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
`
`17/721,831
`
`04/15/2022
`
`Gregory I. OSTROW
`
`46682-701.319
`
`7573
`
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`TRAN,ERIC
`
`PAPER NUMBER
`
`ART UNIT
`
`1629
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/28/2024
`
`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)
`
`

`

`Office Action Summary
`
`Application No.
`17/721,831
`Examiner
`ERIC TRAN
`
`Applicant(s)
`OSTROWetal.
`Art Unit
`AIA (FITF) Status
`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 10/19/2023.
`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*
`49-68 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) 49-68is/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 20240418
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 2
`
`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.
`
`Theinstant application is a CONof application 16/677,538 filed on 11/07/2019, and
`
`claimspriority to provisional application 62/15 1,926 filed on 04/23/2015.
`
`Priority
`
`Election/Restrictions
`
`In responseto the Restriction Requirement submitted on 07/19/2023, Applicant has
`
`elected the invention of Group II. Examinerhas determined that the withdrawn claims (49-58) do
`
`not constitute an undue search burden because the search for the elected method claims
`
`encompassesthe composition of the withdrawn claims. Accordingly, claims 49-58 are rejoined.
`
`Currently, claims 49-68 are pending examination in the instant application.
`
`Claim Rejections - 35 USC § 112 Second Paragraph
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(b) CONCLUSION.—Thespecification shall conclude with one or more claims particularly pointing
`
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`
`claiming the subject matter which the applicant regards as his invention.
`
`Claim 49, 56, 57, 59-63, 66, and 67 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112
`
`(pre-AIA), second paragraph, as being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor ora joint inventor(or for applications
`
`subject to pre-AJA 35 U.S.C. 112, the applicant), regards as the invention.
`
`Claim 49 recites a pH range of from about 3.8 to about 7.5. Dueto the recitation of the
`
`claim,it is unclear whetherthe stated pH rangeis applicable to the composition as a whole, or
`
`only to the water component of the composition. Accordingly, a person of ordinary skill in the
`
`art would not reasonably be able to understand the metes and boundsof the claim. For the
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 3
`
`purposes of examination, the instant claim will be construed by the examinersuch that the pH
`
`range is applicable to the final composition as a whole.
`
`Claims 56-57 each recite an “extended period of time under storage condition”. The
`
`instant claims are indefinite as neither the “extended period of time”or the “storage condition”
`
`place clear limitations on the composition recited in claim 49. It cannot be determined from the
`
`recitation how long the storage time is or what the conditions of storage are. Accordingly, a
`
`person of ordinary skill in the art would not reasonably be able to understand the metes and
`
`boundsof the claims.
`
`Claim 59 recites a pH range of from about3.8 to about 7.5. Dueto the recitation of the
`
`claim,it is unclear whetherthe stated pH rangeis applicable to the composition as a whole, or
`
`only to the water componentof the composition. Accordingly, a person of ordinaryskill in the
`
`art would not reasonably be able to understand the metes and boundsof the claim. For the
`
`purposes of examination, the instant claim will be construed by the examinersuch that the pH
`
`range is applicable to the final composition as a whole.
`
`Claim 60 recites “The method of claim 59, comprising about 0.025% w/v atropine”. The
`
`recitation of the instant claim is indefinite as claim 59 is directed to a method and nota
`
`composition of matter. Accordingly, a person of ordinary skill in the art would not reasonably be
`
`able to understand the metes and boundsof the claim. For the purposes of examination, the
`
`instant claim will be construedto haveits limitation applied to the administered composition
`
`recited in claim 59.
`
`Claim 61 recites “The method of claim 59, comprising about 0.01% w/v atropine”. The
`
`recitation of the instant claim is indefinite as claim 59 is directed to a method and nota
`
`composition of matter. Accordingly, a person of ordinary skill in the art would not reasonably be
`
`able to understand the metes and boundsof the claim. For the purposes of examination, the
`
`instant claim will be construedto haveits limitation applied to the administered composition
`
`recited in claim 59.
`
`Claim 62 recites “The method of claim 59, comprising about 0.05% w/v atropine”. The
`
`recitation of the instant claim is indefinite as claim 59 is directed to a method and nota
`
`composition of matter. Accordingly, a person of ordinary skill in the art would not reas onably be
`
`able to understand the metes and boundsof the claim. For the purposes of examination, the
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 4
`
`instant claim will be construedto haveits limitation applied to the administered composition
`
`recited in claim 59.
