PTO/SB/05 (08-08)
`Approved for use through 09/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
`unaer me Paperwork Reduction MCI or 199o, no persons are requirea to respona to a collection or inrormation unless it aispiays a yaw UlVl control numcier
`.
`'`
`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`
`First Inventor
`
`Title
`
`Attorney Docket No.
`
`NEOME-019A3US-G
`
`SORENSEN, John T.
`
`TUBULAR CUTTER DEVICE AND METHOC
`
`(Only for new nonprovisional applications under 37 CFR 1.53(b))
`
`Express Mail Label No. N/A
`
`....
`
`.1
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`
`1.
`
`q Fee Transmittal Form (e.g., PTO/SB/17)
`
`2.
`
`3.
`
`4.
`
`4/ Applicant claims small entity status.
`See 37 CFR 1.27.
`13
`[Total Pages
`4/ Specification
`Both the claims and abstract must start on a new page
`(For information on the preferred arrangement, see MPEP 608.01(a))
`v Drawing(s) (35 U.S.C. 113)
`[Total Sheets
`3
`
`]
`
`[Total Sheets
`5. Oath or Declaration
`a.
`Newly executed (original or copy)
`b. v
`A copy from a prior application (37 CFR 1.63(d))
`for continuation/divisional with Box 18 completed)
`DELETION OF INVENTOR(S)
`Signed statement attached deleting inventor(s)
`name in the prior application, see 37 CFR
`1.63(d)(2) and 1.33(b).
`
`i.
`
`]
`
`]
`
`6.
`
`V Application Data Sheet. See 37 CFR 1.76
`
`7.
`
`q
`
`8.
`
`CD-ROM or CD-R in duplicate, large table or
`augputer Program (Appendix)
`Li Landscape Table on CD
`
`Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. - c. are required)
`q
`a.
`Computer Readable Form (CRF)
`b.
`Specification Sequence Listing on:
`
`ACCOMPANYING APPLICATION PARTS
`
`9. q Assignment Papers (cover sheet & document(s))
`
`Name of Assignee Neomedix Corporation
`
`10. q 37 CFR 3.73(b) Statement
`(when there is an assignee)
`
`❑Power of
`Attorney
`
`11. q English Translation Document (if applicable)
`
`12. q
`
`Lion Disclosure Statement (PTO/SB/08 or PTO-1449)
`Info
`1-ICopies of citations attached
`
`13.
`
`Preliminary Amendment
`
`14. q Return Receipt Postcard (MPEP 503)
`(Should be specifically itemized)
`
`15. q Certified Copy of Priority Document(s)
`(if foreign priority is claimed)
`
`16. q Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`Applicant must attach form PTO/SB/35 or equivalent.
`
`q
`i.
`ii. q
`
`CD-ROM or CD-R (2 copies); or
`Paper
`
`17. q Other:
`
`q
`
`Statements verifying identity of above copies
`c.
`18. If a CONTINUING APPLICATION,
`check appropriate box, and supply the requisite information below and in the first sentence of the
`specification following the title,
`
`or in an Application Data Sheet under 37 CFR 1.76:
`
`q
`
`Continuation
`
`Divisional
`
`q
`
`Continuation-in-part (CIP)
`
`of prior application No.: 1 0/56Q,20.7
`
`Prior application information:
`
`Examiner TRUONG, Kevin Thao
`
`Art Unit: 3734
`
`19. CORRESPONDENCE ADDRESS
`
`The address associated with Customer Number:
`
`33197
`
`OR
`
`Correspondence address below
`
`Name
`
`Address
`
`City
`
`Country
`
`Signature
`
`Name
`(Print/Type)
`
`State
`
`Telephone
`
`Zip Code
`
`Email
`
`/Robert D. Buyan/
`
`Robert D. Buyan
`
`Date June 13, 2011
`Registration No.
`(Attorney/Agent) 32,460
`
`This collection of info mation is required by 37 CFR 1.53(b). The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 12 minutes to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any
`comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer,
`U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`Petitioner - New World Medical
`Ex. 1019, p. 1 of 285
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection
`with your submission of the attached form related to a patent application or patent. Accordingly,
`pursuant to the requirements of the Act, please be advised that: (1) the general authority for the
`collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary;
`and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark
`Office is to process and/or examine your submission related to a patent application or patent. If you do
`not furnish the requested information, the U.S. Patent and Trademark Office may not be able to
`process and/or examine your submission, which may result in termination of proceedings or
`abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the
`Freedom of Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.0 552a). Records from
`this system of records may be disclosed to the Department of Justice to determine whether
`disclosure of these records is required by the Freedom of Information Act.
`2. A record from this system of records may be disclosed, as a routine use, in the course of
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`5. A record related to an International Application filed under the Patent Cooperation Treaty in
`this system of records may be disclosed, as a routine use, to the International Bureau of the
`World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal
`agency for purposes of National Security review (35 U.S.C. 181) and for review pursuant to
`the Atomic Energy Act (42 U.S.C. 218(c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator,
`General Services, or his/her designee, during an inspection of records conducted by GSA as
`part of that agency's responsibility to recommend improvements in records management
`practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall
`be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not
`be used to make determinations about individuals.
`8. A record from this system of records may be disclosed, as a routine use, to the public after
`either publication of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent
`pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
`CFR 1.14, as a routine use, to the public if the record was filed in an application which
`became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspection or an
`issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State,
`or local law enforcement agency, if the USPTO becomes aware of a violation or potential
`violation of law or regulation.
`
`Petitioner - New World Medical
`Ex. 1019, p. 2 of 285
`
`

