Europaisches
`Patentamt
`European
`Patent Office
`
`Office europeen
`des brevets
`
`Submission in opposition proceedings
`
`Representative:
`HOFFMANN EITLE PATENT- UND RECHTSANWALTE PARTMBB
`151
`ArabellastraBe 30
`81925 Munich
`Germany
`
`Phone: 089/92409-0
`Fax: 089/918356
`
`80298 Munich
`Germany
`Tel. +49(0)89 2399-0 I Fax -4465
`
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`NL-2280 HV Rijswijk
`Netherlands
`Tel. +31 (0)70 340-2040 I Fax -3016
`
`10958 Berlin
`Germany
`Tel. +49(0)30 25901-0 I Fax -840
`
`- representing the proprietor(s):
`
`ALLERGAN INDUSTRIE, SAS
`
`Proprietor/representative's reference
`
`147 001 u3/bst
`
`The information given below is pertaining to the following patent in opposition proceedings:
`
`Patent No.
`
`Application No.
`
`I EP2323617
`
`I EP09785852.6
`
`Date of mention of the grant in the European Patent Bulletin (Art.
`97(3), Art. 99(1) EPC)
`
`118 January 2017
`
`Title of the invention
`
`Proprietor of the patent
`
`Documents attached:
`
`Hyaluronic acid-based gels including lidocaine
`
`I ALLERGAN INDUSTRIE, SAS
`
`Description of document
`
`Original file name
`
`1 Reply of the patent proprietor to the notice(s) of
`
`Response to oppositions.pd!
`
`opposition
`
`2 Auxiliary request in opposition
`
`3 Auxiliary request in opposition
`
`4 Auxiliary request in opposition
`
`5 Any annexes (other than citation) to an opposition
`letter -
`
`Auxiliary request 1.pdf
`
`Auxiliary request 2.pdf
`
`Auxiliary request 3.pdf
`
`List of Documents.PDF
`
`Assigned file name
`
`OBSO3.pdf
`
`AUXREQ-1.pdf
`
`AUXREQ-2.pdf
`
`AUXREQ-3.pdf
`OTHER-1.PDF
`
`6 Clean copy of amended description
`
`Amended description page 1 0.pdf
`
`DESC-CLEAN-R82.pdf
`
`Evidence filed subsequently:
`
`147 001 u3/bst
`
`Page 1 of 71
`
`Exhibit 1109
`Prollenium v. Allergan
`IPR2019-01505 et al.
`
`

`

`D62
`
`Non-patent literature - book
`
`D63
`
`Other evidence
`
`D64
`
`Other evidence
`
`D65
`
`Non-patent literature - book
`
`D66
`
`Other evidence
`
`D67
`
`Non-patent literature - book
`
`McGraw-Hill, "McGraw-Hill Dictionary of scientific and
`technical terms"
`The McGraw-Hill Companies Inc., 2003
`original file name: D62 Dictionary.pdf
`attached as: Published-Evidence-1.pdf
`
`Experimental Data
`original file name: D63 Experimental Data (revised).pdf
`attached as: Other-evidence-1.pdf
`
`Allergan Report
`original file name: D64 Allergan Memo.pdf
`attached as: Other-evidence-2.pdf
`
`Eskes and Mieczyslaw, "Drug Therapy During Pregnancy"
`Butterworth, 1985
`original file name: D65 pKs lidocaine.PDF
`attached as: Published-Evidence-2.PDF
`
`Calculations based on Henderson-Hasslbalch-equation
`original file name: D66 lidocaine calculation based on pka.pdf
`attached as: Other-evidence-4.pdf
`
`Sadick, "Augmentation Fillers"
`Cambridge University Press, 2010
`original file name: D67.PDF
`attached as: Published-Evidence-3.PDF
`
`Signatures
`
`Place:
`
`Date:
`
`Signed by:
`
`Association:
`
`Miinchen
`04 June 2018
`/Dr. Peter Klusmann/
`HOFFMANN EITLE PATENT- UND RECHTSANWALTE PARTMBB
`
`Representative name:
`
`Capacity:
`
`Dr. Peter Klusmann
`(Representative)
`
`Place:
`
`Date:
`
`Signed by:
`
`Association:
`
`Miinchen
`04 June 2018
`/Dr. Katrin Dorfel/
`HOFFMANN EITLE PATENT- UND RECHTSANWALTE PARTMBB
`
`Representative name:
`
`Capacity:
`
`Dr. Katrin Dorfel
`(Representative)
`
`147 001 u3/bst
`
`Page 2 of 71
`
`

