www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`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
`
`HARTSFIELD, KATHRIEN ANN
`
`ART UNIT
`
`1627
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/09/2022
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime 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
`KATHRIEN A CRUZ
`1627
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of 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 4/25/2022.
`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)02 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)\0) 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*
`31-45 and 49-53 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`C) Claim(s)__ is/are allowed.
`Claim(s) 31-45 and 49-53 is/are rejected.
`1) Claim(s)__is/are objectedto.
`Cj} 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)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)1) 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... Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have beenreceived 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 4/25/2022.
`U.S. Patent and Trademark Office
`
`3)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20220901
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 2
`
`Notice of Pre-AlA or AIA Status
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AIA.
`
`DETAILED ACTION
`
`Claims 31-45, 49-53 are pending.
`
`Applicants responsefiled 4/25/2022 has been received and enteredin the
`
`application.
`
`Action Summary
`
`Claims 31-45 and 49-53 is/are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Fang (Prescription of atropine eye drops among children diagnosed
`
`with myopia in Taiwan from 2000 to 2007; a nationwide study, Eye (2013) 27, 418-424)
`
`and in view of WoldeMussie et al. (US 5,716,952) of record is maintained with
`
`modification due to applicant’s amendment of claims.
`
`Responseto Arguments
`
`Applicants again argue that Morris is a balance combination of an edrophonium
`
`component and an atropine component. Which does not meetinstant claim 1
`
`limitation
`
`of “one and no more than one ophthalmic agent” and “sole ophthalmic agent”. This
`
`argumenthas been fully considered but has not been found persuasive. The
`
`edrophonium component is not an ophthalmic agent rather a reversal inhibitor of
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 3
`
`acetylcholinesterase, which allows for possible recurrence of neuromuscular
`
`blockade. Therefore, the only ophthalmic agent in the composition of Morris is atropine.
`
`Applicants again argue that Morris is salient as to the feature of pH of from about
`
`4.8 to about 6.4. And that WoldeMussie does notdisclose atropine formulations,
`
`WoldeMussie merely describes merely describes a broad range of 4.5-7.5 in its general
`
`formulations. This argument has been fully considered but has not been found
`
`persuasive. The ‘586 patent teaches an embodiment wherethe atropine is present at a
`
`concentration of “about 0.01 to about 0.5 mg/g” (e.g. see column 3, lines 27-31; e.g.
`
`0.5 mg atropine in 5-15 ml of an aqueous solution = 0.5 mg/5-15 grams aqueous
`
`solution = about 0.03 mg/g to about 0.10 mg/g of the pharmaceutical composition). And
`
`Morris et al teach that their compositions are preferably prepared and packaged into
`
`ampoules in advanceso that they are "ready for administration", they do not explicitly
`
`use the term “kit”. WoldeMussie etal. teaches the use of the claimed muscarinic
`
`antagonists in an ophthalmic formulation in combination with purified water.
`
`WoldeMussie teaches that the muscarinic antagonistis in the concentration of 0.0001 to
`
`0.1 percent weight by volume (claim 1). The use of sodium chloride is taught in column
`
`5, lines 18-22 (e.g. buffer). The use of the buffering agents, such as phosphate, borate
`
`and citrate is taught in column 2, lines 23-29. The use of preservatives is taught in
`
`column 5, lines 9-14. WoldeMussie teaches a pH adjustor to a pH of 4.5-7.5, a toxicity
`
`adjustor (e.g. sodium chloride, column 5, line 20) and a preservative in the amount of 0-
`
`0.10 (table 1). WoldeMussie teaches the addition of hydroxypropylmethyl-cellulose
`
`(e.g. viscosity agent). WoldeMussie teaches the addition of hydroxypropylmethyl-
`
`cellulose (e.g. viscosity agent) (column 5, line 16). WoldeMussie teaches that the
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 4
`
`preservative is benzalkonium chloride (column 5, line 11). WoldeMussie teaches the
`
`administering the composition in a form of an eye dropplets (claim 4). WoldeMussie
`
`teaches that edetate disodium (e.g. EDTA disodium) is a preferred chelating agent
`
`which may be used in the composition.
