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
`
`17/298,060
`
`05/28/2021
`
`Vinod P. Menon
`
`80979US005
`
`1054
`
`Solventum Intellectual Properties Company
`2510 Conway Ave E
`3M Center, 275-6E-21
`St Paul, MN 5514
`
`THOMAS, TIMOTHY P
`
`1611
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/06/2024
`
`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):
`
`IPDocketing @ Solventum.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Office Action Summary
`
`Application No.
`17/298,060
`Examiner
`TIMOTHY P THOMAS
`
`Applicant(s)
`Menon etal.
`Art Unit
`1611
`
`AIA (FITF) Status
`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 5/15/2024.
`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.
`
`Disposition of Claims*
`1-9,11-12 and 15-23 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 17-18 is/are withdrawn from consideration.
`[] Claim(s)__ is/are allowed.
`Claim(s) 1-9,11-12,15-16 and 19-23 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:/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 20240905
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The presentapplication, filed on or after March 16, 2013, is being examined
`
`underthefirst inventor to file provisions of the AIA.
`
`Election/Restrictions
`
`2.
`
`Applicant's election with traverse of Group I, claims 1-9, 11-12, 15-16, 19-23, in
`
`the reply filed on 5/15/2024 is acknowledged. The traversal is on the ground(s) that the
`
`basis discussed, from WO 2001/24766 (D1), does not teach or suggestthe topical
`
`antimicrobial composition of the present claims (which were newly amendedwith the
`
`election reply filed 5/15/2024). This is not found persuasive becausethe basis for which
`
`unity of invention was found lacking was based on the claim set of record at the time the
`
`Restriction was mailed. Thus, the requirementfor restriction and species election was
`
`properly set forth.
`
`The requirementis still deemed proper and is therefore made FINAL.
`
`Examinerfurther notes that the obviousnessbasis set forth below (based on
`
`current claim amendment and elections made) also supports the position that the
`
`claimed technical feature among the inventions and among the speciesstill lacks
`
`inventive step.
`
`3.
`
`Applicant's election with traverseof:
`
`(i) the combination of:
`
`1) isopropyl myristate as emollient oil (claim 1 and claims dependenttherefrom);
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 3
`
`2) glyceryl monocaprylate as surfactant (claim 1 and claims dependent
`
`therefrom);
`
`3) chlorhexidine gluconate as antimicrobial compound (claim 1 and claims
`
`dependenttherefrom);
`
`4) glycerol (claim 8); and
`
`5) benzyl alcohol (claim 16),
`
`in the reply filed on 5/15/2024 is acknowledged (Examinernotes that claim 1 also
`
`requires water, in addition to the elected species under 1), 2) and 3), above). The
`
`traversal is on the ground(s) that see above. This is not found persuasive because see
`
`above.
`
`The requirementis still deemed proper and is therefore made FINAL.
`
`4.
`
`Claims 17-18 are withdrawn from further consideration pursuant to 37 CFR
`
`1.142(b), as being drawn to a nonelected invention, there being no allowable generic or
`
`linking claim. Applicant timely traversed the restriction (election) requirement in the reply
`
`filed on 5/15/2024.
`
`5.
`
`Claims 10, 13-14 have been canceled.
`
`Specification
`
`6.
`
`The lengthy specification has not been checked to the extent necessary to
`
`determine the presenceof all possible minor errors. Applicant’s cooperation is
`
`requestedin correcting any errors of which applicant may become awarein the
`
`specification.
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 4
`
`Claim Rejections - 35 USC § 112
`
`7.
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS.—Subjectto subsection (e), a claim in dependent
`form shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependent form shall be construed to
`incorporate by referenceall the limitations of the claim to whichit refers.
`
`The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
`
`Subject to the following paragraph[i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim
`in dependent form shall contain a reference to a claim previously set forth and then specify a
`further limitation of the subject matter claimed. A claim in dependent form shall be construed
`to incorporate by referenceall the limitations of the claim to whichit refers.
`
`8.
`
`Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AlA 35 U.S.C. 112, 4th
`
`paragraph, as being of improper dependent form for failing to further limit the subject
`
`matter of the claim upon which it depends, or for failing to include all the limitations of
`
`the claim upon which it depends. The alternatives of claim 12 encompasschoices
`
`outside of the scope of independent claim 1, from which claim 12 depends. Claim 1
`
`requires at least 80%of caprylic acid, but dependent claim 12 recites at least three acyl
`
`choices that are not caprylic acid. These are outside of the scopeof claim 1, and do not
`
`furtherlimit claim 1. Applicant may cancelthe claim(s), amend the claim(s) to place the
`
`claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present
`
`a sufficient showing that the dependent claim(s) complies with the statutory
`
`requirements.
