`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of: Christine Bjoem Jensen et al.
`
`Application No.: Not Yet Assigned
`
`Confirmation No.: NIA
`
`Filed: Concurrently Herewith
`
`Art Unit: NIA
`
`For: Use ofLogn-Acting GLP-1 Peptides
`
`Examiner: Not Yet Assigned
`
`UTILITY PATENT APPLICATION TRANSMITTAL
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`This is a request for filing a Continuation application under 37 C.F.R. l.53(b).
`
`Applicant: Novo Nordisk A/S
`
`Title: Use of Long-Acting GLP-1 Peptides
`
`Applicants enclose a duly filled in Application Data Sheet with all relevant priority information.
`
`Direct all future correspondence to Customer Number 23650.
`
`Please charge the required fee associated with this application and credit any overpayments to
`
`Novo Nordisk, Inc., Deposit Account No. 14-1447, under Order No. 8545US02 from which the undersigned
`
`is authorized to draw. Please charge any additional fees, should they be required, to Deposit Account No.
`
`14-1447.
`
`Dated: July 20, 2017
`
`Respectfully submitted,
`
`Electronic signature: /Leon Y. Lum/
`Leon Y. Lum
`Registration No.: 62,124
`NOVO NORDISK INC
`800 Scudders Mill Road
`Plainsboro, New Jersey 08536
`(609) 987-5800
`Attorney For Applicant
`
`8545US02 - Application Transmittal.doc
`
`MPI EXHIBIT 1002 PAGE 1
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 1 of 369
`
`
`
`Attorney Docket No.: 8545US02
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN etal.
`Inventors: JENSEN et al.
`
`1/6
`
`Lirag I utide
`Semaglutide
`Liraglutide
`Semaglutide
`8.2
`8.0
`8.1
`8.1
`8.1
`8.1
`8.2
`8.2
`Baseline 8.1
`8.1
`8.0
`8.1
`8.1
`8.2
`8.1
`82
`62
`Baseline 8.1
`Placebo 0.1 mg 0.2 mg 0.4 mg 0.8 mg 0.8 mg 1.6 mg 1.2 mg 1.8 mg
`Placebo 0.1 mg 0.2mgq 04mg 0.8mg 08mg 1.6mg 1.2mg 1.8m¢
`T
`T
`T
`
`~
`
` 4%%4%sls
`titséttdditsdde
`
`0 r 00 -r-,❖"-~":::,""'
`........... x:~,{-
`~................
`[,:,., ......... -.. ... ❖'-"'"'"']
`-0 ~ 2 5 L .......... ,,, .. ._._,.,❖}
`i ......... ❖'-"-"":,."-""1
`x
`1::,._,,,,,,._,.,,.,1
`t,~~~:1
`ES
`he
`MALE
`0.5
`
`T
`
`:
`~ -0 r 50
`oo
`in oo
`cf2.
`-........,
`;:: -0.75
`<(
`.0 I
`
`
`
`HbA,(%)
`
`-1.00
`
`-1.25
`
`-1.50
`
`-1.75
`
`-2.00
`
`-1.1
`**
`
`-1.18
`
`-1.34
`
`—1,.46 -1.44
`*“e
`#*
`**
`**
`
`-1.69
`
`*p<0.05 vs. placebo
`*p<0.05 vs. placebo
`**p<0.001 vs. placebo
`**n<0.004 vs. placebo
`#Semag!utide 1.6 mg T superior to lirag!utide 1.2 mg and 1.8 mg
`*Semagiutide 1.6 mg T superior to liraglutide 1.2 mg and 1.8 mg
`Data are LS means.
`Data are LS means.
`
`Fig. 1
`Fig. 1
`
`MPI EXHIBIT 1002 PAGE 2
`
`MPI EXHIBIT 1002 PAGE 2
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 2 of 369
`
`
`
`
`
`00
`
`"' .i:,.
`"' C en
`
`
`
`AttorneyDocketNo.:8545US02
`
`~
`0
`3
`CD
`'<
`0
`0
`C, ,..