`

`PTO/SB/14 (11-08)
`Approved for use through 09/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`NEOME-019A3-US-G
`
`Application Number
`
`Title of Invention
`
`TUBULAR CUTTER DEVICE AND METHODS FOR CUTTING AND REMOVING STRIPS OF TISSUE FROM
`THE BODY OF A PATIENT
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`(Legal Representative under 35 U.S.C. 117
`
`0Party of Interest under 35 U.S.C. 118
`
`Remove
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Secrecy Order 37 CFR 5.2
`Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`Applicant Information:
`Applicant 1
`Applicant Authority °' Inventor
`Prefix Given Name
`John
`T.
`Residence Information (Select One) C) US Residency
`City
`State/Province
`Ladera Ranch
`
`Sorensen
`0 Non US Residency 0 Active US Military Service
`CA
`Country of Residence i US
`
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`Address 1
`19 Barnstable Way
`Address 2
`
`US
`
`City
`
`Ladera Ranch
`
`Postal Code
`
`92694
`
`Applicant 2
`Applicant Authority °' Inventor
`Prefix Given Name
`
`State/Province
`
`CA
`
`Countryi US
`
`Remove
`
`°Legal Representative under 35 U.S.C. 117
`
`°Party of Interest under 35 U.S.C. 118
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Michael
`Residence Information (Select One) C) US Residency
`City
`State/Province
`Laguna Niguel
`
`Mittelstein
`0 Non US Residency 0 Active US Military Service
`CA
`Country of Residence i US
`
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`Address 1
`29412 Clipper Way
`Address 2
`
`US
`
`City
`
`Laguna Niguel
`
`Postal Code
`
`92677
`
`Applicant 3
`Applicant Authority °' Inventor
`Prefix Given Name
`
`State/Province
`
`CA
`
`Countryi US
`
`Remove
`
`°Legal Representative under 35 U.S.C. 117
`
`0Party of Interest under 35 U.S.C. 118
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Soheila
`Residence Information (Select One) ® US Residency
`City
`State/Province
`Laguna Niguel
`
`Mirhashemi
`0 Non US Residency 0 Active US Military Service
`Country of Residence i US
`CA
`
`EFS Web 2.2.2
`
`Petitioner - New World Medical
`Ex. 1019, p. 3 of 285
`
`

`

`PTO/SB/14 (11-08)
`Approved for use through 09/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`NEOME-019A3-US-G
`
`Application Number
`
`Title of Invention
`
`TUBULAR CUTTER DEVICE AND METHODS FOR CUTTING AND REMOVING STRIPS OF TISSUE FROM
`THE BODY OF A PATIENT
`
`Citizenship under 37 CFR 1.41(b) i
`
`US
`
`Mailing Address of Applicant:
`
`Address 1
`
`Address 2
`
`29412 Clipper Way
`
`City
`
`Laguna Niguel
`
`State/Province
`
`CA
`
`Postal Code
`
`92677
`
`Countryi US
`
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`Add
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`q
`
`An Address is being provided for the correspondence Information of this application.
`
`Customer Number
`
`33197
`
`Email Address
`
`rbuyan@patlawyers.com
`
`Add Email
`
`Remove Email
`
`Application Information:
`TUBULAR CUTTER DEVICE AND METHODS FOR CUTTING
`TISSUE FROM THE BODY OF A PATIENT
`Attorney Docket Number NEOME-019A3-US-G
`Small Entity Status Claimed X
`
`Title of the Invention
`
`AND REMOVING STRIPS OF
`
`Application Type
`
`Nonprovisional
`
`Subject Matter
`
`Utility
`
`Suggested Class (if any)
`
`Suggested Technology Center (if any)
`
`Sub Class (if any)
`
`3
`
`Suggested Figure for Publication (if any) 2
`
`Total Number of Drawing Sheets (if any)
`Publication Information:
`q
`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish. I hereby request that the attached application not be published under 35 U.S.
`C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of
`an application filed in another country, or under a multilateral international agreement, that requires publication at
`eighteen months after filing.
`
`q
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Enter either Customer Number or
`complete
`the Representative Name
`section below.
`If both
`are completed the Customer Number will be used for the Representative Information during processing.
`
`sections
`
`Please Select One:
`
`C) Customer Number
`
`0 US Patent Practitioner
`
`0
`
`Limited Recognition (37 CFR 11.9)
`
`EFS Web 2.2.2
`
`Petitioner - New World Medical
`Ex. 1019, p. 4 of 285
`
`

