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
`
`03/28/2023
`
`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)
`
`

`

`
`
`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`is/are withdrawn from consideration.
`Cj] Claim(s)
`is/are allowed.
`Claim(s) 31-45 and 49-53is/are rejected.
`S)
`) © Claim(s)___is/are objected to.
`Cj) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* 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 3/8/2023,
`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 20230323
`
`Application No.
`Applicant(s)
`16/908,426
`OSTROWetal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`KATHRIEN A HARTSFIELD
`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 3/8/2023.
`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)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.
`
`

`

`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.
`
`A request for continued examination under 37 CFR 1.114, including the
`
`fee set forth in 37 CFR 1.17(e), wasfiled in this application after final rejection. Since
`
`this application is eligible for continued examination under 37 CFR 1.114, and the fee
`
`set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office
`
`action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissionfiled on
`
`3/8/2023 has been entered.
`
`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 withdrawn. The examiner
`
`would like to thank the applicants for the correct in the assumption that the rejection is
`
`over Morris instead of Fang. The rejection below reflects the correct citations of Morris
`
`in view of WoldeMussie.
`
`Response to Arguments
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 3
`
`Applicants argue on page 5 (of the arguments, hereinafter only the page number
`
`will be cited) that amended claim 1 renders non-obvious over the cited art. This
`
`argument has been fully considered but has not been found persuasive. Claim 1 has
`
`not been amended.
`
`Applicants argues on page 5 that a person ofordinary skills in the art would have
`
`no reason to modify Morris to stabilize atropine at the claimed pH range because
`
`atropine is not the primary active ingredient, and thus stabilization of atropine is not a
`
`problem considered by Morris. This argument has been fully considered but has not
`
`been found persuasive. Morris explicitly discloses 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 and claim 1 and 6); 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) of atropine or atropine sulfate, water and a buffer and
`
`instructions for use. Morris teaches an aqueous solution, suitable pH adjustors or
`
`buffers, include sodium citrate and citric acid; and suitable preservatives include phenol
`
`and sodium sulfite. WoldeMussie teaches the use of the claimed muscarinic
`
`antagonists in an aqueous ophthalmic formulation in combination with purified water.
`
`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). Taken
`
`the cited art, it would have been obvious to adjust the pH to the desired pH; sinceit is
`
`known in the art to have pH adjuster as taught by both Morris and WoldeMussie with a
`
`reasonable expectation of success absence evidence to the contrary.
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 4
`
`Applicants argue on page 5 that WoldeMussie fails to describe or provide a
`
`reason to arrive at an aqueous solution comprising atropine or atropine sulfate, wherein
`
`the aqueous solution has a pH from about 4.8 to about 6.4. This argument has been
`
`fully considered but has not been found persuasive. This argument has been
`
`addressedin the above paragraph.
`
`Applicants argue on page 5 bridging page 6 that WoldeMussie does not consider
`
`or provide any motivation to stabilize atropine, at least because WoldeMussie does not
`
`disclose atropine. This argument has been fully considered but has not been found
`
`persuasive. Morris teaches a stabilized composition of atropine. Applicants are
`
`reminded that the rejection is an obviousness rejection and not a anticipatory rejection.
`
`Therefore, since the combination of Morris and WoldeMussie teach each and ever
`
`component of the compostion; the composition would consequently result in a stabilized
`
`composition with a reasonable expectation of success absence evidence to the
`
`contrary.
`
`Applicants argue on page 6 that Atropine,
`
`in contrast, is known to significantly
`
`increase intraocular pressure. This argument has been fully considered but has not
`
`been found persuasive. First, applicants has provided no evidence of this assertion.
`
`And the dose of an muscarinic antagonists (in which atropine is an muscarinic
`
`antagonist) is about 0.0001 to 0.1 percent weight by volume and about 0.01 to about 0.5
`
`mg/g as taught by both Morris and WoldeMussie, which are very low doses ofatropine.
`
`Further, applicants are reminded that the claims are drawn to a composition (which
`
`includes kits) and not a method of treating any disease and/or disorder.
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 5
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`Applicants argue on page 6 that in the Morris teachings that atropine is not the
`
`primary active agent. This argument has been fully considered but has not been found
`
`persuasive. Morris clearly discloses atropine or atropine sulfate within the composition
`
`(claim 1 and 6).
`
`Applicants argues on page 6 that WoldeMussie and Morris are silent with respect
`
`the stability and degradation of atropine. This argument has beenfully considered but
`
`has not been found persuasive. First, the stability of the composition has been
`
`addressed in the second and fourth paragraph above. Second, nothing in the
`
`presented claims recite any form of degradation.
`
`Applicants again argue on page 5 and6that Morris is salient as to the feature of
`
`OH of from about 4.8 to about 6.4. And that WoldeMussie does not disclose 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 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). And Morris et al teach that their compositions are preferably prepared
`
`and packaged into ampoules in advance so 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 antagonist is in the concentration of 0.0001 to
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`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 6
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`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
`
`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 agent into 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 because it 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 evidence to the contrary.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis forall
`
`obviousness rejections set forth in this Office action:
`
`Apatent for a claimed invention maynotbe obtained, notwithstanding that the claimed
`invention is not identicallydisclosed as set forth insection 102, if the differences between the
`claimed invention and the prior artare such that the claimed invention as a whole would have
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 7
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`been obvious before the effective filing date of the claimed invention to a person having
`ordinaryskillinthe art to which the claimed invention pertains. Patentabilityshall notbe
`negated by the manner in whichthe invention was made.
`
`The text of those sections of Title 35, U.S. Code not included in 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.
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`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
`
`Claims 31-45 and 49-53 is/are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Morris (U.S. 4,952,586) and in view of WoldeMussie et al. (US
`
`5,716,952) both are of record.
`
`Morris et alteaches 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) of
`
`atropine or atropine sulfate, water and a buffer and instructions for use. Claim 31 uses
`
`opentransitional language (i.e. "comprising") such that the claimed kit can comprise
`
`additional components not explicitly recited in the claim. The term “kit” is not defined in
`
`the specification as necessarily comprising any particular structure or arrangementof
`
`components beyond whatis already recited in claim 31 (e.g. see [00338-00343] at
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`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 8
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`pages 75-76). The instant specification does not appear to even use the term “single
`
`use ampoule”, much less define it in any meaningful way. Thus, this term can
`
`reasonably be read broadly as encompassing any container that can be usedin at least
`
`some context a single time. The nature of the buffer comprised within the
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`pharmaceutical composition is generically claimed without any limitation asto its
`
`function, concentration or composition. Morris et al teach that their compositions are
`
`preferably prepared and packaged into ampoules in advance so that they are "ready for
`
`administration", they do not explicitly use the term “kit”. Morris teaches an aqueous
`
`solution, suitable pH adjustors or buffers, include sodium citrate and citric acid; and
`
`suitable preservatives include phenol and sodium sulfite (column 2, lines 35-45). The
`
`inventive composition may be prepared in advance of use, and packaged by means
`
`such asvials, prefilled syringes, or ampoules in appropriate volumes ready
`
`administration (column 2, lines 32-48). Morris is silent with regards to a preservative (in
`
`which meetsinstant claim 40-41).
`
`Morris et al. does not disclose a pH of about 4.8 to about 6.4. Morris does not
`
`disclose preservative,
`
`toxicity adjustor and viscosity agent.
`
`WoldeMussie etal. teaches the use of the claimed muscarinic antagonists in an
`
`aqueous ophthalmic formulation in combination with purified water. See the abstract,
`
`column 2, lines 46-67 and column 3, lines 1-20 and column 4, lines 23-32.
`
`WoldeMussie teaches that the muscarinic antagonist is 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
`
`

