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`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`HEALTH CARE LOGISTICS, INC.
`Petitioner,
`v.
`KIT CHECK, INC.
`Patent Owner
`_________________________
`Case IPR. No. Unassigned
`U.S. Patent No. 9,367,665
`Title: MANAGEMENT OF PHARMACY KITS
`_________________________
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,367,665
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`TABLE OF CONTENTS
`
`I. INTRODUCTION .............................................................................................. 1
`II. MANDATORY NOTICES ................................................................................ 1
`A. Real Parties-in-Interest (37 C.F.R. § 42.8(b)(1)) ......................................... 1
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) ...................................... 1
`C. Notice of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)) .................. 2
`D. Service Information (37 C.F.R. § 42.8(b)(4)) ............................................... 2
`III.CERTIFICATION OF GROUNDS FOR STANDING .................................. 3
`IV.FEES .................................................................................................................... 3
`V. OVERVIEW OF CHALLEGE AND PRECISE RELIEF REQUESTED ... 3
`VI.SUMMARY OF THE ’665 PATENT ............................................................... 5
`A. Technology Background ................................................................................ 5
`B. The Specification of the ’665 Patent ............................................................. 6
`C. The Prosecution History of the ’665 Patent ................................................. 8
`D. State of the Art Prior to the Critical Date of the ’413 Patent .................... 9
`VII. CLAIM CONSTRUCTION .........................................................................11
`VIII. PERSON HAVING ORDINARY SKILL IN THE ART ......................14
`IX.GROUND 1: CLAIMS 1-3, 5, 7, 8, 24-28, AND 30 ARE
`UNPATENTABLE UNDER 35 U.S.C. § 103(A) AS BEING OBVIOUS
` OVER ANDREASSON (HCL-1005) IN VIEW OF SRIHARTO
`(HCL-1006) AND TETHRAKE (HCL-1007). ..............................................15
`X. GROUND 2: CLAIMS 24-28 AND 30 ARE UNPATENABLE
`UNDER 35 U.S.C. § 103(A) AS BEING OBVIOUS OVER
`ANDREASSON (HCL-1005) IN VIEW OF SRIHARTO (HCL-1006)
`AND TETHRAKE (HCL-1007) AND FURTHER IN VIEW OF
`LOWENSTEIN (HCL-1008). ..........................................................................40
`XI.GROUND 3: CLAIMS 1-3, 5, 7, 8, 24-28, AND 30 ARE
`UNPATENTABLE UNDER 35 U.S.C. § 103(A) AS BEING OBVIOUS
`
`
`
`i
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`
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`OVER DANILEWITZ (HCL-1009) IN VIEW OF CHILDREN’S
` (HCL-1010) AND VISHIK (HCL-1011). .......................................................41
`XII. GROUND 4: CLAIMS 1-3, 5, 7, 8, 24-28, AND 30 ARE
`UNPATENTABLE UNDER 35 U.S.C. § 103(A) AS BEING OBVIOUS
`OVER DANILEWITZ (HCL-1009) IN VIEW OF CHILDREN’S
`(HCL-1010) AND VISHIK (HCL-1011), AND FURTHER IN VIEW
`OF HIGHAM (HCL-1012). ...........................................................................62
`X. CONCLUSION ..................................................................................................63
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`ii
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`PETITIONER HEALTH CARE LOGISTICS, INC.’S EXHIBIT LIST
`Exhibit
`Description
`
`
`1001.
`1002.
`1003.
`1004.
`1005.
`1006.
`
`U.S. Patent No. 9,367,665
`File History for U.S. Patent No. 9,367,665
`Declaration of Dr. Behbood Ben Zoghi
`Curriculum Vitae of Dr. Behbood Ben Zoghi
`U.S. Patent No. 7,175,081 to Andreasson et al. (“Andreasson”)
`U.S. Patent Publication No. 2008/0316045 to Sriharto et al.
`(“Sriharto”)
`U.S. Patent No. 7,268,684 to Tethrake et al. (“Tethrake”)
`U.S. Patent Publication No. 2008/0184719 to Lowenstein
`(“Lowenstein”)
`U.S. Patent Publication No. 2007/0150382 to Danilewitz
`(“Danilewitz”)
`“CHILDREN’S HOSPITAL BOSTON JOINS OTHERS USING RFID TO
`TRACK IMPLANTABLES” (“CHILDREN’S”)
`U.S. Patent Publication No. 2009/0224891 to Vishik et al.