`
`Claim 63 recites “The method of claim 59, comprising edetate disodium”. The recitation
`
`of the instant claim is indefinite as claim 59 is directed to a method and not a composition of
`
`matter. Accordingly, a person of ordinary skill in the art would not reasonably be able to
`
`understand the metes and boundsof the claim. For the purposes of examination,the instant claim
`
`will be construedto have its limitation applied to the administered composition recited in claim
`
`59.
`
`Claims 66-67 each recite an “extendedperiod of time under storage condition”. The
`
`instant claims are indefinite as the neither the “extended period of time”or the “storage
`
`condition” place clear limitations on the composition recited in the method of claim 59. It cannot
`
`be determined from the recitation how longthe storage time is or what the conditions of storage
`
`are. Accordingly, a person of ordinary skill in the art would not reasonably be able to understand
`
`the metes and bounds of the claims.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which formsthe basis for all obviousness
`
`rejections set forth in this Office action:
`
`A patent fora 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 obviousbefore 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 backgroundfor 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.
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 5
`
`Claim(s) 49-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chia
`
`(Ophthalmology Volume 119, Number 2, February 2012) in view of Alonso (JPP 2003, 55:
`
`145]—1463), Abelson (Review of Ophthalmology, 2006), and Pramar(Xavier University of
`
`Louisiana, College ofPharmacy, 2012).
`
`Claims 49-58 are drawn to ophthalmic compositions which have identical limitations to
`
`the compositions recited in the methods of claims 59-68, respectively. Essentially, claims 59-68
`
`are drawn to methodsof use of the compositions of claims 49-58 for the purposeof treating
`
`myopia. As discussed herein, the methods of claims 59-68 are obviated by Chia in view of
`
`Alonso, Abelson, and Pramar. As the methodsof use in treating myopia are obviated, so are the
`
`compositions being used(1.e. claims 49-58). Accordingly, a person of ordinaryskill in the art
`
`would have found such compositions prima facie obvious for the same reasons as specified
`
`below in the rejections of claims 59-68.
`
`Claim 59 recites a method of treating myopia, comprising administering an ophthalmic
`
`composition to a subject in need thereof, wherein the ophthalmic composition comprises:
`
`(i)
`
`(ii)
`
`about 0.001% w/v to about 0.05% w/v atropine;
`
`sodium chloride;
`
`(iii)=glycerin;
`
`(iv)
`
`(v)
`
`(vi)
`
`chitosan;
`
`povidone;
`
`water
`
`Ata pH of from about 3.8 to about 7.5.
`
`Chia teaches the treatment of childhood myopia by administering ophthalmic
`
`compositions comprising atropine. More specifically, Chia discloses the treatment of childhood
`
`myopia by administering atropine compositions with concentrations of 0.01%, 0.1%, and 0.5%
`
`over a two yeartime period. Chia found that the administering of atropine to subjects resulted in
`
`a clinically small dose related response on myopia (page 349)!. The teachings of Chia indicate
`
`1A dose-related response on myopia was noted among the 3 treatmentarms, but differences betweentreatment arms were
`clinically small (Fig 2). An initial hyperopia shift of 0.3 to 0.4 Dwas noted in the 0.1% and 0.5% groups but not in the 0.01% group
`(Table 1). Atthe end of 1 year, there was a significant difference in myopia progression between the 0.5% atropine group and the
`0.01% (P 0.001) and 0.1% (P0.01) groups, but there was no statistical significant diffe rence between the 0.01% and0.1%groups.
`The final myopia progression over 2 years was 0.490.60, 0.380.60, and 0.300.63 Din the atropine 0.01%, 0.1%, and 0.5%groups ,
`respectively (P0.07), with a significant difference only between the 0.01% and 0.5% groups (Table 2). There was no significant
`difference in spherical equivalent levels between groups (P0.20). Fifty percent of the 0.01%group had progressed by less than 0.5
`D, compared with 58%and 63%in the 0.1% and 0.5%groups, respectively, with approximately 18%progressing by 1.0 Din all3
`groups (Fig 3).”