`
`Claim Rejections - 35 USC § 103
`
`9.
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103)is incorrect, any
`
`correction of the statutory basis (i.e., changing from AIA to pre-AlA) for the rejection will
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 5
`
`not be considered a new ground ofrejection if the prior art relied upon, and the rationale
`
`supporting the rejection, would be the same under either status.
`
`10.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basisfor all
`
`obviousnessrejections set forth in this Office action:
`
`A patentfor 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 prior art are such that the claimed invention as a whole would have
`been obvious beforethe 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.
`
`11.|The factual inquiries for establishing a background for determining obviousness
`
`under 35 U.S.C. 103 are summarized asfollows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences betweenthe prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence presentin the application indicating
`
`obviousness or nonobviousness.
`
`12.—This application currently namesjoint inventors. In considering patentability of the
`
`claims the examiner presumesthat the subject matter of the various claims was
`
`commonly ownedasof the effective filing date of the claimed invention(s) absent any
`
`evidenceto the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to
`
`point out the inventor and effective filing dates of each claim that was not commonly
`
`ownedasofthe effectivefiling date of the later invention in order for the examiner to
`
`consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2)
`
`prior art against the later invention.
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 6
`
`13.
`
`Claim(s) 1-9, 11-12, 15-16, 19-23 is/are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Tamarkin et al. (US 2008/0260655 A1; 2008), in view of Zhang
`
`(“Development and Evaluation of Novel Biocompatible Microemulsion Formulations for
`
`Transdermal Drug Delivery”, Master of Science (Research) thesis, School of Biological
`
`Sciences, University of Wollongong, 2016; https://ro.uow.edu.au/theses/4962); and
`
`Ruth et al. (“Phase studies and particle size analysis of oil-in-water phospholipid
`
`microemulsions’; 1995; International Journal of Pharmaceutics; 116: 253-261).
`
`Tamarin teaches, inter alia, microemulsions, when water is present ina
`
`composition [0250]; which, in some embodiments are non-alcoholic or substantially so
`
`[0251].
`
`In an embodiment the non-aqueous solvent is monooctanoin (a.k.a., Applicant
`
`elected glyceryl monocaprylate) [0187]. Glyceryl stearate (monostearate) is also taught
`
`as a surfactant [0326], (bottom table on p. 41, second table on p. 42, bottom table p.
`
`44), [0656], [0658], and is used in water in oil emulsions [0660] 1a & 1b, [0662], 2a,
`
`[0663], 3a. Preferable non-ionic surfactants include a monoglyceride [0319] (a class
`
`that each of monoctanoin and glyceryl monostearatefall into). Each of the emulsions
`
`contain water.
`
`Regarding hydrophobic solvents, ester oils are taught, including Applicant
`
`elected isopropyl myristate [0279]. This compound is also taught as an “emollient”,
`
`possessing a softening or soothing effect, especially when applied to body areas such
`
`as the skin [0287], and is an oil [0301], claim 29, No. 13.
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 7
`
`Regarding active agents, antibacterial agents taught include chlorohexidine
`
`[0428], and chlorhexidine gluconate has some degreeof solubility in water [0451], claim
`
`30.
`
`Additionally, the preference for low or no alcohol including ethanol, is taught to be
`
`less than about 5%, preferably less than about 2%, and more preferably less than about
`
`1%, is taught dueto the skin irritating effect [0192]. These levels (or absence of ethanol
`
`and other short chain alcohols) read on the permitted amounts of lower monohydric
`
`alcohols of claims 1 and 4.
`
`While Tamarkin teaches each elected component, isopropyl myristate, as an
`
`ester oil and emollient, monooctanoin (glyceryl monocaprylate), and the similar
`
`compound glyceryl monostearate, as surfactant (suggesting monooctanoin would also
`
`function as a surfactant), and chlorhexidine gluconate as water soluble antibacterial
`
`active agent, and water, their combination would require picking and choosing from
`
`different portions of this publication. Additionally, microemulsions are taught, but their
`
`droplet particle size is not specified.
`
`Zhang discusses microemulsion (ME) formulations for transdermal drug delivery
`
`(title). MEs can form spontaneously, are thermodynamically stable and possess high
`
`solubilization capacity for drug compounds(i; abstract, 1§' paragraph).
`
`Medium chain monoglycerides (MCM) are discussed as transdermal drug
`
`delivery (8, section 1.3); they are fatty acid monoesters of glycerol (section 1.3.1).
`
`mono-glycerides are commonly added to food products in small quantities as
`
`emulsifiers and considered GRAS compounds(section 1.3.2).
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 8
`
`Regarding transdermal permeation enhancers, MCM have enhancedthe
`
`transdermal permeation rate of numerous drug compounds. Applicant elected Glyceryl
`
`monocaprylate (C8) significantly improved the transdermal delivery rate of pentazocine
`
`compared with other permeation enhancers(i.e., isopropyl myristate solution alone,
`
`carboxylic acids, non-inonic surfactants, I-menthol, alcohols, glycol and urea) from
`
`Applicant elected isopropyl myristate solution system (IPM); two derivatives of glyceryl
`
`monocaprylate (glyceryl diglycerides and glyceryl triglycerides) were proved to have no
`
`permeation enhancementeffect of pentazocine. While the highest flux was reached for
`
`glyceryl monocaproate (GEFA-Ce), when comparing Applicant elected glyceryl
`
`monocaprylate (GRFA-Cs) and glyceryl monocaproate (GRFA-Ce), the formeris suitable
`
`as a permeation enhancer becauseofits safety and odorless properties (9: section
`
`1.3.3).
`
`Section 1.3.4 (p. 10) discusses broad spectrum antimicrobial properties of MCM.
`
`The formation and structure of MEsare discussed in 1.4.1 (p. 10-11). MEs are
`
`defines as a single, optically isotropic structured solution of surfactant, oil and wateris
`
`called a microemulsion. MEs can be formed with a wide range ofoil-surfactant-water
`
`compositions and can beeither water-in-oil (W/O)oroil-in-water (O/W) with a
`
`characteristic droplet size of 150 nm or less. Asit is difficult to predict ME formation
`
`based on the complex physical-chemical interactions between components, pseudo-
`
`ternary phase diagrams are commonly used to determine the specified oil-surfactant-
`
`water concentrations ranges required for the formation of MEs (p. 10).
`
`Monophasic ME areof consideration as potential drug delivery vehicle in this
`
`study since they are stable, can be easily prepared and have high capacity for a wide
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 9
`
`range drug solubilization, including lipophilic and hydrophilic compounds in the one
`
`formulation (p. 11, top).
`
`Section 1.4.2 discusses properties that render MEsasidealliquid vehicles for
`
`drug delivery since the small droplets have better ability to adhere to membranes and to
`
`transport bioactive molecules in a more controlled fashion; MEs can be administered,
`
`including topically on the skin.
`
`Section 1.5 (p. 12) documents MCM, as knowntransdermal penetration
`
`enhancers for a range of compounds, and displaying broad spectrum antimicrobial
`
`activity against a variety of human pathogens, provides a combination of activities that
`
`may be useful in the development of novel antimicrobial formulations for topical use.
`
`MEsare stable mixturesof oils, surfactants and water and are ideal for the development
`
`of topical formulations containing MCM and water-soluble drug compounds.
`
`Zhang discusses how to prepare microemulsions, which have sizes under 150
`
`nm, rendering obvious sizes of claim 1 and 2 obvious as overlapping with the prior art
`
`size range. Among preferred MCM permeation enhancers is Applicant elected glyceryl
`
`monocaprylate (GRFA-Cs), and its combination with isopropyl myristate, demonstrated
`
`to have enhanced transdermal permeation of drugs. The discussion of MEsleadsto an
`
`expectation of improved solubilization of active agents, including
`
`Ruth teaches systems composedof egg or soya lecithins, ethanol, isopropyl
`
`myristate and water, wherestable oil-in water microemulsion regions wereidentified.
`
`Droplet sizes of the microemulsions were between approx. 10 and 60 nm, and
`
`increased with increasing volume fraction of isopropyl myristate (abstract); see also
`
`phase diagrams. Ruth documents isopropyl myristate is a preferable oil material, in
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 10
`
`microemulsions, and documents the effects of varying concentrations including relative
`
`IPM amounts, which are engineering parameters to size microemulsion droplets particle
`
`sizes within the range 10-60 nm, rendering obvious this range.
