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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
`
`16/908,426
`
`06/22/2020
`
`Gregory I. OSTROW
`
`46682-701.317
`
`5508
`
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`SHOWALTER, ALEXANDER KEITH
`
`ART UNIT
`
`1629
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/10/2024
`
`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):
`
`patentdocket @ wsgr.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`16/908,426
`OSTROWetal.
`
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`
`ALEXANDER K SHOWALTER__|1629 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 26 June 2024.
`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*
`31-34,37,39-45 and 49-53 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`CL] Claim(s)__is/are allowed.
`Claim(s) 31-34,37,39-45 and 49-53 is/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://www.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)0) The drawing(s) filedon__ is/are: a)(J 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)7) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.1.) Certified copies of the priority documents have been received.
`2.2) Certified copies of the priority documents have been received in Application No.
`3.1.) 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 20240826
`
`

`

`Application/Control Number: 16/08 ,426
`Art Unit: 1629
`
`Page 2
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`DETAILED ACTION
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`Notice ofPre-AIA or AIA Status
`
`The presentapplication, filed on or after March 16, 2013, is being examined underthe
`
`first inventorto file provisions of the AIA.
`
`Priority
`
`The present Application is a continuation of U.S. Application No. 15/568,381, filed
`
`October 20, 2017, which is a §371 U.S. National Stage Application of International Application
`
`No. PCT/US2016/029222, filed April 25, 2016, which is a continuation of International
`
`Application No. PCT/US2015/037249, filed June 23, 2015, which is a continuation of U.S.
`
`Application No. 14/726,139, filed May 29, 2015, now U.S. Patent No. 9,421,199, issued August
`
`23, 2016, which claims the benefit of U.S. Provisional Application No. 62/151,926,filed April 23,
`
`2015; U.S. Provisional Application No. 62/096,433, filed December 23, 2014, and U.S.
`
`Provisional Application No. 62/016,502, filed June 24, 2014.
`
`Status ofthe Claims
`
`In the amendmentfiled June 26, 2024, claim 35 is canceled; andclaims 31, 34, 44, and
`
`45 are amended. Claims 31-34, 37, 39-45, and 49-53 are currently pending and subject to
`
`examination herein.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on June 27, 2024 is acknowledged.
`
`Previous Rejections and/or Objections
`
`Any objections and/or rejections raised in the previous Office Action butnot reiterated
`
`below are considered to have been withdrawn.
`
`Claim Rejections - 35 USC § 103 — Necessitated by Amendment
`
`The following is a quotation of 35 U.S.C. 103 which formsthebasis for all obviousness
`
`rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not
`identically disclosed as set forth in section 102,if the differences between the claimed invention and the
`
`

`

`Application/Control Number: 16/08 ,426
`Art Unit: 1629
`
`Page 3
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`prior art are such that the claimed invention as a whole would have been obvious before the effective
`filing date of the claimed invention to a person having ordinary skill in the art to which the claimed
`invention pertains. Patentability shall not be negated by the manner in which the invention was made.
`
`The factual inquiries for establishing a background for determining obviousness under 35
`
`U.S.C. 103 are summarized as follows:
`
`1. Determining the scope and contents of the priorart.
`2. Ascertaining the differences betweentheprior art and the claimsat issue.
`3. Resolving the level of ordinary skill in the pertinentart.
`4. Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
`
`Claims 31-33, 37, 39-45, and 49-53 are obvious overAkorn, Kondritzer, Kumar, Chia, and
`
`Cavanaugh:
`
`Claims 31-33,37, 39-45, and 49-53 are rejected under 35 U.S.C. 103 as being unpatentable
`
`over the non-patent publication FDA Drug Label Archive for Atropine Sulfate Solution, NDC
`
`code 17478-215-02, first published in 2010 (hereinafter, “Akorn”), in view of the non-patent
`
`publication, Stability of atropine in aqueous solution, J. Am. Pharm. Assoc., 46, pgs. 531-535
`
`(1957) by Kondritzer et al.
`
`(hereinafter, “Kondritzer”), further in view of the non-patent
`
`publication, Recent Challenges and Advances in Ophthalmic Drug Delivery System, The Pharma
`
`Innov., 1, pgs. 1-15 (2012) by Kumaretal. (hereinafter, “ Kumar’), furtherstill in view of the non-
`
`patent publication, Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%,
`
`0.1%, and 0.01% doses (Atropine for the Treatment ofMyopia 2), Ophthalm., 119, pgs. 347-354
`
`(2011) by Chiaet al., (hereinafter, “Chia”), and furtherstill in view of U.S. Patent Application
`
`Publication No. 2013/0303502 to Cavanaugh et al. (hereinafter, “Cavanaugh”). Akorn was
`
`obtained
`
`from
`
`the
`
`DailyMed
`
`website
`
`at
`
`the
`
`url
`
`dailymed.nlm.nih.gov/dailymed/getArchivalFile.cfm?archive_id=25609, anda consolidated copy
`
`of the 2010 version (including label and box on pg. | and description on pgs. 2-3) is appended to
`
`this Office Action.
`
`Claim 31 recites a kit comprising a container having a monotherapeutic pharmaceutical
`
`composition and instructions for use.
`
`The monotherapeutic pharmaceutical composition
`
`comprises atropine or atropinesulfate as a sole ophthalmic agent, present at about 0.01 mg/g to
`
`about 0.5 mg/g. The composition also includes water; a buffering agent selected from citrate and
`
`acetate to provide a pH from about 4.8 to about 6.4; a tonicity adjusting agent; and a viscosity
`
`agent.
`
`