`~
`z
`
`0
`
`0
`N
`
`N a,
`2/6
`
`
`
`~ Inventors:JENSENetal.
`
`:::,
`<
`CD
`:::,
`0
`cil
`'(cid:173)m z
`en
`m z
`~
`
`{)
`
`1
`
`2
`N
`
`3
`oy
`
`4
`
`S
`
`6
`
`7
`
`Time
`
`B
`oo
`
`9
`
`10
`oFes
`
`1.1
`
`ty
`1.2
`ve
`
`.?'
`
`°axz==3&:=:&
`
`~-3:-,,-,,_,,--4
`E
`' ____ J~=;~:=::::::::;7~
`-:,,,,,,,,,.,,
`
`cers
`lated
`ae
`OOEELPCAALLLIDSETDDRALOLEEAEEbbbbls
`MOIoe
`
`I
`
`fe.
`
`J~
`
`F
`
`·····'·'·'·····sema,;ilutide 02 mg
`·-t:r sBrrw9!utide 0,8 rng r
`.. ✓•• ....... . , ........... Hra.gh,..rtic!€: 1~ 8 rog
`
`semag!ubde 0,1 m,;i
`,,,,/&,,,,placebo
`collionen inced
`-...-sern<)fJ!uUde 0,8 rn9
`,,,,,,0,,,,sernaglutde 0.4 rng
`BENT
`S &
`SENT
`-.-semaglutde 1.6 mg T ""o//"'·l\rag!utide L2 rng
`
`“©
`
`MPI EXHIBIT 1002 PAGE 3
`
` Gr=f3.©GSmMsr18Mm23OOBBBSwweeMetONtg§i$tati$
`
`
`.,,
`-·
`cc
`
`I\)
`
`u
`r l
`<(
`..a
`:r:
`C
`·-
`
`(U
`CJ)
`C
`ro
`..c u
`
`0,0
`-0,2
`-.QA
`-0,6
`-0,8
`
`-LO
`-1,2
`--lA
`-L6
`-·L8
`-2-0
`
`
`
`MPI EXHIBIT 1002 PAGE 3
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 3 of 369
`
`
`
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`3/6
`
`Fig. 3A
`
`MPI EXHIBIT 1002 PAGE 4
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 4 of 369
`
`
`
`Attorney Docket No.: 8545US02
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN etal.
`Inventors: JENSEN et al.
`
`4/6
`
`yan
`
`awhe
`
`•
`
`;'-.;_!
`·&:~:
`
`RE
`~~i
`
`; - : : ; D
`
`:;
`:i
`
`=B
`
`e
`
`~ r~
`
`~ti
`
`ws
`
`... , ... ~
`
`Fig. 3 B
`Fig. 3B
`
`MPI EXHIBIT 1002 PAGE 5
`
`
`
`••~--=-• V
`¥ =•~ ; e
`~ ¥
`
`PH ¥
`
`¥
`
`6 i I g I £ i i 2 2 P
`
`MPI EXHIBIT 1002 PAGE 5
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 5 of 369
`
`
`
` (Sy)yyGiemApogujebueyo
`
`
`O'i
`
`é
`
`.r,
`O}
`(lJ
`>.
`;,,,
`>,,
`u
`0
`,,!";;,
`C --
`©
`O'i
`C
`ro ,-.
`.....
`u
`
`
`
`
`
`
`
`.,,
`-·
`cc
`.
`.,:.
`
`- 0
`;;;,t. --....,
`
`,,1
`
`»2
`
`-3
`
`-4
`
`-5
`
`~6
`
`0
`
`1
`
`2
`
`3
`
`Time (vveeks)
`
`4
`
`,5
`
`6
`
`7
`
`B
`&
`
`9
`
`*
`10
`
`11
`
`12
`
`~ 1
`
`~
`
`osBAY4&Ssswho
`
`.*3=SsgSS<svyee
`
`z
`,,,,,ll; ,,,,,,,,,,,, ,, ,
`,,,,,,,,,,,,, w,,A,,, wnnnnn
`8gxS
`.,,l',l',l'.,,.,.,.,.,,..,..,..,.,,~,,,,,,¼,,,,,,,;:::::w/,.;,,,,;,,,,,,,,,,,,,;;,.;,,,,,;,;;;;;,,,,,,,,,,,,,,0,,,,,,:,~:rt.
`,,,,,,,,,,,,,,,,,,,/,.,,,,,,,
`,
`mm.,,,,,,,iiiW///H/////////////////,W/
`.. . , , , . , , ,_ , __ _
`
`C
`... :~;;;"';~
`~,•
`
`>
`
`,. ,.
`
`, ,,,,,,,_J,_ -~-,,,,,,,,,,,,,!,,,,_,,,,_,,,,,, __ J·· B
`1 LJ
`SSoNaN833=eeae
`l
`~ -.,,,.,,..,,,~..
`.,,J
`--""'- --
`!
`____ ,,,,,.
`•
`---,,,,,~.,,,.~---=»:,,;;.
`~..,,...,~
`= ,, ~ - - - - "
`l
`
`sernag!;Jtide 0, 1 mg
`««0-/-«· p!acebo
`,
`,,,,,;z;,,,,,semaglutide 0.4 mg _.,._sernagbbde: 0.8 mg
`eresMeeptits SSB LUGS
`i
`es
`‘:::
`:::&&
`....,..._sernaglutlde L6 rng T ,,,,,,*""·Hn:igiutlde 1.2 rng
`wx
`mN
`poe
`ytD
`Sh
`
`CFow
`
`.....,,. w..:,
`
`..-.«,
`
`<
`
`sernan!utide 02 rng
`· =·=
`-o,. semmgiutide 0,8 rng T
`,..,,,..,_!lra9iuUde t)} rng
`wwe
`
`MPI EXHIBIT 1002 PAGE 6
`
`
`
`00
`
`"' ,i:,.
`"' C en
`
`0
`N
`
`5/6
`0, a,
`
`:::,
`<
`CD
`:::,
`0
`cil
`'(cid:173)m z
`en
`m z
`
`~
`
`
`
`~ AttorneyDocketNo.:8545US02Inventors:JENSENetal.
`
`~
`0
`3
`CD
`'<
`0
`0
`
`C, " ~
`z
`
`0
`
`
`
`
`
`MPI EXHIBIT 1002 PAGE 6
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 6 of 369
`
`
`
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`6/6
`
`1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111
`
`J]J]J]J]J]J]J]J]J]J]J]J:J
`
`Lf'J O
`
`lf1 C
`
`Ui
`
`CJ.
`c1
`
`0
`('""\
`!
`
`tl'>
`('""\
`!
`
`0
`-q·
`:
`
`L"l
`,1·
`:
`
`0
`l.f':
`l
`
`Fig. 5
`
`MPI EXHIBIT 1002 PAGE 7
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 7 of 369
`
`
`
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`38/40
`
`Claims
`
`1. A method for
`
`a) reduction of HbA1c;
`
`b) treatment of type 2 diabetes, hyperglycemia, impaired glucose tolerance, or non-insulin
`
`dependent diabetes; or
`
`c) treatment of obesity, reducing body weight and/or food intake, or inducing satiety;
`
`wherein said method comprises administration of a GLP-1 agonist to a subject in need thereof,
`
`wherein said GLP-1 agonist
`
`i) has a half-life of at least 72 hours;
`
`ii) is administered in an amount of at least 0.7 mg per week, such an amount equivalent to at
`
`least 0. 7 mg semaglutide per week; and
`
`iii) is administered once weekly or less often.
`
`2. The method according to claim 1, wherein said GLP-1 agonist has a half-life of at least 96
`
`hours.
`
`3. The method according to claim 1, wherein the GLP-1 agonist has an EC50 at or below
`3000pM.
`
`4. The method according to claim 1, wherein said GLP-1 agonist is administered in an amount
`
`of
`
`i) at least 0.8 mg per week; or
`
`ii) in an amount equivalent to at least 0.8 mg semaglutide per week.
