throbber
:0-
`
`
`
`
`
`Samara? P}*‘~‘»TENT»
`A?P.E£:L3.&
`x,e~4T§R$Ez~2*::E:*,Es
`*“:
`.
`I54..
`E’-3%
`,
`
`IN THE UNITED STATES EATEET AND TRADEMARK OFFICE
`BEFORE THE BOARD or PATENT AEPEALS AND INTERFERENCES
`
`25W’
`
`WATTANASIN,
`
`v.
`
`PICARD et al-
`
`v.
`
`FUJIKAWA et al
`
`INTERFERENCE N0. :
`
`102,648
`
`EXAHINER¥IN-CHIEF:
`
`MICHAEL SOFOCLEOUS
`
`FUJIKAWA ET AL REPLY TO THE OPPOSITION
`A TO FUJIKAWA ET AL'S MOTION TO ADD COUNTS 3 AND 4
`
`HONORABLE COMISSIONER OF PATENTS AND TRADEMARKS“
`WASHINGTON, D.C.
`20231
`
`BOX INTERFERENCE '
`
`~SIR:
`
`In opposition to Fujikawa’s Motion to Add Counts 3 and 4, and
`add claims to the Wattanasin appiication, Wattanasin essentially
`
`urges three different grounds of opposition. First, Wattanasin
`
`insists that the claims proposed by Fujikawa for the Wattanasin
`
`application, that correspond to Counts 3 and 4, are not patentable
`to Wattanasin, Wattanasin lacking a written description the same,
`
`35 U.S.C. 112, first paragraph. Second, Wattanasin urges that the
`
`Mylan Exhibit 1031, Page 1
`
`
`
`Mylan Exhibit 1031, Page 1
`
`
`
`
`
`

`
`
`
`
`
`evidence submitted. with the Fujikawa. Motion is inadequate to
`
`demonstrate that the subject matter of Counts 3 and 4 is directed
`
`to subject matter patentably distinct from Counts 1 and 2 in the
`interference.
`Third, Wattanasin objects to the Motion on the
`
`grounds that Fujikawa's Clahm 18 is directed to subject matter
`closely related to the subject matter of Counts 3 and 4, and not
`
`shown to be patentably distinct therefrom.
`
`Each of the arguments
`
`is replied to, below.
`
`I. Written Description in Wattanasin's Application
`
`Wattanasin urges that Fujikawa's proposed Claims 11 and 12 for
`
`the Wattanasin application are unsupported by"
`
`the Wattanasin
`
`disclosure,
`
`in that they lack a written description.
`
`It is to be
`
`particularly noted that the contentions of Wattanasin are unsup-
`
`ported by proof of any kind, and that
`
`in fact the evidence of
`
`record,
`
`including admissions by Wattanasin, supports the opposite
`
`conclusion.
`
`In exploring any question of written description, attention is
`
`focused on whether or not the specification, as originally filed,
`
`Mylan Exhibit 1031, Page 2
`
`
`
`
`
`
`
`
`
`Mylan Exhibit 1031, Page 2
`
`

`
`
`
`
`
`conveys
`
`to those of skill
`
`in ‘the art
`
`that
`
`the inventors had
`
`possession of the invention at the time the application was filed.
`
`Quite conspicuously, any testimony from the inventors,
`
`regarding
`
`their possession of this invention, is absent from the Wattanasin
`
`opposition. Note that the standard for determining compliance with
`
`written description, whether or not those of skill in the art would
`
`conclude that applicants had possession of the invention at the
`
`time of filing, has been long established.
`
`In re Smith,
`
`178
`
`U.S.P.Q. 620 (C.C.P.A. 1973). Thus, the sole inquiry presented to
`
`the Board on this issue is whether or not one of ordinary skill in
`
`tthe art,
`
`reading the Wattanasin disclosure, would conclude that
`
`Wattanasin had possession of the invention addressed in Claims 11
`and 12 at the time the Wattanasin application was filed.
`
`The sole limitation of proposed Claims 11 and 12 Wattanasin
`
`urges
`is pg; described in the Wattanasin application is the
`identity of substituent R as cyclopropyl. Wattanasin urges that
`
`’there is no specific recitation or exemplification of this species.
`
`Fujikawa agrees, but notes that
`the same is not required for
`written description.
`In re Kaslow, 217 U.S.P.Q. 1089, 1996 (Fed.
`
`Cir.
`
`1983)
`
`and cases cited therein.
`
`Specifically, Wattanasin
`
`discloses that the substituent at the 2—position may be cycloalkyl
`
`Mylan Exhibit 1031, Page 3
`
`
`
`Mylan Exhibit 1031, Page 3
`
`

