www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`18/250,921
`
`04/27/2023
`
`Rhett Mead SCHIFFMAN
`
`4902.0110003
`
`A791
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1101 K Street, NW
`10th Floor
`WASHINGTON,DC 20005
`
`HUANG,GIGI GEORGIANA
`
`1613
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/02/2024
`
`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):
`eoffice @sternekessler.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`18/250,921
`SCHIFFMAN etal.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`GIGI G HUANG
`1613
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 2 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof 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
`
`1) Responsive to communication(s)filed on 11/28/2023.
`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) 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)(2) 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.
`
`
`
`Disposition of Claims*
`5)
`(J Claim(s) ___ is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`(s)__ is/are allowed.
`(s)__ is/are rejected.
`(s)__ is/are objected to.
`) ( Claim(s
`Claim(s) 1,8,12-13,15,20,24 28 ,43,48-50,61-63,67,71,73-75 and 82 are subject to restriction and/or
`9)
`election requirement
`* 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://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`6 7 8
`
`) ) )
`
`Application Papers
`10)C) The specification is objected to by the Examiner.
`11)D The drawing(s) filed on
`is/are: a)(} accepted or b)(_) 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)(.) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`cc) None ofthe:
`b)J Some**
`a)O All
`1.) Certified copies of the priority documents have been received.
`2.2.) Certified copies of the priority documents have been received in Application No.
`3.) 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)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240725
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`underthe first inventor to file provisions of the AIA.
`
`Election/Restriction
`
`REQUIREMENT FOR UNITY OF INVENTION
`
`2.
`
`Asprovided in 37 CFR 1.475(a), a national stage application shall relate to one
`
`invention only or to a group of inventions so linked as to form a single general inventive
`
`concept(“requirement of unity of invention’). Where a group of inventions is claimed in
`
`a national stage application, the requirement of unity of invention shall be fulfilled only
`
`whenthereis a technical relationship among thoseinventions involving one or moreof
`
`the same or corresponding special technical features. The expression “special technical
`
`features” shall mean those technical features that define a contribution which each of
`
`the claimed inventions, considered as a whole, makes over the prior art.
`
`The determination whether a group of inventions is so linked as to form a single
`
`general inventive concept shall be made without regard to whether the inventions are
`
`claimed in separate claims or as alternatives within a single claim. See 37 CFR
`
`1.475(e).
`
`WhenClaims Are Directed to Multiple Categories of Inventions:
`
`Asprovided in 37 CFR 1.475 (b), a national stage application containing claims
`
`to different categories of invention will be considered to have unity of invention if the
`
`claims are drawnonly to one of the following combinations of categories:
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 3
`
`(1) A product and a process specially adapted for the manufacture of said
`
`product; or
`
`(2) A product and a process of use of said product; or
`
`(3) A product, a process specially adapted for the manufacture of the said
`
`product, and a useof the said product; or
`
`(4) A process and an apparatus or means specifically designed for carrying out
`
`the said process; or
`
`(5) A product, a process specially adapted for the manufacture of the said
`
`product, and an apparatus or means specifically designed for carrying out
`
`the said process.
`
`Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
`
`Restriction is required under 35 U.S.C. 121 and 372.
`
`This application contains the following inventions or groups of inventions which
`
`are not so linked as to form a single general inventive concept under PCT Rule 13.1.
`
`In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to
`
`elect a single invention to which the claims mustberestricted.
`
`Group |,
`
`claims 1, 8, 12-13, 15, 20, 24, 28, 43, 48 drawn to an ophthalmic
`
`formulation comprising about 2 wt %to about 4 wt % carbachol or its
`
`pharmaceutically acceptable salt, from about 0.05 wt %to about 0.2 wt %
`
`brimonidine or its pharmaceutically acceptable salt, from about 0.05 wt %
`
`to about 1 wt % of one or moreviscosity agents, and from about 0.05 wt %
`
`to about 1 wt %of one or more buffers, wherein the pH of the formulation
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 4
`
`is from about 7 to about 7.6, and various impurity recitations (i.e. impurity
`
`A and B).
`
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`
`Group Il,
`
`claim 49, drawn to Impurity A
`
`Group III,
`
`claim 50, drawn to Impurity B
`
`Group IV,
`
`claims 61-63, 67, 71, 73-75, 82, drawn to a method for ameliorating or
`
`reducing presbyopia in a subject comprising administering to at least one
`
`eye of the subject an ophthalmic formulation comprising about 2 wt %to
`
`about 4 wt % carbachol or its pharmaceutically acceptable salt, from about
`
`0.05 wt %to about 0.2 wt % brimonidine or its pharmaceutically
`
`acceptable salt, from about 0.05 wt % to about 1 wt %of one or more
`
`viscosity agents, and from about 0.05 wt %to about 1 wt %of one or more
`
`buffers, wherein the pH of the formulation is from about 7 to about7.6,
`
`and various impurity recitations (i.e. impurity A and B).
