r
`
`PTO/SB/05 (08-08)
`Approved for use through 06/30/2010. OWIB 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 displays a valid OMB control number.
`10-1188-US-CON1
`UTILITY
`Attorney Docket No.
`Robert Frederick Veasey
`PATENT APPLICATION
`TRANSMITTAL
`(Only for new nonprovlslonal applications under 37 CFR 1.53(b))
`
`First Inventor
`
`Title
`
`Pen-Type Injector
`
`b.
`
`]
`
`APPLICATION ELEMENTS
`See MPEP chapter BOO concerning utility patent application contents.
`1. [X] Fee Transmittal Form (e.g., PTO/SB/17)
`2. Q Applicant claims small entity status.
`See 37 CFR 1.27.
`ITotal Panes 14l
`3. K Specification
`Both the claims and abstract must start on a new page
`(For information on the preferred arrangement, see MPEP 608.01(a))
`4. [X] Drawing(s) (35 U.S. C. 113) [Total Sheets 7]
`5. Oath or Declaration
`[Total Sheets
`_ Newly executed (original or copy)
`J A copy from a prior application (37 CFR 1.63(d))
`(for continuation/divisional with Box 18 completed)
`i. • DELETION OF INVENTORfs)
`Signed statement attached deleting inventor(s)
`name in the prior application, see 37 CFR
`1.63(d)(2) and 1.33(b).
`6. EX] Application Data Sheet. See 37 CFR 1.76
`7. dl CD-ROM or CD-R in duplicate, large table or
`Computer Program (Appendix)
`I I Landscape Table on CD
`8. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. - c. are required)
`a. CD Computer Readable Form (CRF)
`Specification Sequence Listing on:
`b.
`i. • CD-ROM or CD-R (2 copies); or
`ii. O Paper
`c. O Statements verifying identity of above copies
`
`J
`
`Express Mail Label No.
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`ACCOMPANYING APPLICATION PARTS
`9. CD Assignment Papers (cover sheet & document(s))
`Name of Assignee
`
`10. • 37 CFR 3.73(b) Statement
`(when there is an assignee)
`
`I I Power of
`Attorney
`
`11.1 I English Translation Document (if applicable)
`
`12. O Information Disclosure Statement (PTO/SB/08 or PTO-1449)
`I I Copies of citations attached
`
`13. K! Preliminary Amendment
`14. C] Return Receipt Postcard (MPEP 503)
`(Should be specifically itemized)
`15. E] Certified Copy of Priority Document(s)
`(if foreign priority is claimed)
`16.E] Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`Applicant must attach form PTO/SB/35 or equivalent.
`
`17. [X] other: Submission of Substitute Specification,
`Substitute Specification, Submission of
`Replacement Drawings; 7 Pages of
`Replacement Drawings and General
`Authorization
`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:
`£3 Continuation
`of prior application No.: 11/483,546
`I Continuation-in-part (CIP)
`I
`I Divisional
`I
`Art Unit: 3763
`Prior application information: Examiner Mendez, Manuel A.
`19. CORRESPONDENCE ADDRESS
`20306
`
`[Xl The address associated with Customer Number
`
`OR CD Correspondence address below
`
`Name
`
`Address
`
`City
`Country
`
`Signature
`Name
`, (Print/Type)
`
`State
`Telephone
`/Thomas E. Wettermann/
`Thomas E. Wettermann
`
`Zip Code
`Email
`
`Date
`
`November 11, 2010
`Registration No.
`41,523
`(Attorney/Agent)
`
`American LegalNet, Inc.
`www. Forms Wof/cffotv.com
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 1 of 276
`
`