`
`
`
`
`
`of 3-7 carbon atoms.
`
`This identifies a class of five possible
`
`substituents.
`
`The class is not all
`
`that
`
`large,
`
`and Fujikawa
`
`submits that, without more, one of ordinary skill in the art would
`
`clearly conclude that the compound of Claim 11, and process of
`
`Claim 12, was clearly within the scope of the invention discovered
`
`by Wattanasin at the time of filing.
`
`Indeed, Wattanasin urges the
`
`same. See page 6 of the Opposition. Under similar circumstances,
`
`courts of competent jurisdiction have repeatedly held that selec-
`
`tion of one among five is clearly supported, for the purposes of
`
`written description.
`
`In re Driscoll, 195 U.S.P.Q. 434 (C.C.P.A.
`
`1978)
`
`(one of 14); and In re Johnson, 194 U.S.P.Q. 187, 195-96
`
`(C.C.P.A. 1977)
`
`(a reduction of
`
`from 12 to 10 members clearly
`
`‘supported).
`
`While prior.cases may be of
`
`limited value in determining
`
`compliance with the written description provision.of 35 U.S.C. 112,
`
`first paragraph, it is respectfully submitted that, without more,
`
`prior cases have held that the selection of one member of a class
`
`of five, when that member is encompassed by the generic disclosure,
`
`is supported by that generic disclosure, in the absence of counter-
`
`vailing evidence. Clearly, one of ordinary skill in the art taught
`
`that the substituent at the 2-position may be any one of cyclo-
`
`Mylan Exhibit 1031, Page 4
`
`
`
`Mylan Exhibit 1031, Page 4
`
`

`
`
`
`
`
`propyl, cyclobutyl, cyclopentyl, cyclohexyl or cycloheptyl would
`
`clearly conclude that cyclopropyl is within the province of the
`
`invention of Wattanasin.
`
`Indeed, it is the likely starting point,
`
`having the lowest molecular weight. More is not required.
`
`Beyond
`
`that,
`
`however, Wattanasin acknowledges
`
`that
`
`the
`
`Wattanasin application repeatedly exemplifies isopropyl.
`
`Indeed,
`
`isopropyl is mentioned by name as an alternate substituent at the
`
`2-position. Having been taught that isopropyl is an acceptable
`substituent and within the scope of Wattanasin’s invention,
`those
`
`of skill
`
`in the art would readily arrive at
`
`the selection of
`
`cyclopropyl, out of the disclosure of cycloalkyl of 3-7 carbon
`
`atoms, as the next logical, and analogous compound,
`
`isomerically
`
`related to exemplified species. Clearly,
`
`in the given case, there
`
`is more than simple narrowing of the Wattanasin claims from a genus
`
`of five to a sub-genus of one. Here there is additional supportive
`
`teaching that the isomer of that sub-genus is also suitable.
`
`It is
`
`well established that isomeric species are expected to behave in
`
`similar fashion, in the absence of evidence to the contrary. Those
`
`of skill
`
`in the art would certainly consider cyclopropyl
`
`to be
`
`within the scope of the compound and processes taught and claimed
`
`by Wattanasin.
`
`Mylan Exhibit 1031, Page 5
`
`
`
`Mylan Exhibit 1031, Page 5
`
`

