Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 1 of 64 PageID #: 5289
`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 1 of 64 PagelD #: 5289
`
`
`
`
`
`EXHIBIT 9
`EXHIBIT 9
`
`

`

`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 2 of 64 PageID #: 5290
`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 2 of 64 PagelD #: 5290
`
`Express Mail Label No.
`
`EQ 734648969US
`
`aneyometnn fore
`
`
`
`~ OTH
`
`
`a a,
`~CO
`
`
`2
`~
`
`° x
`
`oo
`
`©
`
`wy
`
`]
`
`i.
`
`
`
`
`
`PTO/SB/05 (09-04)
`Approved for use through 07/31/2006. OMB 0651-0032
`U.S. Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respondto a collection of information unless it displays
`a valid OMB control number.
`UTILITY
`
`
`PATENT APPLICATION
`
`TRANSMITTAL
`
` (Only for new nonprovisional applications under 37 CFR 1.53(b))
`
`
`Commissionerfor Patents
`
`
`
`ADDRESSTO:
`P.O. Box 1450
`APPLICATION ELEMENTS
` oO—
`
`-
`Alexandria VA 22313-1450
`See MPEP chapter 600 concemingutility patent application contents.
`
`
`
`
`ACCOMPANYING APPLICATION PARTS— 7
`1.
`Fee Transmittal Form (e.g., PTO/SB/17)
`(Submit an ofginal and a duplicate for fee processing)
`2.0) Applicant claims small entity status.
`9. CL) Assignment Papers (cover sheet & document(s))
`
`See 37 CFR 1.27.
`3.
`32
`[Total Pages.
`Specification
`]
`
`Nameof Assignee.
`Both the claims and abstract muststart on a new page
`~
`
`(For information on the preferred arrangement, see MPEP 608.01(a))
`4.[¥] Drawing(s) (35 U.S.C. 113)
`[Total Sheets
`10
`]
`
`
`
`
`10. [_] 37 CFR 3.73(b) Statement
`[_]Powerof
`5. Oath or Declaration
`[Total Sheets
`2
`a.
`Newly executed(origina! or copy)
`(whenthere is an assignee)
`Attorney
`
`
`
`b.
`Acopyfrom a prior application (37 CFR 1.63(d)}
`
`for continuation/divisional with Box 18 completed)
`11. [_] English Translation Document(if applicable)
`DELETION OF INVENTOR(S)
`
`
`Signed statement attached deleting inventor(s)
`
`12.0] Information Disclosure Statement (PTO/SB/08 or PTO-1449)
`
`namein the prior application, see 37 CFR
`Copies ofcitations attached
`
`
`
`
`1.63(d)(2) and 1.33(b).
`
`
`
`6.[__] Application Data Sheet. See 37 CFR 1.76
`13. preliminary Amendment
`
`7...)
`cD-ROM or CD-Rin duplicate,large table or
`
`
`14,
`Return Receipt Postcard (MPEP 503)
`puter Program (Appendix)
`(Should be specifically itemized)
`
`Landscape Table on CD
`
`
`
`
`15. [7] Certified Copy of Priority Document(s)
`8. Nucleotide and/or Amino Acid Sequence Submission
`’
`, yr
`.
`(if foreign priority is claimed)
`(if applicable, items a.—c. are required)
`
`a.
`Computer Readable Form (CRF)
`
`
`16. | Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`b.
`Specification Sequence Listing on:
`
`
`Applicant must attach form PTO/SB/35 or equivalent.
`i £2 cp-Romor CD-R (2 copies); or
`
`
`
`17. other:
`i. [-)
`Paper
`
` c. LJ Statements verifying identity of above copies
`
`18. If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below andin the first sentence of the
`specification following the title, or in an Application Data Sheet under 37 CFR 1.76:
`
`
`
`Continuation
`[1 divisional
`CJ Continuation-in-part (CIP)
`
`
`Prior application information:
`Examiner Gary Jackson
`
`of prior application No.:10/299,471........0.0000...
