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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`14/859,042
`
`09/18/2015
`
`Gregory 1. Ostrow
`
`46682—701501
`
`2284
`
`WILSON, SONSINI, GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`FAY, ZOHREH A
`
`PAPER NUIVIBER
`
`ART UNIT
`
`1621
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/25/2016
`
`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.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Application No.
`Applicant(s)
`
` 14/859,042 OSTROW ET AL.
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`1621ZOHREH FAY $233
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from 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) MONTHS from 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, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 8/30/2016.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)lX| This action is non-final.
`2a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
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`; the restriction requirement and election have been incorporated into this action.
`
`4)|:I 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 EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`1) D Notice of References Cited (PTO-892)
`3) I] Interview Summary (PTO-413)
`.
`.
`Paper No(s)/Mai| Date.
`2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date 1/7/2015. 4) D Other: —-
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20161018
`
`Disposition of Claims*
`5)|XI Claim(s) fl is/are pending in the application.
`5a) Of the above claim(s) M is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`s fl? is/are rejected.
`
`is/are objected to.
`
`) )
`
`_
`
`
`are subject to restriction and/or election requirement.
`9)|:l Claim(s
`)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usoto. ov/ atents/init events"
`h/index.‘s
`
`
`
`
`
`, or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)I:I All
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I:I Copies of the certified copies of the priority documents have been received in 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.
`
`Attach ment(s)
`
`
`
`

`

`Application/Control Number: 14/859,042
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`Page 2
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`Art Unit: 1621
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`DETAILED ACTION
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`Claims 1-61 are pending in the instant application.
`
`Claims 1-39 are presented for examination.
`
`Claims 40-61 are withdrawn from examination.
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`The response to the restriction requirement of June 30, 2016 has been received and
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`entered.
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`Applicant elected Group I, claims 1-39 without traverse for examination purpose.
`
`Claim Rejections - 35 USC § 1 12
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`IN GENERAL—The specification shall contain a written description of the
`(a)
`invention, and of the manner and process of making and using it, in such full, clear, concise,
`and exact terms as to enable any person skilled in the art to which it pertains, or with which it
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor orjoint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the
`manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly
`connected, to make and use the same, and shall set forth the best mode contemplated by the
`inventor of carrying out his invention.
`
`Claims 1-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first
`
`paragraph, as failing to comply with the written description requirement. The claim(s)
`
`contains subject matter which was not described in the specification in such a way as to
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`reasonably convey to one skilled in the relevant art that the inventor or a joint inventor,
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`or for pre-AIA the inventor(s), at the time the application was filed, had possession of
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`the claimed invention. The claims are drawn to “a muscarinic antagonist”. The instant
`
`

`

`Application/Control Number: 14/859,042
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`Page 3
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`Art Unit: 1621
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`specification discloses a few compounds within the scope of what is claimed. However,
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`in the absence of the compounds being used, the artisan, would not have accepted that
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`applicant was in possession of the claimed method of use. The description requirement of
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`the patent statute requires a description of an invention, not an indication of a result that one
`
`
`might achieve if one made that invention. See, e.g., In re Wilder 22 USPQ 369, 372-3 (Fed. Cir.
`
`1984). (Holding that a claim was not adequately described because the specification did 'little
`
`more than outline goals appellants hope the claimed invention achieves and the problems the
`
`invention will hopefully ameliorate.')Mere indistinct terms (such as known classes of compounds
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`which are now claimed based on a limited functional capability, such as “a muscarinic
`
`antagonist” however, may not suffice to meet the written description requirement. This is
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`particularly true when known compound classes, which otherwise meet the written description
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`requirement, are limited to a smaller subgroup claimed in purely functional terms, such as the
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`case in the instant claims. See Univ. of Rochester v. G.D. Searle 69USPQ2d 1886 (CAFC
`
`2004) at 1892, stating: The appearance of mere indistinct words in a specification or a claim,
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`even an original claim, does not necessarily satisfy that requirement. A description of an anti-
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`inflammatory steroid, Le, a steroid (a generic structural term) described even in terms of its
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`functioning of lessening inflammation of tissues fails to distinguish any steroid from others
`
`having the same activity or function. A description of what a material does, rather than of what it
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`is, usually does not suffice. The disclosure must allow one skilled in the art to visualize or
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`recognize the identity of the subject matter purportedly described. (Emphasis added).
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`Conversely, a description of a chemical genus will usually comprise a recitation of structural
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`features common to the members of the genus, which features constitute a substantial portion
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`of the genus. See Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is
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`analogous to enablement of a genus under Section 112, l[ 1, by showing the enablement of a
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`

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`Application/Control Number: 14/859,042
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`Page 4
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`Art Unit: 1621
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`representative number of species within the genus. A chemical genus can be adequately
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`described if the disclosure presents a sufficient number of representative species that
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`encompass the genus. If the genus has substantial variance, the disclosure must describe a
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`sufficient number of species to reflect the variation within that genus. See MPEP 2163. The
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`MPEP lists factors that can be used to determine if sufficient evidence of possession has been
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`furnished in the disclosure of the Application. These include the level of skill and knowledge in
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`the art, partial structure, physical and/or chemical properties, functional characteristics alone or
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`coupled with a known or disclosed correlation between structure and function, and the method
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`of making the claimed invention. Disclosure of any combination of such identifying
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`characteristics that distinguish the claimed invention from other materials and would lead one of
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`skill in the art to the conclusion that the applicant was in possession of the claimed species is
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`sufficient. MPEP 2163. Here, the specification does not provide a reasonably representative
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`disclosure of useful compounds which are “muscarinic antagonists”.
`
`Claim Rejections - 35 USC § 1 12
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION—The specification 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 36 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
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`subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards
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`as the invention.
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`

