www.uspto.gov
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`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
`
`12/04/2024
`
`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)
`
`

`

`
`
`Disposition of Claims*
`49 and 147-159 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 147-159 is/are withdrawn from consideration.
`() Claim(s)__is/are allowed.
`Claim(s) 49is/are rejected.
`[) Claim(s)__ is/are objectedto.
`C] Claim(s)
`are subjectto restriction and/or 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:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)() The drawing(s) filedon__ is/are: a)C) 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:
`—_c)LJ None ofthe:
`b)LJ Some**
`a)D) All
`1.) Certified copies of the priority documents have been received.
`2.1 Certified copies of the priority documents have been received in Application No.
`3.2.) 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)
`
`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 20241127
`
`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 3 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 11/04/2024.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)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.
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 2
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`DETAILED ACTION
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`Election/Restrictions
`
`1.
`
`Applicant’s election without traverse of Group II in the reply filed on 11/04/2024 is
`
`acknowledged. Applicant asserts that new claims 147-159 fall within Group I. While
`
`claims 149-156fall within Group | which is not elected, claims 157-159 fall under Group
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`IV as addressedin the previously presentedrestriction; wherein these claims are
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`withdrawn being to the non-elected invention. Newly submitted claims 147 and 148 are
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`withdrawnby election by original presentation as claim 147 (would have been Group V)
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`and claim 148 (would have been Group VI) are each directed to an invention thatis
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`independentor distinct from the invention originally claimed for the following reasons:
`
`claim 147 is to a composition comprising carbachol with the presence of the impurity A
`
`but doesnotrecite the presence of brimonidine which is required in Group | and IV and
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`carbachol is not recited in Group II or III, claim 148 is to a composition comprising
`
`brimonidine with the presence of the impurity A but does notrecite the presenceof
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`carbachol whichis required in Group | and IV and brimonidine notrecited in Group II or
`
`Ill; wherein there is not unity of invention.
`
`Since applicant has received an action on the merits for the originally presented
`
`invention, this invention has been constructively elected by original presentation for
`
`prosecution on the merits. Accordingly, claims 147 and 148, along with claims 149-159
`
`withdrawn from consideration as being directed to a non-elected invention. See 37 CFR
`
`1.142(b) and MPEP § 821.03.
`
`To preservea right to petition, the reply to this action must distinctly and
`
`specifically point out supposederrors in the restriction requirement. Otherwise, the
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 3
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`election shall be treated as a final election without traverse. Traversal must be timely.
`
`Failure to timely traverse the requirementwill result in the loss of right to petition under
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`37 CFR 1.144.If claims are subsequently added, applicant mustindicate which of the
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`subsequently added claims are readable upon the elected invention.
`
`Should applicant traverse on the ground that the inventions are not patentably
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`distinct, applicant should submit evidenceor identify such evidence now of record
`
`showing the inventions to be obvious variants or clearly admit on the record thatthis is
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`the case. In either instance, if the examiner finds one of the inventions unpatentable
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`overthe prior art, the evidence or admission maybe usedin a rejection under 35 U.S.C.
`
`103 or pre-AlIA 35 U.S.C. 103(a) of the other invention.
`
`Status of Application
`
`2.
`
`Applicant has elected Group Il in responseto restriction requirement and for the
`
`examination.
`
`Due to restriction, based on election of Group Il, claims 147-159 are withdrawn
`
`from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-
`
`elected invention.
`
`3.
`
`4.
`
`5.
`
`Claims 49, 147-159 are pending.
`
`Claim 49 is present for examination at this time.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`underthe first inventor to file provisions of the AIA.
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 4
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`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section madein this Office action:
`
`A personshall be entitled to a patent unless —
`
`(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
`on sale, or otherwise available to the public before the effectivefiling date of the claimed
`invention.
`
`6.
`
`Claim 49 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaufman
`
`(U.S. Pat. Pub. 2011/0152274).
`
`Rejection:
`
`Kaufman teaches the combination of brimonidine and carbachol togetherat
`
`various concentrations wherein the presenceof impurity A is inherently present
`
`Example |
`
`at
`
`Cmhihalasc sohstiog In LOml
`
`{ngeediest
`
`AGH OUR
`
`y its pharmaceutically
`
`OL GES TES or O38 &
`
`H#H62] The above ingredients are prepared ima ustal man-
`Ner into a sterilized preparation as an ophthalmic solution,
`adjusting, Uf necessary, the pH to about 7.3. This exaniple
`provides for sixty different ophthalmic preparations.
`
`(Example 1, [61-62]).
`
`The instant specification addresses that the impurity A is formed in formulation
`
`comprising carbachol and brimonidine and has a RRTof about0.9 of brimonidine ([28-
`
`