`(“Vishik”)
`U.S. Patent No. 7,348,884 to Higham (“Higham”)
`Health Care Logistics, Inc.’s Opening Claim Construction Brief.
`(Kit Check, Inc., v. Health Care Logistics, Inc.)
`Kit Check, Inc.’s Opening Claim Construction Brief. (Kit Check,
`Inc., v. Health Care Logistics, Inc.)
`
`1007.
`1008.
`
`1009.
`
`1010.
`
`1011.
`
`1012.
`1013.
`
`1014.
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`
`iii
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`I.
`
`INTRODUCTION
`
`Pursuant to 35 U.S.C. §§ 311-319, Health Care Logistics, Inc. (“Petitioner”)
`
`hereby petitions the Patent Trial and Appeal Board to institute an inter partes review
`
`of claims 1-3, 5, 7, 8, 24-28, and 30 of U.S. Patent No. 9,367,665, titled
`
`“Management of Pharmacy Kits” (“the ’665 Patent). As demonstrated by this
`
`Petition, there is a reasonable likelihood that these claims of the ’665 Patent are
`
`unpatentable because they would have been obvious to a person of ordinary skill in
`
`the art.
`
`II. MANDATORY NOTICES
`
`A. Real Parties-in-Interest (37 C.F.R. § 42.8(b)(1))
`
`Petitioner, Health Care Logistics, Inc., is the real party-in-interest. No other
`
`parties exercised or could have exercised control over this petition; no other parties
`
`funded or directed this petition.
`
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`
`The ’665 Patent is at issue in Kit Check, Inc. v. Health Care Logistics, Inc.,
`
`Case No. 2:17-cv-01041, pending in the United States District Court for the Southern
`
`District of Ohio (herein the “Ohio Litigation”). Kit Check, Inc. (“Patent Owner”)
`
`has asserted the ’665 Patent along with U.S. Patent Nos. 8,990,099 (“the ’099
`
`Patent”); 9,058,412 (“the ’412 Patent”); 9,058, 413 (“the ’413 Patent”); 9,805,169
`1
`
`
`
`
`
`(“the ’169 Patent”); 9,037,479 (“the ’479 Patent”); and 9,734,294 (“the ’294 Patent”)
`
`(collectively the “asserted patents”) against Petitioner in the Ohio Litigation.
`
`In addition to this Petition, Petitioner is filing petitions for inter partes review
`
`of the ’099 Patent (Petition for Inter Partes Review of U.S. Patent No. 8,990,099);
`
`’412 Patent (Petition for Inter Partes Review of U.S. Patent No. 9,058,412); ’413
`
`Patent (Petition for Inter Partes Review of U.S. Patent No. 9,058,413); and the ’169
`
`Patent (Petition for Inter Partes Review of U.S. Patent No. 9,805,169).1
`
`C. Notice of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3))
`
`Lead counsel is Beverly A. Marsh (Reg. No. 62,302). Backup counsel is Eric
`
`M. Gayan (Reg. No. 46,103). All counsel are with Standley Law Group LLP, 6300
`
`Riverside Drive, Dublin, Ohio 43017, tel. 614-792-5555, fax 614-792-5536. Email
`
`contact for counsel is bmarsh@standleyllp.com, egayan@standleyllp.com, and
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`standleydocketing@standleyllp.com.
`
`D. Service Information (37 C.F.R. § 42.8(b)(4))
`
`Please direct all correspondence to counsel at the contact information above.
`
`Petitioner consents to service by electronic mail at bmarsh@standleyllp.com,
`
`egayan@standleyllp.com, and standleydocketing@standleyllp.com.
`
`
`1 These petitions will be filed concurrently.
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`
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`2
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`
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`III. CERTIFICATION OF GROUNDS FOR STANDING
`
`Petitioner certifies pursuant to 37 C.F.R. § 42.104(a) that the ’665 Patent is
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`available for inter partes review and that Petitioner is not barred or estopped from
`
`requesting an inter partes review challenging the ’665 Patent claims on the grounds
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`identified in this petition.
