means "information" relating to a "request." Examples of "request information" are set forth on page 44, line 24 - page 45, line 3, page 58, lines 18-22, page 72, lines 17-25, page 85, lines 22-26, and page 89, lines 1-3. The "request information" might be information pertaining to a patient-related request. It might be information on an object or service. (See page 3 of OA Resp. July 3, 2007)."object" - a medicament. (See Col. 33, lines 13-15). "The system, however, is not limited to medicaments but is also applicable to the provision of objects such as foods, cosmetics, or organism-related materials. In this case, for example, as semantic information implied by the polymorphism pattern and information associated with semantic information, a type of substance contained in an object such 65 as food, cosmetics, or organism-related materials is selected using, for example, immunity against substances or responsiveness to medicaments as an index. A suitable object for the individual can be provided by producing or selecting an object in accordance with the type of selected substances and the like. (Col. 38, line 59 - Col. 39, line 3)."service" - "Through utilization of this system, medical examination services including "specific" examination items that are appropriate for the individual can be provided." (See Col. 46, lines 54-56). "This enables the requester to receive the medical services through the medical center." (See Col. 47, lines 48-50). See also "This enables declaration of intention (i.e., request for services) to register as a donor for the "given property," using the system." (Col. 49, lines 19-21).“does not include genetic information” Negative limitation added to overcome a 102 rejection over Holden in OA Response filed February 5, 2009. "The Office Action presumably equates the "request information" of claim 14 with genetic information in Holden. Claim 14 has been amended to emphasize that the recited "request information" does not include genetic information. Therefore, the rejection based on Holden should be withdrawn, and there are also other reasons why claim 14 should be allowable over Holden." (page 9 of OA response).See also page 8 of the OA response - "Claim 14 has been amended to emphasize that the request information does not include genetic information. Indeed an advantage of the claimed invention is that genetic information 28 is not transmitted to the shared computer 2 with the request information, but rather is transmitted later, and then only in a limited amount (page 49, lines 8-11; Steps A7-Al1).““Positional information” = polymorphism address. See Col. 22, lines 18-20, or Paragraphs [0242]-[0244])."corresponding" is used in the claims consistent with its ordinary, dictionary-definition meaning. (See page 3 of OA Resp. filed July 3, 2007)."classification of the object or service" limitation added in OA Resp. filed December 18, 2007. Defined in Specification as "Also, semantic information is associated with, for example, "polymorphism classification," "classification (name of diseases)" and the like corresponding to the predetermined "polymorphism address." (See Col.22, lines 23-25). Classification used multiple times in the Specification."Polymorphism information" - replaced "nucleotide sequence related information to overcome a 112 rejection in the OA Resp. filed Dec. 17, 2008. The OA response expressly states: The term "polymorphism information" should be broadly construed to cover at least the broadest use of the term in t1:J e present specification, including pages 38-39." (page 5). However, the term "nucleotide sequence-related information" was defined in the previous OA response as: "information" related to a "nucleotide sequence." The term is not limited to polymorphism, but includes, among other things, a pattern of nucleotides or nucleotide sequences existing only at a frequency of less than 1% in a species. (Page 4 of OA Resp. July 3, 2007).“Nucleotide-sequence related information” is defined as polymorphism pattern in the Specification.A "polymorphism pattern (nucleotide sequence-related information)" is information on nucleotide sequences which differ among individual organisms, and contains, at least, a pattern of nucleotides or nucleotide sequences in a polymorphism. (See Col. 22, lines 50-55, or Paragraph [0244]).Also - "In database 8, for example, data such as nucleotide sequence-related information that is the genetic information of the individual requester utilizing the system can be recorded in storage DB-B16." (See col. 24, lines 29-33 or Paragraph [0254]).
  • Distributed infringement – situation where it takes two separate and independent parties to perform all the steps of a claim. If a claim requires two independent parties to perform all the steps the claim cannot be directly infringed.