`

`feN
`S(LID
`
`N
`
`N
`
`NH,
`
`) where the presence of the impurity A is present/formed
`
`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`29], brimonidine
`
`_
`
`~
`
`with carbachol ~
`
`
`
`Page 5
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`form
`
`Oo
`
`N
`
`when brimonidine and carbachol are present together. lt is noted that “[T]he discovery
`
`of a previously unappreciated property of a prior art composition, or of a scientific
`
`explanation for the prior art's functioning, does not render the old composition
`
`patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342,1347,
`
`51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function
`
`or unknownproperty which is inherently present in the prior art does not necessarily
`
`make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433
`
`(CCPA 1977).
`
`Aninherent feature need not be recognized at the time of the invention.
`
`There is no requirement that a person of ordinary skill in the art would have recognized
`
`the inherent disclosure at the time of invention, but only that the subject matteris in
`
`fact inherent in the prior art reference. The fact that a characteristic is a necessary
`
`feature or result of a prior-art embodiment(thatis itself sufficiently described and
`
`enabled) is enough for inherent anticipation, even if that fact was unknownatthe time of
`
`the prior invention.
`
`All the critical elements are taught by the cited reference and thus the claims are
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`anticipated.
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 6
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`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the “right to exclude” granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the conflicting claims are not identical, but at
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`least one examined application claim is not patentably distinct from the reference
`
`claim(s) because the examined application claim is either anticipated by, or would have
`
`been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
`
`USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timelyfiled terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actualor provisional rejection based on nonstatutory
`
`double patenting provided the reference application or patent either is shown to be
`
`commonly owned with the examined application, or claims an invention made as a
`
`result of activities undertaken within the scopeof a joint research agreement. See
`
`MPEP § 717.02 for applications subject to examination underthe first inventor to file
`
`provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146et seq.for
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 7
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`applications not subject to examination underthe first inventor to file provisions of the
`
`AlA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`
`The filing of a terminal disclaimerbyitself is not a complete reply to a
`
`nonstatutory double patenting (NSDP)rejection. A complete reply requires that the
`
`terminal disclaimer be accompanied by a reply requesting reconsideration of the prior
`
`Office action. Even where the NSDP rejection is provisional the reply must be complete.
`
`See MPEP § 804, subsection |.B.1. For a reply to a non-final Office action, see 37 CFR
`
`1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A requestfor
`
`reconsideration while not provided for in 37 CFR 1.113(c) may befiled after final for
`
`consideration. See MPEP §§ 706.07(e) and 714.13.
`
`The USPTOInternet website contains terminal disclaimer forms which may be
`
`used. Please visit www.uspto.gov/patent/patents-forms. The actualfiling date of the
`
`application in which the form is filed determines what form (e.g., PTO/SB/25,
`
`PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal
`
`Disclaimer may befilled out completely online using web-screens. An eTerminal
`
`Disclaimer that meets all requirements is auto-processed and approved immediately
`
`upon submission. For more information about eTerminal Disclaimers, refer to
`
`
`
`7.
`
`Claim 49 is provisionally rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over claim 155 of copending Application No. 18/535520
`
`(reference application). Although the claims at issue are notidentical, they are not
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 8
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`patentably distinct from each other because the copending claim recites the presenceof
`
`the instant claimed compound.
`
`This is a provisional nonstatutory double patenting rejection because the
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`patentably indistinct claims have not in fact been patented.
`
`8.
`
`Claim 49 is rejected.
`
`Conclusion
`
`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-based collaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http:/Avwww.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone numberfor
`
`the organization wherethis 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
`
`

`

`Application/Control Number: 18/250,921
`Art Unit: 1613
`
`Page 9
`
`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
`
`