`
`IV. FEES
`
`The Commissioner is hereby authorized to charge all fees due in connection
`
`with this matter to Deposit Account 19-4076.
`
`V. OVERVIEW OF CHALLEGE AND PRECISE RELIEF REQUESTED
`
`
`Petitioner requests IPR of claims 1-3, 5, 7, 8, 24-28, and 30 of the ’665
`
`Patent on the grounds listed below:
`
`GROUNDS
`Ground 1
`
`Ground 2
`
`CLAIMS
`1-3, 5, 7, 8, 24-28,
`and 30
`24-28 and 30
`
`Ground 3
`
`Ground 4
`
`1-3, 5, 7, 8, 24-28,
`and 30
`1-3, 5, 7, 8, 24-28,
`and 30
`
`BASIS FOR REJECTION
`103: Andreasson in view of Sriharto
`and Tethrake
`103: Andreasson in view of Sriharto
`and Tethrake, and further in view of
`Lowenstein
`103: Danilewitz in view of
`CHILDREN’S and Vishik.
`103: Danilewitz in view of
`CHILDREN’S and Vishik, and further
`in view of Higham
`
`3
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`
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`• U.S. Patent No. 7,175,081 to Andreasson et al. (“Andreasson”) was granted
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`on February 13, 2007; it is prior art at least under § 102(b) and is attached as
`
`Exhibit HCL-1005.
`
`• U.S. Patent Publication No. 2008/0316045 to Sriharto et al. (“Sriharto”)
`
`published on December 25, 2008; it is prior art at least under § 102(b) and is
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`attached as Exhibit HCL-1006.
`
`• U.S. Patent No. 7,268,684 to Tethrake et al. (“Tethrake”) was granted on
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`September 11, 2007; it is prior art at least under § 102(b) and is attached as
`
`Exhibit HCL-1007.
`
`• U.S. Patent Publication No. 2008/0184719 to Lowenstein (“Lowenstein”)
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`published on August 7, 2008; it is prior art at least under § 102(b) and is
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`attached as Exhibit HCL-1008.
`
`• U.S. Patent Publication No. 2007/0150382 to Danilewitz (“Danilewitz”)
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`published on June 28, 2007; it is prior art at least under § 102(b) and is
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`attached as Exhibit HCL-1009.
`
`• “CHILDREN’S HOSPITAL BOSTON JOINS OTHERS USING RFID TO TRACK
`
`IMPLANTABLES” (“CHILDREN’S”) is an article published by RFID Journal
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`on March 5, 2008; it is prior art at least under § 102(b) and is attached as
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`Exhibit HCL-1010. RFID Journal is a media company devoted to radio
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`
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`4
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`
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`frequency identification and its business applications. Published RFID Journal
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`articles can be accessed with a subscription. See rfidjournal.com.
`
`• U.S. Patent Publication No. 2009/0224891 to Vishik et al. (“Vishik”) was
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`published on September 10, 2009; it is prior art at least under § 102(b) and is
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`attached as Exhibit HCL-1011.
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`• U.S. Patent No. 7,348,884 to Higham (“Higham”) was granted on March 25,
`
`2008; it is prior art at least under § 102(b) and is attached as Exhibit HCL-
`
`1012.
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`VI. SUMMARY OF THE ’665 PATENT
`
`The ’665 Patent issued on June 14, 2016, from Application No. 14/818,113
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`(the ’113 Application”), which claims priority through a chain of applications to U.S.
`
`Provisional Application No. 61/514,231 filed on August 2, 2011 (the “’231
`
`Provisional Application”). HCL-1001. For the purposes of this petition only,
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`Petitioner assumes that the ’665 Patent is entitled to this claim of priority. The named
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`inventors of the ’665 Patent are Kevin William MacDonald and Timothy James Leo
`
`Kress-Spatz.
`
`A. Technology Background
`
`
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`Radio-frequency identification (RFID) technology is based on the use of
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`electromagnetic fields to remotely read RFID tags that may be attached to items.