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`Application/Control Number: 14/859,042
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`Page 5
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`Art Unit: 1621
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`Claim 20 is indefinite as to the expression “DCI, NaOD, CD3COOD, or C6D807".
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`Such expression fails to set forth the intended meaning and the chemical structure of
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`the intended compound.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
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`obviousness rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102 of this title, 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 factual inquiries set forth in Graham v. John Deere 00., 383 U.S. 1, 148
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`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under 35 U.S.C. 103 are summarized as follows:
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`1. Determining the scope and contents of the prior art.
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`2. Ascertaining the differences between the prior art and the claims at issue.
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`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.
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`This application currently names joint inventors. In considering patentability of the
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`claims the examiner presumes that the subject matter of the various claims was
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`commonly owned as of the effective filing date of the claimed invention(s) absent any
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`

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`Application/Control Number: 14/859,042
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`Page 6
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`Art Unit: 1621
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`evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to
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`point out the inventor and effective filing dates of each claim that was not commonly
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`owned as of the effective filing date of the later invention in order for the examiner to
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`consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2)
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`prior art against the later invention.
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`Claims 1-39 are rejected under 35 U.S.C. 103 as being unpatentable over
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`WoldeMussie et al. (US 5,716,952) as applied to claim 1-27 above, and further in view
`
`of Widsoet et al. (US 20120015035) and Herekar (20120203161).
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`WoldeMussie etal. Teach the use of the claimed muscarinic antagonists in an
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`ophthalmic formulation in combination with purified water. See the abstract, column 2,
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`lines 46-67 and column 3, lines 1-20 and column 4, lines 23-32. The use of sodium
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`chloride is taught in column 5, lines 18-22. The use of the buffering agents, such as
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`phosphate, borate and citrate is taught in column 2, lines 23-29. The use of
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`preservatives is taught in column 5, lines 9-14. WooldeMussie differs from the claimed
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`invention in using deuterated water and the use of atropine. Wildsoet et al. teach the
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`use of atropine as a muscarinic antagonist, being used in ophthalmic formulations. See
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`Para [0031]. Herekar teaches the use of deuterated water in combination with
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`riboflavin in an ophthalmic formulation. Herekar teaches the increased shelf life and the
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`need for the use of lower concentration of riboflavin if deuterated water is used instead
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`of water. See para [0026] and [0029]. The combination of water and deuterated water
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`is taught in claim 2.
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`It would have been obvious to use deuterated water instead of
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`water or in combination with water in the composition of WoldeMussie et al., motivated
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`

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`Application/Control Number: 14/859,042
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`Page 7
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`Art Unit: 1621
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`by the teachings of Herekar, which teaches the use of deuterated water instead of water
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`or in combination with water increases the shelf life and reduces the amount of active
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`ingredient needed for the pharmaceutical activity. Herekar makes clear that the use of
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`deuterated water increases the shelf life of a pharmaceutical formulation. Therefore, it
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`would have been obvious to a person skilled in the art to add deuterated water to a
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`pharmaceutical formulation with the expectation of getting an increased shelf life and
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`stability.
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`Double Patenting
`
`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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`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the claims at issue are not identical, but at least
`
`one examined application claim is not patentably distinct from the reference claim(s)
`
`because the examined application claim is either anticipated by, or would have been
`
`obvious over, the reference claim(s). See, e.g., In 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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`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 actual or provisional rejection based on a nonstatutory
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`

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`Application/Control Number: 14/859,042
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`Page 8
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`Art Unit: 1621
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`double patenting ground provided the reference application or patent either is shown to
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`be commonly owned with this application, or claims an invention made as a result of
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`activities undertaken within the scope of a joint research agreement. A terminal
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`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
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`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
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`Claims 1-39 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 1-24 of U.S. Patent 9,421,199. Although
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`the claims at issue are not identical, they are not patentably distinct from each other
`
`because they overlap. The claims of the US Patent are drawn to an ophthalmic
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`formulation of a muscarinic antagonist and deuterated water at a pD of 4.2 to about 7.9.
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`The claims of the instant application are drawn to the use of a muscarinic antagonist
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`and deuterated water. The pD of 4.2 to about 7.9 is the expected property of the claims
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`of the instant application, since it uses the same components at the same
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`concentrations as claimed herein.
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`

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`Application/Control Number: 14/859,042
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`Page 9
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`Art Unit: 1621
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to ZOHREH FAY whose telephone number is (571 )272—
`
`0573. The examiner can normally be reached on Monday to Friday 9:30-6:00.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Winston Shen can be reached on (571) 272-3157. The fax phone number
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`for the organization where this application or proceeding is assigned is 571 -273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private 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 to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272—1000.
`
`ZF
`
`/ZOHREH FAY/
`
`Primary Examiner, Art Unit 1621
`
`