`

`PTO/SB/14 (11-08)
`Approved for use through 09/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`NEOME-019A3-US-G
`
`Application Number
`
`Title of Invention
`
`TUBULAR CUTTER DEVICE AND METHODS FOR CUTTING AND REMOVING STRIPS OF TISSUE FROM
`THE BODY OF A PATIENT
`
`Customer Number
`
`33197
`
`Domestic Benefit/National Stage Information:
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate National Stage
`entry from a PCT application. Providing this information in the application data sheet constitutes the specific reference required by
`35 U.S.C. 119(e) or 120, and 37 CFR 1.78(a)(2) or CFR 1.78(a)(4 , and need not otherwise be made part of the specification.
`
`Prior Application Status Pending
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`Division of
`
`10560267
`
`2006-05-11
`
`Prior Application Status Expired
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`10560267
`
`a 371 of international
`
`PCT/US2004/018488
`
`2004-06-10
`
`Prior Application Status Expired
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`PCT/US2004/018488
`
`non provisional of
`
`60477258
`
`2003-06-10
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`Add
`
`Foreign Priority Information:
`This section allows for the applicant to claim benefit of foreign priority and to identify any prior foreign application for which priority is
`not claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U.S.C. 119(b)
`and 37 CFR 1.55(a).
`
`Remove
`
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`
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`
`Parent Filing Date (YYYY-MM-DD)
`
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`
`C) Yes 0 No
`
`Additional Foreign Priority Data may be generated within this
`Add button.
`Assignee Information:
`Providing this information in the application data sheet does not substitute for compliance with any requirement of part 3 of Title 37
`of the CFR to have an assignment recorded in the Office.
`
`form by
`
`selecting
`
`the
`
`Add
`
`Assignee 1
`If the Assignee is an Organization check here.
`
`X
`
`Organization Name
`
`Neomedix Corporation
`
`Remove
`
`EFS Web 2.2.2
`
`Petitioner - New World Medical
`Ex. 1019, p. 5 of 285
`
`

`

`PTO/SB/14 (11-08)
`Approved for use through 09/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`NEOME-019A3-US-G
`
`Application Number
`
`Title of Invention
`
`TUBULAR CUTTER DEVICE AND METHODS FOR CUTTING AND REMOVING STRIPS OF TISSUE FROM
`THE BODY OF A PATIENT
`
`Mailing Address Information:
`
`Address 1
`
`Address 2
`
`City
`
`Country i US
`
`Phone Number
`
`Email Address
`
`15042 Parkway Loop # A
`
`Tustin
`
`State/Province
`
`CA
`
`Postal Code
`
`Fax Number
`
`92780-6528
`
`Additional Assignee Data may be generated within this form by selecting the Add
`button.
`
`Add
`
`Signature:
`A signature of the applicant or representative is required in accordance with 37 CFR 1.33 and 10.18. Please see 37
`CFR 1.4(d) for the form of the signature.
`
`Signature
`
`/Robert D. Buyan/
`
`Date (YYYY-MM-DD) 2011-06-13
`
`First Name
`
`Robert
`
`Last Name
`
`Buyan
`
`Registration Number
`
`32460
`
`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which
`is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This
`collection is estimated to take 23 minutes to complete, including gathering, preparing, and submitting the completed application data
`sheet form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to
`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR
`COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`EFS Web 2.2.2
`
`Petitioner - New World Medical
`Ex. 1019, p. 6 of 285
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the attached form related to
`a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised that: (1) the general authority for the collection
`of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is
`used by the U.S. Patent and Trademark Office is to process and/or examine your submission related to a patent application or patent. If you do not
`furnish the requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act (5 U.S.C. 552)
`and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the Department of Justice to determine
`whether the Freedom of Information Act requires disclosure of these records.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or
`administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an
`individual, to whom the record pertains, when the individual has requested assistance from the Member with respect to the subject matter of
`the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for the information in
`order to perform a contract. Recipients of information shall be required to comply with the requirements of the Privacy Act of 1974, as
`amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records may be disclosed,
`as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of National Security
`review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or his/her designee,
`during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records
`management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the
`GSA regulations governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive. Such
`disclosure shall not be used to make determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of the application pursuant
`to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
`CFR 1.14, as a routine use, to the public if the record was filed in an application which became abandoned or in which the proceedings were
`terminated and which application is referenced by either a published application, an application open to public inspections or an issued
`patent.
`
`9.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law enforcement agency, if the
`USPTO becomes aware of a violation or potential violation of law or regulation.
`
`EFS Web 2.2.2
`
`Petitioner - New World Medical
`Ex. 1019, p. 7 of 285
`
`