`
`Art Unit:
`
`:
`
`19. CORRESPONDENCE ADDRESS
`
`
`
`The address associated with Customer Number.
`
`021394
`
`OR [| Correspondence address below
`
`
`
`ae
`AaN
`
`yet
`
`Registration No.
`:
`ame
`[43-485
`‘Attomey/Agent)
`Richard R. Batt
`Print/Type
`This collection of information 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 uponthe individual case. Any
`comments on the amountof 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
`FORMSTO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`if you need assistance in completing the form, call 1-800-PTO-9199 and select option2.
`
`1
`
`

`

`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 3 of 64 PageID #: 5291
`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 3 of 64 PagelD #: 5291
`
`PTO/SBN17 (12-04v2)
`°
`Approved for use through 07/31/2006. OMB 0651-0032
`~
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`&
`Paar the Panerwark Redurctinn Act af 1995 nao nersans are required to resnand to a enilectinn of infarmatian unlessit disolavs a valid OMR enntrol numher
`
`Cc
`Effective on 12/08/2004.
`
`&pps pursuantto the Consolidated Appropriations Act. 2005 (H.R. 4818).
`
`Complete if Known
`
`902080
`
`r
`
`(8)
`
`4,000.00
`
`
`
`METHOD OF PAYMENT(checkall that apply)
`
`(A
`Notyet assigned
`
`
`3 FEE TRANSMITTAL
`
`3
`For FY 2005
`
`[ExaminerName__[Notyetassigned
`
`Applicant claims small entity status. See 37 CFR 1.27
`Not yet assigned
`
`
`Notyet assigned
`
`OP-16-1
`
`
`
`["] Check L Credit Card L_]Money Order LC NoneCJother (please identify):
`
`
`Deposit Account Oeposit Account Number:50-0359 Deposit Account Name:_ ArthroCare Corporation
`
`
`For the above-identified deposit account, the Director is hereby authorized to: (check all that apply)
`
`
`Chargefee(s) indicated below
`[J Charge fee(s) indicated below, except forthefiling fee
`Charge any additional fee(s) or underpayments of fee(s)
`Credit any overpayments
`WV indes 37 CFR 1.16 and 1.17
`y
`overpay
`WARNING:Information on this form may become public. Credit card information should not be included onthis form. Provide credit card
`
`information and authorization on PTO-2038.
`
`
`FEE CALCULATION
`
`
`1. BASIC FILING, SEARCH, AND EXAMINATION FEES
`SEARCH FEES
`EXAMINATION FEES
`FILINGFEES '
`
`
`mall
`Entity
`Small Entity
`Small Entity
`Fee ($)
`Fee ($)
`Fee ($) ee rN
`Fee ($) — 3)
`300
`150
`500
`250
`200
`100
`200
`100
`100
`50
`130
`65
`200
`100
`300
`150
`160
`80
`
`Application Type
`Utility
`Design
`Plant
`
`Fees Paid ($)
`4000
`
`
`
`
`
`
`
`
`
`Reissue
`
`300
`
`150
`
`500
`
`250
`
`600
`
`300
`
`200
`
`100
`
`0
`
`0
`
`0
`
`0
`
`Fee Paid ($)
`
`=
`
`Fee Paid ($)
`
`
`
`
`
`
`
`
`
`Provisional
`SmailEntity
`2. EXCESS CLAIM FEES
`
`Fee DescriptionFee($) Fee ($)
`Eachclaim over 20 (including Reissues)
`50
`25
`Each independent claim over 3 (including Reissues)
`200
`100
`Multiple dependent claims
`360
`180
`Fee ($)
`Total Claims
`Extra Claims
`Multiple Dependent Claims
`50
`x
`8
`- 20 or HP =
`0
`Fee ($)
`Fee Paid ($)
`HP= highest numberoftotal claims paidfor, if greater than 20.
`Indep. Claims
`Extra Claims .