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 6
`
`that the administering of ophthalmic atropine compositions in a concentration range of 0.01% to
`
`0.5% provides an effective treatment for myopia in children (page 353)?. The effective range
`
`taught by Chia provides a case of obviousness on the basis of MPEP 2144.05(1) Obviousness of
`
`Similar and Overlapping Ranges, Amounts, and Proportions:
`“Tn the case where the claimed ranges “overlap orlie insideranges disclosed by the prior art” a primafacie case of
`obvicusnes
`
`sists. Ja re Wertheim, 341 F.2d 257, if) USPQ 90 (CCPA 1978): In re Woodruff, G19 F 2d 1875, 16
`
`USbQ2d 1954 Ped. Cir, 19903 (Phe prior art taught carbou monoxide concentrations of "about 1-5%" while the claim was
`
` hivaited to "ysore than $%.""The court netd thar "shou: 1-59" allowed for
`
`
`
`overlapped ) dare Geisler, 116 P 3d 1465, 1469-71,
`
`
`
`
`
` gstroms |." The court slated that "by stating that ‘suitable protection’ is provided ifthe protective laver is
`
`
`
`‘about’ 10G Angstroms thick, {the price art reference] directly teaches the use of a thickness within lapplicant’s} claimed
`
`range.").”
`
`While Chia teaches the use of atropine containing composition foruse in treating
`
`myopia, they do not explicitly teach the use of NaCl, glycerin, chitosan, or povidone. However,
`
`it would be obvious to use such constituents in an ophthalmic composition because Alonso
`
`teaches chitosan as an enhancerof ocular drug delivery, Abelson teaches the use of glycerin and
`
`povidone as common demulcents in ophthalmic compositions, and Pramar teaches the use of
`
`NaCl in aqueous ophthalmic compositions as a commontonicity adjuster.
`
`Alonso teaches the use of chitosan in ophthalmic topical compositions to overcome
`
`limitations of topical ocular dosing with liquid eye drops, these limitations being: 1) rapid and
`
`extensive precorneal loss cause by drainage and high tear turnover; 2) limited capacity of liquid
`
`retention of the eye surface; 3) systemic absorption via the conjunctiva and nasolacrimal duct; 4)
`
`limited permeation of active drug across the cornea (page 1453). Alonso further teaches that the
`
`use of chitosan provides increased residence time, enhanced permeation ofactives, is
`
`2 In conclusion, our results suggestthat 0.5%, 0.1%, and 0.01% atropine remain effective in reducing myopia progression,
`compared with placebo treatment, and thatthe clinical differences in myopia progression among these 3 groups are small. The
`lowest concentration of 0.01% atropine thus seemsto retain efficacy andis a viable concentration for reducing myopia progre ssion
`in children, while attaining a clinically significant improved safetyprofile in terms of accommodation, pupil size, and near visual
`acuity, and subsequently reduced adverse impact on visual function.”
`3 “one of the major problems encountered with the topical administration of liquid forms is the rapid and extensive pre -corneal loss
`caused by drainage and hightear turnover.Afterinstillation of an eye-drop, a major fraction of the instilled doseis lost due to the
`limited capacity of liquid retention of the eye surface and also as a consequenceofthe blinking process, whichis no rmally
`stimulated after instillation. Additionally, a certain amount of drug is often absorbed systemically via the conjunctiva and the
`nasolachrymal duct. In addition to these anatomical constraints to the retention of drugs at the eye’s surface, the seco nd major
`limiting step forthe transport of drugs to the inner eyeis diffusion across the cormea.”
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 7
`
`biodegradable, and has excellent ocular tolerance (pages 1454-1455)*. Furthermore, Alonso
`
`discloses the versatility of chitosan in drug delivery systemsas it can be usedin solution as a
`
`gelling/viscosity agent, or used in the preparation of microspheres, nanoparticles, or colloidal
`
`carriers. As the teachings of Chia are directed towards the topical ophthalmic administration of
`
`compositions comprising atropine, it would be obvious for a person of ordinary skill in the art to
`
`apply the teachings of Alonso as chitosan provides desirable beneficial effects for ophthalmic
`
`application.