`
`
`
`
`
`The Wattanasin argument that there is no written description
`lof the claims in question, Claims 11 and 12, must be rejected. The
`
`"selection", urged by Wattanasin to be totally beyond those of
`
`ordinary skill in the art,
`
`is simple, straightforward, and addi-
`
`tionally supported by the selection of isopropyl as an alternate
`
`substituent in the disclosure of Wattanasin.
`
`If
`
`further
`
`evidence were
`
`required,
`
`it
`
`is provided by
`
`Wattanasin. Wattanasin urges, pages 8-9 of its Opposition,
`
`that
`
`those of skill in the art were well aware that both isopropyl and
`
`cyclopropyl substituents could be employed in a similar position on
`
`related compounds.
`
`Specifically, Wattanasin relies on European
`
`Patent Publication 179,559. Regardless of what that publication
`actually teaches,
`there is a clear admission, on the part of
`
`Wattanasin, pages 8-9, that those of skill in the art, reading the
`
`Wattanasin application, would be aware that wherever isopropyl is
`
`taught for substitution next
`to the nitrogen atom on the ring,
`cyclopropyl may be similarly employed (note, as discussed below,
`
`Fujikawa does not agree that the art teaches that one would expect
`
`particular improvements in going from isopropyl to cyclopropyl in
`
`the subject matter of the claims of Wattanasin and Fujikawa).
`
`It
`
`is sufficient, for the issue of written description, to note that
`
`Mylan Exhibit 1031, Page 6
`
`
`
`Mylan Exhibit 1031, Page 6
`
`

`
`
`
`
`
`those of ordinary skill in the art would be aware that given a
`
`A teaching of
`
`isopropyl
`
`as
`
`an appropriate substituent
`
`for
`
`the
`
`position in question, one of skill in the art, taught that cyclo-
`
`alkyl of 3 carbon atoms was acceptable, would move to cyclopropyl.
`
`Again, Wattanasin’s argument undercuts its position, and grant of
`
`the Fujikawa Motion is respectfully solicited.
`
`II.
`
`The Evidence Offered in Support is Inadequate to.Make Out
`Patentable Distinction
`
`Fujikawa agrees with ‘Wattanasin that it is incumbent on
`
`Fujikawa to demonstrate that the subject matter of Counts 3 and 4
`
`is patentably distinct from the subject matter of Counts 1 and 2.
`
`Evidence of that patentable distinction is made out in the Declara-
`
`tion of Kitahara submitted with the Fujikawa Motion.
`
`Fujikawa
`
`submits herewith the Supplemental Declaration of Kitahara, provid-
`
`ing similar evidence for the lactone species, Test B. As made out
`
`in paragraph.
`
`2 of
`
`the Declaration,
`
`this data simply' was not
`
`available at the time of filing of the Fujikawa Motion.
`It is
`submitted herewith,
`in completion of the evidential burden placed
`
`on Fujikawa to demonstrate patentable distinction.
`
`Mylan Exhibit 1031, Page 7
`
`
`
`Mylan Exhibit 1031, Page 7
`
`

`
`
`
`
`
`Wattanasin urges that the type of evidence presented does not
`
`make out
`
`an unexpected difference between the isopropyls and
`
`cyclopropyl classes (in the language adopted in the Wattanasin
`
`Opposition, the cyclopropyl class is the class of proposed Counts 3
`
`and 4, while the isopropyl class is the class of current Counts 1
`
`and 2).
`
`The Wattanasin position, unsupported by any evidence of
`
`record,
`
`is that
`
`the type of differences
`
`set
`
`forth, uniform
`
`_ superiority for the cyclopropyl class independent of substituent Z
`
`identity and test type, would be expected by those of ordinary
`skill in the art. Quite simply, the position adopted.by Wattanasin
`
`is contrary to the expectations of those of ordinary skill in the
`
`art.
`
`As made out
`
`in the Kitahara Declaration and Supplemental
`
`Declaration, regardless of the identity of moiety Z,
`
`the cyclo-
`
`propyl class is always more than twice as active as the closely
`
`related isomeric species isopropyl and n—propyl.
`
`Indeed, for the
`
`sodium salt, the Icw value for isopropyl is about 2.5 times greater
`
`than that for cyclopropyl, and the ICW value for n-propyl is 22
`
`times greater than that of cyclopropyl. Where other values for Z
`
`are considered,
`
`the comparison is even more‘drastic,
`
`the calcium
`
`salt cyclopropyl species having a five—fold greater activity,
`
`the
`
`Mylan Exhibit 1031, Page 8
`
`
`
`Mylan Exhibit 1031, Page 8
`
`