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`
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`5
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`(HCL-1003 at ¶ 14). The ’665 Patent discusses passive tags, which lack their own
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`power source and are only powered through the signal received from the antenna.
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`(HCL-1003 at ¶ 23). A basic passive RFID system consists of: (1) a reader with an
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`antenna that sends an interrogation signal in the form of an electromagnetic wave;
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`and (2) one or more RFID tags that are charged by the interrogation signal and
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`transmit data in response. (HCL-1003 at ¶ 23).
`
`RFID tags contain an integrated chip that may be programmed with a unique
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`identification number. (HCL-1003 at ¶ 20). Accordingly, RFID tags may be used
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`to uniquely identify different items to which they are attached. (HCL-1003 at ¶ 20).
`
`The unique identification number may also be used to relate a particular item bearing
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`a particular tag with information stored in one or more databases. (HCL-1003 at ¶
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`21). At the time the ’231 Application was filed, it was well-known that an advantage
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`of RFID technology, particularly over the use of barcode technology or manual
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`methods, is that multiple RFID tags may be scanned at the same time. (HCL-1003
`
`at ¶ 28). This generally reduces the amount of time it takes to inventory or otherwise
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`validate a group of items. (HCL-1003 at ¶ 28).
`
`B. The Specification of the ’665 Patent
`
`
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`The ’665 Patent purports to disclose a system for managing the contents of
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`pharmacy kits using RFID tags. As explained in the ’665 Patent, pharmacy kits may
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`6
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`be used “to provide a group of items for a specific medical procedure, a particular
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`physician, or a designated location of a hospital.” (HCL-1001, ’665 Patent, Col. 1,
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`ll. 21-24). The kits typically comprise a group of items that is specified by a template
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`and are loaded into a common container such as a box, tray, or canister. (Id., ’665
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`Patent, Col. 1, ll. 27-29, 51-54).
`
`The claims of the ’665 Patent focus on a reading station wherein a pharmacy
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`kit, containing multiple items in individual containers, and each associated with an
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`RFID tag, can be “verified” to confirm whether all items are present, as well as
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`identify information about each item, such as expiration or recall status. A template
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`identifies which items belong in a particular pharmacy kit, and a processor compares
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`information received from RFID tags with information stored in the template. The
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`system may recognize substitute relationships between items such that if one item is
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`not present, the system may determine if a substitute item is present. The reading
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`station includes a pharmacy kit container formed from material that provides
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`electromagnetic shielding, and an antenna that emits a radio signal within the
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`pharmacy kit container. A display provides information regarding the items in the
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`kit, such as whether any substitute items are present, any items are missing, or any
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`items are expired or recalled.
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`7
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`C. The Prosecution History of the ’665 Patent
`
`
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`The ’113 Application was filed on August 4, 2015 with 20 original claims.
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`On September 10, 2015, a Non-Final Rejection was issued that included rejections
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`of all claims under 35 U.S.C. §§ 101 and 103. (HCL-1002, pg. 169 of 256). As part
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`of the § 103 Rejections, the Examiner took official notice that “more than one brand
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`of product may be considered equivalent (generic vs. brand name) and one of
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`ordinary skill in the art would have been motivated to recognize this equivalency to
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`reduce costs by using cheaper equivalent product.” (Id., pg. 178 of 256). An
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`Examiner interview was conducted and the applicant subsequently cancelled claims
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`1-20 and presented new claims 21-50. A Final Rejection issued on January 14, 2016
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`rejected all pending claims on the grounds of non-statutory double patenting. (Id.,
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`pg. 107 of 256). Following another Examiner interview and the filing of a terminal
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`disclaimer, claims 21-50 were allowed. (Id., pg. 55 of 256). No reason for allowance
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`was stated by the Examiner. (Id., pg. 59 of 256). The applicant submitted
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`amendments of certain claims after Allowance, which were entered by the Examiner.
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`Only two references2 were ever cited against original claims 1-20 of the ’113
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`Application, and neither of those references are asserted in this Petition as a basis
`
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`2 U.S. Patent Application Publication 2007/0229268 to Swan et al. and U.S. Patent Application
`Publication 2007/0023512 to Miller et al.