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`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 9
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`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 amountof 0-
`
`0.10 (table 1). WoldeMussie teaches the addition of hydroxypropylmethyl-cellulose
`
`(e.g. viscosity agent) (column 5, line 16). WoldeMussie teachesthat 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 agent into 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 because it 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 evidence to the contrary.
`
`With regards to the specific buffers, WolldeMussie teaches the use of the
`
`buffering agents, such as phosphate, borate and citrate. While specific buffers is not
`
`disclose, however,
`
`it would have been obvious to employ any buffer because all buffers
`
`perform the same functions (e.g. maintaining, modulating the pH of the composition).
`
`It would have been obvious to one of ordinary skills in the art to administer a
`
`chelating agent (stabilizer) (for example: edetate disodium (e.g. EDTA disodium)) in
`
`such a dose to minimize the degradation of the muscarinic antagonist with a reasonable
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`

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`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 10
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`expectation of success. The amounts of active agents to be used, the pharmaceutical
`
`forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed
`
`obvious since they are all within the knowledge of the skilled pharmacologist and
`
`represent conventional formulations and modes of administration. Furthermore, no
`
`unobviousness is seen in the ratio claimed because once the usefulness of a compound
`
`is known to treat a condition,
`
`it is within the skill of the artisan to determine the optimum
`
`ratio with a reasonable expectation of success absence evidence to the contrary.
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`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 Morris 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 success in doing so
`
`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 components to 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
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`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 11
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`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
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`the instant specification doesn't define this term atall.
`
`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”.
`
`Regarding the inclusion of instructions for how to use the composition(s) of
`
`Morris et al, itis 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 because there 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
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`

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`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 12
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`not arranged in 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 deck of
`
`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 deck of
`
`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 processof 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
`
`rejected on prior art because there was no new feature 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, ina 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(IIl), which states that non-
`
`