`

`HOFFMANN EITLE
`Patent- und Rechtsanwalte
`Partnerschaftsgesellschaft mbB
`
`Arabellastral?,e 30
`81925 Munchen
`Deutschland I Germany
`
`T +49. (0)89. 92 409. 0
`F +49. (0)89. 91 83 56
`
`pm@hoffmanneitle.com
`www.hoffmanneitle.com
`
`Dr. Peter Klusmann
`pklusmann@hoffmanneitle.com
`
`Dr. Katrin Dorfel
`kdoerfel@hoffmanneitle.com
`
`MUNCH EN
`LONDON
`D0SSELDORF
`HAMBURG
`MILANO
`MADRID
`AMSTERDAM
`
`Hoffmann Eitle's professionals include:
`
`European Patent Attorneys
`
`Patentanwalte I German Patent Attorneys
`
`Rechtsanwalte I German Attorneys at Law
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`HOFFMANN EITLE
`
`HOFFMANN EITLE I Postfach 81 04 20 I 81904 Munchen
`European Patent Office
`
`80298 Munich
`
`Munich, June 4, 2018
`
`147 001 u3/u18
`Our Ref.:
`European Patent 2 323 617
`ALLERGAN INDUSTRIE, SAS
`
`In response to the Communication of Notices of Opposition pursuant
`to Rule 79(1) EPC dated November 23, 2017, we hereby file our
`observations on behalf of Patentee.
`
`1
`
`Requests
`
`We request:
`
`•
`
`• Rejection of the oppositions and maintenance of the opposed
`patent, EP 2 323 617 Bl, as granted.
`In
`the event that the Main Request cannot be granted,
`maintenance of the opposed patent in amended form on the
`basis of the enclosed Auxiliary Requests 1-3.
`• Oral proceedings in the event that the Opposition Division is
`unable to grant the Main Request on the basis of the written
`proceedings.
`
`Partnerschaftsregister Amtsgericht Munchen I PR 1372
`Eine Lisle der Partner i.S.d. PartGG isl einsehbar unter www.hoffmanneitle.com/partner, Ober die obige Adresse und unser Buro in London:
`A list of members of the partnership is open to inspection at www.hoffmanneitle.com/partner, at the above address and our London office:
`Hoffmann Eitle I Harmsworth House I 13-15 Bouverie Street I London EC4Y 8DP
`
`Page 3 of 71
`
`

`

`2
`
`The Cited Documents
`
`2
`
`We suggest referring to the documents cited by the Opponents (OPP) and filed by Patentee
`(Pl) herewith according to the table filed herewith in order to simplify the discussion.
`
`We note that D1-D5 have already been cited and considered in the EP examination
`proceedings (as D1-DS).
`
`3
`
`Content of the Opposed Patent
`
`The present invention concerns a process for preparing a soft tissue filler composition as
`defined in claim 1 which solves the problem that hyaluronic acid (HA)-based compositions
`
`which incorporate lidocaine HCI during the manufacturing process are prone to partial or
`almost complete degradation prior to injection, particularly during high temperature
`treatment and/or when stored for any significant time (see paragraphs [0012], [0039] and
`[0048] of the opposed patent). This problem was solved by applying specific process
`conditions, and in particular a specific pH adjustment step, during the manufacturing process.
`
`As a result, the claimed process provides hyaluronic acid (HA) compositions which include a
`therapeutically effective amount of lidocaine as its HCI salt and which have an enhanced
`stability, relative to conventional HA-based compositions including lidocaine HCI, when
`subjected to sterilization techniques and/or when stored over a long period of time at room
`temperature (see also paragraph [0039] of the opposed patent).
`
`In and for the following substantiation, the technical features of independent claim 1 of the
`opposed patent are grouped and designated as follows:
`
`1.
`
`A method of preparing a soft tissue filler composition, the method comprising the steps
`
`of:
`providing a hyaluronic acid component cross/inked with at least one cross/inking agent
`selected from the group consisting of 1,4-butanediol diglycidyl ether {BODE}, 1,2-bis{2,3-
`epoxypropoxy)ethylene and 1-{2,3-epoxypropy/)-2,3-epoxycyclohexane, or combinations
`
`thereat
`adjusting the pH of said hyaluronic acid component to an adjusted pH above 7.2; and
`
`2.
`
`3.
`
`Page 4 of 71
`
`

`

`3
`
`4.
`
`5.
`
`adding a solution containing at least one anesthetic agent to said hyaluronic acid
`component having said adjusted pH to obtain a hyaluronic acid-based soft tissue filler
`composition,
`wherein the at least one anesthetic agent is lidocaine HCI.
`
`Claim 1 may be interpreted in accordance with the guidance provided in the Guidelines, F-IV,
`4.2 which reads as follows:
`
`"Each claim should be read giving the words the meaning and scope which they
`
`normally have in the relevant art, unless in particular cases the description gives the
`words a special meaning, by explicit definition or otherwise. ( ... ) The claim should also be
`read with an attempt to make technical sense out of it." (emphasis added)
`
`When interpreting feature 2 in accordance with the Guidelines, F-IV.4.2, paragraph [0065]
`provides guidance that "providing a HA component cross/inked ... " concerns the provision of a
`hydrated, alkaline NaHA gel in a first step which may then be crosslinked:
`
`"The next step in the manufacturing process involves the step of cross/inking the
`hydrated, alkaline NaHA gel with a cross/inking agent selected from 1,4-butanediol
`diglycidyl ether (or 1,4-bis{2,3-epoxypropoxy)butane or 1,4-bis-glycidyloxybutane, all of
`which are commonly known as BODE}, 1,2-bis{2,3-epoxypropoxy)ethylene and 1-{2,3-
`
`epoxy-propy/)-2,3-epoxycyclohexane. The use of more than one cross/inking agent or a
`different cross/inking agent is not excluded from the scope of the present disclosure."
`(Emphasis added)
`
`In and for the following substantiation, the technical features of independent claim 8 of the
`opposed patent are grouped and designated as follows:
`
`A.
`
`8.
`
`C.
`
`A method of preparing a cohesive hyaluronic acid-based filler composition, the method
`comprising the steps of:
`providing dry uncross/inked sodium hyaluronate material and hydrating said dry
`uncross/inked sodium hyaluronate material in an alkaline solution to obtain an alkaline,
`uncross/inked sodium hyaluronate gel;
`cross/inking said uncross/inked sodium hyaluronate gel with BODE to form a cross/inked
`alkaline hyaluronic acid composition with a pH above 7.2;
`
`Page 5 of 71
`
`

`

`4
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`adding a solution containing lidocaine HCI to said hyaluronic acid component having
`said adjusted pH to obtain said HA-based filler composition;
`homogenizing said HA-based filler composition
`thereby forming a homogenized
`hyaluronic acid-based filler composition; and
`sterilizing said homogenized HA-based filler composition thereby forming said cohesive
`HA-based filler composition,
`wherein said cohesive HA-based filler composition has an extrusion force of between 10
`N and 13 Nat an extrusion rate of 12.5 mm/minute and
`has a viscosity of between 5 Pa*s and 450 Pa*s when measured at 5 Hz.
`
`We submit that the above features of claims 1 and 8 are common for every person skilled in
`the art of HA-based soft tissue fillers.
`
`Claim 8 is a process claim in which the subject-matter is to some extent defined in terms of
`
`structural features of the soft tissue filler composition prepared from said process (see also
`Guidelines, Section F-IV, 3.8). In other words, features G and H of claim 8 concern structural
`features of the prepared soft tissue filler compositions. This is allowable according to
`Guidelines, Section F-IV, 3.8 (and a matter of clarity which, according to G 3/14, cannot be
`objected at all).
`
`3.1
`
`Opponents' claim constructions
`
`Opponent 3 was of the opinion that several features of claim 1 require interpretation in order
`to determine the scope of the claim (see Section IV.2 of the notice of opposition, pages 6-8).
`However, Opponent 3's considerations in terms of the HA component, the adjusted pH, the
`"comprising" language, the pH of the final product with respect to claim 1 and how the pH is
`adjusted, the reference to "said hyaluronic acid component" with respect to claim 8 are not
`
`exceptional in any way, but merely concern the breadth of claim 1.
`
`As regards claim 8, Opponent 3 also objected the wording "cohesive" as having no clear
`
`meaning in the art. We disagree.
`
`As already noted in the examination proceedings, we submit that this term is common
`general knowledge for a skilled person in the art. For support, an extract of a pre-published
`textbook is filed herewith as D62 which defines the term "cohesion" as follows:
`
`Page 6 of 71
`
`