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`
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`8
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`
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`for invalidity. No references were cited against original claims 21-50, now issued
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`claims 1-30.
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`D. State of the Art Prior to the Critical Date of the ’665 Patent
`
`
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`While the claims of the ’665 Patent are lengthy, length does not equal
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`patentability. All of the RFID technology and associated manipulation and
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`comparison of RFID tag data that is described and claimed in the ’665 Patent was
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`known well prior to the critical date.
`
`The system described in the ’665 Patent can be divided essentially into two
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`parts – a hardware portion and a software portion. The hardware portion will
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`typically include the RFID tags, an antenna, a reader and processor, etc. The
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`function of the hardware is to store data about items of interest (via the RFID tags)
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`and to extract said data from the tags when desired using the remainder of the
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`hardware.
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`The overall RFID hardware architecture described in the ’665 Patent, as well
`
`as the individual components thereof, would have been well known to a person
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`having ordinary skill in the art (“PHOSITA”) prior to the critical date of the ’665
`
`Patent. What is described in the ’665 Patent and recited in the claims is nothing
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`more than the basic componentry and interaction of virtually every passive RFID
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`system in existence. The software portion (i.e., the backend system) receives data
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`from the RFID tags via the hardware – often after conversion into a usable format
`9
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`
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`by middleware, etc. – and uses the data to provide a user with desired information.
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`Prior to the critical date, there were a number of commercially available backend
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`systems/software packages available that could receive data from RFID tags and
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`output any of a myriad of item information, analyses, comparisons, etc. (HCL-1003,
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`at ¶ 30-45). RFID technology in cooperation with such backend systems was
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`frequently employed in general industry sectors such as warehouse and inventory
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`management, and kitting verification. Id. For example, such a system could be used
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`in a kitting system to set the required contents of a kit of items; scan the contents of
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`a kit containing a plurality of RFID tagged items to identify various attributes of the
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`items and/or to determine if any expected items are missing or any unexpected items
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`are present; determine if a substitute item is present or if a substitute item is available
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`to substitute for a missing item; determine if an item is expired; determine if an item
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`is within some predetermined window of its expiration date, etc. HCL-1003 at ¶ 37.
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`In other words, as long as the scanned RFID tags included the requisite data, known
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`backend systems could provide a user with virtually any desired information output,
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`analysis, comparison or check function.
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`Therefore, it should be understood that at the time the ’231 Provisional
`
`Application was filed, the use of RFID technology like that disclosed and claimed
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`in the ’665 Patent to generally inventory, manage, and track volumes of items was
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`well-known. (HCL-1003 at ¶ 37; HCL-1005-1012). Furthermore, RFID tag-based
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`
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`10
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`
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`tracking of medical items such as pharmaceuticals was also known, as was placing
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`RFID tag-based tracking of various items that comprise a kit – whether to verify the
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`contents of the kit, to determine properties about particular items in a kit, or
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`otherwise. (HCL-1003 at ¶ 44; HCL-1005-1010). For example, it was well-known
`
`at the time that RFID tags could be used in connection with pharmaceuticals to
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`monitor their location, expiration information, inventory, and whether their
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`configuration status matched a desired configuration. (HCL-1003 at ¶ 34-44; HCL-
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`1005-1006, 1008). It was also well-known that RFID system technology made it
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`possible to scan various items held in a container without the need to open the
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`container and scan each item individually. (HCL-1003 at ¶ 27; HCL-1005-1010,
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`1012). The references cited herein demonstrate the vast breath of knowledge and
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`reduction to practice of various RFID systems that existed prior to the filing of the
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`’231 Provisional Application. Had the Examiner been aware of the teachings of
`
`these references, the ’665 Patent would not have issued.
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`VII. CLAIM CONSTRUCTION3
`
`
`
`In accordance with the recently revised version of 37 C.F.R. § 42.100(b):
`
`
`3 Petitioner reserves the right to challenge the validity of the asserted claims in the Ohio
`Litigation on the grounds that they do not satisfy the requirements of 35 U.S.C. §112, which
`cannot be raised in this Petition. Petitioner also reserves the right to argue additional or
`alternative claim construction positions in the Ohio Litigation.
