UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`15/568,266
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`10/20/2017
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`Hyeon-A YIM
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`068374-000052
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`1285
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`Vorys, Sater, Seymour and Pease LLP
`1909 K St NW
`9th Floor
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`WASHINGTON, DC 20006-1152
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`SONGJIANFENG
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`1613
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`02/26/2019
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`patlaw@ yorys.eom
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`PTOL-90A (Rev. 04/07)
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`

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`Off/09 A0170” Summary
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`Application No.
`15/568,266
`Examiner
`JIANFENG SONG
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`Applicant(s)
`YIM et al.
`Art Unit
`1613
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`AIA Status
`Yes
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`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`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). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f 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).
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`Status
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`1)[:] Responsive to communication(s) filed on
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)D This action is FINAL.
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`2b)
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`This action is non-final.
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`3)C] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
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`4):] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`5)
`Claim(s)
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`1—15 is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`[:1 Claim(s)
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`is/are allowed.
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`Claim(s) fl is/are rejected.
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`[j Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`C] Claim(s)
`9
`* If any claims have been determined aflowabte. you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.”smong/patents/init_event§/pph/index.'§p or send an inquiry to PPeredhagk@usptg.ggv.
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`Application Papers
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`10):] The specification is objected to by the Examiner.
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`11). The drawing(s) filed on 10/20/2017 is/are: a). accepted or b)C] 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).
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`Priority under 35 U.S.C. § 119
`12). Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a). All
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`b)I:J Some”
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`c)C] None of the:
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`1.. Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`3.[:] 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)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail DateW.
`U.S. Patent and Trademark Office
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`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20190124
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`

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`Application/Control Number: 15/568,266
`Art Unit: 1613
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`Page 2
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`Notice of Pre-AIA or AIA Status
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`The present application, filed on or after March 16, 2013,
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`is being examined
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`under the first inventor to file provisions of the AIA.
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`DETAILED ACTION
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`Claims 1-15 are pending and under examination.
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`Priority
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`Acknowledge is made that this application is national stage of international
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`application PCT/KR2016/004084,
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`filed on 04/20/2016; which claims priority from Korean
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`patent application KR1020150056977,
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`filed on 04/23/2015.
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`Information Disclosure Statement
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`The information disclosure statement (IDS) submitted on 10/20/2017 is being
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`considered by the examiner.
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`Claim Rejections - 35 USC § 112
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`The following is a quotation ofthe first paragraph of 35 U.S.C. 112(a):
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`(a) IN GENERAL—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 usethe same, and shall set forth the
`best mode contemplated by the inventor orjoint inventor of carrying out the invention.
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`The following is a quotation ofthe first paragraph of pre-AIA 35 U.S.C. 112:
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`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, orwith 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.
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`

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`Application/Control Number: 15/568,266
`Art Unit: 1613
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`Page 3
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`Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first
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`paragraph, as failing to comply with the written description requirement. The claim(s)
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`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.
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`The factors considered in the Written Description requirement are (1) level of skill
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`and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties,
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`(4) functional characteristics alone or coupled with a known or disclosed correlation
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`between structure and function, and the (5) method of making the claimed invention.
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`While all of the factors have been considered, only those required for a prima
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`facie case are set forth below.
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`The specification discloses a process for preparing a polyurethane foam dressing
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`in which an anti-inflammatory agent is homogeneously dispersed, the process
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`comprising: (a) mixing dexibuprofen; one or more dispersing agents selected from the
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`group consisting of methanol, ethanol, n-propanol,
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`isopropanol, ethyl acetate and n-
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`hexane; and a polyurethane prepolymer comprising a polyol and an isocyanate to
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`obtain a drug-containing polyurethane prepolymer.
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`The claims are drawn to a process for preparing a polyurethane foam dressing in
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`which an anti-inflammatory agent is homogeneously dispersed, the process comprising:
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`(a) mixing an alkaline anti-inflammatory agent having a pKa value more than pKa 7
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`(interpreted as sodium dexibuprofen); one or more dispersing agents selected from
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`