Klevan presentation slides v3 Klevan presentation slides v3 Presentation Transcript

  • REVIEW OF US PATENT NO. 7,912,650 Information Processing System Using Nucleotide Sequence-Related Information June 12, 2013
  • China, Japan, Canada, Korea, Taiw an, Europe US 7,912,650; App. 10/153,691, Filed May 24, 2002. JP 2001-156943, Filed May 25, 2001 Divisional US App. No 2005/0086011 Filed October 29, 2004 Status: Abandoned Divisional US 7,945,389 Filed October 24, 2004 Status: Issued Continuation US 8,103,368 Filed February 26, 2003 Status: Issued Divisional US 2012/0101601 Filed January 3, 2012 Status: Pending – Likely Allowable Non-US Applications 2Proprietary & Confidential Information INFORMATION PROCESSING SYSTEM USING NUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT FAMILY MAP
  • HOW HITACHI‟S ATTORNEYS DESCRIBED INVENTION BEING CLAIMED Shared Apparatus 2, 4, 17, 14 (Figs.1-3) Personal Computer 3 (Figs. 1, 4 and 5) From page 10 of OA response filed January 18, 2011 in the „368 patent which claims an apparatus – i.e., the “remote host computer”. Request information (morbidity rate of large-bowel cancer?) Positional information (for large-bowel cancer, address = 223456) Polymorphism information (for address = 223456, pattern = G) Semantic (or corresponding) information (for address, pattern = 223456, G, morbidity rate = (i)) 3Proprietary & Confidential Information
  • (a) Service request for disease information (f) Outputting obtained semantic info PATIENT APPLICATION SERVICE Personal Genome Information stored PRECISION MEDICINE – GENOME INFORMATION SERVICES (b) & (e) databases only have to be “remote” to user – e.g., in the cloud, down the hall, or separate computers in same room Personalized Medicine Disease Identified US PATENT 7,912,650 ISSUED MAR 22, 2011 (c) Polymorphism address sent back to patient/local computer (d) Patient specific polymorphism pattern at polymorphism address Vendor C Vendor D The entire personal genomic information of the patient is never available outside of local computer Semantic info is stored in constantly updating database (e) Obtaining semantic info for patient specific polymorphism pattern (b) polymorphism address obtained for requested disease Vendor N 4Proprietary & Confidential Information
  • INFORMATION PROCESSING SYSTEM USING NUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT NO. 7,912,650 MAP Proprietary & Confidential Information 5 • via a communication network, •request information of an object or service, wherein the object or service • for positional information • retrieving the positional information • wherein the first memory area is permitted to be accessed by a firstprocessor • via the communication network • the positional information retrieved in step (b) above • to a second processor • via the communication network • polymorphism information • a third memory area • for semantic information or information corresponding to the semantic information • for retrieving said semantic information or information responding to semantic information and • the semantic information or information corresponding to the semantic information • to a user; and (a) receiving, (b) searching, a first memory area (c) transmitting, (d) receiving [first processor receives from second processor], (e) searching (f) outputting (Original) 1. A computer implemented method for processing information on a nucleotide sequence comprising the steps of: Wherein steps (a)-(f) are conducted under the control of the first processor. • is provided for an individual • based on one or more genetic differences between individuals and • wherein the request information does not include genetic information; • corresponding to information on classification of the object or service and • wherein the positional information represents a position in a nucleotide sequence. which is permitted to access a secondary memory area storing polymorphism information regarding the individual based on the positional information transmitted in step (c) above; retrieved in step (e) above 7,912,650 CLAIM CHART } } } } }
  • Proprietary & Confidential Information 6 INFORMATION PROCESSING SYSTEM USING NUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT NO. 7,912,650 “REWRITTEN” MAP • a request for information based on genetic polymorphisms and concerning a particular disease or condition for an individual • for a polymorphism address [a position in a nucleotide sequence where a polymorphism is present and associated with the particular disease or condition requested] • and retrieves the polymorphism address • the polymorphism address retrieved in step (b) above • to a local computer • a polymorphism pattern [the sequence or polymorphism of the individual at the position determined above] • the information associated with the individual‟s polymorphism pattern • to a user; and • a third database [a dynamic and ever changing database of information] • for information associated with the individual‟s polymorphism pattern (i.e., responsiveness to medicaments, disease risk) and • retrieves the information associated with the individual‟s polymorphism pattern, and (a) a remote computer receives (b) the remote computer accesses and searches a first database (c) the remote computer transmits to the local computer (d) the remote computer receives from the local computer (e) the remote computer searches (f) the remote computer outputs (Rewritten) 1. A computer implemented method for processing information on a nucleotide sequence compromising the steps of: wherein steps (a)-(f) are conducted under the control of the remote computer. •wherein the request does not include genetic information; •corresponding to the particular disease or condition requested • which is permitted to access a second database storing the individual‟s genetic information • wherein the third memory area is permitted to be accessed by the first processor; and 7,912,650 CLAIM CHART } } } }