`
`
`
`
`
`ethyl ester species having a fourteen-fold greater activity, and
`
`the lactone activity, again as measured by Test A, being nearly
`
`four times higher.
`
`When the alternative test, Test B,
`
`is given,
`
`the relative
`
`values are similar. Further, Kitahara, one of particular skill in
`
`this art,
`
`concludes
`
`in both the Supplemental Declaration and
`
`original Declaration that such increased activity could not have
`
`been predicted on the basis of structure alone. While Wattanasin
`
`urges to the contrary,
`
`the Wattanasin position is unsupported by
`
`any evidence of any type. Attorney argument, alone,
`
`is not an
`
`adequate substitute for proof.
`
`The Wattanasin position must be
`
`rejected.
`
`Wattanasin also urges that the level of skill in the art, as
`
`V reflected by European Patent Publication 179,559 and U.S. Patent
`
`4,925,852, would have predicted the differences obtained and
`
`reported in the Kitahara Declarations.
`
`Initially, it must be noted
`
`that U.S. Patent 4,925,852 is not part of the prior art, and not
`
`appropriate for consideration as to the level of skill brought to
`
`the question by artisans prior
`
`to the Fujikawa filing date.
`
`Specifically,rWattanasin urges that
`
`this patent was
`
`in the art
`
`prior to Fujikawa’s assertion herein of patentable distinction and,
`
`Mylan Exhibit 1031, Page 9
`
`
`
`Mylan Exhibit 1031, Page 9
`
`

`
`
`
`
`
`-10..
`
`~ accordingly, must be considered. No legal support is provided, and
`
`Wattanasin’s position is contrary to specific holdings on this
`
`issue.
`
`It is well established that facts, determined at a date
`
`after
`
`filing,V are permissible to support
`
`a
`
`finding of non-
`
`obviousness as to compounds and processes, at the time of filing.
`
`Kansas Jack,
`
`Inc. v. Kuhn, 219 U.S.P.Q.
`
`857
`
`(Fed. Cir. 1983).
`
`Thus, the U;S. patent relied on by Wattanasin must be ignored, and
`
`attention focused only on the European patent publication.
`
`European Patent Publication 179,559 is confined to compounds
`
`and processes patentably distinct
`
`from the compounds claimed
`
`herein.
`
`The formulas are substantially unrelated. Note that the
`
`European patent publication is confined to trans-6-[2-substituted-
`
`pyrrol-1—yl)alkyl]-pyran-2-ones, thus, compounds quitevunrelated to
`the phenyl—substituted,
`lactone—substituted quinolines of
`the
`
`claimed invention.
`
`It is respectfully submitted that Wattanasin
`
`Mylan Exhibit 1031, Page 10
`
`
`
`Mylan Exhibit 1031, Page 10
`
`