`
`Thus, it would have been obvious to one of ordinary skill in the art to combine
`
`glyceryl monocaprylate (taught by Tamarkin as monooctanoin, and reasonably
`
`expected to act as surfactant/emulsifier), together with isopropyl myristate (taught by
`
`Tamarkin as oil, and emollient), which are preferable based on Zhang (and isopropyl
`
`myristate is preferred by Ruth as an oil componentof microemulsions), to combine with
`
`water as the three components necessary to form microemulsions.
`
`It would further
`
`have been obvious to solubilize Applicant elected chlorhexidine gluconate, taught by
`
`Tamarkin as having some degree of solubility in water, and taught by Tamarkin as an
`
`antibacterial agent within the microemulsion. Selection of this active compound would
`
`have been obvious
`
`It is noted that Applicant’s election indicates that glyceryl monocaprylate has the
`
`recited HLB value of claims 1 & 23; thus, and obvious formulation containing this
`
`surfactant/emulsifier satisfies the HLB limitations.
`
`Regarding claim 3, the microemulsions appearto beliquids at room temperature,
`
`rendering obvious this characteristic.
`
`Regarding claim 5, chlorhexidine gluconate is taught to be antimicrobial, and
`
`Zhang teaches GRFA-C8is also antimicrobial. Accordingly, the elected composition is
`
`presumed to havethe characteristics recited in this claim, absent evidenceto the
`
`contrary.
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 11
`
`Regarding amounts of water of claim 6-7, and amounts oflipophilic component of
`
`claim 9, the amountof chlorhexidine gluconate of claim 11 & 15, it would have been
`
`obvious to construct a ternary phase diagram, in the manner used by Zhang (see
`
`chapter 3), or the manner used by Ruth (Figures 1-2), where water (or water and
`
`glycerol and benzyl alcohol) replace the ethanol/water side of Ruth figures and glyceryl
`
`monocaprylate replacesthe lecithin sides of Ruth figures, to determine ME regions.
`
`Absent evidenceto the contrary, this optimization of microemulsions would have
`
`resulted in workable ranges within the scopesof each of these claimed ranges.
`
`Examiner notes that GTCCin oil phase was used by Zhang, in amounts as high
`
`as 57%(Table 31), rendering majority concentration of isopropyl myristate (higher
`
`emollient oil than surfactant amount, reading on claim 19), whenit is used asoil
`
`component. Water ranges from 10-86%, rendering obvious amounts throughoutthis
`
`range. MCM amounts of 19%render obvious similar amounts of the glyceryl
`
`monocaprylate (this compound hasat least 80%glycerol monocaprylate, and reads on
`
`claims 21 & 23). The dissolved active compound concentration would also have been
`
`determined via dissolution based on the obvious optimization via ternary phase
`
`diagrams, then evaluation of amount of chlorhexidine gluconate that will dissolve in MEs
`
`formed.
`
`As pointed out in MPEP 2144.05Il, generally differences in concentration or
`
`temperaturewill not support the patentability of subject matter encompassed by the
`
`prior art unless there is evidenceindicating such concentration or temperatureiscritical.
`
`“[W]here the general conditions of a claim are disclosed in the prior art,it is not
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 12
`
`inventive to discover the optimum or workable ranges by routine experimentation.” In re
`
`Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`Regarding the elected glycerol componentof claim 8 and the elected benzyl
`
`alcohol componentof claim 16, each of these components are taught by Tamarkin as
`
`other non-aqueous solvents, preferably added in small amounts [0186], [0355]; and can
`
`be considered potentsolvents [0387]. Thus, each of their additions, giving the elected
`
`embodiment of the claims, would have been obvious, motivated to further enhance
`
`solvation capacity of the obvious chlorohexidine gluconate in the formulated
`
`microemulsions.
`
`14.
`
`No-claim is allowed.
`
`Conclusion
`
`15.—Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to TIMOTHY P THOMASwhosetelephone numberis
`
`(571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
`
`Examinerinterviews 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:/Awww.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Bethany P Barham can be reached on 571-272-6175. The fax phone
`
`numberfor the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`

`

`Application/Control Number: 17/298,060
`Art Unit: 1611
`
`Page 13
`
`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://www.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.
`
`/TIMOTHY P THOMAS/
`Primary Examiner, Art Unit 1611
`
`