  • China, Japan, Canada, Korea, Taiw an, Europe US 7,912,650; App. 10/153,691, Filed May 24, 2002. JP 2001-156943, Filed May 25, 2001 Divisional US App. No 2005/0086011 Filed October 29, 2004 Status: Abandoned Divisional US 7,945,389 Filed October 24, 2004 Status: Issued Continuation US 8,103,368 Filed February 26, 2003 Status: Issued Method & Software Claims Divisional US 2012/0101601 Filed January 3, 2012 Status: Pending – Likely Allowable Method & Software Claims similar in scope to „650 – “a user” issue Non-US Applications 7Proprietary & Confidential Information INFORMATION PROCESSING SYSTEM USING NUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT FAMILY MAP
  • Proprietary & Confidential Information 8 INFORMATION PROCESSING SYSTEM USINGNUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT NO. 7,945,389 MAP • wherein the object or service is provided for an individual based on one or more genetic differences between individuals, and • wherein the request information does not include genetic information • and wherein the positional information to information on classification of the object or service, • and wherein the positional information represents a position in a nucleotide sequence, and • retrieving the positional information, • wherein the first memory area is permitted to be accessed by a first processor • to a second processor • based on the positional information transmitted in step (c); and • to a user • and wherein the user includes athird processor “A User” defined in the specification as an individual/person – unknown how a person can have a “third processor” to do certain functions. (a) receiving, via a communication network, request information of an object or service, (b) searching a first memory area for positional information, (c) Transmitting, via a communication network, the positional information retrieved in step (b) (d) Receiving, via a communication network, polymorphism information (e) Outputting, via a communication network, the polymorphism information received in step (d) 1. A computer- implemented method for processing information on a nucleotide sequence comprising the steps of: Wherein steps (a)-(e) are conducted under the control of the first processor. • which is permitted to access a second memory area storing polymorphism information regarding the individual • which is permitted to access a third memory area storing semantic information • and which searches the third memory area to retrieve, in response to said transmission of the polymorphism information based on the transmitted polymorphism information, and • outputs the semantic information to a device • that utilizes the semantic information or information corresponding to the semantic information, • which is used for a provision of the object or service substantially included in the request information, US 7,945,389 CLAIM CHART } }
  • China, Japan, Canada, Korea, Taiw an, Europe US 7,912,650; App. 10/153,691, Filed May 24, 2002. JP 2001-156943, Filed May 25, 2001 Divisional US App. No 2005/0086011 Filed October 29, 2004 Status: Abandoned Divisional US 7,945,389 Filed October 24, 2004 Status: Issued Continuation US 8,103,368 Filed February 26, 2003 Status: Issued Method & Software Claims Divisional US 2012/0101601 Filed January 3, 2012 Status: Pending – Likely Allowable Apparatus claims – “a CPU” controlling shared computer Method & Software Claims similar in scope to „650 – “a user” issue Non-US Applications 9Proprietary & Confidential Information INFORMATION PROCESSING SYSTEM USING NUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT FAMILY MAP
  • Proprietary & Confidential Information 10 INFORMATION PROCESSING SYSTEM USINGNUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT NO. 8,103,368 MAP • that is configured to receive request information from a request computer, • search the database for positional information • cause the transmitter/receiver to transmit, via the communication network, the retrieved positional information, which corresponds to the received request information, to a computer • obtain polymorphism information based on the transmitted positional information, received by the transmitter/receiver via communication network; • search the database for semantic information or search for information that is stored in the database or another database based on the polymorphism information • output the semantic information or information corresponding to the retrieved semantic information to the request computer a