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`Application/Control Number: 16/08 ,426
`Art Unit: 1629
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`Page 4
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`Akorn teaches an aqueoussolution containing atropine sulfate as the sole active ophthalmic
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`ingredient(i.e. a monotherapeutic solution having atropine sulfate; see pg. 2, lines 5-7, describing
`
`atropine sulfate as
`
`sole active ingredient.
`
`Akorn teaches that
`
`the solution contains
`
`dibasic/monobasic sodium phosphate(i.e. a buffer) and can have hydrochloric acid and/or sodium
`
`hydroxide addedto adjust pH to a pH within a range of from 3.5 to 6.0 (pg. 2, lines 9-11). The
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`sodium phosphate of Akorn is both a buffer of claim 31 (see paragraph [0021] of the instant
`
`application anda tonicity adjusting agent (see paragraph [0021] of the instant application). Akeorn
`
`further teaches, at pg. 2, line 9 that the solution contains Hypromellose (i.e. hydroxypropyl
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`methylcellulose, or HPMC,a viscosity agent).
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`The pH range of from about 4.8 to about 6.4 of instant claim 31 is obvious over the
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`overlapping pH range of 3.5 to 6.0 taughtby Akorn. In the case wherethe claimed ranges "overlap
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`or lie inside ranges disclosed by the priorart," a primafacie case of obviousness exists. See MPEP
`
`§ 2144.05() and cases cited therein. Furthermore, Kondritzer teaches that atropine in aqueous
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`solution is far morestable against hydrolysis (i.e. degradation) at moderately acidic pH thanitis
`
`at neutral or alkaline pH. See, for example, Table III of Kondritzer, showing a predicted half-life
`
`of 27 years for atropine at 20 °C and pH 6.0, as opposed to a half-life of 2.7 years at the same
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`temperature and pH 7.0.
`
`
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`Assuch, it would have been obviousto select a pH within the recited range of from about
`
`4.8 to about 6.4, which overlaps with the pH range of Akorn, and as promptedby the teaching of
`
`Kondritzer of significantly improvedstability at moderately acidic pH.
`
`Akorn does not explicitly teach that the buffering agent is selected fromacitrate buffering
`
`agent and an acetate buffering agent, but it would have been obvious to one of ordinary skill in the
`
`art to use such buffer systems, however, becausecitrate, forexample, was well-knownin the art
`
`as a safe and effective buffer for ophthalmic solutions. See, for example, Kumar.
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`