`
`
`
`
`
`-11-
`
`has
`
`failed to :make out any art-recognized. equivalency’ between
`
`phenyl-substituted quinolines and the pyrroles of the reference.
`Indeed,
`review" of
`the file history" of U.S. Patent 5,011,930
`
`reflects the conclusion of Fujikawa and the Patent Office that,
`
`without evidence of any type,
`
`the subject matter of Counts 3 and 4
`
`and
`the disclosure of
`the European patent publication are
`patentably distinct, one from the other.
`In the absence of such an
`
`art-recognized equivalence, Wattanasin’s
`defective.
`1
`
`argument
`
`is
`
`fatally
`
`Moreover,
`
`Fujikawa
`
`respectfully submits
`
`that Wattanasin
`
`deliberately, and without support, misrepresents the teaching of
`
`the European patent publication. Specifically, Wattanasin urges,
`in the last paragraph on page 9 and first paragraph of page 10 of
`
`its Opposition, that this European patent publication teaches that
`
`one of skill in the art would expect "particular improvements in
`
`activity relative to a genus of compounds with the same series."
`
`Further, Wattanasin urges that one of ordinary skill in the art
`
`would have expected the cyolopropyl species to be better than the
`
`isopropyl species. No such teaching appears in the European patent
`publication.
`» Indeed, at best,
`the European patent publication
`
`identifies isopropyl and cyclopropyl as equivalent.
`
`See, e.g.,
`
`Mylan Exhibit 1031, Page 11
`
`
`
`Mylan Exhibit 1031, Page 11
`
`

`
`
`
`
`
`_ 12 _
`
`page 8,
`
`lines 30-35, wherein these two species are identified as
`
`equivalent. Many other preferences in the European.patent publica-
`
`A tion identify isopropyl as preferred to the cyclic species.
`
`See
`
`the sixth preferred genus, page 9, line 31 — page 10, line 12; the
`
`fifth preferred genus, particularly, page 9,
`
`lines 28-30;
`
`the
`
`fourth, page 7, line 29; and the second, page 7, line 20.
`
`Indeed,
`
`only the
`
`first
`
`and
`
`third preferences
`
`equate
`
`isopropyl
`
`land
`
`«cyclopropyl. Accordingly, it is respectfully submitted that the
`
`only‘ reference ‘Wattanasin submits that. may’ be looked.
`
`to,
`
`the
`
`European patent publication, at best establishes isopropyl and
`cyclopropyl
`to be equivalent, and may indicate isopropyl
`to be
`
`superior.
`
`Further,
`
`it is respectfully’ submitted that
`
`in fact,
`
`the
`
`the European. Patent Publication relied upon by
`compounds of
`Wattanasin have a much higher activity when isopropyl, rather than
`
`cyclopropyl is used as a substituent at the identified position.
`
`Submitted herewith please find Roth et al, Journal of Medicinal
`Chemist
`, 1990, 33, pages 21-31, which, authored by the inventors
`
`identified in the European Patent Publication relied upon by
`Wattanasin in its Opposition, reflects the activities of certain of
`
`the compounds embraced by the European Patent Publication, EP 179-
`
`559.
`
`4
`
`Mylan Exhibit 1031, Page 12
`
`
`
`Mylan Exhibit 1031, Page 12
`
`

`
`
`
`
`
`- 13 _
`
`Particular attention is directed to page 25 of the reference,
`
`which shows, Table III, that the ICW value for compound 8x (trans-
`6- [ 2 [2— ( 4-flluoropphenyl )*-5- ( 1-methylethyl)41-H-pyrrol-1—yl]-ethyl]
`
`tetrahydro-4-hydroxy-2-H—pyran-2-one is 0.40, while the Icm value
`
`for the cyclopropyl
`
`isomeric counterpart
`
`(compound 8aa)
`
`is 2.2.
`
`Thus,
`
`the isopropyl species is 5.5 times more active, by Warner-
`
`Lambert’s
`
`own
`
`reckoning,
`
`than the corresponding cyclopropyl
`
`species.
`
`To the extent the Warner Lambert European Publication is
`
`relevant to the issue at all, it again suggests those of ordinary
`
`skill in the art would look to the isopropyl species to have higher
`
`activity than the cyclopropyl species. Rather than supporting the
`
`Wattanasin position, the Warner Lambert publication serves to only
`more clearly highlight
`the fact
`that
`the art would not expect
`higher activities in the cyclopropyl species designated for the
`
`Count of
`
`the Interference,
`
`clearly" drawing attention to the
`
`unexpected and unobvious nature of the proposed Counts 3 and 4.
`
`Certainly, at best, there is no teaching in the art anywhere
`
`that one of ordinary skill in the art would expect the cyclopropyl
`
`class to be superior, consistently so by better than a factor of
`
`two, regardless of the identity of the Z substituent.. This, it has
`
`been sworn to, could not have been predicted on the basis of
`
`Mylan Exhibit 1031, Page 13
`
`
`
`Mylan Exhibit 1031, Page 13
`
`