transmitter/receiver a CPU that is configured to: 1. An apparatus for processing information on a nucleotide sequence, in which the apparatus is configured to access a database storing positional information representing a position in the nucleotide sequence, polymorphis m information, and semantic information, comprising : CPU – a CPU must “totally” control shared computer • via a communication network, corresponding to an object or service, • and wherein the request information does not include genome-related information; and • corresponding to the received request information, and retrieve the positional information • which is configured to access a recording medium storing polymorphism information regarding an individual; US 8,103,368 CLAIM CHART } } } • and retrieve the semantic information or information corresponding to the semantic information; and •or a device that utilizes the semantic information corresponding to the semantic information to comply with a request substantially included in the request information } }
  • China, Japan, Canada, Korea, Taiw an, Europe US 7,912,650; App. 10/153,691, Filed May 24, 2002. JP 2001-156943, Filed May 25, 2001 Divisional US App. No 2005/0086011 Filed October 29, 2004 Status: Abandoned Divisional US 7,945,389 Filed October 24, 2004 Status: Issued Continuation US 8,103,368 Filed February 26, 2003 Status: Issued Method & Software Claims Divisional US 2012/0101601 Filed January 3, 2012 Status: Pending – Likely Allowable Apparatus claims – “a CPU” controlling shared computer Method & Software Claims similar in scope to „650 – “a user” issue Non-US Applications Apparatus claims similar to „368 – “a CPU” replaced with “controller” 11Proprietary & Confidential Information INFORMATION PROCESSING SYSTEM USING NUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT FAMILY MAP
  • Proprietary & Confidential Information 12 INFORMATION PROCESSING SYSTEM USINGNUCLEOTIDE SEQUENCE-RELATED INFORMATION US PATENT APP. NO. 2012/0101601 MAP • transmits, via a communication network, request information and • receives, via the communication network, positional information form the first processor • Searches nucleotide sequence-related information regarding an individual to retrieve nucleotide sequence-related information based on the received positional information, and • retrieves said nucleotide sequence-related information, wherein the nucleotide sequence-related information that is searched • causes the transmitter/receiver to transmit, via the communication network, the retrieved nucleotide sequence-related information to the processor a transmitter/receiver that a controller that 103. An apparatus for processing information on a nucleotide sequence comprising: Wherein the controller and the transmitter/receiver are under the control of the second processor. • to a first processor which is permitted to access positional information, wherein the positional information represents a position in a nucleotide sequence, • wherein the received positional information is based on the transmitted request information; • is permitted to be accessed by a second processor; and • to the first processor which is permitted to access semantic information, • and which searches the semantic information to retrieve, in response to said transmission of the nucleotide sequence-related information, semantic information based on the transmitted nucleotide sequence-related information, • and outputs the semantic information • to a device that utilizes the semantic information or information corresponding to the semantic information to comply with a request substantially included in the request information, US 2012/0101601 CLAIM CHART (AS ALLOWABLE PER OA DEC. 12, 2012 AND PER TERMINAL DISCLAIMER FILED) } } } } “a Controller” replaced “a CPU” – arguably broader – may provide basis for distributed network
  • 7,912,650 Patent Distributed infringement issue re: method claims – functionalities being done by 2 or more parties. Included software claims require software to be on single “medium” (i.e., the shared memory) – the described functions are, however, performed in a distributed manner among several processors/computers. 7,945,389 Distributed infringement issue re: method claims – functionalities being done by 2 or more parties. Included software claims require software to be on single “medium” (i.e., the shared memory) – the described functions are, however, performed in a distributed manner among several processors/computers. Claim requires that “a user” have “a processor”. 8,103,368 Apparatus claims require a single CPU which “totally controls operation” of the shared computer – the described functions are, however, performed in a distributed manner among several processors/computers. 2012/0101601 Broadened the claims to recite “a controller” instead of “a CPU”. Claims are split to cover either the shared computer (claim 101) or the user’s computer (claim 103). Broadest set of claims consistent with current patent law requirements for components of a computer system. PORTFOLIO OVERVIEW 13Proprietary & Confidential Information