`

`5
`
`"The tendency of parts of a body of like composition to hold together, as s result of
`intermolecular attractive forces."
`
`This definition corresponds to the one found in paragraph [0045] of the opposed patent
`specifying "cohesion" as the "ability of a HA-based composition to retain its shape and resist
`deformation". Accordingly, the meaning of the term "cohesive" has a clear meaning for the
`person skilled in the art.
`
`As regards features G and H of claim 8, we note that Opponent 3 simply neglected said
`
`features based on the following assertions:
`
`Opponent 3 asserted that the extrusion force of claim 8 is meaningless without indication of
`
`the used syringe. First, we note that this assertion is not supported by any evidence.
`
`Secondly, reference is made to paragraph [0080] of the opposed patent which provides
`
`guidance on suitable gauges of needles in order to achieve the desired extrusion forces.
`
`Opponent 3 also asserted that the viscosity of claim 8 is not adequately defined since claim 8
`fails to indicate inter alia the measurement temperature which is allegedly "well known in the
`art to have a significant influence on the viscosity values measured". First, we note that this
`assertion is also not supported by any evidence. Secondly, reference is made to paragraph
`
`[0099] of the opposed patent which provides guidance on a suitable measurement device in
`order to determine the desired viscosity (see also Section 5.2 below).
`
`As a result, features G and H of claim 8 relating to the extrusion force and viscosity cannot be
`
`neglected, but characterize the soft tissue filler obtained by the process as set forth in claim 8.
`
`4
`
`On the Grounds of Opposition
`
`4.1
`
`No Added Subject Matter
`
`4.1.1
`
`Claim 1
`
`Opponent 1 alleges in Section VI of his Notice of Opposition that the above features 2 and 5
`
`of claim 1 in combination with the other features of claim 1 are not derivable from the
`
`application as filed. Opponent 6 also provides similar assertions with respect to feature 2 (see
`
`section 3 of the notice of opposition). These objections are not correct.
`
`Page 7 of 71
`
`

`

`6
`
`Claim 1 as granted is supported by original claims 1 and 2, wherein (i) the crosslinking agents
`"1,4-bis{2,3-epoxypropoxy)butane, 1,4-bisglycidyloxybutane" have been deleted, (ii) the
`wording "above about 7.2" has been replaced by "above 7.2" and (iii) the lidocaine has been
`
`specified to be lidocaine HCI. Support for the amendment (iii) is found e.g. in original claim 3
`and paragraph [0051] or [0085] of the application as filed (see page 11, line 23 and page 19,
`lines 6-14).
`
`As regards the amendment (i), we submit that these deletions cannot be considered to add
`
`subject matter, since the list of remaining crosslinking agents is disclosed in original claim 1
`and is still generic. Moreover, the deleted compounds are alternative names for BDDE only
`and can therefore not be reasonably considered to add matter. A deletion of two crosslinking
`agents from a list of five members does not result in subject matter which extends beyond
`the application as filed. No singling out was carried out (particularly since the deleted agents
`are merely alternative names of BDDE only!). Opponent 1 is therefore wrong in asserting that
`this amendment contravenes Article 123(2) EPC (see Item 3 at page 55 of Opponent l's
`
`Notice of Opposition).
`
`As regards the amendment (ii), a deletion of the wording "about" in "about above 7.2" or
`
`original claim 1 cannot add new matter, since it merely restricts the originally disclosed range
`of a specific value± error margin to the specific value (without error margins).
`
`As regards the amendment (iii), the application as filed makes it clear from the general
`disclosures in e.g. paragraphs [0051] and [0085] that lidocaine in the sense of the opposed
`patent is preferably present in its HCI salt form. Hence, Opponent 1 is wrong in asserting that
`the limitation of lidocaine HCI is supported by the specific disclosures of the examples only
`(see page 55, Item 2 of Opponent l's Notice of Opposition).
`
`The same considerations apply for Opponent l's objections raised in Item 4 at page 55: the
`replacement of "lidocaine" by "lidocaine HCI" in paragraph [0014] of the opposed patent is
`
`supported by the disclosure of the original application text underlying the opposed patent as
`a whole, namely e.g. paragraphs [0051] and [0085]. Contrary to Opponent l's assertions,
`paragraph [0051] of the opposed patent does not include a reference to lidocaine HCI at all.
`
`As a result, the subject-matter of the claim 1 is directly and unambigously derivable from the
`
`application as filed and meets the requirements of Article 123(2) in connection with
`Article 100(c) EPC.
`
`Page 8 of 71
`
`