`
`
`
`
`
`; 14 _
`
`structure alone. Wattanasin offers no proof to the contrary, and,
`
`accordingly,
`
`the Wattanasin Opposition cannot succeed. Grant of
`
`the Motion is respectfully requested.
`
`III. Fujikawa's Claim 18
`
`On page 14 of the Opposition, in the final paragraph, prior to
`
`the Conclusion, Wattanasin makes reference to Fujikawa’s Claim 18,
`which is 21 4—chlorophenyl-substituted species.
`The Wattanasin
`
`reference to this claim is not clearly understood. Fujikawa has no
`
`data to indicate that the chlorine—substituted species is equiva-
`
`the record
`indeed,
`lent to the fluorine-substituted species, and,
`lacks disclosure of the same.
`‘The burden would be on Wattanasin to
`
`demonstrate to the contrary. Notwithstanding the above, should the
`
`Examiner find it appropriate, it would be acceptable to designate
`Claim 18 of the Fujikawa patent application as corresponding to
`
`Counts 3 and 4 of the interference.
`
`Mylan Exhibit 1031, Page 14
`
`
`
`Mylan Exhibit 1031, Page 14
`
`

`
`
`
`
`
`_ 15 _
`
`IV. Conclusion
`
`'The Wattanasin position is totally unsupported by evidence
`
`confirming
`
`the
`
`arguments
`
`offered by Wattanasin's
`
`counsel.
`
`Wattanasin, having urged that
`
`those of ordinary skill would
`
`recognize both isopropyl and cyclopropyl as suitable substituents
`
`at the 2-position in the compounds of the claimed invention, and
`
`having disclosed the suitability of both isopropyl and cycloalkyl
`of 3 carbon atoms as suitable substituents at that position, cannot
`
`successfully argue that Claims 11 and 12 proposed by Fujikawa are
`
`not supported by the written description of the Wattanasin appli-
`
`cation. Similarly, there is absolutely no evidence of record that
`suggests that the differences between the compounds of Counts 3
`
`and 4, proposed by Fujikawa, and Counts
`
`1 and 2,
`
`respectively,
`
`would be anywhere predicted by those of skill in the art.
`
`Indeed,
`
`the prediction would be quite to the contrary, that those of skill
`
`would expect similar performance, given the isomeric relationship
`
`of the compounds tested. Having successfully demonstrated patent-
`
`able distinction between Counts 3 and 4 and Counts 1 and 2, and
`
`having an appropriate claim for Wattanasin to contest priority with
`
`respect thereto, the Fujikawa Motion should be granted. Should the
`
`Mylan Exhibit 1031, Page 15
`
`
`
`Mylan Exhibit 1031, Page 15
`
`

`
`
`
`
`
`_ 15 -
`
`Examiner-in-Chief find it necessary, Claim 18 may be designated as
`
`corresponding to Counts 3 and 4, and benefit with respect thereto,
`
`on the grounds previously urged in Fujikawa's Motion for Benefit as
`
`to those counts, is respectfully requested.
`
`Respectfully submitted,
`
`OBLON, SPIVAK, MCCLELLAND,
`MAIER & NEUSTADT, P.C.
`
`even fig/helber
`
`30,073
`Registration No.:
`Attorney for Fujikawa et al
`
`Crystal Square Five
`Fourth Floor
`
`1755 Jefferson Davis Highway
`Arlington, Virginia 22202
`(703) 521-5940
`
`Mylan Exhibit 1031, Page 16
`
`
`
`Mylan Exhibit 1031, Page 16

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket