PATENT COOPERATION TREATY
`
`PCT
`
`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY
`
`(Chapter I of the Patent Cooperation Treaty)
`
`(PCT Rule 44bis)
`
`Applicant’s or agent’s file reference
`3685.042PC02
`
`FOR FURTHER ACTION
`
`See item 4 below
`
`International filing date (day/month/yeGE)
`International application No.
`20 January 2016 (20.01.2016)
`PCT/U82016/014005
`International Patent Classification (8th edition unless older edition indicated)
`See relevant information in Form PCT/ISA/237
`
`Priority date (day/month/yeCIE)
`20 January 2015 (20.01.2015)
`
`Applicant
`ABBVI E INC.
`
`This international preliminary report on patentability (Chapter I) is issued by the International Bureau on behalf of the
`International Searching Authority under Rule 44 bis.1(a).
`
`This REPORT consists of a total of 9 sheets, including this cover sheet.
`
`In the attached sheets, any reference to the written opinion of the International Searching Authority should be read as a
`reference to the international preliminary report on patentability (Chapter I) instead.
`
`This report contains indications relating to the following items:
`
`Box \o. I
`
`Basis of the report
`
`Box \o. II
`
`Box \o.
`
`
`
`Priority
`
`Non—establishment of opinion with regard to novelty, inventive step and industrial
`applicability
`
`Lack of unity of invention
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step or
`industrial applicability; citations and explanations supporting such statement
`
`Certain documents cited
`
`Certain defects in the international application
`
`Certain observations on the international application
`
`lhe International Bureau will communicate this report to designated Offices in accordance with Rules 44bis.3(c) and 93bis.1
`but not, except where the applicant makes an express request under Article 23(2), before the expiration of 30 months from
`the priority date (Rule 44bis .2).
`
`The International Bureau of WIPO
`34, chemin des Colombettes
`1211 Geneva 20, Switzerland
`Facsimile NO. +41 22 338 82 70
`Form PCT/IB/373 (January 2004)
`
`Date of issuance of this report
`25 July 2017 (25.07.2017)
`
`AthHZEd officer
`
`.
`.
`.
`Llngfel Bal
`e—mail; pct.[eam2@wip0.int
`
`
`
`
`
`Box \o.
`
`Box \o.
`
`Box \o.
`
`Box \o.
`
`Box \o.
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`E E E E E E E E '
`
`

`

`PATENT COOPERATION TREATY
`
`From the
`INTERNATIONAL SEARCHING AUTHORITY
`
`see form PCT/ISA/220
`
`
`
`PCT
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`(PCT Rule 43bis.1)
`
`
`Date of mailing
`(day/month4/ear)
`
`see form PCT/ISA/210 (second sheet)
`
`
`
`Applicant's or agent‘s file reference
`see form PCT/ISA/220
`
`FOR FURTHER ACTION
`See paragraph 2 below
`
`International application No.
`PCT/US2016/014005
`
`International filing date (day/fnonth/year)
`20.01.2016
`
`Priority date (day/month4/ear)
`20.01.2015
`
`
`
`
`
`International Patent Classification (IPC) or both national classification and IPC
`INV. A61 K9/00 A61K9/10 A61K47/38 A61K31/195 A61K31/198
`
`
`Applicant
`ABBVIE INC.
`
`1.
`
`This opinion contains indications relating to the following items:
`
`Box No. I
`
`Basis of the opinion
`
`Box No. II
`
`Priority
`
`EDKEIE Box No. V
`KEIE Box No. VIII Certain observations on the international application
`
`Box No. III
`
`Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
`
`Box No. IV
`
`Box No. VI
`
`Lack of unity of invention
`Reasoned statement under Rule 43bis.1(a)(i) with regard to novelty, inventive step and industrial
`applicability; citations and explanations supporting such statement
`Certain documents cited
`
`Box No. VII
`
`Certain defects in the international application
`
`2.
`
`FURTHER ACTION
`
`If a demand for international preliminary examination is made, this opinion will usually be considered to be a
`written opinion of the International Preliminary Examining Authority ("IPEA") except that this does not apply where
`the applicant chooses an Authority other than this one to be the IPEA and the chosen IPEA has notifed the
`International Bureau under Rule 66.1bis(b) that written opinions of this International Searching Authority
`will not be so considered.
`
`If this opinion is, as provided above, considered to be a written opinion of the IPEA, the applicant is invited to
`submit to the IPEA a written reply together, where appropriate, with amendments, before the expiration of 3 months
`from the date of mailing of Form PCT/ISA/22O or before the expiration of 22 months from the priority date,
`whichever expires later.
`
`For further options, see Form PCT/ISA/220.
`
` Name and mailing address of the ISA:
`
`
`
`
`Date of completion of
`this opinion
`see form
`PCT/ISA/210
`
`Authorized Officer
`
`Hede aard, Anette
`g
`Telephone No. +49 89 2399-0
`
`F
`we“ “BMW-ts
`f3 o 6%:
`>
`3
`94’
`3.
`ewmmw
`-
`
`
`
`—
`a) European Patent Office
`, )
`— D-80298 Munich
`Tel- +49 89 2399 ' 0
`Fax: +49 89 2399 - 4465
`
`Form PCT/ISA/237 (Cover Sheet) (January 2015)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/U82016/014005
`
`Box No. I Basis of the opinion
`
`1. With regard to the language, this opinion has been established on the basis of:
`
`IZI
`
`El
`
`the international application in the language in which it was filed.
`
`a translation of the international application into , which is the language of a translation furnished for the
`purposes of international search (Rules 12.3(a) and 23.1 (b)).
`
`This opinion has been established taking into account the rectification of an obvious mistake authorized
`by or notified to this Authority under Rule 91 (Rule 43bis.1(a))
`
`With regard to any nucleotide and/or amino acid sequence disclosed in the international application, this
`opinion has been established on the basis of a sequence listing:
`
`a. El
`
`forming part of the international application as filed:
`
`CI
`
`in the form of an Annex C/ST.25 text file.
`
`[I on paper or in the form of an image file.
`
`b. El furnished together with the international application under PCT Rule 13ter.1(a) for the purposes of
`international search only in the form of an Annex C/ST.25 text file.
`
`c. D furnished subsequent to the international filing date for the purposes of international search only:
`
`CI
`
`in the form of an Annex C/ST.25 text file (Rule 13ter.1(a)).
`
`El on paper or in the form of an image file (Rule 13ter.1(b) and Administrative Instructions, Section
`713).
`
`In addition, in the case that more than one version or copy of a sequence listing has been filed or furnished,
`the required statements that the information in the subsequent or additional copies is identical to that
`forming part of the application as filed or does not go beyond the application as filed, as appropriate, were
`furnished.
`
`5. Additional comments:
`
`Box No. II Priority
`
`1.|Z|
`
`2.|:|
`
`The validity of the priority claim has not been considered because the International Searching Authority
`does not have in its possession a copy of the earlier application whose priority has been claimed or, where
`required, a translation of that earlier application. This opinion has nevertheless been established on the
`assumption that the relevant date (Rules 43bis.1 and 64.1) is the claimed priority date.
`
`This opinion has been established as if no priority had been claimed due to the fact that the priority claim
`has been found invalid (Rules 43bis.1 and 64.1). Thus for the purposes of this opinion, the international
`filing date indicated above is considered to be the relevant date.
`
`3. Additional observations, if necessary:
`
`Form PCT/ISA/237 (January 2015)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2016/O14005
`
`Box No. Ill Non-establishment of opinion with regard to novelty, inventive step and industrial
`applicability
`
`The questions whether the claimed invention appears to be novel, to involve an inventive step (to be non
`obvious), or to be industrially applicable have not been examined in respect of
`
`El
`
`IZI
`
`the entire international application
`
`claims Nos. 26-34
`
`because:
`
`IXI
`
`the said international application, or the said claims Nos. 26-34 relate to the following subject matter which
`does not require an international search (specify):
`
`see separate sheet
`
`the description, claims or drawings (indicate particular elements below) or said claims Nos.
`that no meaningful opinion could be formed (specify):
`
`are so unclear
`
`the claims, or said claims Nos. are so inadequately supported by the description that no meaningful opinion
`could be formed (specify):
`
`no international search report has been established for the whole application or for said claims Nos.
`
`a meaningful opinion could not be formed without the sequence listing; the applicant did not, within the
`prescribed time limit:
`
`III furnish a sequence listing in the form of an Annex C/ST.25 text file, and such listing was not available
`to the International Searching Authority in the form and manner acceptable to it; or the sequence listing
`furnished did not comply with the standard provided for in Annex C of the Administrative Instructions.
`
`El furnish a sequence listing on paper or in the form of an image file complying with the standard provided
`for in Annex C of the Administrative Instructions, and such listing was not available to the International
`Searching Authority in the form and manner acceptable to it; or the sequence listing furnished did not
`comply with the standard provided for in Annex C of the Administrative Instructions.
`
`El pay the required late furnishing fee for the furnishing of a sequence listing in response to an
`invitation under Rule 13fer.1(a) or (b).
`
`See Supplemental Box for further details
`
`Form PCT/ISA/237 (January 2015)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/U82016/014005
`
`Box No. V Reasoned statement under Rule 43bis.1(a)(i) with regard to novelty, inventive step or
`industrial applicability; citations and explanations supporting such statement
`
`1. Statement
`
`Novelty (N)
`
`Yes: Claims
`No:
`Claims
`
`16-20
`
`1—15 21—36
`
`Inventive step (IS)
`
`Yes: Claims
`No:
`Claims
`
`1-36
`
`Industrial applicability (IA)
`
`Yes: Claims
`No:
`Claims
`
`1-25I 35I 36
`
`2. Citations and explanations
`
`see separate sheet
`
`Box No. VI Certain documents cited
`
`1. Certain published documents (Rules 43bis.1 and 70.10)
`
`and / or
`
`2. Non-written disclosures (Rules 43bis.1 and 70.9)
`
`see form 210
`
`Box No. VII Certain defects in the international application
`
`The following defects in the form or contents of the international application have been noted:
`
`see separate sheet
`
`Box No. VIII Certain observations on the international application
`
`The following observations on the clarity of the claims, description, and drawings or on the question whether the
`claims are fully supported by the description, are made:
`
`see separate sheet
`
`Form PCT/ISA/237 (January 2015)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`
`International application No.
`
`AUTHORITY (SEPARATE SHEET)
`
`PCT/U82016/O14005
`
`w N
`
`on-establishment of opinion with regard to novelty, inventive step and
`
`industrial applicability
`
`1
`
`Claims 26-34 relate to subject-matter considered by this Authority to be
`
`covered by the provisions of Rule 39.1 (iv)/67.1 (iv) PCT.
`
`w R
`
`easoned statement under Rule 66.2(a)(ii) with regard to novelty, inventive step
`
`or industrial applicability; citations and explanations supporting such
`statement
`
`1
`
`Reference is made to the following documents:
`
`D1
`
`D2
`
`D3
`
`WO 2007/138086 A1
`
`WO 94/12153 A1
`
`WO 2012/066538 A1
`
`D1 (see claim 13) discloses compositions comprising levodopa and carbidopa
`
`in form of particles suspended in an aqueous carrier having a viscosity of at
`
`least 300 mPas at a moderate shear rate. Paragraph [0037] of D1 discloses a
`
`gel (Duodopa®) comprising levodopa, carbidopa, carmellose sodium and
`
`water. Paragraph [0024] of D1 discloses the combination with a portable
`
`pump for intestinal administration. The use for treating Parkinson's disease is
`disclosed in claim 1 of D1.
`
`D2 (see Example 1) discloses a suspension of levodopa and carbidopa in a
`
`viscous water solution of methyl cellulose.
`
`D3 (see paragraphs [0067] and [00103]) discloses the improved stability of
`
`levodopa under N2 atmosphere.
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 1) (EPO-April 2005)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`
`International application No.
`
`AUTHORITY (SEPARATE SHEET)
`
`PCT/US2016/014005
`
`2
`
`The subject-matter of independent claims 1 and 26 is not novel (Art. 33(2)
`
`PCT) since all the essential features have already been disclosed in D1 and
`
`D2 (see above under item 1).
`
`In the absence of proof to the contrary it is considered that the compositions
`
`according to D1 and D2 meet the functional requirements defined in present
`
`Claims 1 and 26 (see also below in Section VIII).
`
`3
`
`Having regard to the disclosures of D1 -D3, claims 2-25 and 27-36 do not
`
`appear to contain new and/or inventive features per se and are only allowable
`
`when related to an independent claim which fulfils the requirements of the
`PCT.
`
`It is here pointed out that it is known from D1 and D2 to improve physical
`
`stability of suspensions comprising levodopa and carbidopa by controlling
`
`viscosity (see eg. D2, page 2, lines 20—25). Furthermore, D2 and D3 disclose
`
`exclusion of air (and use of N2) for improving chemical stability (see D2, page
`
`6, lines 21-23 and D3, par. [0103]).
`
`Hence, the subject-matter of the present claims is not considered to involve
`
`an inventive step (Art. 33(3) PCT).
`
`4
`
`Claims 26-34 relate to subject-matter considered by this Authority to be
`
`covered by the provisions of Rule 39.1 (iv)/67.1 (iv) PCT.
`
`The patentability can be dependent upon the formulation of the claims. The
`
`EPO, for example, does not recognize as patentable claims to the use of a
`
`compound in medical treatment, but may allow claims to a product, in
`
`particular substances or compositions for use in a first or further medical
`treatment.
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 2) (EPO-April 2005)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`
`International application No.
`
`AUTHORITY (SEPARATE SHEET)
`
`PCT/US2016/O14005
`
`w C
`
`9”3i n._SI.9.EH.[EEl].t.:‘i_E.I339'.._____________________.
`
`
`
`
`
`5
`
`Application No
`
`5, Publication
`date
`
`Filing date
`
`Priority date
`
`
`
`WO2015/069773 A1
`
`14.05.2015 ‘ 05.11.2014
`
`05.11.2013
`
`Although WO2015/069773 A1 does not constitute prior art within the meaning
`
`of Rule 64.1 (b) PCT, it could become of relevance in the regional phase (see
`
`Examples 14-15 and 32-34 of said WO application).
`
`Re Section VII
`
`Certain defects in the international application
`
`1
`
`Contrary to the requirements of Rule 5.1 (a)(ii) PCT, the closest prior art (see
`
`D1 and D2) is not mentioned in the description, nor are these documents
`identified therein.
`
`w C
`
`ertain observations on the international application
`
`1
`
`Claims 1 and 26 do not meet the requirements of Article 6 PCT because the
`
`matter for which protection is sought is not clearly defined. The claim attempts
`
`to define the subject-matter in terms of the result to be achieved (a certain
`
`viscosity profile), which merely amounts to a statement of the underlying
`
`problem, without providing the technical features necessary for achieving this
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 3) (EPO-April 2005)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`
`International application No.
`
`AUTHORITY (SEPARATE SHEET)
`
`PCT/US2016/O14005
`
`result.
`
`2
`
`3
`
`The word "about", particularly when applied to a range, detracts from the
`
`general clarity and should be deleted in the claims (Art. 6 PCT).
`
`The terms "room temperature" and "refrigerated conditions" used in claims 1
`
`and 26 are vague and unclear and leave the reader in doubt as to the
`
`meaning of the technical features to which they refer, thereby rendering the
`
`definition of the subject—matter of said claims unclear, Article 6 PCT.
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 4) (EPO-April 2005)
`
`