`
`MPI EXHIBIT 1002 PAGE 8
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 8 of 369
`
`
`
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`39/40
`
`5. The method according to claim 1, wherein the GLP-1 agonist is a GLP-1 peptide.
`
`6. The method according to claim 5, wherein said GLP-1 peptide comprises no more than 6
`
`amino acid residues which have been substituted, inserted or deleted as compared to GLP-1 (7-
`
`37).
`
`7. The method according to claim 1, wherein said GLP-1 agonist is selected from the group
`
`consisting of semaglutide, exenatide, albiglutide, and dulaglutide.
`
`8. The method according to claim 1, wherein said GLP-1 agonist is administered by parenteral
`
`administration.
`
`9. The method according to claim 1, wherein said GLP-1 agonist is administered simultaneously
`
`or sequentially with another therapeutic agent.
`
`10. The method according to claim 1, wherein the method comprises treatment, reduction or
`
`induction in one or more diseases or conditions selected from a) and b), a) and c), b) and c), or
`
`a), b) and c) as defined in claim 1.
`
`MPI EXHIBIT 1002 PAGE 9
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 9 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`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:
`D 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.)
`
`Inventor Information:
`
`Inventor
`11
`Legal Name
`
`I Remove
`
`I
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`I El J:hristine
`
`Residence Information (Select One)
`
`City
`
`~harlottenlund
`
`~joern
`US Residency
`
`• Non US Residency
`l1country of Residence i
`
`~ensen
`
`Active US Military Service
`
`l~K
`
`Mailing Address of Inventor:
`
`Address 1
`
`~o Novo Nordisk A/S
`
`Address 2
`City
`I l3agsvaerd
`Postal Code
`Inventor ~
`Legal Name
`
`Novo Alie
`
`I IDK-2880
`
`I State/Province
`I Countryi
`II°K
`
`11
`
`I Remove
`
`I
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`I El t,lads
`
`Residence Information (Select One)
`
`~asmussen
`frederik
`US Residency @ Non US Residency
`
`Active US Military Service
`
`City
`
`~openhagen OE
`
`IICountry of Residence i
`
`l~K
`
`Mailing Address of Inventor:
`
`Address 1
`
`~o Novo Nordisk A/S
`
`Address 2
`City
`I l3agsvaerd
`Postal Code
`
`Novo Alie
`
`I IDK-2880
`
`Inventor b
`
`Legal Name
`
`EFSWeb2.2.12
`
`I State/Province
`I Countryi
`II°K
`
`11
`
`I Remove
`
`I
`
`Suffix
`
`I El
`
`I
`
`Suffix
`
`I El
`
`I
`
`MPI EXHIBIT 1002 PAGE 10
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 10 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`I El IVlilan
`
`Residence Information (Select One)
`
`jldravkovic
`I
`US Residency @ Non US Residency
`
`Active US Military Service
`
`City
`
`Eolte
`
`IICountry of Residence i
`
`l~K
`
`Suffix
`
`I El
`
`I
`
`Mailing Address of Inventor:
`
`Address 1
`
`~o Novo Nordisk A/S
`
`Novo Alie
`
`I IDK-2880
`
`Address 2
`City
`I l3agsvaerd
`Postal Code
`Inventor ~
`Legal Name
`
`Prefix Given Name
`
`I State/Province
`I Countryi
`II°K
`
`11
`
`I Remove I
`
`Middle Name
`
`Family Name
`
`I El f"eter
`
`Residence Information (Select One)
`
`l<ristensen
`I
`US Residency @ Non US Residency
`
`Active US Military Service
`
`City
`
`~roenshoej
`
`IICountry of Residence i
`
`l~K
`
`Suffix
`
`I El
`
`I
`
`Mailing Address of Inventor:
`
`Address 1
`
`~o Novo Nordisk A/S
`
`Novo Alie
`
`Address 2
`City
`I '3agsvaerd
`Postal Code
`
`I State/Province
`I IDK-2880
`I Countryi
`II°K
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`11
`
`I Add
`
`I
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`D An Address is being provided for the correspondence Information of this application.