`Fee ($)
`=
`3
`-3orHP =
`0
`x
`200
`HP = highest numberof independentclaimspaid for, if greater than 3.
`.
`;
`3. APPLICATION SIZE FEE |
`If the specification and drawings exceed 100 sheets of paper (excluding electronically filed sequence or computer
`listings under 37 CFR 1.52(e)), the application size fee due is $250 ($125 for small entity) for each additional 50
`sheets or fraction thereof. See 35 U.S.C. 41(a)(1)(G) and 37 CFR 1 16(s).
`Total Sheets
`Extra Sheets
`Numberof each additional 50 or fraction thereof
`- 100 =
`/50=
`(round up toa whole number)
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Fee ($)
`
`Fee Paid ($)
`
`
`
`
`4. OTHER FEE(S)
`$130 fee (no smallentity discount)
`Non-English Specification,
`Other(e.g., late filing surcharge):
`
`SUBMITTED BY
`
`Fees Paid ($)
`
`
`
`Name (Print/Type)] Richard R. BattDatege“2Yo &
`
`
`This collection of information is required by 37 CFR 1.136. The information is required to obtain or retain a benefit by the public whichisto file (and by the
`USPTOto process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 30 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Timewill vary depending upon the individual case. Any comments
`on the amountof time you require to completethis 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 FORMSTO THIS
`ADDRESS. SEND TO: Commissionerfor 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.
`
`2
`
`

`

`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 4 of 64 PageID #: 5292
`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 4 of 64 PagelD #: 5292
`
`‘Express Mail” mailing label number: EQ 734648969 US
`
`Date ofDeposit:
`
`sLNIO
`
`I hereby certify that I am causing this paper or fee to be
`deposited with the United States Postal Service “Express Mail
`Post Office to Addressee” service on the date indicated below
`and that this paper or fee has been addressedto the
`Commissionerfor Patents, P.O. Box 1450, Alexandria, Virginia
`22313-1450
`
`Dawn Rose
`
`on mailing paperor fee)
`
`prin
`
`(Signature orpersonspaline piperfee
`
`(Date signed)
`
`
`
`
`3
`
`

`

`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 5 of 64 PageID #: 5293
`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 5 of 64 PagelD #: 5293
`
`Express Mail Label No.
`
`EQ 734648969US
`
`aneyometnn fore
`
`
`
`~ OTH
`
`
`a a,
`~CO
`
`
`2
`~
`
`° x
`
`oo
`
`©
`
`wy
`
`]
`
`i.
`
`
`
`
`
`PTO/SB/05 (09-04)
`Approved for use through 07/31/2006. OMB 0651-0032
`U.S. Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respondto a collection of information unless it displays
`a valid OMB control number.
`UTILITY
`
`
`PATENT APPLICATION
`
`TRANSMITTAL
`
` (Only for new nonprovisional applications under 37 CFR 1.53(b))
`
`
`Commissionerfor Patents
`
`
`
`ADDRESSTO:
`P.O. Box 1450
`APPLICATION ELEMENTS
` oO—
`
`-
`Alexandria VA 22313-1450
`See MPEP chapter 600 concemingutility patent application contents.
`
`
`
`
`ACCOMPANYING APPLICATION PARTS— 7
`1.
`Fee Transmittal Form (e.g., PTO/SB/17)
`(Submit an ofginal and a duplicate for fee processing)
`2.0) Applicant claims small entity status.
`9. CL) Assignment Papers (cover sheet & document(s))
`
`See 37 CFR 1.27.
`3.
`32
`[Total Pages.
`Specification
`]
`
`Nameof Assignee.
`Both the claims and abstract muststart on a new page
`~
`
`(For information on the preferred arrangement, see MPEP 608.01(a))
`4.[¥] Drawing(s) (35 U.S.C. 113)
`[Total Sheets
`10
`]
`
`
`
`
`10. [_] 37 CFR 3.73(b) Statement
`[_]Powerof
`5. Oath or Declaration
`[Total Sheets
`2
`a.