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`Application/Control Number: 16/08 ,426
`Art Unit: 1629
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`Page 5
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`Kumar teaches that citrate is a commonly used buffer in the context of ophthalmic
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`solutions (pg. 5, third paragraph). And while Kumarteaches that citrate would be undesirable in
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`a formulation intended to be ata pH of about 7.4, due to poor buffering capacity at this pH, citrate
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`would be highly effective within the pH range recited in claim 31, as citrate has pKa’s across this
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`range.
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`It thus would have been obvious to replace the phosphate buffer of Akorn with the
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`commonly usedcitrate buffer as taught by Kumar.
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`Akorn does not explicitly teach that the atropine sulfate is present in the monotherapeutic
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`pharmaceutical composition at about 0.01 mg/g to about 0.05 mg/g. It would have been obvious
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`to one of ordinaryskill in the art, however,to utilize an atropine sulfate concentration within this
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`range, because concentrations within this range were knownin theart to be safe and effective for
`
`treating various ophthalmological conditions. See, for example, Chia.
`
`Chia teaches a randomized study of low concentration atropine (0.5%, 0.1% and 0.01%)
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`for the treatmentof atropine in children (Abstract). Chia further teaches that the 0.01% atropine
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`(approximately 0.1 mg/g) retains efficacy for reducing myopia progression in children, and has
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`fewer adverse events compared to higher concentrations (pg. 353, right column, last paragraph
`
`continuing to top of left column of pg. 354). It thus would have been obvious to utilize the low
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`concentration of about 0.1 mg/g as taught by Chia, in the ophthalmic solution of Akorn, to treat
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`an ophthalmic condition such as reducing myopia progression in children, with fewer adverse
`
`events
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`Akorn, in view of Kumar, Kondritzer and Chia (modified Akorn), thus teaches all
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`elements of the monotherapeutic composition of claim 31, but does not teach incorporating the
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`monotherapeutic composition into a kit that includes a bottle to contain the composition and
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`instructions foruse. It would have been obvious to one of ordinary skill in the art, however, to
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`incorporate the monotherapeutic composition of modified Akorn into such a kit, as ophthalmic
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`kits including bottles to contain ophthalmic solutions andinstructions for use were well-known in
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`the art. See, forexample, Cavanaugh.
`
`Cavanaugh teaches, inter alia, a kit that comprises a container containing one or more
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`ophthalmic solutions or formulations (paragraph [0347]). Cavanaugh further teaches that the kit
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`can include instructional materials containing directions disclosing means of use of the
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`formulations (i.e. instructions for use, paragraph [0349]). Cavanaugh further references atropine
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`as one drug from among manyalternatives that can be included in the formulation or solution
`
`

`

`Application/Control Number: 16/08 ,426
`Art Unit: 1629
`
`Page 6
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`(paragraph [0210]) that is includedin the kit, and that the kit can facilitate various aspects of
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`shipping, use, and storage (paragraph [0347]).
`
`It would have been obvious to incorporate the
`
`monotherapeutic atropine composition of modified Akorninto the kit of Cavanaugh, including
`
`the containerandinstructions, to facilitate various aspects of shipping, use, and storage.
`
`With respect to claims 32 and 33, as noted, Chia teaches the benefits of a 0.01% (about 0.1
`
`mg/g) atropine solution. With respect to claim 37, as noted Akorn teaches that the bufferis
`
`monobasic/dibasic sodium phosphate and that this may be pH adjusted with hydrochloric acid. It
`
`will be understood that such adjustment would produce sodium ions and chloride ions in solution,
`
`i.e. sodium chloride, present as a tonicity -adjusting agent.
`
`In addition, Cavanaugh teaches that
`
`the formulations to be used with the kit can include tonicity enhancers such as NaBr or NaCl
`
`(paragraph [0298]).
`
`With respect to claim 39, as noted, Akorn teaches wherein the viscosity agent is HPMC.
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`With respect to claim 40, while Akorn teaches the presenceof a preservative, Cavanaugh teaches
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`that the use of single-dose packaging can rendera preservative unnecessary. Cavanaugh further
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`teaches that this is beneficial because preservatives can at times cause ocularirritation (paragraph
`
`[0343]).
`
`It thus would have been obvious to prepare the kit of Akoern, Kondritzer, Chia, and
`
`Cavanaugh such that
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`the monotherapeutic composition is
`
`in single dose form without
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`preservative, thereby reducing ocularirritation.
`
`With respect
`
`to claims 41-44, Akorn teaches that
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`the solution contains 0.01%
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`benzalkonium chloride (pg. 2, line 9). With respect to claim 45, Akorn teaches that the solution
`
`does not contain either procaine or benactyzine (the complete list of ingredients at pg. 2 lines 8-11
`
`does not include procaine, benactyzine, or synonymsthereof).
`
`With respect to claims 49-50, Akorn teaches that the solution is a “sterile topical
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`anticholinergic for ophthalmic use”(pg.2, lines 4-5). With respectto claims 51-53, Akorn teaches
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`that the solution contains Edetate Disodium (i.e. EDTA, pg.2, line 10).
`
`Claims 34 is obvious over Akorn, Kondritzer, Kumar, Chia, Cavanaugh, andAleo:
`
`Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Akorn, Kondritzer,
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`Kumar, Chia, and Cavanaugh and further in view of U.S. Patent Application Publication No.
`
`2011/0028477 to Aleo et al. (hereinafter, “Aleo”).
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`

