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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`15/765,515
`
`04/03/2018
`
`Philip E. Brandish
`
`23597-US-PCT
`
`3652
`
`MERCK
`P Oo BOX 2000
`RAHWAY,NJ 07065-0907
`
`DUFFY, PATRICIA ANN
`
`ART UNIT
`
`1645
`
`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`07/29/2021
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`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`US-DOCKET-PATENT @ merck.com
`
`lori_schepisi@ merck.com
`merck_pair@firsttofile.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-4,17-21,51 and 66-75 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 17-21 and 67 is/are withdrawn from consideration.
`Claim(s) 51 and 68-75 is/are allowed.
`Claim(s) 1-4 and 66 is/are rejected.
`[J Claim(s)__ is/are objectedto.
`O) Claim(s
`are subjectto restriction and/or election requirement
`S)
`“ If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10)CL) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)C] accepted or b)C) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)C) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)LJ None of the:
`b)L) Some**
`a)LJ} All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have beenreceived in Application No.
`3.0.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
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`4)
`
`PTOL-326 (Rev. 11-13)
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`Office Action Summary
`
`Part of Paper No./Mail Date 20210726
`
`Application No.
`Applicant(s)
`15/765,515
`Brandish etal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`Patricia Duffy
`1645
`Yes
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133}.
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
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`1) Responsive to communication(s) filed on 4-8-2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)¥) This action is FINAL.
`2b) (J This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4\0) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 15/765,515
`Art Unit: 1645
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`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined underthe
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`first inventor to file provisions of the AIA.
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`RESPONSE TO AMENDMENT
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`The amendmentfiled 4-8-2021 has been entered into the record. Claims 5-16, 22-50
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`and 52-65 have been cancelled. Claims 1-4, 17-21, 51 and 66-75 are pending. Claims 1-4, 51,
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`66 and 68-75 are under examination.
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`The text of Title 35 of the U.S. Code not reiterated herein can be foundin the previous
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`office action.
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`This application contains claims 17-21 and 67 drawn to an invention nonelected without
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`traverse. These claims remain withdrawn from consideration.
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`Election/Restrictions
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`Any objection/rejection not maintained herein is withdrawn based upon the amendment
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`Rejections Withdrawn
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`to the claims.
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`New Rejections Based on Amendment
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`Claim Rejections - 35 USC § 112
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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`(a) INGENERAL.—The specification shall contain a written description of the
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`invention, and of the manner and process of making and usingit, in suchfull, clear, concise,
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`and exact terms as to enable any person skilled in the art to which it pertains, or with whichit
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`is most nearly connected, to make and use the same, and shall set forth the best mode
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`contemplated by the inventor or joint inventor of carrying out the invention.
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`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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`The specification shall contain a written description of the invention, and of the
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`manner and process of making and usingit, in suchfull, clear, concise, and exact terms as to
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`enable any person skilled in the art to which it pertains, or with whichit is most nearly
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`connected, to make and use the same, and shall set forth the best mode contemplated by the
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`inventor of carrying out his invention.
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`

`

`Application/Control Number: 15/765,515
`Art Unit: 1645
`
`Page 3
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`Claims 1-4 and 66 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first
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`paragraph, asfailing to comply with the enablement requirement. The claim(s) contains subject
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`matter which wasnot described in the specification in such a way as to enable one skilled in the
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`art to whichit pertains, or with which it is most nearly connected, to make and/or use the
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`invention.
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`The independent claim has been amended to removethe functional property that the
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`conjugate binds CD74. The anti-inflammatory agent is disclosed as specifically delivering the
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`drug to cells expressing CD74 and upregulating genes corresponding to the effects of
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`glucocorticoid agonists.
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`In the absence of binding CD74, the conjugated anti-inflammatory
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`agent has no demonstrated pharmaceuticalactivity.
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`The art teaches that anti-inflammatory agents and glucocorticoid receptor agonists in
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`particular bind to the glucocorticoid receptor which is a family of intracellular receptors
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`(Timmermans et al, Frontiers in Immunology, 10:1545, pages 1-17, 2019; page 1 secondfull
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`paragraph). Due to their lipophilic nature, free glucocorticoids diffuse through the cell
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`membrane to exert their function (page 2, column 2, third paragraph and paragraph bridging
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`pages 2-3). Other anti-inflammatory agents such as non-steroidal anti-inflammatory agents
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`(NSAIDS) also actin the intracellular environment as the cyclooxygenase enzyme inhibitors.
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`The claimed conjugates would not be expectedto diffuse through a cell membrane in orderfor
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`the agonist to bind the receptor or enzyme to exert the knownbiological effects of these anti-
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`inflammatory agents. The specification does not demonstrate that the conjugate freely diffused
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`through the plasma membrane of cells and as such, in the absenceof further guidance from
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`Applicants, the skilled artisan would not know howto use a conjugate that does not bind CD74.
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`The art fails to teach diffusion across the plasma membrane for these large conjugates and rely
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`upon mechanisms such as endocytosis, pinocytosis and receptor/protein
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`internalization/recycling to deliver the drug intracellularly.
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`In the absence of a specific delivery
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`the specification disclose no mechanism to deliver the anti-inflammatory agent to acell and the
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`art suggests none.
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`For the foregoing reasons, the claims are not enabled for a use.
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`Claims 1-4 and 66 stand rejected. Claims 51 and 68-75are allowable. Claims 17-21
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`and 67 remain withdrawn from consideration.
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`Status of Claims
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`

`

`Application/Control Number: 15/765,515
`Art Unit: 1645
`
`Page 4
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`Conclusion
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`Applicant's amendment necessitated the new ground(s) of rejection presentedin this
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`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant
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`is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`
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`MONTHS from the mailing date of this action. In the eventafirst reply is filed within TWO
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`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE-MONTH shortenedstatutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action.
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`In no event,
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`however, will the statutory period for reply expire later than SIX MONTHS from the date of this
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`final action.
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair-direct.uspto.gov. Should you have questions on accessto the Private
`
`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
`
`Anyinquiry concerning this communication or earlier communications from the examiner
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`should be directed to Patricia Duffy whose telephone numberis 571-272-0855. The examiner
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`can generally be reached on 7:30 am - 4:00 pm.
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`If attempts to reach the examiner by telephone
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`are unsuccessful, the examiner’s Supervisor Gary Nickol can be reached at 571-272-0835.
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`The fax phone numberfor the organization wherethis application or proceeding is
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`assigned is 571-273-8300.
`
`/Patricia Duffy/
`
`Primary Examiner, Art Unit 1645
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`