`Newly executed(origina! or copy)
`(whenthere is an assignee)
`Attorney
`
`
`
`b.
`Acopyfrom a prior application (37 CFR 1.63(d)}
`
`for continuation/divisional with Box 18 completed)
`11. [_] English Translation Document(if applicable)
`DELETION OF INVENTOR(S)
`
`
`Signed statement attached deleting inventor(s)
`
`12.0] Information Disclosure Statement (PTO/SB/08 or PTO-1449)
`
`namein the prior application, see 37 CFR
`Copies ofcitations attached
`
`
`
`
`1.63(d)(2) and 1.33(b).
`
`
`
`6.[__] Application Data Sheet. See 37 CFR 1.76
`13. preliminary Amendment
`
`7...)
`cD-ROM or CD-Rin duplicate,large table or
`
`
`14,
`Return Receipt Postcard (MPEP 503)
`puter Program (Appendix)
`(Should be specifically itemized)
`
`Landscape Table on CD
`
`
`
`
`15. [7] Certified Copy of Priority Document(s)
`8. Nucleotide and/or Amino Acid Sequence Submission
`’
`, yr
`.
`(if foreign priority is claimed)
`(if applicable, items a.—c. are required)
`
`a.
`Computer Readable Form (CRF)
`
`
`16. | Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`b.
`Specification Sequence Listing on:
`
`
`Applicant must attach form PTO/SB/35 or equivalent.
`i £2 cp-Romor CD-R (2 copies); or
`
`
`
`17. other:
`i. [-)
`Paper
`
` c. LJ Statements verifying identity of above copies
`
`18. If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below andin the first sentence of the
`specification following the title, or in an Application Data Sheet under 37 CFR 1.76:
`
`
`
`Continuation
`[1 divisional
`CJ Continuation-in-part (CIP)
`
`
`Prior application information:
`Examiner Gary Jackson
`
`of prior application No.:10/299,471........0.0000...
`
`Art Unit:
`
`:
`
`19. CORRESPONDENCE ADDRESS
`
`
`
`The address associated with Customer Number.
`
`021394
`
`OR [| Correspondence address below
`
`
`
`ae
`AaN
`
`yet
`
`Registration No.
`:
`ame
`[43-485
`‘Attomey/Agent)
`Richard R. Batt
`Print/Type
`This collection of information 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 uponthe individual case. Any
`comments on the amountof 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
`FORMSTO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`if you need assistance in completing the form, call 1-800-PTO-9199 and select option2.
`
`4
`
`

`

`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 6 of 64 PageID #: 5294
`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 6 of 64 PagelD #: 5294
`
`PTO/SBN17 (12-04v2)
`°
`Approved for use through 07/31/2006. OMB 0651-0032
`~
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`&
`Paar the Panerwark Redurctinn Act af 1995 nao nersans are required to resnand to a enilectinn of infarmatian unlessit disolavs a valid OMR enntrol numher
`
`Cc
`Effective on 12/08/2004.
`
`&pps pursuantto the Consolidated Appropriations Act. 2005 (H.R. 4818).
`
`Complete if Known
`
`902080
`
`r
`
`(8)
`
`4,000.00
`
`
`
`METHOD OF PAYMENT(checkall that apply)
`
`(A
`Notyet assigned
`
`
`3 FEE TRANSMITTAL
`
`3
`For FY 2005
`
`[ExaminerName__[Notyetassigned
`
`Applicant claims small entity status. See 37 CFR 1.27
`Not yet assigned
`
`
`Notyet assigned
`
`OP-16-1
`
`
`
`["] Check L Credit Card L_]Money Order LC NoneCJother (please identify):
`
`
`Deposit Account Oeposit Account Number:50-0359 Deposit Account Name:_ ArthroCare Corporation
`
`
`For the above-identified deposit account, the Director is hereby authorized to: (check all that apply)
`
`
`Chargefee(s) indicated below
`[J Charge fee(s) indicated below, except forthefiling fee
`Charge any additional fee(s) or underpayments of fee(s)
`Credit any overpayments
`WV indes 37 CFR 1.16 and 1.17
`y
`overpay
`WARNING:Information on this form may become public. Credit card information should not be included onthis form. Provide credit card
`
`information and authorization on PTO-2038.