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`Application/Control Number: 16/08 ,426
`Art Unit: 1629
`
`Page 7
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`Akorn, Kondritzer, Kumar, Chia, and Cavanaughare applied to claim 34 as to claim 31,
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`above, but none explicitly teaches the combined buffering agent as recited. It would have been
`
`obvious to use a combination buffering agent such as citrate/borate, however, because such
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`combination buffering agents for acidic ophthalmic solutions were well-knownin the art. See, for
`
`example, Aleo.
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`Aleo teaches an ophthalmic composition (eye drops) having a therapeutic component, a
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`buffering agent, and a pH between 5.8 and 6.5, substantially overlapping with the recited pH of
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`the instant claims (Aleo claims | and 2). Aleo further teaches that the buffering agent can be,
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`among other choices, a citrate buffer, a borate buffer, ora combination thereof.
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`It would have
`
`been obvious to use the combinedcitrate/borate buffer of Aleo to maintain the desired acidic pH
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`of the ophthalmic solution of Akorn, Kondritzer, Kumar, Chia, and Cavanaugh, i.e. for the same
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`purposethat this combined bufferis utilized in Aleo.
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`Response to Arguments
`
`With respect to the previous rejections under 35 U.S.C. § 103, Applicant notes that none
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`of Akorn, Kondritzer, Chia or Cavanaughteaches a buffering agent to provide a pH from about
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`4.8 to about 5.8, wherein the buffer comprises a buffering agent selected from a citrate buffering
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`agent and an acetate buffering agent,” as recited by amendedclaim 31 (last paragraphofpg. 5 to
`
`first paragraph of pg. 6 of Applicant’s response, emphasis in Applicant’s response). The feature
`
`of amended claim 31 where the buffering agent is selected fromacitrate buffering agent and an
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`acetate buffering agent was previously the feature of claim 34, now canceled.
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`This feature was found in Kumar, in the rejection of claim 34 from the Office Action of
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`April 1,2024. While itis true that the previous rejection of claim 31, which did not include Kumar,
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`is overcome by the current amendment, the reasoning applied in the previous rejection of claim
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`34, utilizing Kumar, is now applied to claim 31.
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`Applicantcontendsthata person of ordinary skillin the art would not be motivated to apply
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`the citrate buffer of Kumar to the composition of Akorn for two reasons: (i) Kumar does not
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`motivate the person of skill in the art to modify Akorn with a “strong buffer,” and (11) Replacing
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`the phosphate buffer of Akorn frustrates the purpose of Akorn (pg. 6 of Applicant’s response,
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`second through fifth paragraphs). These arguments have been fully considered, but are not found
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`persuasive.
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`