`
`It would have been obvious to one of ordinary
`
`skills in the art obvious to incorporate buffers, preservative, toxicity adjustor and
`
`viscosity agentinto the kit of the composition as disclosed by Morris. One would have
`
`been motivated to incorporate buffers, preservative, toxicity adjustor and viscosity agent
`
`into the kit of the composition as disclosed by Morris becauseit is well knownin the art
`
`to incorporate buffers, preservative, toxicity adjustor and viscosity agent with atropine
`
`for stabilization and in a kit as disclose by both Morris and WoldeMussie with a
`
`reasonable expectation of success absence evidenceto the contrary.
`
`Applicants argue that Morris and WoldeMussie fail to describe or provide a
`
`reason for a kit comprising a monotherapeutic pharmaceutical composition, the
`
`monotherapeutic pharmaceutical composition comprising an ophthalmic agent
`
`comprising atropine or atropine sulfate. This argument has been fully considered but
`
`has not been found persuasive. The ‘586 patent teaches an embodiment where the
`
`atropine is present at a concentration of “about 0.01 to about 0.5 mg/g”(e.g. see
`
`column 3, lines 27-31; e.g. 0.5 mg atropine in 5-15 ml of an aqueous solution = 0.5
`
`mg/5-15 grams aqueous solution = about 0.03 mg/g to about 0.10 mg/g of the
`
`pharmaceutical composition). Morris et al teach that their compositions are preferably
`
`prepared and packaged into ampoules in advanceso that they are "ready for
`
`administration", they do not explicitly use the term “kit”.
`
`In addition, Morris et al do not
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 5
`
`explicitly teach or suggest the creation and utilization of instructions for using the
`
`prepackaged compositions of their invention (i.e. “instructions for use”).
`
`Applicants again argue unexpectedstability. This argument has been fully
`
`considered but has not been found persuasive. By applicants own admission in the
`
`response dated 10/27/2021, the instant claimed formulation recited “better” atropine
`
`stability, better pH stability, this is not unexpected. Better results does not give rise the
`
`standard of unexpected results.
`
`"A greater than expected result is an evidentiary factor
`
`pertinent to the legal conclusion of obviousness... of the claims at issue." In re Corkill,
`
`711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). In Corkhill, the claimed combination
`
`showed an additive result when a diminished result would have been expected. This
`
`result was persuasive of nonobviousness even though the result was equalto that of
`
`one component alone. Evidence of a greater than expected result may also be shown
`
`by demonstrating an effect which is greater than the sum of eachof the effects taken
`
`separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories
`
`Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
`
`However, a greater than additive effect is not necessarily sufficient to overcome a prima
`
`facie case of obviousness because such an effect can either be expected or
`
`unexpected. Applicants must further show that the results were greater than those
`
`which would have been expected from the prior art to an unobvious extent, and that the
`
`results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19
`
`USPQe2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive
`
`sweetnessresulting from the claimed mixture of saccharin and L-aspartyl-L-
`
`phenylalanine was notsufficient to outweigh the evidence of obviousness because the
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 6
`
`teachings of the prior art lead to a general expectation of greater than additive
`
`sweetening effects when using mixtures of synthetic sweeteners.) (MPEP 716.02(a)).
`
`WoldeMussie and Morris are silent with respect to the stability and degradation of
`
`atropine. This argument has been fully considered but has not been found persuasive.
`
`The instant claims are not drawn to the method of stabilizing a compound, rather the
`
`instant claims are drawn to a kit.
`
`Previous Rejection
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousnessrejections setforth 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 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 text of those sections of Title 35, U.S. Code not includedin this action can
`
`be found in a prior Office action.
`
`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 between the 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.
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 7
`
`Claims 31-45 and 49-53 is/are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Fang (Prescription of atropine eye drops among children diagnosed
`
`with myopia in Taiwan from 2000 to 2007; a nationwide study, Eye (2013) 27, 418-424)
`
`and in view of WoldeMussie et al. (US 5,716,952) of record.
`
`Morris et al teaches edrophonium-atropine compositions and their therapeutic
`
`use in medical treatments to antagonize non-depolarization blockades when muscle
`
`relaxation is no longer necessary (e.g. Title; Abstract; etc.). The ‘586 patent teaches
`
`that the preferred compositions of the inventions are ones where the composition is an
`
`aqueous solution comprising the active ingredients and a buffer and where the
`
`compositions can be prepared in advance of use and packaged by means suchasvials,
`
`pre-filled syringes or ampoules in appropriate volumes for ready administration (e.g.
