DOCKET NO.: TIBO-0063
`Application No.: 12/536,807
`Actions Dated: May 22, 2012 and July 27, 2012
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re Application of:
`Hans Wim Pieter Vermeersch
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`Confirmation No.: 4088
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`Application No.: 12/536,807
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`Group Art Unit: 1625
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`Filing Date: August 6, 2009
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`Examiner: Celia C. Chang
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`For:
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`PSEUDOPOLYMORPHIC FORMS OF A H1V PROTEASE INHIBITOR
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`Mail Stop AF
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Sir:
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`PRE-APPEAL BRIEF REQUEST FOR REVIEW
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`Applicants respectfully request a pre-appeal brief conference for review and
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`reconsideration of the final rejection of claims 15-17, 20, 21, and 23-36 (the only pending
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`claims) dated May 22, 2012, in the above-identified patent application.
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`This request is being filed together with a notice of appeal, no amendments are being
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`filed with this request, and no more than five sheets of remarks.
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`Page 1 of 5
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`Lupin Ex. 1013 (Page 1 of 5)
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`

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`DOCKET NO.: TIBO-0063
`Application No.: 12/536,807
`Actions Dated: May 22, 2012 and July 27, 2012
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`REMARKS
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`Claims 15-17, 20, 21, and 23-36 are pending in this patent application. The Examiner
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`alleges that these claims are indefinite under 35 U.S.C. § 112, second paragraph. The
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`Examiner also alleges that all the claims lack both written description and enablement under
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`35 U.S.C. § 112, first paragraph.
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`The Examiner Has Not Identified Any Respect In Which Those Skilled In The Art
`Would Have Found The Claims Indefinite
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`Claims 15-17, 20, 21, and 23-36 stand rejected under 35 U.S.C. § 112, second
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`paragraph, due to an alleged inconsistency between the fact that claim 15 is directed to "A
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`hydrate" yet embraces multiple hydrates that each include the specified proportions of water
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`and recited compound. However, it is well established that an applicant may present a patent
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`claim that (as in claim 15) uses the definite article "a" to embrace each of multiple
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`embodiments of an invention (see, e.g., U.S. Patent No. 7,553,974). The Office Action also
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`alleges that it is unclear "how many hydrates" are within the scope of claim 15 (May 22,
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`2012 Final Office Action at page 2), but there is no requirement under the patent laws for a
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`claim to specify how many embodiments it includes. Accordingly, there is no basis for the
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`Examiner’s assertions regarding alleged indefiniteness.
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`There is similarly no basis for the Examiner’s assertion that the term "hydrate" is
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`indefinite. The instant specification expressly defines "hydrates" as "substances that are
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`formed by adding water molecules." (Specification at page 6, lines 6-7). This clear definition
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`refutes the Examiner’s assertion that those skilled in the art would have found Applicants’
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`claim language to have been "confusing" (May 22, 2012 Final Office Action at page 2).
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`Claim 16 has been alleged to make claim 15 confusing, but this rejection also lacks
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`basis. Claim 16 specifies that the ratio of compound to water be 1:1, which is well within the
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`range (i.e., 1:0.5 to about 1:3) that is recited in claim 15.
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`Accordingly, Applicants request that the rejection for alleged indefiniteness be
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`withdrawn.
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`Page 2 of 5
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`Lupin Ex. 1013 (Page 2 of 5)
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`

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`DOCKET NO.: TIBO-0063
`Application No.: 12/536,807
`Actions Dated: May 22, 2012 and July 27, 2012
`
`The Examiner Has Failed To Identify Any Respect In Which Those Skilled In The Art
`Would Have Questioned Applicants’ Possession Of The Claimed Methods
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`Claims 15-17, 20, 21, and 23-36 stand rejected under 35 U.S.C. § 112, first paragraph,
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`because Applicants’ disclosure allegedly does not provide adequate support for the ratios that
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`are recited in claim 15. Applicants request withdrawal of this rejection because their
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`disclosure reasonably conveys to those skilled in the art that Applicants were in possession of
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`the claimed subject matter.
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`To determine whether a specification contains adequate written description of the
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`claimed subject matter, the critical question is not whether literal description of the claimed
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`subject matter is present in the specification but, rather, whether review of the specification
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`would convey the claimed subject matter to those having skill in the art. In re Edwards’, 568
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`F.2d 1349, 1351-1352 (C.C.P.A. 1978). In rejecting a claim for lack of written description,
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`the examiner carries the burden of providing reasons why a person skilled in the art at the
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`time the application was filed would not have recognized that the inventor was in possession
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`of the invention as claimed in view of the disclosure of the application as filed (see MPEP
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`§2163.04).
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`Here, the Examiner has failed to make any such showing. The Examiner contends
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`that Applicants were not in possession of "hydrates" at the time of filing because the instant
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`specification describes compounds that are not only hydrated (by virtue of their inclusion of
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`water) but also include ethanol. (May 22, 2012 Final Office Action at page 32). However,
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`there is no basis for the Examiner’s restrictive definition of the term "hydrate." As noted
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`above, for example, the Specification clearly defines "hydrates," in a non-limiting way, as
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`"substances that are formed by adding water molecules." The presence, or absence, of
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`ethanol is, per this definition, irrelevant in determining whether a substance of interest is a
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`"hydrate."
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`The Examiner also appears to contend that the pending claims lack written description
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`because they recite a "continuous range" of water molecules per molecule of compound,
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`whereas hydrates include discrete ratios of these components (id. at page 3). Applicants’ use
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`of a continuous range, however, does not demonstrate any lack of written description.
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`Indeed, those skilled in the art frequently use "continuous" ranges to describe phenomena that
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`are know to occur in fixed intervals. For example, the term "C1-1o alkyl group" is widely
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`Page 3 of 5
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`Lupin Ex. 1013 (Page 3 of 5)
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`