`
`
`FEE CALCULATION
`
`
`1. BASIC FILING, SEARCH, AND EXAMINATION FEES
`SEARCH FEES
`EXAMINATION FEES
`FILINGFEES '
`
`
`mall
`Entity
`Small Entity
`Small Entity
`Fee ($)
`Fee ($)
`Fee ($) ee rN
`Fee ($) — 3)
`300
`150
`500
`250
`200
`100
`200
`100
`100
`50
`130
`65
`200
`100
`300
`150
`160
`80
`
`Application Type
`Utility
`Design
`Plant
`
`Fees Paid ($)
`4000
`
`
`
`
`
`
`
`
`
`Reissue
`
`300
`
`150
`
`500
`
`250
`
`600
`
`300
`
`200
`
`100
`
`0
`
`0
`
`0
`
`0
`
`Fee Paid ($)
`
`=
`
`Fee Paid ($)
`
`
`
`
`
`
`
`
`
`Provisional
`SmailEntity
`2. EXCESS CLAIM FEES
`
`Fee DescriptionFee($) Fee ($)
`Eachclaim over 20 (including Reissues)
`50
`25
`Each independent claim over 3 (including Reissues)
`200
`100
`Multiple dependent claims
`360
`180
`Fee ($)
`Total Claims
`Extra Claims
`Multiple Dependent Claims
`50
`x
`8
`- 20 or HP =
`0
`Fee ($)
`Fee Paid ($)
`HP= highest numberoftotal claims paidfor, if greater than 20.
`Indep. Claims
`Extra Claims .
`Fee ($)
`=
`3
`-3orHP =
`0
`x
`200
`HP = highest numberof independentclaimspaid for, if greater than 3.
`.
`;
`3. APPLICATION SIZE FEE |
`If the specification and drawings exceed 100 sheets of paper (excluding electronically filed sequence or computer
`listings under 37 CFR 1.52(e)), the application size fee due is $250 ($125 for small entity) for each additional 50
`sheets or fraction thereof. See 35 U.S.C. 41(a)(1)(G) and 37 CFR 1 16(s).
`Total Sheets
`Extra Sheets
`Numberof each additional 50 or fraction thereof
`- 100 =
`/50=
`(round up toa whole number)
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Fee ($)
`
`Fee Paid ($)
`
`
`
`
`4. OTHER FEE(S)
`$130 fee (no smallentity discount)
`Non-English Specification,
`Other(e.g., late filing surcharge):
`
`SUBMITTED BY
`
`Fees Paid ($)
`
`
`
`Name (Print/Type)] Richard R. BattDatege“2Yo &
`
`
`This collection of information is required by 37 CFR 1.136. The information is required to obtain or retain a benefit by the public whichisto file (and by the
`USPTOto process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 30 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Timewill vary depending upon the individual case. Any comments
`on the amountof time you require to completethis 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 FORMSTO THIS
`ADDRESS. SEND TO: Commissionerfor 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.