`

`TUBULAR CUTTER DEVICE AND METHODS FOR CUTTING
`AND REMOVING STRIPS OF TISSUE FROM THE BODY
`OF A PATIENT
`
`RELATED APPLICATIONS
`[0001] This application is a division of copending United States Patent
`Application No. 10/560,267 filed May 11, 2006, which is a 35 U.S.C. §371
`national
`stage
`of PCT
`International Patent Application No.
`PCT/US2004/018488 filed June 10, 2004, which claims priority to United States
`Provisional Patent Application No. 60/477,258 filed on June 10, 2003, the entire
`disclosure of each such prior application being expressly incorporated herein
`by reference.
`
`BACKGROUND OF THE INVENTION
`[0002] There are numerous medical and surgical procedures in which it is
`desirable to cut and remove a strip of tissue of controlled width from the body of
`a human or veterinary patient. For example, it may sometimes be desirable to
`form an incision of a controlled width (e.g., an incision that is wider than an
`incision made by a typical scalpel or cutting blade) in the skin, mucous
`membrane, tumor, organ or other tissue or a human or animal. Also, it may
`sometimes desirable to remove a strip or quantity of tissue from the body of a
`human or animal for use as a biopsy specimen, for chemical/biological analysis,
`for retention or archival of DNA identification purposes, etc. Also, some
`surgical procedures require removal of a strip of tissue of a known width from
`an anatomical location within the body of a patient.
`[0003] One surgical procedure wherein a strip of tissue of a known width is
`removed from an anatomical location within the body of a patient is an
`ophthalmological procedure used to treat glaucoma. This ophthalmological
`procedure is sometimes refered to as a goniectomy.
`In a goniectomy
`procedure, a device that is operative to cut or ablate a strip of tissue of
`approximately 2-10 mm in length and about 50-200 pm in width is inserted into
`the anterior chamber of the eye and used to remove a full thickness strip of
`tissue from the trabecular meshwork. The trabecular meshwork is a loosly
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`Ex. 1019, p. 8 of 285
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`organized, porous network of tissue that overlies a collecting canal known as
`Schlemm's canal. A fluid, known as aqueous humor, is continually produced in
`the anterior chamber of the eye. In normal individuals, aqueous humor flows
`through the trabecular meshwork, into Shlemm's Canal and out of the eye
`through a series of ducts. In patients who suffer from glaucoma, the drainage of
`aqueous humor from the eye may be impared by elevated flow resistance
`through the trabecular meshwork, thereby resulting in an increase in
`intraoccular pressure. The goniectomy procedure can restore normal drainage
`of aqueous humor from the eye by removing a full thickness segment of the
`trabecular meshwork, thus allowing the aqueous humor to drain through the
`open area from which the strip of trabecular meshwork has been removed. The
`goniectomy procedure and certain prior art instruments useable to perform
`such procedure are described in United States Patent Application Serial No.
`10/052,473 published as No. 2002/011608A1 (Baerveldt), the entirety of which
`is expressly incorporated herein by reference.
`[0004] At present there remains a need in the art for the development of simple,
`inexpensive and accurate instruments useable to perform the goniectomy
`procedure as well as other procedures where it is desired to remove a strip of
`tissue from a larger mass of tissue.
`
`SUMMARY OF THE INVENTION
`[0005] The present invention provides a device for cutting a strip of tissue of
`approximate width W from a mass of tissue. The device generally comprises a)
`an elongate cutting tube that has a distal end and a lumen that opens through
`an opening in the distal end and b) first and second cutting edges formed on
`generally opposite edges of the distal end of the cutting tube and separated by
`a distance D. The cutting tube is advanceable through tissue such that the first
`and second cutting edges will cut a strip of tissue having approximate width W,
`wherein the approximate width W is approximately equal to the distance D
`between the first and second cutting edges. In some embodiments, the strip of
`tissue may be aspirated or otherwise removed through the lumen of the cutter
`tube.
`In some embodiments, the device may include apparatus useable to
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`Ex. 1019, p. 9 of 285
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`