`

`7
`
`4.1.2 General Description
`
`4.1.2.1 Opponent 3's objections
`
`Opponent 3 raised added matter objections (see section X at pages 25-26 of the notice of
`opposition):
`
`Paragraph [0114]
`In particular, it was objected to with respect to paragraph [0114] that there is no basis for the
`replacement of the originally disclosed wording
`
`"Figures 3, 4 and 5 illustrate that Samples 3, 4 and 5 were stable when prepared with
`lidocaine and no pH adjustment, but were not stable when lidocaine was added and the
`pH adjusted accordingly."
`
`by
`
`"Figures 3, 4 and 5 illustrate that Samples 3, 4 and 5 were not stable when prepared
`with lidocaine and no pH adjustment, but were stable when lidocaine was added and the
`pH adjusted accordingly."
`
`We disagree for the following reasons:
`
`The amendments rendered in paragraph [0114] are corrections of obvious errors which are
`allowable under Rule 139 EPC. This is because (i) it is clear that an error occurred and (ii) what
`the correction should be (see Guidelines, section H-Vl.2.2.1):
`
`As regards the pre-requisite (i), the following is submitted:
`
`Paragraph [00124] of the application underlying the opposed patent includes guidance what a
`stable sample according to the invention is supposed to be:
`
`"It was discovered that neither of Samples 1 and 2 with lidocaine was stable to
`autoclaving and as a result, degrade and become substantially less viscous in both Test 1
`and Test 2. Figures 1 and 2 in particular illustrate that Samples 1 and 2 have a lowered
`viscosity, and hence were less stable to sheer when the product was prepared with
`lidocaine as compared to the product without lidocaine, even when the Sample was
`
`Page 9 of 71
`
`

`

`8
`
`prepared according to Test 2 wherein a pH adjustment was performed." (Emphasis
`added)
`
`It follows from the above underlined passages in paragraph [00124] that a stable sample
`
`including lidocaine has not a lowered viscosity.
`
`The above statements on stable samples are also underlined by Figures 1-2 which show that
`
`the samples including lidocaine with/without pH adjustment step have a lowered viscosity.
`
`Therefore, Figures 1-2 show unstable samples.
`
`Applying these rationales to the viscosity data in Figures 3-5, we note that the sample
`including lidocaine with pH adjustment (= "Lido with pH control") has not a lowered viscosity,
`i.e. the samples of Figures 3-5 are stable (= Samples 3, 4, and 5). In contrast, the sample
`including lidocaine without pH adjustment (= "Lido without pH control") has a lowered
`
`viscosity, i.e. this sample is not stable.
`
`120--------SA_M __ 'PLE ____ J ______ ~
`
`No Lida
`1()() - -+ - - - - - - - - - -1 --()--
`-t::r- /id() with pH @trol
`~
`Stab I e - - - - BQ 1 ~~-----t__-o-...:::___:lida=· :..:no:::..!:pH:..:co:::a::trol:.......J
`i ~-+--·-""""-------------i
`
`~ ➔
`
`Unstable
`
`20
`
`0.1
`
`1
`Frequency (Ht)
`
`10
`FIG. 3
`
`Therefore, the sample "Lido with pH control" is stable while the sample "Lido without pH
`control" is unstable. Similar considerations apply for the samples of Figures 4 and 5.
`
`This conclusion is contrary to the original disclosure in paragraph [0125] according to which:
`
`"Figures 3, 4 and 5 illustrate that Samples 3, 4 and 5 were stable when prepared with
`lidocaine and no pH adjustment, but were not stable when lidocaine was added and the
`pH adjusted accordingly."
`
`Page 10 of 71
`
`

`

`9
`
`Accordingly, we submit that it is clear from the disclosure in paragraph [00124] and Figures 3-
`
`5 that an error occurred in paragraph [00125] of the application underlying the opposed
`
`patent.
`
`As regards the pre-requisite (ii), the correction of this error is obvious from the viscosity data
`
`in Figures 3-5 itself when properly applying the rationale of paragraphs [00124]:
`
`"Figures 3, 4 and 5 illustrate that Samples 3, 4 and 5 were not stable when prepared
`with lidocaine and no pH adjustment, but were stable when lidocaine was added and the
`pH adjusted accordingly."
`
`Opponent 3 asserted that an alternative correction may be rendered (see page 25, last
`
`paragraph of notice of opposition). This "alternative correction" is however contrary to the
`
`guidance provided in paragraph [00124] of the application underlying the opposed patent
`
`with respect to what a stable or unstable sample is. Hence, Opponent 3's assertions are
`
`unjustified under consideration of the patent as a whole.
`
`Paragraph [0094]
`
`As far as paragraph [0094] is concerned, it was objected that the deletion of the wording
`"(pH=7.2}" after the wording "stabilize the pH close to neutrality'' adds new matter. Patentee
`
`herewith files amended description page 10 in which the omitted wording "(pH=7.2}" in
`
`paragraph [0094] has been re-introduced.
`
`4.1.2.2 Opponent S's objections
`
`Further, Opponent 5 asserted in Item II of the notice of opposition that the classification of
`
`sample 2 as a comparative example violates the requirements of Article 123(2) EPC. We
`
`disagree.
`
`Sample 2 includes uncrosslinked HA only and, as such, is not an exemplary embodiment of the
`claimed subject matter. Hence, its declaration as a "comparative" sample is in line with EP
`
`practice and cannot
`
`reasonably be considered
`
`to add new matter contrary
`
`to
`
`Article 123(2) EPC.
`
`Accordingly, we submit that the subject-matter of the opposed patent is directly and
`
`unambigously derivable from the application as filed and meets the requirements of Article
`
`123(2) in connection with Article 100(c) EPC.
`
`Page 11 of 71
`
`

`

`4.2
`
`No Insufficient Disclosure
`
`10
`
`Opponents 1, 3-6 assert that the opposed patent does not disclose the invention in a manner
`
`sufficiently clear and complete for it to be carried out by a person skilled in the art.
`
`Firstly, we note that the Opponents only raise assertions as to why the skilled person would
`
`not have been able to carry out the present invention, yet do not provide any evidence in the
`
`form of verifiable facts that would be able to raise serious doubts as required in accordance
`with established case law (see T 19/90, Case Law Book, 8th edition, II.C.6.1.4, page 346,
`second paragraph). However, the burden of proof, in order to establish that the invention
`
`cannot be
`
`reproduced,
`
`lies with the Opponents. For this reason alone, Opponents'
`
`insufficiency attacks are nothing more than unsubstantiated assertions, which must fail for
`
`this reason alone.
`
`This deficiency is aggravated by the fact that Opponent 1 and Opponent 3 adopted an
`
`unreasonably broad interpretation of claim 1 as granted, including pHs that a skilled person
`
`would immediately exclude as being clearly outside the scope of practical application of the
`
`claimed subject-matter (see section V.2.b at pages 44-45 of Opponent l's notice of opposition
`
`and section Xl.1 at pages 26-27 of Opponent 3's notice of opposition).
`
`It is respectfully submitted that a skilled person, taking a realistic view of the scope of
`
`practical application of the claimed subject-matter, would have had no undue burden in
`
`carrying out the claimed process. The patent includes at last one working example
`
`(example 2) that would have guided him/her in carrying out the claimed subject-matter.
`
`In the following, we will deal with the Opponents' claim interpretation and concrete
`
`objections in more detail:
`
`4.2.1
`
`Interpretation of Claim 1
`
`Guidance for interpretation of a claim was provided by the Boards e.g. in decision T 190/99
`(see Case Law Book, 8th edition, page 287, 11.A.6.1). As stated by the Board, the patent must
`be construed with a mind willing to understand, not a mind desirous of misunderstanding.
`
`I.e., one has to rule out interpretations which are illogical or which do not make technical
`
`sense and needs to arrive at an interpretation of the claim which is technically sensible and
`
`takes into account the whole disclosure of the patent as understood by the skilled person.
`
`Page 12 of 71
`
`

`

`11
`
`These principles were applied e.g. in T 1204/06. Here, the Board held (emphasis added):
`
`... it is apparent that the interpretation of present claim 1 outlined under point 3.2 above
`and shared by the Respondent, namely an interpretation that clings strictly to the
`wording, is unrealistic.
`
`The claims are, however, directed to the person skilled in the art who will rule out
`interpretations which are illogical or do not make technical sense (see T 190/99 of 6
`March 2001, point 2.4 of the reasons; and T 920/00 of 16 June 2003, point 2.1 of the
`reasons).
`
`When adopting these principles, the skilled person would not interpret the open pH range
`"above 7.2" of claim 1 so as to encompass pH values which do not make technical sense e.g.
`because of a too alkaline pH for physiological applications. Conversely, the Opponent's
`objections are directed to pH values which would be excluded by the skilled person for exactly
`these reasons. For example, the skilled person would not understand the process of claim 1 to
`include a pH of as high as 14.
`
`The relevance of this principle on the question of sufficiency was addressed in T 1018/05 (see
`Case Law Book, 8th edition, page 356, 11.C.7.1). In this decision, the Board made the following
`observations (emphasis added):
`
`It is important in this respect to note that in the Board's view the above-mentioned
`established principle of the case law ... , according to which a detailed disclosure of all
`the variants encompassed by a claim is not necessary if the skilled person, who has
`common general knowledge at his immediate disposal, is capable of putting them into
`practice without the burden of exercising inventive skill, is not to be understood as also
`referring to those variants falling under the literal wording of the claim but which the
`skilled person would immediately exclude as being clearly outside the scope of practical
`application of the claimed subject-matter. That is, in cases where the skilled person
`would construe the claim as not extending to those variants. This is the case, for
`example, with claims including an open-ended range for a parameter where it is clear
`for a skilled person that the open-ended range is limited in practice. Such a claim must
`be seen as seeking to embrace values of the parameter as high as can be attained above
`a specified minimum level (see e.g. T 487 /89, not reported, point 3.5). Values of the
`parameter not obtainable in practice would not be regarded by the skilled person as
`
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`12
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`being covered by the claims and thus could not justify an objection of insufficiency of
`disclosure.
`
`This decision relates to open-ended ranges and is therefore fully applicable to the present
`case (see also Guidelines Section F-111, 5.1).
`
`In view of the above, Opponent l's assertions in Item V.2.b and V.2.d at pages 44-45 and 47,
`first dash, are therefore unconvincing. The Opponent merely tried to give claim 1 an
`unreasonably broad construction only to then allege that the claim, if so interpreted, has an
`insufficiency problem.
`
`4.2.2 Other Objections
`
`4.2.2.1 Opponent 1
`
`As regards Opponent l's assertions in Item V.1.b at page 42 according to which the protective
`scope of claim 1 is unknown with reference to T 464/05, we submit that T 464/05 is outdated
`(see Case Law Book, 8th edition, page 341, II.C.5.6.5). More recent decisions ruled that the
`concept of protective scope or "forbidden area" is a matter of clarity and not of sufficiency of
`disclosure (see T 2331/11).
`
`Similar considerations apply for Opponent l's assertions in Items V.1.b, and V.2.a at pages 42-
`44 according to which the wordings "hyaluronic acid component", "sodium hyaluronate
`material" and "cohesive" of claims 1, 2 and 8 were objected to as being unknown. These
`assertions are hidden clarity objections raised to avoid the fact that clarity is not a ground of
`opposition.
`
`However, in accordance with established case law, we would like to emphasize that it is not
`enough to show that an ambiguity exists in the claims, but it is necessary to show that "the