`

`PTO/SB/17 (10-08)
`Approved for use through 06/30/2010. 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 displays a valid OMB control number.
`Complete If Known
`Unassigned
`Unassigned
`Robert Frederick Veasey
`Unassigned
`Unassigned
`10-1188-US-CON1
`
`Effective on 12/08/2004.
`Fees pursuant to the Consolidated Appropriations Act, 2005 (H.R. 4818).
`
`FEE TRANSMITTAL
`For FY 2009
`I Applicant claims small entity status. See 37 CFR 1.27
`I
`VjOTAL AMOUNT OF PAYMENT
`($)3,222.00
`
`Application Number
`
`Filing Date
`
`First Named Inventor
`
`Examiner Name
`
`Art Unit
`
`Attorney Docket No.
`
`y
`
`METHOD OF PAYMENT (check all that apply)
`I | Check | | Credit Card | | Money Order | | None | | Other (please identify):
`Deposit Account Deposit Account Number: 13-2490
`Deposit Account Name: MBHB
`For the above-identified deposit account, the Director is hereby authorized to: (check all that apply)
`I
`
`EXAMINATION FEES
`Small Entity
`Fee ($)
`110
`70
`85
`325
`0
`
`Fee ($)
`220
`140
`170
`650
`0
`
`Fees Paid ($)
`1,090.00
`
`| Charge fee(s) indicated below, except for the filing fee
`Charge fee(s) indicated below
`l\/| Charge any additional fee(s) or underpayments of fee(s)
`Credit any overpayments
`launder 37 CFR 1.16 and 1.17
`WARNING: Information on this form may become public. Credit card information should not be included on this form. Provide credit card
`information and authorization on PTO-2038.
`FEE CALCULATION
`1. BASIC FILING, SEARCH, AND EXAMINATION FEES
`FILING FEES
`SEARCH FEES
`Small Entity
`Small Entity
`Fee ($)
`Fee ($)
`165
`270
`50
`110
`165
`110
`165
`270
`110
`0
`
`Application Type
`Utility
`Design
`Plant
`Reissue
`Provisional
`2. EXCESS CLAIM FEES
`Fee Description
`Each claim over 20 (including Reissues)
`Each independent claim over 3 (including Reissues)
`Multiple dependent claims
`Total Claims
`Extra Claims
`- 20 or HP = 41
`x 52
`61
`HP = highest number of total claims paid for, if greater than 20
`Fee ($)
`Indep. Claims
`Extra Claims
`-3 or HP = 0
`x0
`3
`HP = highest number of independent claims paid 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 $270 ($135 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
`Number of each additional 50 or fraction thereof
`- 1 0 0 = 0
`(round up to a whole number)
`14
`x
`4. OTHER FEE(S)
`Non-English Specification, $130 fee (no small entity discount)
`Other (e.g., late filing surcharge):
`
`Fee ($)
`330
`220
`220
`330
`220
`
`Fee ($)
`540
`100
`330
`540
`0
`
`Fee ($)
`
`Fees Paid ($)
`= 2,132.00
`
`Fees Paid ($)
`= 0
`
`Small Entity
`Fee ($)
`Fee ($)
`52
`26
`110
`220
`195
`390
`Multiple Dependent Claims
`Fee ($)
`Fee Paid ($)
`
`/50= 0
`
`Fee ($)
`
`Fee Paid ($)
`
`Fee Paid ($)
`
`SUBMITTED BY
`Signature
`
`Registration No. 41,523
`jAttorney/Ac|ent2^^_^^_
`
`Telephone 312 913 2138
`
`/Thomas E. Wettermann/
`^Name (Print/Type)| Thomas E. Wettermann
`Date November 11. 2010 ^
`This collection of information is required by 37 CFR 1.136. 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 30 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.
`
`AmericanLegalNet, Inc.
`www. Forms Workflow.com
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 2 of 276
`
`