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`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 13
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`functional printed matter does notdistinguish a claimed product from an otherwise
`
`identical prior art product.
`
`In any case, even if one considered the “instructions for
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`use”in this instance to have patentable weight, the inclusion of such instructions in a kit
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`is so well known and a common practice in the art as to maketheir inclusion in the
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`invention taught and suggested by Morris et al prima facie obvious to the ordinarily
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`skilled artisan.
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`For these reasons, the claimed subject matter is deemed to fail to be patentably
`
`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
`
`discussion, the Examiner concludes that the subject matter defined by the instant claims
`
`would have been obvious within the meaning of 35 USC 103(a).
`
`From the teachings of the references, it is apparent that one of ordinary skill in
`
`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 bythe references,
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`especially in the absence of evidence to the contrary.
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`Double Patenting
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`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the “right to exclude” granted by a patent
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`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 14
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the conflicting claims are not identical, but at
`
`least one examined application claim is not patentably distinct from the reference
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`claim(s) because the examined application claim is either anticipated by, or would have
`
`been obvious over, the reference claim(s). See, e.g.,
`
`/n re Berg, 140 F.3d 1428, 46
`
`USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985);
`
`In re Van Ornum,
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`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d)
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`may be used to overcome an actualor provisional rejection based on nonstatutory
`
`double patenting provided the reference application or patent either is shown to be
`
`commonly owned with the examined application, or claims an invention made as a
`
`result of activities undertaken within the scope of a joint research agreement. See
`
`MPEP § 717.02 for applications subject to examination under the first inventor to file
`
`provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq.for
`
`applications not subject to examination under the first inventor to file provisions of the
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`AlA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO Internet website contains terminal disclaimer forms which may be
`
`used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application
`
`in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26,
`
`PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may
`
`be filled out completely online using web-screens. An eTerminal Disclaimer that meets
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 15
`
`all requirements is auto-processed and approved immediately upon submission. For
`
`more information about eTerminal Disclaimers, refer to
`
`VATA AL PED ent,
`etn: 8g. of inventions.
`WASAW US AL
`
`Claims 31-45 and 49-53 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1-15 of US Patent 11,520,095.
`
`Although the claims at issue are notidentical, they are not patentably distinct from each
`
`other because the claims of the instant application are drawn to an ophthalmic
`
`formulation of a muscarinic antagonist and water at a pH of 4.4 to about 6.4. The claims
`
`of the ‘095 patent are drawnto the use of a muscarinic antagonist and water. The pH of
`
`4.4 to about 6.4 is the expected property of the claims of the ‘095 patent since it uses
`
`the same components at the same concentrations as claimed herein. Thus, the instant
`
`claims and the ’095 possess overlapping scopes of inventions.
`
`Claims 31-45 and 49-53 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1-23 of US Patent 11,052,094.
`
`Although the claims at issue are notidentical, they are not patentably distinct from each
`
`other because the claims of the instant application are drawn to an ophthalmic
`
`formulation of a muscarinic antagonist and water at a pH of 4.4 to about 6.4. The claims
`
`of the ‘094 patent are drawn to the use of a muscarinic antagonist and heavy water. The
`
`pH/pD of 4 to about 8 is the expected property of the claims of the ‘094 patent since it
`
`uses the same components at the same concentrations as claimed herein. Thus, the
`
`instant claims and the 094 possess overlapping scopesof inventions.
`
`Claims 31-45 and 49-53 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1-23 of US Patent 11, 596, 625.
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 16
`
`Although the claims at issue are notidentical, they are not patentably distinct from each
`
`other because the claims of the instant application are drawn to an ophthalmic
`
`formulation of a muscarinic antagonist and water at a pH of 4.4 to about 6.4. The claims
`
`of the ‘625 patent are drawn to the composition of a muscarinic antagonist use of a
`
`muscarinic antagonist and heavy water. The pH/pD of 4 to about 8 is the expected
`
`property of the claims of the ‘625 patent since it uses the same components at the same
`
`concentrations as claimed herein. Thus, the instant claims and the 094 possess
`
`overlapping scopesof inventions.
`
`Claims 31-45 and 49-53 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1-23 of US Patent 10,940,145.
`
`Although the claims at issue are notidentical, they are not patentably distinct from each
`
`other because the claims of the instant application are drawn to an ophthalmic
`
`formulation of a muscarinic antagonist and water at a pH of less than 5. The claims of
`
`the ‘145 patent are drawn to the composition of Atropine in a kit. The pH/pD of 308 to
`
`about 6.4 is the expected property of the claims of the ‘625 patent since it uses the
`
`same components at the same concentrations as claimed herein. Thus, the instant
`
`claims and the ‘145 possess overlapping scopesof inventions.
`
`Claims 31-45 and 49-53 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1-23 of US Patent 11,464,769.
`
`Although the claims at issue are notidentical, they are not patentably distinct from each
`
`other because the claims of the instant application are drawn to an ophthalmic
`
`formulation of a muscarinic antagonist and water at a pH less than 5. The claims of the
`
`

`

`Application/Control Number: 16/908,426
`Art Unit: 1627
`
`Page 17
`
`‘769 patent are drawn to the composition of a low dose of Atropine. Thus, the instant
`
`claims and the ’534 possess overlapping scopesof inventions.
`
`Claims 31-45 and 49-53 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1-20 of US Patent 10,251,875.
`
`Although the claims at issue are not identical, they are not patentably distinct from each
`
`other because the claims of the instan