`
`Abelson teaches the use of common demulcents in ophthalmic compositions. Abelson
`
`teaches demulcents as agents which soothe inflamed or otherwiseirritated areas of the
`
`epithelium and providerelief from external pain or discomfort. In the case of ophthalmic
`
`solutions, such functions of demulcents apply to the ocular surface. Abelson further provides the
`
`following common compounds whichare considered as demulcents:
`
`4 «The residencetime ofa topically applied ophthalmic drug refers to the duration of its contact with the ocularsurface. This concept
`is of particular interest in the formulation of topical ocular drug vehicles, where mucoadhesive polymersare frequently used as an
`approachto prolong drug residence times... It has penetration -enhancing properties, which wereinitially attributed to the modulaton
`of the tight junction barrier between epithelial cells (Artursson et al 1994; Schipperet al 1997;Kochet al 1998) and recently also
`related to intracellular routes (Dodane et al 1999)... Chitosan is biodegradable (Pangburn et al 1982; Hirano et al 1989a, 1990),
`which enables the safe administration and degradation of topically applied ocular chitosan vehicles... Chitosanhas excellent ocular
`tolerance. This has been reported in a rabbit model following topical application of chitosan solutions and using confocal la ser
`scanning ophthalmoscopy combinedwith corneal fluorescein staining (Felt et al 1999a).”
`Srne term demulcent 's often usedrather loosely—an agent with dernulcent propertiesis one that southes inflamed or
`atherwise t
`on
`cent usually accomplishes this symptom amel!
`
`as
`
`
`by targeting an
`c
`i
`tency. Falling under the more
`
`
`heading of “ienitives’
`lances providing anys
`fralief from pain or discamfort), demiulcents should rie
`
`gaction for interna! surfaces, while demulcents are agents exciusively
`with emoilients—the latter provide a similar sooth!
`providing alleviation of externa! discomfort.”
`
`
`
`

`

`Page 8
`
`Application/Control Number: 17/721,831
`
`Art Unit: 1629
`
`Amongthe suggested demulcents are glycerin and povidone, wherein Abelson specifies
`
`that glycerin is often used in conjunction with other lubricants, and povidone has seen positive
`
`results in a new capacity as a lubricating a soothing componentin ocular anti-allergy drops.
`
`Given that Chia discloses the most common adverse effect of ophthalmic atropine beingallergic
`
`conjunctivitis (page 351)°, a person of ordinary skill in the art would have foundit obvious to
`
`apply the teachings of Abelson and use glycerin and povidone, as there would be a reasonable
`
`expectation to ameliorate the allergic conjunctivitis.
`
`Pramarteaches guidelines for the formulation and preparation of compounded
`
`ophthalmic liquids. Pramar provides that ideal ophthalmic solutions display the following
`
`properties: A)sterility and clarity; B) preservation; C) pH; D) isotonicity; E) stability; F)
`
`therapeutic efficacy; G) compatibility with the eye. With regards to element C) pH, Pramar
`
`teaches that the ideal pH for topical ophthalmic solutions is 7.4, the same pH asbiological
`
`lacrimalfluid, howeverfurther provides a usable range of 6.5-8.5 which avoids corneal damage
`
`(page 2)’. With regards to element D) isotonicity, Pramar teaches the inclusion of NaCl provides
`
`6 «adverse reactions directly attributable to atropine included allergic conjunctivitis, which occurred in 13 children (4.1%)in the
`atropine 0.1% and 0.5%groups. In 3 subjects (1.2%), symptoms were severe enough to warrant ceasingtrial medication. Four
`children in the 0.1% and 0.5%groups (1.3%) had allergy-related dermatitis of the eyelids.”
`7 “Although solutions with the same pH as lacrimal fluid (7.4) are ideal, the outer surfaces of the eye toleratealarger range, 3.5 to
`8.5. The normal useful range to prevent corneal damage is 6.5 to 8.5.”
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 9
`
`a tolerable amountof tonicity to avoid patient discomfort (page 2)8. Provided the teachings of
`
`Chia, which are directed towards the use of ophthalmic compositions of atropine, it would have
`
`been obvious fora person of ordinary skill in the art to be able to apply the teachings of Pramar
`
`to the composition of Chia in order to enhancetolerability, safety, and subsequently, patient
`
`compliance.