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`Application/Control Number: 16/08 ,426
`Art Unit: 1629
`
`Page 8
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`With respect to the first contention, Applicantcites the statement from Kumar that “the
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`limited buffer capacity of the lachrymalfluid precludes the use of strong buffers outside the pH
`
`range of 6.8-7.6” (Kumar, pg. 5, fourth paragraph; cited at pg. 8, fourth full paragraph of
`
`Applicant’s response). Applicantasserts that the citrate buffer of Kumaris a strong bufferat the
`
`claimed pH of 4.8 to 5.8 and that Kumartherefore teaches away from combiningthecitrate buffer
`
`of Kumar with the composition of Akorn, which hasan acidic pH. While Kumar does notspecify
`
`whatis meantby “strong buffer”in this context, itcan be surmised to bea buffer with a high buffer
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`capacity; i.e. for an ophthalmic solution outside of physiological pH, such as the acidic pH of
`
`Akorn andinstant claim 31, one would wantto use a low capacity buffer so that pH would quickly
`
`adjust to pH after administration to the eye.
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`Evenif one accepts that Kumar teaches alow capacity buffer should be used in ophthalmic
`
`solutions at non-physiological pH, such as the acidic pH ofthe solution of instant claim 31, it
`
`would have been well-knownto oneof ordinary skill in the would have understoodthat buffer
`
`capacity ata given pH can be modulated by (a) buffer pK,, or (b) buffer concentration. See, for
`
`example, the non-patent publication, Buffer Capacity — an underestimated parameter in prep RP-
`
`HPLC, Kromasil web page, (2011) by Kromasil (hereinafter, “Kromasil”), obtained at the url
`
`https://www.kromasil.com/notes/?NOTEhexl(2011), stating that buffer capacity is a function of
`
`pH, concentration, and pK,of the weak acid(i.e. a function of (1) the difference between pH and
`
`pK,, and (ii) buffer concentration), second paragraph). Indeed, Kumaritself states that, “[t]he
`
`buffer capacity is determined by buffer concentration.” As such, one of ordinary skill in the art
`
`would have understood that one could avoida “strongbuffer”by utilizinga citrate or acetate buffer
`
`at a pH near one of its acidic pK,s (e.g. 4.7 or 6.4 forcitrate), albeit at a relatively low buffer
`
`concentration.
`
`To Applicant’s second contention, that replacing the phosphate of Akorn with, for
`
`example, the citrate taught by Kumar as a common ophthalmic buffer, would frustrate the purpose
`
`of Akorn, this appearsto be largely the same as the first contention. It appears to be Applicant’s
`
`contention that it is a purpose of Akorn to utilize a weak buffer(i.e. a non-“strong” buffer as
`
`allegedly suggested by Kumar) in the acidic ophthalmic solution so that the solution can rapidly
`
`shift to physiological pH after administration to the eye. There is no statementor suggestion of
`
`such a purpose in Akorn, but Applicant apparently assumes this to be a purposeandtherationale
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`for using phosphate as the buffer in Akorn. As noted above, however, one could achieve this
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`

`

`Application/Control Number: 16/08 ,426
`Art Unit: 1629
`
`Page 9
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`alleged purpose of Akorn by substituting the phosphate of Akorn with the citrate of Kumar, and
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`utilizing the citrate at a lower concentration to facilitate rapid shift to physiological pH upon
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`administration. As such, and contrary to Applicant’s contention, substituting the phosphate of
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`Akorn does not intrinsically frustrate the purpose of Akorn, even assuming this this unstated
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`purposeis an actual purpose of Akorn.
`
`Conclusion
`
`Applicant's amendment necessitated the new ground(s) of rejection presentedinthis Office
`
`action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicantis
`
`reminded of the extension oftime policy as set forth in 37 CFR 1.136(a).
`
`A shortenedstatutory period forreply to this final actionis set to expire THREE MONTHS
`
`from the mailing date of this action. In the eventa first reply is filed within TWO MONTHSof
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`the mailing date of this final action and the advisory action is not mailed until after the end of the
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`THREE-MONTHshortenedstatutory period, then the shortenedstatutory period will expire on
`
`the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be
`
`calculated from the mailing date of the advisory action.
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`In no event, however, will the statutory
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`period for reply expire later than SIX MONTHSfrom the date of this final action.
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`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to ALEXANDER K SHOWALTER whosetelephone numberis (571)270-
`
`0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm,eastern time.
`
`Examinerinterviews are available via telephone, in-person, and video conferencing using
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`USPTO
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`If attempts to reach the examinerby telephone areunsuccessful, the examiner’s supervisor,
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`Jeffrey S Lundgren can be reached on (571) 272-5541. The fax phone numberfor the organization
`
`wherethis application or proceedingis assigned is 571-273-8300.
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`Information regarding the status of published or unpublished applications may be obtained
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`

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`Application/Control Number: 16/08 ,426
`Art Unit: 1629
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`Page 10
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`and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For
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`additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).If
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`you would like assistance from a USPTO CustomerService Representative, call 800-786-9199
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`(IN USA OR CANADA)or 571-272-1000.
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`/ALEXANDER K. SHOWALTER/
`Examiner, Art Unit 1629
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`/JEFFREY S LUNDGREN/
`Supervisory Patent Examiner, Art Unit 1629
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