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`DOCKET NO.: TIBO-0063
`Application No.: 12/536,807
`Actions Dated: May 22, 2012 and July 27, 2012
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`used to describe chemical substituent groups, even in instances in which the substituent does
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`not include a non-integer number of carbon atoms, e.g., 3.5 carbon atoms. (see, e.g., U.S.
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`Patent No. 8,227,506). The Examiner thus has failed to identify any basis for questioning
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`Applicants’ possession of the claimed subject matter.
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`The Examiner Has Failed To Establish That Those Skilled In The Art Would Not Be
`Able To Practice The Claimed Methods
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`Claims 15-17.20, 21, and 23-36 stand rejected under 35 U.S.C. § 112, first paragraph,
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`as allegedly not enabled. According to the Office Action, "the disclosure does not contain
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`sufficient information to enable one skilled in the pertinent art for recovery of [specific
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`crystal preparations]." (May 22, 2012 Final Office Action at page 4). Applicants request
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`withdrawal of this rejection because the evidence of record indicates that Applicants’
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`disclosure would have enabled those skilled in the art to practice the claimed inventions.
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`Enablement must be evaluated against the claimed subject matter. MPEP 2164.08.
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`"Accordingly, the first analytical step requires that the examiner determine exactly what
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`subject matter is encompassed by the claims." Id. The pending claims are directed to, among
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`other things, hydrates of the claimed compound. As defined in the specification, "hydrates"
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`are "substances that are formed by adding water molecules." (Specification at page 6, lines 6-
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`7).1
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`The Examiner has failed to identify any respect in which those skilled in the art would
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`have been unable to practice the claimed methods and prepare compositions wherein water
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`molecules have been added to the recited compound. The specification sets forth several
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`examples describing the claimed compound and water. As noted above, Example 2 describes
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`the preparation of a mixture of Form D (acetonate) and Form B. As stated in Example 2, the
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`starting compound was stirred in acetone and heated until the compound dissolved. Water
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`was then added and the solution was cooled. The resulting crystals were a mixture of the
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`acetonate (Form D) and the hydrate (Form B). Various Form B hydrates were also formed by
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`The Examiner, rather than interpreting the claims in light of the specification, has
`alleged that the claims "are drawn to polymorphic crystalline forms of" the claimed
`compound (May 22, 2012 Office Action at page 4). The claims must be interpreted in light
`of the specification which, as originally filed, clearly establishes that the Applicants had
`possession of water molecules added to the claimed compound.
`Page 4 of 5
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`Lupin Ex. 1013 (Page 4 of 5)
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`

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`DOCKET NO.: TIBO-0063
`Application No.: 12/536,807
`Actions Dated: May 22, 2012 and July 27, 2012
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`subjecting Form A to adsorption/desorption tests, as described at Example 7. Form B
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`hydrates were also formed by subjecting a sample of Form B to adsorption/desorption. See,
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`e.g., Example 12.
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`Because there is no evidence indicating that this disclosure would have been
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`insufficient for those skilled in the art to make the claimed hydrates (i.e. substances formed
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`by adding water molecules to the claimed compound) the rejection for alleged lack of
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`enablement should be withdrawn.
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`The Examiner contends that the claims are not enabled because some of Applicants’
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`experimental examples produce hydrates that include ethanol or amorphous material (May
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`22, 2012 Final Office Action at pages 6-7), but this fact is irrelevant in assessing enablement
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`because, as noted above, such hydrates are within the scope of Applicants’ claims. Because
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`the Examiner’s arguments are based upon a restrictive definition of"hydrate" that is at odds
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`with the definition that Applicants provide in their specification, such arguments fail to
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`support rejection of the instant claims for alleged lack of enablement.
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`Conclusion
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`The pending claims are in condition for allowance. An early and favorable notice to
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`that effect is, therefore, earnestly solicited.
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`/In~nh T
`Joseph Lucci
`Registration No. 33,307
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`Stephanie A. Barbosa
`Registration No. 51,430
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`Date: September 17, 2012
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`Woodcock Washburn LLP
`Cira Centre
`2929 Arch Street, 12th Floor
`Philadelphia, PA 19104-2891
`Telephone: (215) 568-3100
`Facsimile: (215) 568-3439
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`Page 5 of 5
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`Lupin Ex. 1013 (Page 5 of 5)