`ambiguity deprives the person skilled in the art of the promise of the invention" (see T 608/07,
`Case Law Book, 8th edition, C.11.7.2, page 359, third paragraph).
`
`In view of (at least) Example 2 of the opposed patent, the skilled person is provided with the
`required "at least one way" to carry out the invention. Therefore, the skilled person knows
`how to prepare the soft tissue filler in accordance with the process as set forth in opposed
`claim 1.
`
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`13
`
`Contrary to Opponent l's allegations in Items 111.5, V.2.c und V.2.d, Example 2 is an example
`
`according to the present invention. As Opponent 1 itself admitted in Item 111.1, claim 1 is an
`
`open claim allowing for additional process steps which are not specified in claim 1. Additional
`process steps such as hydrating or crosslinking in alkaline medium, neutralization of the HA
`
`composition, or hydrating of the obtained crosslinked HA gel are therefore not excluded from
`
`claim 1. To the contrary, it is clear from dependent claims 5-7 that hydrating or crosslinking in
`alkaline medium are e.g. preferred ways of how to provide the HA component of claim 1. A
`neutralization step is also preferred according to paragraph [0073] of the opposed patent.
`
`Opponent 1 also overlooked that claim 1 requires the pH adjustment of "said HA
`component'', i.e. no additional process steps are envisaged between the step of providing the
`HA component and the adjustment step of claim 1.
`Accordingly, there cannot be any doubts that the skilled person knows how to carry out the
`
`claimed process for preparing soft tissue filler compositions for achieving the desired results.
`
`As discussed below in more detail, the problem underlying the opposed patent is the
`provision of an improved process for producing a soft tissue filler composition comprising
`lidocaine HCI which is characterized by less degradation and an enhanced stability. Under
`
`consideration of the teachings provided by the opposed patent, we therefore submit that the
`
`skilled person is not deprived of the promise of the invention, but understands how to solve
`
`this problem, namely by adjusting the pH as set forth in opposed claims 1 and 8.
`
`In Item V.2.e, Opponent 1 then objects that the features concerning the parameters viscosity
`and extrusion force of claim 8 are not sufficiently disclosed by citing inter alia the Guidelines,
`Section F-IV, 4.18. This section of the Guidelines falls in the category "clarity''. Hence, this
`citation illustrates that Opponent 1 mixes up the requirements of clarity and sufficiency which
`
`is of course not allowable.
`
`In this regard, Opponent 1 is also wrong in arguing that the extrusion force and viscosity are
`"unusual parameters" in the technical field. For evidence, reference is made to the review
`article D31 entitled "The science of hyaluronic acid dermal fillers" published in 2008 (i.e. in the
`priority year) which includes a section about "viscosity, elasticity and extrusion forces" at
`pages 40 ff. (see also Table I which includes a definition of the parameters viscosity and
`extrusion force). In accordance with the Guidelines, Section G-VII, 3.1, second paragraph D31
`is an article providing a broad review and may therefore form common general knowledge.
`
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`D31 discloses at page 40, right column, last paragraph:
`
`14
`
`"The viscosity of the dermal filler and the force necessary to extrude the product through
`a needle are related to the degree of cross-linking, amount of cross-linked and uncross(cid:173)
`/inked HA in the final product, sizing method, average cell particle size and size
`distribution, and the manufacturing process itself When all other factors are held
`constant, increasing the degree of cross-linking hardens the gel, but also increases its
`viscosity and extrusion force. Similarly, under otherwise identical conditions, products
`manufactured by using sieves to create particles of a well-defined size and to have a
`higher viscosity and extrusion force than products of smooth consistency with a broad
`range of job particle sizes."
`
`Accordingly, we submit that it is common general knowledge how to fine-tune viscosity