`
`column 2, lines 32-48):
`
`
`
`A oimupnaition is ascomdence with the presentbowen |
`&
`fon inchudes an cdrophoaium coamencet
`
`ine compoeemt. Beck composent
`ia commercislly
`available.
`
`‘The competion is prefecshly premered bs advance
`ready for administration, se an aguegas aclution §
`
`
`wink the two cssentind comporents ane caluiiiieed, aad
`
`
`may inclade other, pshemmacslogivally ecitebls comme
`ments, such ag ineifers, pieasetogiog! salty, pmeservativ
`
`and the Eke.
`Por example, aninhls ph adjusters, or buffers, bi
`
`clades siaes citrate amd stivic acicdk and, auiteive pre.
`servatives inchals phenc! andsadiam sulfite,
`>
`N
`
`The byventive comecition may ie pregared in acd
`SS
`N vanes of use, and packaged by means such ag vias,
`grelilint evrisges, or eeuocades in aoeenriate volumes
`
`SIE
`ul
`wad
`ore
`
`
`
`In addition, the ‘586 patent teaches an embodiment wherethe atropine is present at a
`
`concentration of “about 0.01 to about 0.5 mg/g” (e.g. see column 3, lines 27-31; e.g.
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 8
`
`0.5 mg atropine in 5-15 ml of an aqueous solution = 0.5 mg/5-15 grams aqueous
`
`solution = about 0.03 mg/g to about 0.10 mg/g of the pharmaceutical composition):
`
`
`Ain ander© that mioarinke affects ieradyoerdia} Qe ae
`\head and anticholinergic fisckyeurdial on the other
`N bard are avoided. A welght radio af the adrophosiun
`Noommpement with reapest 6 the abosine component
`\shoukd be in the ceage of abort Ski to 1d, more
`\ preferably G23] toTLL. ishould be undersiondthat
`
`wherethe inventive8 ocmmarePswee mad aa Be ~ X : composition’g volume aedthememoeatration Srthe nen
`
`N caseetial components therein may Rave bars selentecdso
`\ as gy prea enfficiene af che bee coenpement with
`A
`reagenct 1c) Bk AVOREgE PeRiend's weight for s acomal &
`A range ofweights),
`:
`N
`For ememnie, gaaumeing a Average tation acight af
`\ 70 kg, the inventive compositios muy be packaged in
`\ vinis or amogies Chaving about S-1S al voalame) with ®
`\ shoutJf mgedrophoniamcomparent and shout 6.9 mg ae
`
`‘S ates pine© comapenentfthereis,
`
`While Morris et al teach that their compositions are preferably prepared and
`
`packaged into ampoules in advanceso that they are "ready for administration", they do
`
`not explicitly use the term “kit”.
`
`In addition, Morris et al do not explicitly teach or
`
`suggest the creation and utilization of instructions for using the prepackaged
`
`compositions of their invention (i.e. “instructions for use”). Morris is silent with
`
`regards to a preservative (in which meetsinstant claim 40-41).
`
`It would have been prima facie obvious to one of ordinary skill in the art prior to
`
`the effective filing date of the claimed invention, having read Morris etal, to fill ampoules
`
`with edrophonium and atropine because the ‘586 patent explicitly suggests such pre-
`
`packaged preparations of their inventive compositions. Absent any evidence to the
`
`contrary, there would have been a reasonable expectation of successin doing so
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 9
`
`because the production and packaging of such compositions into ampoules waswell
`
`within the skill of the art prior to the effective filing date of the claimed invention (e.g. see
`
`the 101 SME Rejection Omitted section of this review for a list of references that teach
`
`packaging of compositions comprising atropine into vials or ampoules).
`
`With regard to the “kit”limitation, such pre-packaging of componentsto be
`
`“ready for administration”in the practice of a given method would be understood by
`
`one of skill in the art to qualify as the generation of a “kit”.
`
`In addition, the instant
`
`specification defines the term “kit” in such broad terms that the ampoules of Morris et
`
`al would necessarily read on the term “kit” as it is used in claim 31.
`
`In addition, the
`
`packaging of the ampoule comprising atropine according to the teachings of Morris et al
`
`with other components (e.g. “instructions for use”) into a larger kit or container would
`
`have been obvious to one ofskill in the art because such “kits” comprising ‘ready to
`
`use’ components are commonplacein the art.