`Customer Number
`23650
`
`Email Address
`
`nnipatent@novonordisk.com
`
`I
`
`I Add Email
`
`I
`
`I Remove Email I
`
`EFS Web 2.2.12
`
`MPI EXHIBIT 1002 PAGE 11
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 11 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Application Information:
`
`Title of the Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Attorney Docket Number
`
`'3545US02
`
`Application Type
`
`Non provisional
`
`Subject Matter
`
`Utility
`
`I Small Entity Status Claimed □
`
`Total Number of Drawing Sheets (if any)
`Filing By Reference:
`Only complete this section when filing an application by reference under 35 U.S.C. 111 (c) and 37 CFR 1.57(a). Do not complete this section if
`application papers including a specification and any drawings are being filed. Any domestic benefit or foreign priority information must be
`provided in the appropriate section(s) below (i.e., "Domestic Benefit/National Stage Information" and "Foreign Priority Information").
`
`I Suggested Figure for Publication (if any) 11
`
`Ir
`
`.
`.
`
`For the purposes of a filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`reference to the previously filed application, subject to conditions and requirements of 37 CFR 1.57(a).
`
`Application number of the previously
`filed application
`
`Filing date (YYYY-MM-DD)
`
`Intellectual Property Authority or Country
`
`;_
`
`Publication Information:
`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.
`
`□
`
`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).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer
`Number will be used for the Representative Information during processing.
`
`Please Select One:
`
`• Customer Number
`
`I
`
`US Patent Practitioner lo Limited Recognition (37 CFR 11.9)
`
`Customer Number
`
`~3650
`
`EFS Web 2.2.12
`
`MPI EXHIBIT 1002 PAGE 12
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 12 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Domestic Benefit/National Stage Information:
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) or indicate
`National Stage entry from a PCT application. Providing benefit claim 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.
`When referring to the current application, please leave the "Application Number" field blank.
`
`I Remove I
`Filing or 371 (c) Date
`(YYYY-MM-DD)
`
`~014-12-19
`I Remove I
`Filing or 371 (c) Date
`(YYYY-MM-DD)
`
`~013-06-21
`I Remove I
`Filing or 371 (c) Date
`(YYYY-MM-DD)
`
`~012-10-01
`I Remove I
`Filing or 371 (c) Date
`(YYYY-MM-DD)
`
`~012-08-30
`
`Prior Application Status
`
`!='ending
`
`.
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`I
`
`Prior Application Status
`
`l=xpired
`
`Continuation of
`
`. 14/409493
`.
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`~4/409493
`
`~ 371 of international
`
`Prior Application Status
`
`l=xpired
`
`. PCT /EP2013/063004
`.
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`tcT /EP2013/063004
`
`Claims benefit of provisional
`
`Prior Application Status
`
`l=xpired
`
`. 61/708162
`.
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`tcT /EP2013/063004
`
`J:laims benefit of provisional
`
`. 61/694837
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`I Add
`
`I
`
`Foreign Priority Information:
`
`This section allows for the applicant to claim priority to a foreign application. 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. When priority is claimed to a foreign application
`that is eligible for retrieval under the priority document exchange program (PDXi the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55(i)(1) and (2). Under the POX program, applicant bears the ultimate
`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
`property office, or a certified copy of the foreign priority application is filed, within the lime period specified in 37 CFR 1.55(g)(1 ).
`
`Application Number
`
`Countryi
`
`Filing Date (YYYY-MM-DD)
`
`~2186781.6
`
`f=P
`
`J/012-10-01
`
`I Remove I
`Access Codei (if applicable)
`
`EFS Web 2.2.12
`
`MPI EXHIBIT 1002 PAGE 13
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 13 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Application Number
`
`Countryi
`
`Filing Date (YYYY-MM-DD)
`
`f=P
`J/012-07-01
`~2174535.0
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`I Remove I
`Access Codei (if applicable)
`
`I Add
`
`I
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`Applications
`
`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`□ 16,2013.