`11
`
`
`
`
`
`In an inter partes review proceeding, a claim of a patent, or a claim
`proposed in a motion to amend under § 42.121, shall be construed using
`the same claim construction standard that would be used to construe the
`claim in a civil action under 35 U.S.C. 282(b), including construing the
`claim in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the
`prosecution history pertaining to the patent. Any prior claim
`construction determination concerning a term of the claim in a civil
`action, or a proceeding before the International Trade Commission, that
`is timely made of record in the inter partes review proceeding will be
`considered.
`
`83 FR 51340 (October 2018).
`
`At the time of filing this Petition, there has been no claim construction ruling
`
`in the Ohio Litigation4. However, the parties have proposed the following
`
`constructions for certain claim terms of relevance in this Petition:
`
`Term
`
`“Pharmacy Kit[s]”
`
`Petitioner’s Proposed
`Construction
`(See HCL-1013)
`Transportable container
`having a collection of
`medical items for a
`common purpose that
`can be deployed for a
`specific medical
`procedure, for a specific
`
`Patent Owner’s
`Proposed Construction
`(See HC-1014)
`Transportable container
`having a collection of
`pharmacy items for a
`common purpose that
`can be deployed for a
`specific medical
`procedure, for a specific
`
`
`4 At the time of filing this Petition, only opening claim construction briefs have been filed by the
`parties in the Ohio Litigation.
`
`
`
`12
`
`
`
`“Pharmacy item”
`
`“Template”/“Pharmacy
`kit template”
`
`“Substitute first
`pharmacy item”/
`“substitute first
`medication”
`
`
`
`physician, or to a
`designated location.
`Medicine or medicine-
`related supplies.
`Predetermined
`specification of
`permissible pharmacy
`items that form the
`contents of a pharmacy
`kit/ Predetermined
`specification of
`permissible pharmacy
`items that form the
`contents of a pharmacy
`kit.
`
`Plain and ordinary
`
`meaning.
`
`physician, or to a
`designated location.
`Medicines or medical
`supplies.
`A specification that
`defines the contents of a
`kit containing at least one
`segment/ A specification
`that defines the contents
`of a pharmacy kit
`containing at least one
`segment.
`
`
`Substitute refers to an
`available drug/pharmacy
`item/medication
`identified by the template
`as an alternative to
`another drug/pharmacy
`item/medication.
`
`
`Petitioner believes that the grounds for invalidity asserted herein are
`
`applicable regardless of which proposed constructions are applied to the claims.
`
`That is, Petitioner asserts that the differences in the proposed claim constructions do
`
`not materially impact a finding of obviousness over the asserted prior art.5
`
`
`5 This is not to say that the differences in proposed constructions have no impact on the
`infringement analysis in the Ohio Litigation. Petitioner is in no way waiving any argument of
`non-infringement that may be based in whole or in part on an eventual Markman decision from
`the Court.
`
`
`
`13
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`
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`VIII. PERSON HAVING ORDINARY SKILL IN THE ART
`
`
`For purposes of this IPR, Petitioner submits that a PHOSITA would have had
`
`at least a bachelor’s degree or equivalent experience in inventory control related
`
`technology including knowledge and experience in RFID technology. In addition,
`
`a PHOSITA would have knowledge, education or experience with software relating
`
`to inventory management. Such a person would also have the ability, based upon
`
`their industry experience, to utilize RFID technology in managing pharmaceutical
`
`and medical-item inventory. Specifically, a PHOSITA would possess the requisite
`
`knowledge and skills to utilize RFID to assist with healthcare inventory
`
`management. See HCL-1013, Petitioner’s Opening Claim Construction Brief in the
`
`Ohio Litigation.
`
`In the Ohio Litigation, Patent Owner has asserted that a PHOSITA would have
`
`had (1) a Bachelor’s Degree in Electrical Engineering or Computer Science and at
`
`least 3 years of industrial or academic experience in wireless communications
`
`technology and computer systems, including experience with RFID systems, or,
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`equivalently, (2) a Bachelor’s Degree in Electrical Engineering or Computer
`
`Science, with a master’s degree in Electrical Engineering or Computer Science and
`
`at least 1 year of industrial or academic experience in wireless communications
`
`technology and computer systems, including experience with RFID systems. See
`
`HCL-1014, Patent Owner’s Opening Claim Construction Brief.