`
`With regard to the limitation “a single use ampoule”, it is reiterated here that
`
`the instant specification doesn't define this term at all.
`
`In addition, Moriss etal
`
`emphasize the importance of providing a rapid onset of action using the compositions of
`
`their invention utilizing a formulation that is “ready for administration” (e.g. Column 2,
`
`lines 32-48, Abstract; claim 1; etc.). The need to provide such a rapid response
`
`suggests and makes obvious that it would be helpful to have a pre-packaged
`
`composition of the invention at an appropriate volume for a single dose of the
`
`composition (e.g. column 2, lines 45-48). Such a single dose formulation packagedin
`
`an ampoule would necessarily read on the term “a single use ampoule”.
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 10
`
`Finally, with regard to the inclusion of instructions for how to use the
`
`composition(s) of Morris etal, it is noted that one can reasonably interpret such
`
`generically-recited instructions as merely being non-functional descriptive material (e.g.
`
`see MPEP 2111.05). Such non-functional descriptive material is in this case properly
`
`considered as not carrying any patentable weight becausethere is no functional
`
`relationship between the instructions and the claimed product (e.g. see MPEP
`
`2111.05(I)(b)):
`
`Where a product merely serves as a support for printed matter, no functional
`
`relationship exists. These situations may arise where the claim as a whole is directed
`
`towards conveying a message or meaning to a human reader independent of the
`
`supporting product. For example, a hatband with images displayed on the hatband but
`
`not arrangedin any particular sequence wasfound to only serve as support and display
`
`for the printed matter. See Gulack, 703 F.2d at 1386, 217 USPQ at 404. Another
`
`example in which a product merely serves as a support would occur for a deckof
`
`playing cards having images on each card. See /n re Bryan, 323 Fed. App'x 898 (Fed.
`
`Cir. 2009) (unpublished). In Bryan the applicant asserted that the printed matter allowed
`
`the cards to be "collected, traded, and drawn"; “identify and distinguish one deckof
`
`cards from another"; and "enable[] the card to be traded and blind drawn". However, the
`
`court found that these functions do not pertain to the structure of the apparatus and
`
`were instead drawn to the method or process of playing a game. See also Ex parte
`
`Gwinn, 112 USPQ 439, 446-47 (Bd. Pat. App. & Int. 1955), in which the invention was
`
`directed to a set of dice by means of which a game maybe played. The claims differed
`
`from the prior art solely by the printed matter in the dice. The claims were properly
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 11
`
`rejected on prior art because there was no newfeature of physical structure and no new
`
`relation of printed matter to physical structure. For example, a claimed measuring tape
`
`having electrical wiring information thereon, or a generically claimed substrate having a
`
`picture of a golf ball thereupon, would lack a functional relationship as the claims as a
`
`whole are directed towards conveying wiring information (unrelated to the measuring
`
`tape) or an aesthetically pleasing image (unrelated to the substrate) to the reader.
`
`Additionally, where the printed matter and product do not depend upon each
`
`other, no functional relationship exists. For example, in a kit containing a set of
`
`chemicals and a printed set of instructions for using the chemicals, the
`
`instructions are not related to that particular set of chemicals. /n re Ngai, 367 F.3d
`
`at 1339, 70 USPQ2d at 1864.
`
`See also MPEP 2112.02(III), which states that non-functional printed matter does not
`
`distinguish a claimed product from an otherwise identical prior art product.
`
`In any case,
`
`even if one considered the “instructions for use”in this instance to have patentable
`
`weight, the inclusion of such instructions in a kit is so well Known and a common
`
`practice in the art as to make their inclusion in the invention taught and suggested by
`
`Morris et al prima facie obvious to the ordinarily skilled artisan.
`
`Morris does notdisclose preservative, toxicity adjustor and viscosity agent.
`
`WoldeMussie etal. teaches the use of the claimed muscarinic antagonists in an
`
`ophthalmic formulation in combination with purified water. See the abstract, column 2,
`
`lines 46-67 and column 98, lines 1-20 and column 4, lines 23-32. WoldeMussie teaches
`
`that the muscarinic antagonistis in the concentration of 0.0001 to 0.1 percent weight by
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 12
`
`volume (claim 1). The use of sodium chloride is taught in column 5, lines 18-22 (e.g.