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`16, 2013, will be examined under the first inventor to file provisions of the AIA.
`
`EFS Web 2.2.12
`
`MPI EXHIBIT 1002 PAGE 14
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 14 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Authorization or Opt-Out of Authorization to Permit Access:
`
`When this Application Data Sheet is properly signed and filed with the application, applicant has provided written
`authority to permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see
`paragraph A in subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant
`application (see paragraph Bin subsection 1 below).
`
`Should applicant choose not to provide an authorization identified in subsection 1 below, applicant must opt-out of the
`authorization by checking the corresponding box A or B or both in subsection 2 below.
`
`NOTE: This section of the Application Data Sheet is ONLY reviewed and processed with the INITIAL filing of an
`application. After the initial filing of an application, an Application Data Sheet cannot be used to provide or rescind
`authorization for access by a foreign IP office(s). Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
`
`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
`
`A. Priority Document Exchange (PDXl - Unless box A in subsection 2 (opt-out of authorization) is checked, the
`undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent Office
`(JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People's Republic of
`China (SIPO), the World Intellectual Property Organization (WIPO), and any other foreign intellectual property office
`participating with the USPTO in a bilateral or multilateral priority document exchange agreement in which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`and its related bibliographic data, (2) any foreign or domestic application to which priority or benefit is claimed by the
`instant application and its related bibliographic data, and (3) the date of filing of this Authorization. See 37 CFR 1.14(h)
`(1 ).
`
`B. Search Results from U.S. Application to EPO - Unless box Bin subsection 2 (opt-out of authorization) is checked,
`the undersigned hereby grants the USPTO authority to provide the EPO access to the bibliographic data and search
`results from the instant patent application when a European patent application claiming priority to the instant patent
`application is filed. See 37 CFR 1.14(h)(2).
`
`The applicant is reminded that the EPO's Rule 141(1) EPC (European Patent Convention) requires applicants to submit a
`copy of search results from the instant application without delay in a European patent application that claims priority to
`the instant application.
`
`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s)
`
`A. Applicant DOES NOT authorize the USPTO to permit a participating foreign IP office access to the instant
`D application-as-filed. If this box is checked, the USPTO will not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
`
`B. Applicant DOES NOT authorize the USPTO to transmit to the EPO any search results from the instant patent
`D application. If this box is checked, the USPTO will not be providing the EPO with search results from the instant
`application.
`NOTE: Once the application has published or is otherwise publicly available, the USPTO may provide access to the
`application in accordance with 37 CFR 1.14.
`
`EFS Web 2.2.12
`
`MPI EXHIBIT 1002 PAGE 15
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 15 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Tille 37 of CFR
`to have an assignment recorded by the Office.
`
`I Remove I
`Applicant
`11
`If the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`I Clear
`
`I
`
`• Assignee
`
`I
`Person to whom the inventor is obligated to assign.
`
`Legal Representative under 35 U.S.C. 117
`
`Joint Inventor
`
`I
`Person who shows sufficient proprietary interest
`
`I
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`Name of the Deceased or Legally Incapacitated Inventor: I
`
`If the Applicant is an Organization check here.
`
`~
`
`Organization Name
`
`I ~ova Nordisk A/S
`Mailing Address Information For Applicant:
`
`Novo Alie
`
`Bagsvaerd
`
`Address 1
`
`Address 2
`
`City
`Country I !=>K
`Phone Number
`
`Email Address
`
`1~1
`
`State/Province
`
`Postal Code
`
`Fax Number
`
`DK-2880
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`I Add
`
`I
`
`Assignee Information including Non-Applicant Assignee Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title
`37 of CFR to have an assignment recorded by the Office.