`

`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
`Application Number
`
`10-1188-US-CON1
`
`Title of Invention
`
`Pen-Type Injector
`
`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.
`
`Secrecy Order 37 CFR 5.2
`Q 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
`QParty of Interest under 35 U.S.C. 118
`Applicant Authority ® lnventor QLeQal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`Family Name
`Suffix
`Veasey
`Robert
`Frederick
`Residence Information (Select One) Q US Residency
`<•) Non US Residency 0 Active US Military Service
`City Warwickshire
`Country Of Residence!
`UK
`Citizenship under 37 CFR 1.41(b) i
`UK
`Mailing Address of Applicant:
`Address 1
`35 Hitchman Road
`Leamington Spa
`Address 2
`City
`Postal Code
`
`Warwickshire
`
`CV31 3
`
`State/Province
`Country!
`
`UK
`
`Remove |
`
`Remove |
`
`Applicant 2
`QParty of Interest under 35 U.S.C. 118
`Applicant Authority ® lnventor QLeQal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`Family Name
`Suffix
`Robert
`Perkins
`Residence Information (Select One) Q US Residency
`{•) Non US Residency 0 Active US Military Service
`City Warwickshire
`Country Of Residence!
`UK
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`Address 1
`67 Erica Drive
`Leamington Spa
`Address 2
`City
`Postal Code
`
`UK
`
`Warwickshire
`
`CV31 2RW
`
`State/Province
`Country!
`
`UK
`
`Applicant 3
`0Party of Interest under 35 U.S.C. 118
`Applicant Authority ® lnventor 0Legal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`Family Name
`Suffix
`Aubrey
`David
`Plumptre
`Residence Information (Select One) Q US Residency
`{•) Non US Residency 0 Active US Military Service
`City Worcestershire
`Country Of Residence!
`UK
`
`Remove |
`
`EFS Web 2.2.2
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 3 of 276
`
`

`

`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.
`Attorney Docket Number
`Application Number
`
`10-1188-US-CON1
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`Pen-Type Injector
`
`UK
`
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`36 Shire Way
`Address 1
`Address 2
`City
`State/Province
`Postal Code
`Country!
`WR9 7
`UK
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`Droitwich
`
`Worcestershire
`
`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
`20306
`Email Address
`
`docketing@mbhb.com
`
`Add Email
`
`Add
`
`Remove Email
`
`Application Information:
`Pen-Type Injector
`Title of the Invention
`Attorney Docket Number 10-1188-US-CON1
`Application Type
`Subject Matter
`Suggested Class (if any)
`
`Nonprovisional
`
`Utility
`
`Small Entity Status Claimed Q
`
`Sub Class (if any)
`
`Suggested Technology Center (if any)
`
`7
`
`Total Number of Drawing Sheets (if any)
`Publication Information:
`• Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`R6C|U6St Not to Publish. I hereby request that the attached application not be published under 35 U.S.
`Q 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.
`
`Suggested Figure for Publication (if any)
`
`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.
`(•) Customer Number O US Patent Practitioner O Limited Recognition (37 CFR 11.9)
`
`Please Select One:
`
`sections
`
`EFS Web 2.2.2
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 4 of 276
`
`

`

`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.
`Attorney Docket Number
`Application Number
`
`10-1188-US-CON1
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`Pen-Type Injector
`
`Customer Number
`
`20306
`
`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
`Application Number
`Continuity Type
`Continuation of
`Prior Application Status Abandoned
`Prior Application Number
`Application Number
`Continuity Type
`10790225
`Continuation of
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`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).
`
`Prior Application Number
`11483546
`
`Filing Date (YYYY-MM-DD)
`2006-07-11
`
`Remove
`
`Remove
`
`Filing Date (YYYY-MM-DD)
`2004-03-02
`
`Add
`
`Country '
`
`Parent Filing Date (YYYY-MM-DD)
`Application Number
`2003-03-03
`GB
`0304822.0
`Additional Foreign Priority Data may be generated within this form by selecting the
`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.
`
`Remove
`Priority Claimed
`(J) Yes O No
`
`Add
`
`[x]
`
`Assignee 1
`If the Assignee is an Organization check here.
`Organization Name
`DCA Design International LTD
`Mailing Address Information:
`Address 1
`19 Church Street
`Address 2
`City
`Country ' UK
`Phone Number
`Email Address
`Additional Assignee Data may be generated within this form by selecting the Add
`button.
`
`Warwick
`
`State/Province
`Postal Code
`Fax Number
`
`Remove
`
`CV34 4AB
`
`Add
`
`EFS Web 2.2.2
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 5 of 276
`
`