`14
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`
`
`
`
`IX. GROUND 1: CLAIMS 1-3, 5, 7, 8, 24-28, AND 30 ARE
`UNPATENTABLE UNDER 35 U.S.C. § 103(A) AS BEING OBVIOUS
`OVER ANDREASSON (HCL-1005) IN VIEW OF SRIHARTO (HCL-
`1006) AND TETHRAKE (HCL-1007).
`
`
`
`Neither Andreasson nor Sriharto nor Tethrake formed a basis for any rejection
`
`during examination of the ’665 Patent. The issue dates of Andreasson and Tethrake,
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`and the publication date of Sriharto, are both more than one year before the effective
`
`filing date of the ’665 Patent and, therefore, these three references qualify as prior
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`art under 35 U.S.C. §103(a).
`
`Andreasson describes RFID-based “systems and methods for tracking,
`
`monitoring and inventorying medical products within a healthcare facility, such as a
`
`hospital.” (HCL-1005 at Col. 2, ll. 41-43). The medical products may obviously be
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`pharmaceuticals (see, e.g., title) and the pharmaceuticals or other medical products
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`may be placed in medical containers, such as bottles, etc., to which RFID tags are
`
`attached to provide any of a multitude of information relative to the medical product
`
`within the container. (Id., at, e.g., Col. 5, ll. 64-67; Col. 6, ll. 4-7 and 20-24; Col. 8,
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`ll. 39-46).
`
`Embodiments of Andreasson may be provided in the form of a medical
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`dispensing unit 410 that can be transported to a desired location within a healthcare
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`facility (e.g., an operating room, a patient’s bedside). (Id., at, e.g., Col. 10, l. 65 -
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`Col. 11, 27.). The dispensing unit 410 also includes an RFID reader with a processor
`15
`
`
`
`
`
`and an antenna, which allows the RFID tags of the pharmaceutical containers to be
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`interrogated while residing within the dispensing unit. (See Id. at, e.g., Col. 6, ll. 13-
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`14 and 36-39). Consequently, in conjunction with the claim charts below, it is
`
`obvious that the dispensing unit 410 of Andreasson, with its RFID reading
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`components and the removable storage compartment(s) 440 containing a number of
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`RFID tagged containers of pharmaceuticals, teaches the “reading station” having a
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`“pharmacy kit container” within which a “pharmacy kit” as recited in the claims
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`below. It is further evident that the embodiments of Andreasson are configured to
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`consider, among many other possible conditions or characteristics, the expiration
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`dates of the medical products to which the RFID tags are attached (see Id. at, e.g.,
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`Col. 6, ll. 23-27; Col. 8, ll. 39-43; Col. 11, ll. 30-33), and to display the results of the
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`pharmacy kit verification process (see Id. at, e.g., Col. 11, ll. 10-13; FIG. 4A; Col.
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`3,, ll. 28-33; Col. 12, ll. 55-64; Col. 14, ll. 42-46; Col. 15, ll. 18-26; Col. 16, ll. 22-
`
`28 and 33-36).
`
`
`
` Sriharto, in a similar manner to Andreasson, teaches systems and methods for
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`containing, controlling, monitoring and inventorying medical material (e.g., drugs)
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`within a healthcare facility, such as with respect to an operating room. System
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`embodiments in Sriharto may be provided in the form of an enclosed and
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`transportable medical container, which is referred to as an intelligent medical
`
`material cart (IMMC). Notably, the IMMC contains multiple receptacles designed
`
`
`
`16
`
`
`
`to hold a plurality of dissimilar medical products. (See, HLC-1006 at, e.g., Abstract;
`
`¶¶ [0017] - [0019], [0025]). While Sriharto teaches many of the same elements of
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`claim 14 that are taught by Andreasson, Sriharto is offered for its more express
`
`teaching that is was also known to look for and verify substitute items within an
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`analyzed kit of items – whether a pharmacy kit or otherwise – and for its teaching
`
`that a “pharmacy kit container” of a “reading station” may be provided with
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`electromagnetic shielding. In this regard, Sriharto teaches that the disclosed IMMC
`
`is programmed – when a given drug is determined by the IMMC to be missing
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`therefrom – to recommend the use of an alternative (substitute) drug that is available
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`in the IMMC and is closely related to the type of the missing prescribed drug. (See
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`Id. at ¶ [0039], ll. 1-18; Claim 9). Sriharto also teaches that the IMMC and/or
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`drawers thereof may include an electromagnetic shielding element to ensure that the
`
`magnetic generated during RFID scanning of a container of medical products inside
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`the IMMC do not pass through the medical container. (See Id. at ¶¶ [0025] and
`
`[0033]; FIG. 2).