`
`5
`
`

`

`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 7 of 64 PageID #: 5295
`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 7 of 64 PagelD #: 5295
`
`‘Express Mail” mailing label number: EQ 734648969 US
`
`Date ofDeposit:
`
`sLNIO
`
`I hereby certify that I am causing this paper or fee to be
`deposited with the United States Postal Service “Express Mail
`Post Office to Addressee” service on the date indicated below
`and that this paper or fee has been addressedto the
`Commissionerfor Patents, P.O. Box 1450, Alexandria, Virginia
`22313-1450
`
`Dawn Rose
`
`on mailing paperor fee)
`
`prin
`
`(Signature orpersonspaline piperfee
`
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`Case 2:15-cv-01047-RSP Document 100-9 Filed 04/08/16 Page 8 of 64 PageID #: 5296
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`UNITED STATES PATENT APPLICATION
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`DEVICES AND METHODS FOR REPAIRING SOFT TISSUE
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`SETH FOERESTER
`NORMAN GORDON
`MARK RITCHART
`GREGORY BAIN
`GEORGE WHITE
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`DEVICES AND METHODS FOR REPAIRING SOFT TISSUE
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`CROSS-REFERENCE TO RELATED CASE
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`This application is a continuation application of co-pending US Patent
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`application serial number 10/299,171 to Seth Foerester, et al. filed November 19,
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`2002, the subject matter being incorporated herein by referenceinits entirety.
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`Background of the Invention
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`The present invention relates to devices and methodsfor repairing soft
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`tissue, and moreparticularly to devices and methodsfor arthroscopic repair of a
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`torn rotator cuff.
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`It is an increasingly common problem for tendonsand other soft, connective
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`tissues to tear or to detach from associated bone. One such type oftear or
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`detachmentis a “rotator cuff’ tear, wherein the supraspinatus tendon separates from
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`the humerus, causing pain andlossofability to elevate and externally rotate the
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`arm. Complete separation can occur if the shoulder is subjected to gross trauma,
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`but typically, the tear begins as a small lesion, especially in older patients.
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`To repair a torn rotator cuff, the typical course today is to do so surgically,
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`through a large incision. This approach is presently taken in almost 99% of rotator
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`cuff repair cases. There are two types of open surgical approachesfor repair of the
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`rotator cuff, one known as the “classic open” and the other as the “mini-open’’. The
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`classic open approachrequiresa large incision and complete detachmentofthe deltoid
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`muscle from the acromionto facilitate exposure. The cuff is debrided to ensure suture
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`attachmentto viable tissue and to create a reasonable edge approximation. In addition,
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`the humeral head is abraded or notched at
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`the proposed soft
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`tissue to bone
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`reattachmentpoint, as healing is enhanced on a raw bone surface. A series of small
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`diameterholes,referred to as “‘transosseous tunnels”, are “punched” through the bone
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`laterally from the abraded or notched surface to a point on the outside surface of the
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`greater tuberosity, commonly a distance of 2 to 3 cm. Finally, the cuff is sutured and
`secured to the bone by pulling the suture ends through the transosseous tunnels and
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`tying them together using the bone between twosuccessive tunnelsas a bridge, after
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`which the deltoid muscle must be surgically reattached to the acromion. Because of
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`this maneuver,
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`the deltoid requires postoperative protection,
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`thus retarding
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`rehabilitation and possibly resulting in residual weakness. Complete rehabilitation
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`takes approximately 9 to 12 months.
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`The mini-open technique, which represents the current growing trend and the
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`majority of all surgical repair procedures, differs from the classic approach by gaining
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`access through a smaller incision and splitting rather than detaching the deltoid.
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`Additionally, this procedure is typically performed in conjunction with arthroscopic
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`acromial decompression. Oncethe deltoidis split, it is retracted to expose the rotator
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`cuff tear. As before, the cuff is debrided, the humeral head is abraded, and the so-
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`called “‘transosseous tunnels”, are “punched”through the bone or suture anchors are
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`inserted. Following the suturing of the rotator cuff to the humeral head, the split
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`deltoid is surgically repaired.
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`Although the above described surgical techniques are the current standard of
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`care for rotator cuff repair, they are associated with a great deal of patient discomfort
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`and a lengthy recovery time, ranging from at least four months to one year or more. It
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`is the above described manipulation of the deltoid muscle together with the large skin
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`incision that causes the majority of patient discomfort and an increased recovery time.
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`Less invasive arthroscopic techniques are beginning to be developed in an
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`effort to address the shortcomings of open surgical repair. Working through small
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`trocar portals that minimize disruption ofthe deltoid muscle, a few surgeons have been
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`able to reattach the rotator cuff using various bone anchorandsuture configurations.