`
`buffer). The use of the buffering agents, such as phosphate, borate and citrate is taught
`
`in column 2, lines 23-29. The use of preservatives is taught in column 5, lines 9-14.
`
`WoldeMussie teaches a pH adjustor to a pH of 4.5-7.5, a toxicity adjustor (e.g. sodium
`
`chloride, column 5, line 20) and a preservative in the amount of 0-0.10 (table 1).
`
`WoldeMussie teaches the addition of hydroxypropylmethyl-cellulose (e.g. viscosity
`
`agent) (column 5, line 16). WoldeMussie teaches that the preservative is benzalkonium
`
`chloride (column 5, line 11). WoldeMussie teaches the administering the composition in
`
`a form of an eye dropplets (claim 4). WoldeMussie teaches that edetate disodium (e.g.
`
`EDTA disodium) is a preferred chelating agent which may be usedin the composition
`
`(column 5, lines 36-38).
`
`It would have been obvious to incorporate buffers, preservative, toxicity adjustor
`
`and viscosity agentinto the kit of the composition as disclosed by Morris. One would
`
`have been motivated to incorporate buffers, preservative, toxicity adjustor and viscosity
`
`agent into the kit of the composition as disclosed by Morris becauseit is well known in
`
`the art to incorporate buffers, preservative, toxicity adjustor and viscosity agent with
`
`atropine for stabilization and in a kit as disclose by both Morris and WoldeMussie with a
`
`reasonable expectation of success absence evidenceto the contrary.
`
`With regards to the specific buffers, WolldeMussie teaches the useof the
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`buffering agents, such as phosphate, borate and citrate. While specific buffers is not
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`disclose, however, it would have been obvious to employ any buffer becauseall buffers
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`perform the same functions (e.g. maintaining, modulating the pH of the composition).
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`

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`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 13
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`It would have been obvious to one of ordinary skills in the art to administer a
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`chelating agent(stabilizer) (for example: edetate disodium (e.g. EDTA disodium)) in
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`such a dose to minimize the degradation of the muscarinic antagonist with a reasonable
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`expectation of success. The amounts of active agents to be used, the pharmaceutical
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`forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed
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`obvious since theyare all within the knowledge ofthe skilled pharmacologist and
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`represent conventional formulations and modes of administration. Furthermore, no
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`unobviousnessis seen in the ratio claimed because once the usefulness of a compound
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`is Knownto treat a condition, it is within the skill of the artisan to determine the optimum
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`ratio with a reasonable expectation of success absence evidenceto the contrary.
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`For these reasons, the claimed subject matter is deemedto fail to be patentably
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`distinguishable over the state of the art as represented by the cited reference. The
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`claims are therefore, properly rejected under 35 U.S.C. 103.In light of the forgoing
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`discussion, the Examiner concludes that the subject matter defined by the instant claims
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`would have been obvious within the meaning of 35 USC 103(a).
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`From the teachings of the references, it is apparent that one of ordinary skill in
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`the art would have had a reasonable expectation of success in producing the claimed
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`invention.
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`Therefore, the invention as a whole was prima facie obvious to one of ordinary
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`skill in the art at the time the invention was made, as evidenced by the references,
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`especially in the absence of evidence to the contrary.
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`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 14
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR 1.136(a).
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`A shortenedstatutory period for reply to this final action is set to expire THREE
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`
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`MONTHS from the mailing date of this action. In the eventafirst replyis filed within
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`TWO MONTHS ofthe mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortenedstatutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Conclusion
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`Claims 31-45 and 49-53 are rejected.
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`No claims are allowed.
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`Communication
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to KATHRIEN A. CRUZ whosetelephone number is
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`(571)270-5238. The examiner can normally be reached on Monday- Thursday 8-6pm.
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`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 15
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`Examiner interviews are available via telephone, in-person, and video
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`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
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`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http:/Awww.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Kortney L. Klinkel can be reached on (571) 270-5239. The fax phone
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`number for the organization wherethis application or proceeding is assigned is 571-
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`273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see https://ppair-
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`my.uspto.gov/pair/PrivatePair. Should you have questions on accessto the Private
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`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197(toll-free).
`
`If you would like assistance from a USPTO Customer Service Representative or access
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`to the automated information system, call 800-786-9199 (IN USA OR CANADA)or 571-
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`272-1000.
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`/KATHRIEN A CRUZ/
`Primary Examiner, Art Unit 1627
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`