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`Application/Control Number: 15/568,266
`Art Unit: 1613
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`Page 4
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`the group consisting of methanol, ethanol, n-propanol,
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`isopropanol, ethyl acetate and n-
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`hexane; and a polyurethane prepolymer comprising a polyol and an isocyanate to
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`obtain a drug-containing polyurethane prepolymer.
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`Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey
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`with reasonable clarity to those skilled in the art that, as of the filing date sought, he or
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`she was in possession of the invention. The invention, for purposes of the written
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`description inquiry,
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`is whatever is now claimed (see page 1117). A review of the
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`language of the claim indicates that these claims are drawn to a process for preparing a
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`polyurethane foam dressing in which an anti-inflammatory agent is homogeneously
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`dispersed, the process comprising: (a) mixing an alkaline anti-inflammatory agent
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`having a pKa value more than pKa 7 (interpreted as sodium dexibuprofen); one or
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`more dispersing agents selected from the group consisting of methanol, ethanol, n-
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`propanol,
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`isopropanol, ethyl acetate and n-hexane; and a polyurethane prepolymer
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`comprising a polyol and an isocyanate to obtain a drug-containing polyurethane
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`prepolymer.
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`There is substantial difference regarding solubility and reactivity between anti-
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`inflammatory agent dexibuprofen and the corresponding sodium dexibuprofen in the
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`polymerization process. The disclosure of a process for preparing a polyurethane foam
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`dressing from anti-inflammatory agent dexibuprofen does not provide an adequate
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`description of the claimed invention of a process for preparing a polyurethane foam
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`dressing from sodium dexibuprofen.
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`Weighing all the factors, the breadth of the claims reading on alkaline anti-
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`inflammatory agent yet to be discovered, the difference in solubility and reactivity in the
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`

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`Application/Control Number: 15/568,266
`Art Unit: 1613
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`Page 5
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`polymerization process between dexibuprofen and sodium dexibuprofen, level of
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`knowledge and skill in the art, one of ordinary skill in the art would not recognize from
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`the disclosure that the applicant was in possession of a process for preparing a
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`polyurethane foam dressing in which an anti-inflammatory agent is homogeneously
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`dispersed, the process comprising: (a) mixing an alkaline anti-inflammatory agent
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`having a pKa value more than pKa 7 (interpreted as sodium dexibuprofen); one or
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`more dispersing agents selected from the group consisting of methanol, ethanol, n-
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`propanol,
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`isopropanol, ethyl acetate and n-hexane; and a polyurethane prepolymer
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`comprising a polyol and an isocyanate to obtain a drug-containing polyurethane
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`prepolymer. At best, it simply indicates that one should run tests in the hope that the
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`claimed process will work.
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`In essence, the specification simply directs those skilled in
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`the art to go figure out for themselves whether the claimed process would work.
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`The written description requirement is not satisfied.
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`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION—The specification shall concludewith one or more claims particularly
`pointing out and distinctlyclaiming the subject matterwhich the inventoror a joint inventor
`regards as the invention.
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`The following is aquotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specifications hall conclude with one or more claims particularlypointing outand distinctly
`claiming the subject matterwhich the applicant regards as his invention.
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`Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
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`second paragraph, as being indefinite for failing to particularly point out and distinctly
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`claim the subject matter which the inventor or a joint inventor, or for pre-AIA the
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`applicant regards as the invention.
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`

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`Application/Control Number: 15/568,266
`Art Unit: 1613
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`Page 6
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`Regarding claim 1, claim 1 recites “an alkaline anti-inflammatory agent having
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`pka value more than pka 7”, which is not disclosed in applicant’s specification, and this
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`term is unclear. Since applicant’s specification and dependent claims recites three anti-
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`inflammatory agents acetaminophen,
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`ibuprofen, or dexibuprofen, an alkaline anti-
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`inflammatory agent can be possibly interpreted as sodium ibuprofen or dexibuprofen
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`(isomer of ibuprofen). However, as evidenced by Oh et al.
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`(“Effects of pH, dissolved
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`organic matter, and salinity on ibuprofen sorption on sediment”, Environ Sci. Pollut Res
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`(2016) 23: 22882-22889) that both ibuprofen and sodium ibuprofen have pKa 4.52,
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`it is
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`unclear what “an alkaline anti-inflammatory agent having pka value more than pka 7”
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`refers to, and the scope and boundary of claim 1 are unclear. This is indefinite. For
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`compact prosecution purpose, “an alkaline anti-inflammatory agent having pka value
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`more than pka 7” is interpreted as salt of anti-inflammatory agent, for example, sodium
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`ibuprofen or dexibuprofen.
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`Claims 2-15 are rejected for depending on rejected claim 1.
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`Conclusion
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`No claim is allowed.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to JIANFENG SONG whose telephone number is
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`(571)270-1978. The examiner can normally be reached on M—F 8-5.
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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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`