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`sever (e.g., transversely cut or transect) the strip of tissue when the strip of
`tissue has reached a desired length.
`[0006] Further in accordance with the invention there is provided a method for
`cutting a strip of tissue of width W from a tissue mass. This method generally
`comprises the steps of a) providing a device that comprises i) an elongate
`cutting tube that has a distal end and a lumen that opens through an opening in
`the distal end and ii) first and second cutting edges formed on generally
`opposite edges of the distal end of the cutting tube and separated by a distance
`D that is approximately equal to the width W of the strip of tissue to be cut; and
`b) advancing the distal end of the cutting tube through the mass of tissue such
`that the first and second cutting edges cut a strip of tissue of approximate width
`W. Further aspects and elements of the invention will be understood by those
`of skill in the art upon reading the detailed description of specific examples set
`forth herebelow.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`[0007] Figure 1 is a perspective view of a system incorporating a needle cutting
`device of the present invention.
`[0008] Figure 2 is an enlarged perspective view of section 2 of Figure 1.
`[0009] Figures 3A-3D show various steps in a method for manufacturing a
`needle cutter of the present invention.
`[0010] Figure 4 is a side view of a distal portion of a needle cutter device of the
`present invention being used to cut a strip of tissue of approximate width W.
`[0011] Figure 5 is a perspective view of the distal portion of a needle cuter
`device of the present invention incorporating apparatus for severing a strip of
`tissue cut by the needle cutter device after the strip of tissue has reached a
`desired length.
`[0012] Figure 6 is a side view of the distal portion of another embodiment of a
`needle cutter device of the present invention having a plurality of curves or
`bends formed in the cutting tube.
`
`DETAILED DESCRIPTION
`[0013] The following detailed description, and the drawings to which it refers,
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`Ex. 1019, p. 10 of 285
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`are provided for the purpose of describing and illustrating certain preferred
`embodiments or examples of the invention only, and no attempt has been made
`to exhaustively describe all possible embodiments or examples of the
`invention. Thus, the following detailed description and the accompanying
`drawings shall not be construed to limit, in any way, the scope of the claims
`recited in this patent application and any patent(s) issuing therefrom.
`[0014] One example of a needle cutter device 10 of the present invention is
`shown in Figures 1-4. This needle cutter device 10 generally comprises an
`elongate cutting tube 14 that has a distal end and a lumen 27 that opens
`through an opening in the distal end. First and second cutting edges 20, 22 are
`formed on generally opposite edges of the distal end of the cutting tube 14.
`These first and second cutting edges 20, 22 are separated by a distance D, as
`shown in the distal end view of Figure 3B.
`In the particular example shown in
`the drawings, the first and second cutting edges 20, 22 are located on opposite
`lateral sides of the distal end of the cutting tube 14 and a blunt, protruding tip 24
`is located on the bottom of the distal end of the cutting tube. Also, a blunt edge
`26 is located at the top of the distal end of the cutting tube 14. Thus, only the
`lateral cutting edges 20, 22 are sharp and intended to cut tissue. The blunt,
`protruding tip 24 can, in some applications, be configured and used to facilitate
`insertion of the device 10 to its intended location and/or the blunt protruding tip
`24 may be placed in an anatomical or man made grove or channel (e.g.,
`Schlemm's Canal of the eye) such that it will then advance through the channel
`or groove and guide the advancement and positioning of the remainder of the
`device 10.
`[0015] One or more bends or curves may optionally be formed in the cutting
`tube 14 to facilitate its use for its intended purpose. For example, in the
`embodiment of the device 10 shown in Figure 2, a single bend 17 of
`approximately 90 degrees is formed near the distal end of the cutting tube 14.
`In the embodiment of the device 10b shown in Figure 6, two separate bends of
`approximately 90 degrees each are formed at spaced apart locations on the
`cutting tube 14, thereby giving the cutting tube 14 a generally U shaped
`configuration. It will be appreciated that any number of bends or curves, in any
`direction and of any severity may be formed in the cutting tube 14 to facilitate its
`4
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`

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`use in specific procedures or to enable it to be inserted through tortuous
`anatomical channels of the body. In most cases, the degree of curvature in
`embodiments where a single bend or curve is formed will be between
`approximately 30 and approximately 90 degrees and in embodiments where
`more than one bend or curve are formed in the cutting tube 14 each such bend
`or curve will typically be between approximately 15 to approximately 90
`degree