`
`In summary, Chia teaches the use of topical ophthalmic compositions comprising
`
`atropine in an effective range of 0.01% to 0.5% in treating myopiain children, Alonso teaches
`
`the use of chitosan in enhancing ocular drug delivery, Abelson teaches the use of demulcents
`
`such as glycerin and povidonein ophthalmic compositions, and Pramarteachesideal pH of
`
`ophthalmic compositions and the use of NaCl for tonicity adjustment. Given each ofthe
`
`aforementioned teachings, a person of ordinary skill in the art would have foundit prima facie
`
`obvious to be able to combine eachto provide an enhanced ophthalmic atropine composition. In
`
`addition, a person of ordinary skill in the art would likely recognize that components such as
`
`NaCl, glycerin, povidone, and chitosan would fall under the umbrella of acceptable
`
`pharmaceutical excipients in the context of ophthalmic compositions, making their inclusion
`
`further obvious, as it is common practice in the art to deduce ideal excipient combinations for
`
`pharmaceutical use through experimentation.
`
`Claim 60 recites the method of claim 59, comprising about 0.025% w/v atropine.
`
`Asdiscussed previously in the claim 59 rejection above, Chia teaches an effective dosing
`
`range of 0.01-0.5% atropine to treat myopia, wherein the effects are dose-dependent.
`
`Accordingly, the instant claim is rejected for the same obviousness reasonsas claim 59.
`
`Claim 61 recites the method of claim 59, comprising about 0.01% w/vatropine.
`
`Asdiscussed previously in the claim 59 rejection above, Chia teaches an effective dosing
`
`range of 0.01-0.5% atropine to treat myopia, wherein the effects are dose-dependent.
`
`Accordingly, the instant claim is rejected for the same obviousness reasonsas claim 59.
`
`Claim 62 recites the method of claim 59, comprising about 0.05% w/v atropine.
`
`8 «Solutions that are isotonic with tears are preferred. An amount equivalent to 0.9% NaClis ideal for comfort and should be used
`when possible. The eye can tolerate tonicities within the equivalent range of 0.6-2% NaCl without discomfort.”
`
`

`

`Application/Control Number: 17/721,831
`Art Unit: 1629
`
`Page 10
`
`Asdiscussed previously in the claim 59 rejection above, Chia teaches an effective dosing
`
`range of 0.01-0.5% atropine to treat myopia, wherein the effects are dose-dependent.
`
`Accordingly, the instant claim is rejected for the same obviousness reasonsas claim 59.
`
`Claim 63 recites the method of claim 59, comprising edetate disodium.
`
`Pramarteaches the inclusion of disodium edetate as an antioxidant in ophthalmic
`
`compositions to prevent metal catalyzed oxidative degradation of actives in compositions (page
`
`5)’. Accordingly, the instant claim is rejected for the same obviousness reasonsas claim 59.
`
`Conclusion
`No claims are in condition for allowance.
`Any inquiry concerning this communication or earlier communications from the
`examinershould be directed to ERIC TRAN whosetelephone numberis (57 1)272-7854. The
`examiner can normally be reached Mon-Fri 8:00-5:00.
`Examinerinterviews are available via telephone, in-person, and video conferencing using
`a USPTO supplied web-based collaboration tool. To schedule an interview, applicantis
`encouragedto use the USPTO Automated Interview Request (AIR)at
`http://www.uspto.gov/interviewpractice.
`If attempts to reach the examinerby telephone are unsuccessful, the examiner’s
`supervisor, Jeffrey S Lundgren can be reached on (571) 272-5541. The fax phone numberfor the
`organization where this application or proceedingis assignedis 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 submissionsin Patent Center,visit:
`https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more
`information about Patent Center and https://www.uspto.gov/patents/docx for information about
`filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC)
`at 866-217-9197 (toll-free). If you would like assistance froma USPTO CustomerService
`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/ERIC TRAN/
`Examiner, Art Unit 1629
`
`/JEFFREY S LUNDGREN/
`Supervisory Patent Examiner, Art Unit 1629
`
`9 «Disodium edetate is technically not an antioxidant, but a chelator of heavy metalions.It serves as an antioxidant for drug s that
`have their oxidation catalyzed by heavy metals.”
`
`