`

`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.
`Attorney Docket Number
`Application Number
`
`10-1188-US-CON1
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`Pen-Type Injector
`
`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
`
`/Thomas E. Wettermann/
`
`Date (YYYY-MM-DD)
`
`2010-11-11
`
`First Name
`
`Thomas E.
`
`Last Name
`
`Wettermann
`
`Registration Number
`
`41523
`
`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
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 6 of 276
`
`

`

`Privacy Act Statement
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`The information provided by you in this form will be subject to the following routine uses:
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`as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`
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`review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
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`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
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`
`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
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`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.
`
`5.
`
`6.
`
`8.
`
`g
`
`EFS Web 2.2.2
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 7 of 276
`
`

`

`•. 1. MAR.'2004 11:55
`
`I
`
`riiRUCK MANNH
`
`.49 621 4227131
`
`0 NR. 177
`
`S. 4/24
`
`P96042
`
`Improvements iniand relating to a pen-type injector
`
`5 The present invention relates to pen-type injectors, that is to injectors of the kind
`that provide for administration by injection of medicinal products from a multidose
`cartridge. In particular, the present invention relates to such Injectors where a
`user may set the dose.
`
`10 Such injectors have application where regular injection by persons without formal
`medical training occurs. This is increasingly common amongst those having
`diabetes where self-treatment enables such persons to conduct effective
`management of their diabetes.
`
`15 These circumstances set a number of requirements for pen-type injectors of this
`kind. The injector must be robust in construction, yet easy to use both in terms of
`the manipulation of the parts and understanding by a user of its operation. In the
`case of those with diabetes, many users will be physically infirm and may also
`have impaired vision. Where the injector is to be disposable rather than
`reusable, the injector should be cheap to manufacture and easy to dispose of
`(preferably being suitable for recycling).
`
`20
`
`|
`
`It is an advantage of the present invention ihat an improved pen-type injector is
`provided.
`
`25
`
`According to a first aspect of the present invention, a pen-type injector comprises
`a housing;
`a piston rod adapted to operate through the housing;
`. 30 a dose dial sleeve located between the housing and the piston rod, the dose dial
`sleeve having a helical thread of first lead;
`a drive sleeve located between the dose dial sleeve and the piston rod, the drive
`sleeve having a helical groove of second lead;
`characterised in that the first lead of the helical thread and the second lead of the
`35 helical groove are the same.
`
`BEST AVAILABLE COPY
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 8 of 276
`
`

`

`4. MAR. 7004 1 1:55
`
`IS^pUCK MANNH
`
`. 49 621 4227131
`
`•NR. 177
`
`S. 5/24
`
`P9S042
`
`2
`
`5
`
`Preferably, the piston rod has a first threaded portion at a first end and a second
`threaded portion at a second end;
`an insert or radially inwardly extending flange is located in the housing and
`through which the first threaded portion of the piston rod may rotate;
`the dose dial sleeve being rotatable with respect to the housing and the insert;
`the drive sleeve being releasably connected to the dose dial sleeve and
`connected to the piston rod for rotation with respect thereto along the second
`threaded portion of the piston rod;
`10 a button is located on the dose dial sleeve and rotatable with respect to the dose
`dial sleeve; and
`clutch means are provided which upon depression of the button permit rotation
`between the dose dial sleeve and the drive sleeve.
`
`15 Preferably, the injector further comprises a nut which is rotatable with respect to
`the drive sleeve and axially displaceable but not rotatable with respect to the
`housing.
`
`20
`
`25
`
`More preferably, the drive sleeve is provided at a first end with first and second
`flanges with an intermediate thread between the first and second flanges, the nut
`being disposed between the first and second flanges and keyed to the housing by
`spline means. Additionally, a first radial stop may be provided oh a second face
`of the nut and a second radial stop may be provided on a first face of the second .
`flange.
`
`Preferably, the first thread of the piston rod is oppositely disposed to the second
`thread of the piston rod.
`
`Preferably, a second end of the clutch is provided with a plurality of dog teeth
`30 adapted to engage with a second end of the dose dial sleeve.
`
`Preferably, the pen-type injector further includes clicker means disposed between
`the clutch means and spline means provided on the housing.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 9 of 276
`
`