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`The rotator cuff is sutured intracorporeally and an anchoris driven into boneat a
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`location appropriate for repair. Rather than thread the suture through transosseous
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`tunnels which are difficult or impossible to create arthroscopically using current
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`techniques, the repair is completed by tying the cuff down against bone using the
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`anchor and suture. Early results of less invasive techniques are encouraging, with a
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`substantial reduction in both patient recovery time and discomfort.
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`Unfortunately, the skill level required to facilitate an entirely arthroscopic
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`repair of the rotator cuff is inordinately high. Intracorporeal suturing is clumsy and
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`time consuming, andonly the simplest stitch patterns can be utilized. Extracorporeal
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`knot tying is somewhatless difficult, but the tightness of the knotsis difficult to judge,
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`and the tension cannotlater be adjusted. Also, because of the use of bone anchors to
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`provide a suture fixation point in the bone, the knots that secure the soft tissues to the
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`anchor by necessity leave the knot bundle on top of the soft tissues.
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`In the case of
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`rotator cuff repair, this meansthat the knot bundleis left in the shoulder capsule where
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`it can be felt by the patient postoperatively when the patient exercises the shoulder
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`joint. So, knots tied arthroscopically are difficult to achieve, impossible to adjust, and
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`are located in less than optimal areas ofthe shoulder. Suture tensionis also impossible
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`to measure and adjust once the knot has been fixed. Consequently, because of the
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`technical difficulty of the procedure, presently less than 1% ofall rotator cuff
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`proceduresis of the arthroscopic type, and is considered investigational in nature.
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`Another significant difficulty with current arthroscopic rotator cuff repair
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`techniques is shortcomingsrelated to currently available suture anchors. Suture eyelets
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`in bone anchorsavailable today, which like the eye of a needle are threaded with the
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`thread or suture, are small in radius, and can causethe suture to fail at the eyelet when
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`the anchoris placed underhigh tensile loads.
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`There are various bone anchor designs available for use by an orthopedic
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`surgeon for attachment of soft tissues to bone. The basic commonality between the
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`designsis that they create an attachmentpoint in the bonefor a suture that may then be
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`passed throughthe soft tissues and tied, thereby immobilizing the soft tissue. This
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`attachment point may be accomplished by different means. Screws are known for
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`creating such attachments, but existing designs suffer from a numberof disadvantages,
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`including their tendency to loosen over time, requiring a second procedure to later
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`remove them, andtheir requirementfor a relatively flat attachment geometry.
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`Another approachisto utilize the difference in density in the cortical bone (the
`tough, dense outer layer of bone) and the cancellous bone (the less dense, airy and
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`somewhatvascular interior of the bone). There is a clear demarcation between the
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`cortical bone and cancellous bone, where the cortical bone presents a kind ofhard shell
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`over the less dense cancellous bone. The aspect ratio of the anchoris such thatit
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`typically has a longer axis and a shorter axis and usually is pre-threaded with a suture.
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`These designsuse a hole in the cortical bone through which an anchoris inserted. The
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`holeis drilled such that the shorter axis of the anchorwill fit through the diameter of
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`the hole, with the longer axis of the anchorbeing parallel to the axis ofthe drilled hole.
`After deploymentin to the cancellous bone, the anchoris rotated 90° so that the long
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`axis is aligned perpendicularly to the axis of the hole. The suture is pulled, and the
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`anchoris seated up against the inside surface of the cortical layer of bone. Dueto the
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`mismatch in the dimensionsof the long axis of the anchor and the hole diameter, the
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`anchor cannotbe retracted proximally from the hole, thus providing resistance to pull-
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`out. These anchorsstill suffer from the aforementioned problem of eyelet design that
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`stresses the sutures.
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`Still other prior art approaches have attempted to use a “poprivet” approach.