`
`Tethrake describes systems, apparatus and methods for tracking, inspecting
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`and verifying the contents of surgical instrument kits using RFID technology. (See
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`HCL-1007 at, e.g., Abstract; Col. 1, ll. 19-23; Col. 6, ll. 32-36; Col. 8, ll. 50-60; Col.
`
`10, ll. 1-5; FIG. 1). While Tethrake teaches some of the same elements of
`
`
`
`17
`
`
`
`Andreasson and/or Sriharto, Tethrake is offered primarily for its more overt
`
`description of a kit and the containing tray, etc.
`
`
`
`1
`
`Claim of the ’665 Patent
`
`A system, comprising:
`
`
`
`
`a pharmacy kit container that
`includes an enclosed space
`for receiving a pharmacy kit
`
`
`Andreasson in view of Sriharto and
`Tethrake
`Andreasson discloses “systems and
`methods for tracking, monitoring and
`inventorying medical products” which
`“may include systems and method for
`monitoring medical products entering
`and/or leaving a pharmacy, for dispensing
`medical products from a medication-
`dispensing unit, and/or for delivering
`medical products to individuals within the
`facility.” See Col. 2, ll. 41-48.
`
`Sriharto discloses a “system for monitoring,
`control and containment of medical
`material in an operation theatre in a
`healthcare facility.” See ¶ [0007], ll. 1-3.
`
`Andreasson discloses a pharmacy kit
`container including an enclosed space
`comprising a dispensing unit having a
`casing within which is located the plurality
`of storage compartments for storing
`medical products therein. See FIG. 4A;
`Col. 10, l. 66 – Col. 11, l. 8. “The
`dispensing unit 410 may include lockable
`drawers that may be pulled out from the
`storage compartments 440.” Col. 11, ll. 6-8;
`Fig. 4A (showing removable, transportable
`drawer).
`
`Sriharto describes a similar container in the
`form of the enclosed intelligent medical
`material cart having a plurality of
`
`
`
`18
`
`
`
`and at least one door,
`
`
`wherein the enclosed space
`is accessible through the at
`least one door,
`
`and wherein the pharmacy
`kit container provides
`electromagnetic shielding;
`and
`
`an information processing
`system communicatively
`coupled to a radio frequency
`identification (RFID) reader,
`
`receptacles for storing a plurality of medical
`products. See FIG. 2; ¶ [0017]; Claim 1.
`
`Andreasson discloses that “Each of the
`storage compartments 440 may store
`medical products for an individual patient
`or for general use. The dispensing unit 410
`may include lockable doors for controlling
`access to the storage compartments 440.”
`See Col. 11, ll. 2-6; Fig. 4A.
`
`Andreasson discloses that “Each of the
`storage compartments 440 may store
`medical products for an individual patient
`or for general use. The dispensing unit 410
`may include lockable doors for controlling
`access to the storage compartments 440.”
`See Col. 11, ll. 2-6; Fig. 4A.
`
`Electromagnetic shielding would be
`inherent to the dispensing unit of
`Andreasson based on the construction of the
`dispensing unit.
`
`Sriharto expressly describes that the
`intelligent medical material cart may
`include a shielding element to ensure that
`the magnetic field and the signals
`emanating from RFID scanning of a
`medical container of medical products
`inside the cart do not pass through the
`medical container. Each drawer may have a
`shielding element, and the cart may also
`have a shielding element. See ¶¶ [0025]
`and [0033]; FIG. 2.
`
`In Andreasson, a “processor is coupled to
`the reader for