`

`J.MAR.'2004 1 1:56
`
`RUCK MANNH
`IS :^l
`
`.49 6214227131
`
`NR.-177
`
`S. -6/24
`
`P96042
`
`3
`
`More preferably, the clicker means comprises a sleeve provided at a first end
`with a helically extending arm, a free 2nd of the arm having a toothed member,
`and at a second end with a plurality o circumferentially directed sawteeth
`5 adapted to engage a corresponding p urality of circumferentially saw teeth
`provided on the clutch means.
`
`10
`
`Altematively, the dicker means comprises a sleeve provided at a first end with at
`least one helically extending arm and at least one spring member, a free end of
`the arm having a toothed member, an' 1 at a second end with a plurality of
`circumferentially directed saw teeth ac apted to engage a corresponding plurality
`of circumferentially directed saw teeth provided on the clutch means.
`
`Preferably, the main housing is provided with a plurality of maximum dose stops
`15 adapted to be abutted by a radial stop provided on the dose dial sleeve. More
`preferably, at least one of the maximui n dose stops comprises a radial stop
`located between a helical rib and splin ? means provided at a second end of the
`housing. Altematively, at least one of he maximum dose stops comprises a part
`of a raised window portion provided at a second end of the housing.
`
`20
`
`Preferably, the dose dial sleeve is provided with a plurality of radially extending
`members adapted to abut a corresponding plurality of radial stops provided at a
`second end of the housing.
`
`25 The invention will now be described with reference to the accompanying
`drawings, in which:-
`Figure 1 shows a sectional view of a pe n-type injector in accordance with the
`present invention in a first, cartridge ful, position;
`Figure 2 shows a sectional view of the | len-type injector of Figure 1 in a second,
`30 maximum first dose dialed, position;
`Figure 3 shows a sectional view of the j ien-type injector of Figure 1 in a third, first
`maximum first dose dispensed, posrtion;
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 10 of 276
`
`

`

`.MAR.'2004 11:56
`
`IS
`
`UCK MANNH
`
`.49 6214227131
`
`NR. 177
`
`S. 7/24
`
`P96042
`4
`Rgure 4 shows a sectional view of trie pen-type injector of Figure 1 in a fourth,
`final dose dialed, position;
`Rgure 5 shows a sectional view of th 3 pen-type injector of Rgure 1 in a fifth, final
`dose dispensed, position;
`5 Rgure 6 shows a cut-away view of a i'rst detail of the pen-type injector of
`Rgure 1;
`Rgure 7 shows a partially cut-away v ew of a second detail of the pen-type
`injector of Rgure 1;
`Figure 8 shows a partially cut-away v ew of a third detail of the pen-type injector
`10 of Rgure 1;
`Rgure 9 shows the relative moveinent of parts of the pen-type injector shown in
`Rgure 1 during dialing up of a dose;
`Rgure 10 shows the relative moveme it of parts of the pen-type injector shown in
`Rgure 1 during dialing down of a dose!;
`15 Figure 11 shows the relative moveme rt of parts of the pen-type injector shown in
`Figure 1 during dispensing of a dose;
`Figure 12 shows a partially cut-away \ iew of the pen-type injector of Rgure 1 in
`the second, maximum first dose dialed, position;
`Rgure 13 shows a partially cut-away \ iew of the pen-type injector of Rgure 1 in
`the fourth, final dose dialed, position;
`Figure 14 shows a partially cut-away v iew of the pen-type injector of Rgure 1 in
`one of the first, third or fifth positions;
`Rgure 15 shows a cut-away view of a Eirst part of a main housing of the pen-type
`injector of Figure 1; and
`25 Rgure 16 shows a cut-away view of a second part of the main housing of the
`pen-type injector of Figure 1.
`
`20
`
`Referring first to Rgures 1 to 5, there n lay be seen a pen-type injector in
`accordance with the present invention n a number of positions.
`
`30
`
`The pen-type injector comprises a housing having a first cartridge retaining
`part 2, and second main housing part 4. A first end of the cartridge retaining
`means 2 and a second end of the main housing 4 are secured together by
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 11 of 276
`
`