`
`EFS Web 2.2.12
`
`MPI EXHIBIT 1002 PAGE 16
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 16 of 369
`
`
`
`Prefix
`
`Given Name
`
`Middle Name
`
`Family Name
`I
`I
`I
`Mailing Address Information For Assignee including Non-Applicant Assignee:
`
`I Remove I
`□
`Suffix
`
`I
`
`B
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Assignee
`
`11
`
`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent
`application publication. An assignee-applicant identified in the "Applicant Information" section will appear on the patent application
`publication as an applicant. For an assignee-applicant, complete this section only if identification as an assignee is also desired on the
`patent application publication.
`
`If the Assignee or Non-Applicant Assignee is an Organization check here.
`
`B I
`
`Address 1
`
`Address 2
`
`City
`
`Countryi
`
`11
`Phone Number
`
`Email Address
`
`11
`
`State/Province
`
`Postal Code
`
`Fax Number
`
`Additional Assignee or Non-Applicant Assignee Data may be generated within this form by
`selecting the Add button.
`
`Add
`
`I
`
`I
`
`Signature:
`NOTE: This Application Data Sheet must be signed in accordance with 37 CFR 1.33(b ). However, if this Application
`Data Sheet is submitted with the INITIAL filing of the application and either box A or B is not checked in
`subsection 2 of the "Authorization or Opt-Out of Authorization to Permit Access" section, then this form must
`also be signed in accordance with 37 CFR 1.14(c).
`This Application Data Sheet must be signed by a patent practitioner if one or more of the applicants is a juristic
`entity (e.g., corporation or association). If the applicant is two or more joint inventors, this form must be signed by a
`patent practitioner, all joint inventors who are the applicant, or one or more joint inventor-applicants who have been given
`power of attorney (e.g., see US PTO Form PTO/AIA/81) on behalf of all joint inventor-applicants.
`See 37 CFR 1.4(d) for the manner of making signatures and certifications.
`
`Remove
`
`Signature
`
`liLeon Y. Lum/
`
`Date (YYYY-MM-DD) 12017-07-20
`
`First Name
`
`~eon Y.
`
`I Last Name I ~um
`
`Registration Number
`
`~2,124
`
`Additional Signature may be generated within this form by selecting the Add button.
`
`I Add
`
`I
`
`EFS Web 2.2.12
`
`MPI EXHIBIT 1002 PAGE 17
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 17 of 369
`
`
`
`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`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 lime 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 2.2.12
`
`MPI EXHIBIT 1002 PAGE 18
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 18 of 369
`
`
`
`PTO/SB/0Ba (03-15)
`Doc code: IDS
`Approved for use through 07/31/2016. 0MB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Filed
`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 0MB control number.
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`First Named Inventor
`
`Art Unit
`
`Examiner Name
`
`2017-07-21
`I J:;hristine Bjoem Jensen
`
`IN/A
`I Not Yet Assigned
`I B545US02
`
`Attorney Docket Number
`
`Examiner Cite
`Initial*
`No
`
`Patent Number
`
`Kind
`Code1 Issue Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`U.S.PATENTS
`
`I Remove I
`
`1
`
`as36122
`
`A1
`
`R013-09-17
`
`caU et al.
`
`2
`
`a129343
`
`A1
`
`Ro12-03-06
`
`au et al.
`
`If you wish to add additional U.S. Patent citation information please click the Add button.
`
`U.S.PATENT APPLICATION PUBLICATIONS
`
`I Add
`I
`I Remove I
`
`Examiner
`Initial*
`
`Cite No
`
`Publication
`Number
`
`Kind Publication
`Code1 Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`1
`
`20110301080
`
`Ro11-12-oa
`
`Bush et al.
`
`2
`
`3
`
`20100292133
`
`Ro10-11-1a
`
`Spetzler et al.
`
`20100047762
`
`Ro10-02-2s
`
`Button et al.
`
`If you wish to add additional U.S. Published Application citation information please click the Add button.I Add
`I
`IRemovel
`FOREIGN PATENT DOCUMENTS
`
`Examiner Cite Foreign Document
`Initial*
`No Number3
`
`Country
`Code2i
`
`Kind Publication
`Code4 Date
`
`Name of Patentee or
`Applicant of cited
`Do