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 5
`
`The groupsof inventions listed above do notrelate to a single general inventive
`
`concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or
`
`corresponding special technical features for the following reasons:
`
`There is not common technical feature between the groups. Group II whichis to
`
`impurity A does notrequire the actives or excipients present in Group |, Group III which
`
`is to impurity B does not require the presenceof impurity A of Group II or the actives or
`
`excipients of Group | or the methodology or components of Group Ill.
`
`Wherein the groups do not share a commontechnical feature.
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include (i) an election of a species or invention to be examined even though the
`
`requirement may be traversed (37 CFR 1.143) and(ii) identification of the claims
`
`encompassing the elected invention.
`
`The election of an invention or species may be madewith or without traverse. To
`
`preserve a right to petition, the election must be madewith traverse. If the reply does
`
`not distinctly and specifically point out supposed errorsin the restriction requirement,
`
`the election shall be treated as an election without traverse. Traversal must be
`
`presentedat the time of election in order to be considered timely. Failure to timely
`
`traverse the requirementwill result in the loss of right to petition under 37 CFR 1.144.
`
`If
`
`claims are added after the election, applicant must indicate which of these claims are
`
`readable on the elected invention or species.
`
`Should applicant traverse on the ground that the inventions have unity of
`
`invention (87 CFR 1.475(a)), applicant must provide reasons in support thereof.
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 6
`
`Applicant may submit evidence or identify such evidence now of record showing the
`
`inventions to be obvious variants or clearly admit on the record thatthis is the case.
`
`Wheresuch evidence or admission is provided by applicant, if the examiner finds one of
`
`the inventions unpatentable over the prior art, the evidence or admission may be used
`
`in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
`
`Applicant is reminded that upon the cancelation of claims to a non-elected
`
`invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one
`
`or more of the currently named inventors is no longer an inventor of at least one claim
`
`remaining in the application. A request to correct inventorship under 37 CFR 1.48(a)
`
`must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that
`
`identifies each inventor by his or her legal name and by the processing fee required
`
`under 37 CFR 1.17(i).
`
`The examiner has required restriction between product or apparatus claims and
`
`processclaims. Where applicant elects claims directed to the product/apparatus, and all
`
`product/apparatus claims are subsequently found allowable, withdrawn process claims
`
`that includeall the limitations of the allowable product/apparatus claims should be
`
`consideredfor rejoinder. All claims directed to a nonelected process invention must
`
`include all the limitations of an allowable product/apparatus claim for that process
`
`invention to be rejoined.
`
`In the eventof rejoinder, the requirementfor restriction between the
`
`product/apparatus claims and the rejoined process claims will be withdrawn, and the
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 7
`
`rejoined processclaimswill be fully examined for patentability in accordance with 37
`
`CFR 1.104. Thus, to be allowable, the rejoined claims must meetall criteria for
`
`patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all
`
`claims to the elected product/apparatus are found allowable, an otherwise proper
`
`restriction requirement between product/apparatus claims and process claims may be
`
`maintained. Withdrawn processclaims that are not commensurate in scope with an
`
`allowable product/apparatus claim will not be rejoined. See MPEP § 821.04.
`
`Additionally, in order for rejoinder to occur, applicant is advised that the process claims
`
`should be amended during prosecution to require the limitations of the
`
`product/apparatus claims. Failure to do so mayresult in no rejoinder. Further, note
`
`that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply
`
`wherethe restriction requirement is withdrawn by the examiner before the patent
`
`issues. See MPEP § 804.01.
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to GIG] GEORGIANA HUANG whosetelephone numberis
`
`(571)272-9073. The examiner can normally be reached Monday-Friday 8:30-5:00pm.
`
`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-basedcollaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http:/Avwww.uspto.gov/interviewpractice.
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 8
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`If attempts to reach the examinerby telephone are unsuccessful, the examiner's
`
`supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Centeris
`
`available to registered users. To file and manage patent submissions in Patent Center,
`
`visit: https://patentcenter.uspto.gov. Visit https:/Awww.uspto.gov/patents/apply/patent-
`
`center for more information about Patent Center and
`
`https:/Awww.uspto.gov/patents/docx for information aboutfiling in DOCX format. For
`
`additional questions, contact the Electronic Business Center (EBC) at 866-217-9197
`
`(toll-free). If you would like assistance from a USPTO Customer Service
`
`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/GIGI G HUANG/
`Primary Examiner, Art Unit 1613
`
`