`

`.1. MAR. f004 1 1:57
`
`IS
`
`1)CR MANNH
`
`.49 621 4227131
`
`NR. 177
`
`•
`
`3. 8/24
`
`•V
`
`P98042
`5
`retaining features 6. In the illustrated embodiment, the cartridge retaining
`means 2 is secured within the second end of the main housing 4.
`
`A cartridge 8 from which a number of doses of medicinal product may be
`5 dispensed is provided in the cartridge retaining part 2. A piston 10 is retained in
`a first end of the cartridge 8.
`
`A removable cap 12 is reieasably reta ned over a second end of the cartridge
`retaining part 2. In use the removable cap 12 can be replaced by a user with a
`suitable needle unit (not shown). A re )lacable cap 14 is used to cover the
`cartridge retaining part 2 extending fro n the main housing 4. Preferably, the
`outer dimensions of the replaceable cj p 14 are similar or identical to the outer
`dimensions of the main housing 4 to p ovide the impression of a unitary whole
`when the replaceable cap 14 is in posr ion covering the cartridge retaining part 2.
`
`In the illustrated embodiment, an inser 16 is provided at a first end of the main
`housing 4. The insert 16 is secured ac ainst rotational or longitudinal motion. The
`insert 16 is provided with a threaded ci cular opening 18 extending therethrough.
`Alternatively, the insert may be formed integrally with the main housing 4 the form
`of a radially inwardly directed flange he ving an internal thread.
`
`A first thread 19 extends from a first en 1 of a piston rod 20. The piston rod 20 is
`of generally circular section. The first e nd of the piston rod 20 extends through
`the threaded opening 18 in the insert 1>. A pressure foot 22 is located at the first
`end of the piston rod 20. The pressure foot 22 is disposed to abut a second end
`of the cartridge piston 10. A second thi ead 24 extends from a second end of the
`piston rod 20. In the illustrated embodiment the second thread 24 comprises a
`series of part threads rather than a corr plete thread. The illustrated embodiment
`is easier to manufacture and helps redi ce the overall force required for a user to
`cause medicinal product to be dispensed.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`The first thread 19 and the second thread 24 are oppositely disposed. The
`second end of the piston rod 20 is provi Jed with a receiving recess 26.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1006, p. 12 of 276
`
`

`

`•1. MAR. ^004 1 1:57
`
`UCK MAHNH
`
`.49 6214227131
`
`NR. 177
`
`S. 9/24
`
`P86042
`
`6
`
`A drive sleeve 30 extends about the piston rod 20. The drive sleeve 30 is
`generally cylindrical. The drive sleeve 30 is provided at a first end with a first
`radially extending flange 32. A second radially extending flange 34 is provided
`5 spaced a distance along the drive sle jve 30 from the first flange 32. An
`intermediate thread 36 is provided on an outer part of the drive sleeve 30
`extending between the