  • POTENTIAL CLAIMS TO ADD IN CONTINUATION APPLICATION(S) TO ADDRESS NOTED ISSUES The definition of distributed memory is: In computer science, distributed memory refers to a multiple-processor computer system in which each processor has its own private memory. Computational tasks can only operate on local data, and if remote data is required, the computational task must communicate with one or more remote processors. In contrast, a shared memory multi processor offers a single memory space used by all processors. Processors do not have to be aware where data resides, except that there may be performance penalties, and that race conditions are to be avoided. See, Wikipedia, for example. The ordinary definition of distributed system is: A distributed system is a software system in which components located on networked computers communicate and coordinate their actions by passing messages. The components interact with each other in order to achieve a common goal." See, Wikipedia, for example. The ordinary definition of distributed program is "a computer program that runs in a distributed system" See, Wikipedia, for example. The terms "distributed memory", "distributed program" and "distributed system" are not found in the specification of the patent(s) and application, but concept is arguably implicit or inherent in the disclosure as the system describe and shown is a distributed system. 2. Non-transitory computer readable mediums encoded with a distributed program for processing information on a nucleotide sequence which allows a distributed system to execute processes including: .... 1. A non-transitory distributed memory encoded with programs for processing information on a nucleotide sequence which allows computers to execute processes including… 14Proprietary & Confidential Information
  • FEATURES OF THE PORTFOLIO REMOTE COMPUTER CAN BE IN THE CLOUD, IN ANOTHER ROOM, IN ANOTHER DATA CENTER, FOR EXAMPLE. Not required to be in the cloud – simply must be connected to the local computer via a communication network. LANGUAGE IN APPLICATIONS BROADLY DEFINES THE FUNCTIONAL ABILITIES OF A DISTRIBUTED COMPUTER SYSTEM: Entirety of patient DNA not made available to “remote location”. THE SEMANTIC INFORMATION ENCOMPASSES ALL TYPES OF INFORMATION – MORBIDITY, TREATMENTS, MEDICATIONS, ET C.The semantic information is constantly updating. THE PATENT ASSETS COVER MULTIPLE ASPECTS OF THE TECHNOLOGY IN THE „650 PATENT AND CONTINUATION/DIVISIONAL APPLICATIONS: Apparatus claims, method claims, computer readable mediums (software). 15Proprietary & Confidential Information
  • OPPORTUNITY TO FILE CONTINUATION/NEW APPLICATIONS STILL EXISTS: Apply for new claims to cover additional features. New applications will have benefit of 2001 priority date for purposes of prior art. BROAD FUNCTIONAL/METHOD DISCLOSURE WITH AN EARLY FILING DATE: Priority re: prior art is 2001 (Japan). US Expiration in 2022. INVENTION IS KEY COMPONENT OF REGULATORY FOCUS – SAFETY & SECURITY OF PERSONAL GENOMIC INFORMATION. Claims directed to “remote” use of only the patient’s polymorphism pattern and not the entirety of the genome. ABILITY TO COVER IN ADDITIONAL APPLICATION(S) HARDWARE/DATABASES BEING USED OUTSIDE US TO PROVIDE BENEFIT WITHIN US. Such activity would be an infringement of patent(s). BENEFITS OF THE PORTFOLIO 16Proprietary & Confidential Information
  • Proprietary & Confidential Information 17 ISSUES OF THE PORTFOLIO APPARATUS & HARDWARE DISCLOSURE IS MORE LIMITED IN SCOPE AND BREADTH. SIGNIFICANT AMOUNT OF BACK/FORTH BETWEEN US ATTY AND USPTO – MAY CREATE UNHELPFUL ADMISSIONS RE: SCOPE OF CLAIMS. CURRENT ISSUED CLAIMS MAY REQUIRE COORDINATED EFFORT BETWEEN PATIENT/DOCTOR/RESEAR CHER & REMOTE DB PROVIDER TO INFRINGE THE CLAIMS. 2012 PUBLISHED APP. MAY BE STRONGEST ITEM IN FAMILY. NINE (9) YEARS LEFT ON PATENT TERM. • Will have to rely on common dictionary definitions. • What did terms mean in 2001? • If two are not operating in conjunction, may not be able to assert infringement of method claims. • Claim focused on “controller” rather than “CPU”. • Likely to be allowed Summer 2013. • Any new apps need to be filed quickly and prioritized for early issuance. • New apps must be filed before 2012 app. Issues in order to maintain priority date.
  • FREEDOM TO OPERATE/LANDSCAPE REVIEW AND OPINION OBTAINED: Identify 3rd party patents/apps in the field. Determine impact, if any, on ability to implement envisioned commercial embodiment(s). IMMEDIATE FILING OF NEW APPLICATION(S) DIRECTED TO ADDITIONAL FEATURES OF INVENTION. Claims directed to current envisioned commercial embodiment(s) or activities of potential licensees. REVIEW OF PATENT NO. 7,337,071 AND FAMILY WHICH APPEARS TO BE RELATED TO AND SIMILAR IN SCOPE: Disclosure & claims cover similar processing steps for nucleotide sequences for semantic information. May not be limited to polymorphism address/patterns. DETERMINE OTHER HITACHI OWNED/LICENSED PATENTS/APPS THAT MAY FALL WITHIN SCOPE OF POTENTIAL COMMERCIAL EMBODIMENTS. Text ITEMS FOR CONSIDERATION 18Proprietary & Confidential Information
  • Proprietary & Confidential Information 19 TEXT HERE Statement or quote Title
  • DUNLAP CODDING, PC The Film Exchange District 609 W. Sheridan Avenue Oklahoma City, OK 73102 dunlapcodding.com 405.607.8600 (p) 405.607.8686 (f) 20Proprietary & Confidential Information