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`This type of design requires a hole in the cortical bone into whicha split shaft is
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`inserted. The split shaft is hollow, and hasa tapered plug leadinginto its inner lumen.
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`Thetapered plug is extended out through the top of the shaft, and whentheplugis
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`retracted into the inner lumen,the tapered portion causes the split shaft to be flared
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`outwardly, ostensibly locking the device into the bone.
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`Other methodsof securing soft tissue to bone are known in thepriorart, but are
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`not presently considered to be feasible for shoulder repair procedures, because of
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`physicians’ reluctance to leave anything but a suture in the capsule area of the
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`shoulder. The reasonforthis is that staples, tacks, and the like could possibly fall out
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`and cause injury during movement. Asaresult of this constraint, the attachment point
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`often must be located at a less than ideal position. Also, the tacks or staples require a
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`substantial hole in the soft tissue, and makeit difficult for the surgeon to precisely
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`locate the soft tissue relative to the bone.
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`Aspreviously discussed, any of the anchor points for sutures mentioned above
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`require that a length of suture be passed through an eyelet fashioned in the anchor and
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`then looped throughthe soft tissues and tied down to complete the securement. Much
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`skill is required, however, to both place the suturesin the soft tissues, and to tie knots
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`while working through a trocar under endoscopic visualization.
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`Whatis needed, therefore, are new approachesfor repairing the rotator cuff or
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`fixing other soft tissues to bone, wherein both the bone and suture anchorsreside
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`completely below the cortical bone surface, there is no requirement for the surgeon to
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`tie a knot to attach the suture to the bone anchor, and wherein suture tension can be
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`adjusted and possibly measured. The procedures associated with the new approaches
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`should be better for the patient than existing procedures, should save time, be
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`uncomplicated to use, and be easily taught to practitioners having skill in the art.
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`Summary ofthe Invention
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`Accordingly, the inventors have developed new and novel approachesfor
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`securing soft tissue to bone, and particularly for axially anchoring suture which
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`attaches the soft tissue to adjacent bonestructure.
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`Moreparticularly, in one aspect of the invention there is disclosed a suture
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`anchoring device, comprising an anchor housing having an outer wall, a
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`compressible plug member disposed within the housing and extending proximally
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`of the housing, and a channel extending through the plug memberfor
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`accommodating a length of suture. A cap memberis provided for enclosing a
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`proximalend of the housing. In operation, the compressible plug memberis
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`compressedin order to anchorthe length of suture when the cap memberis engaged
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`with the housing.
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`In another aspect of the invention, there is disclosed a suture anchoring
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`device which comprises an anchor body having an interior threaded wall, as well as
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`a suture return memberassociated with the body, such as a pin, for returning a
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`distally extending length of suture in a proximal direction. A length offiberis
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`provided, having a first end securedto a distal portion of the body, and a second
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`end extending from an end of the body, the fiber being wrapped aboutthe interior
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`threaded wall of the body a plurality of times. In operation, when the length of
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`fiber is pulled in a predetermined direction, the wrapped fiber becomestightly
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`engaged about the suture to anchor the suture.
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`In yet another aspect of the invention, there is provided a suture anchoring
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`device, which comprises an anchor body having an outer wall, and a suture return
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`memberdisposed at a distal end of the anchor body,for receiving a length of suture
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`extending distally through the body, and returning a portion of the suture length in a
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`proximaldirection. A passage extends along an interior surface of the wall for
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`accommodating the length of suture. The passage tapers in width in a proximal
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`direction, for the purpose of permitting the suture to be movedaxially when pulled
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`in a first direction, for approximating a portion of soft tissue to which the suture
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`wasattached to adjacent bone, and anchoringthe suture axially in place when the
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`suture is pulled in an opposing direction.
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`In still another aspect of the invention, there is provided a suture anchoring
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`device, comprising an anchor body having an outer wall, as well as a lumen for
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`accommodating a length of suture within the outer wall. A plurality of members
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`are disposed within the anchor body for contacting the length of suture and creating
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`a