UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`111357,687
`
`02/16/2006
`
`Stephen J. Baker
`
`64507-5014-US
`
`4964
`
`43850
`7590
`08/26/2008
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`
`EXAMINER
`
`SHIAO, REI TSANG
`
`ART UNIT
`
`PAPER NUMBER
`
`1626
`
`MAILDATE
`
`DELIVERY MODE
`
`08/26/2008
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`1
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`CFAD Exhibit 1012
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`

`
`Office Action Summary
`
`Application No.
`
`11/357,687
`
`Examiner
`
`Applicant(s)
`
`BAKER ET AL.
`
`Art Unit
`
`REI-TSANG SHIAO
`1626
`I
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;l_ MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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.
`If 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).
`
`Status
`
`1)[8J Responsive to communication(s) filed on 06 June 2008.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 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 Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)[8J Claim(s) 27-31and40-42 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 27-31and40-42 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)[8J The drawing(s) filed on 16 February 2006 is/are: a)IZ! accepted or b)O 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).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some* c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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)).
`*See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8J Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 5107107 6121107.
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20080820
`
`2
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
`
`DETAILED ACTION
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`Page 2
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`1.
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`This application claims benefit of the provisional application:
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`60/654,060 with a filing date 02/16/2005.
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`2.
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`Amendment of claims 27, cancellation of claims 1-26 and 32-39, and addition of
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`claims 40-42 in the amendment filed on June 06, 2008 is acknowledged. Claims 27-31
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`and 40-42 are pending in the application. No new matter is found. Since the newly
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`added claims 40-42 are commensurate with the scope of the invention, claims 27-31
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`and 40-42 are prosecuted in the case.
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`Information Disclosure Statement
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`3.
`
`Applicant's Information Disclosure Statements, filed on May 07, 2007 and June
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`21, 2007 has been considered. Please refer to Applicant's copies of the 1449's
`
`submitted herein.
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`Responses to Election/Restriction
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`4.
`
`Applicant's election of Group V claims 27-36 (now are 27-31 and 40-42) in the
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`reply filed on June 06, 2008 is acknowledged. Election of a species, i.e., 1, 3-dihydro-5-
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`fluoro- 1-hydroxy-2, 1-benzoxaborole, is also acknowledged. Because applicant did not
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`distinctly and specifically point out the supposed errors in the restriction requirement,
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`the election has been treated as an election without traverse (MPEP § 818.03(a)).
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`Claims 27-31 and 40-42 are pending in the application. The scope of the
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`invention of the elected subject matter is as follows.
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`3
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 3
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`Claims 27-31 and 40-42 are drawn to methods of use using a compound
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`1, 3-dihydro-5-fluoro- 1-hydroxy-2, 1-benzoxaborole.
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`Claims 27-31 and 40-42 are prosecuted in the case.
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`The requirement is still deemed proper and therefore is made FINAL.
`
`Claim Rejections - 35 USC § 112
`
`5.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112:
`
`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 use the same and
`shall set forth the best mode contemplated by the inventor of carrying out his invention.
`
`5.1
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`Claims 27-31 and 40-42 are rejected under 35 U.S.C. 112, first paragraph,
`
`because the specification, while being enabling for using the instant compound for
`
`treating fungal infection, it does not reasonably provide enablement for using the
`
`instant compound for preventing infection, see claim 27. The specification does not
`
`enable any person skilled in the art to which it pertains, or with which it is most nearly
`
`connected, to make the invention commensurate in scope with these claims.
`
`Dependent claims 28-31 and 40-42 are also rejected along with claim 27 under 35
`
`U.S.C. 112, first paragraph.
`
`In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
`
`whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
`
`paragraph, have been described. They are:
`
`1. the nature of the invention,
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`4
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`Page 4
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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`2. the state of the prior art,
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`3. the predictability or lack thereof in the art,
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`4. the amount of direction or guidance present,
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`5. the presence or absence of working examples,
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`6. the breadth of the claims,
`
`7. the quantity of experimentation needed, and
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`8. the level of the skill in the art.
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`In the instant case:
`
`The nature of the invention
`
`The nature of the invention of claims 27-31 and 40-42 is drawn to intent methods of
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`use using the instant compound for treating or preventing infection without limitation
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`(I.e., no named infection), see claim 27.
`
`The state of the prior art and the predictability or lack thereof in the art
`
`The state of the prior art is that the pharmacological art involves screening in
`
`vitro and in vivo to determine which compounds exhibit the desired pharmacological
`
`activities (i.e. what compounds can treat which specific diseases by what mechanism).
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`There is no absolute predictability even in view of the seemingly high level of skill in the
`
`art. The existence of these obstacles establishes that the contemporary knowledge in
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`the art would prevent one of ordinary skill in the art from accepting any therapeutic or
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`preventive regimen on its face.
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`5
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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 5
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`The instant claimed invention is highly unpredictable as discussed below:
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`It is noted that the pharmaceutical art is unpredictable, requiring each
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`embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d
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`833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the
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`more specific enablement is necessary in order to satisfy the statute. Adams et al. US
`
`6,083,903 disclose similar boron compounds for treating HIV infection. Applicants are
`
`claiming intent methods of use using the instant compound effective to "treating or
`
`preventing infection" without limitation. As such, the specification fails to enable the
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`skilled artisan to use the compounds of claims 27-31 and 40-42 effective to "treating or
`
`preventing infection" without limitation.
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`In addition, there is no established correlation between in vitro activity and
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`accomplishing treatment of "treating or preventing disorders in vitro or in vivo "treating
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`or preventing infection" without limitation, in vivo, and those skilled in the art would not
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`accept allegations in the instant specification to be reliable predictors of success, and
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`those skilled in the ad would not be able to use the instant compound since there is no
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`description of an actual method wherein "treating or preventing infection" without
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`limitation in a host is treated or prevented.
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`Hence, one of skill in the art is unable to fully predict possible results from the
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`administration of the compounds of claims 27-31 and 40-42 due to the unpredictability
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`of the "treating or preventing infection" without limitation. The treating or preventing
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`infection" without limitation is known to have many obstacles that would prevent one of
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`ordinary skill in the art from accepting treating or preventing regimen on its face.
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`6
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 6
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`The amount of direction or guidance present and the presence or absence
`of working examples
`The only direction or guidance present in the instant specification is the listing of
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`exemplary assays of inhibiting fungal growth,, see Fig.1 - Fig.9 There are no in vivo
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`working examples present for the prevention of infection by the administration of
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`compounds of the instant invention.
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`The breadth of the claims
`
`The breadth of the claims is methods of use using the instant compound effective
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`to "treating or preventing infection" without limitation.
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`The quantity of experimentation needed
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`The quantity of experimentation needed is undue experimentation. One of skill in the
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`art would need to determine what "treating or preventing infection" without limitation
`
`would be benefited (i.e., prevented) by the administration of the instant compounds of
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`the instant invention and would furthermore then have to determine which of the
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`claimed methods of use would provide prevention of infection, if any.
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`The level of the skill in the art
`
`The level of skill in the art is high. However, due to the unpredictability in the
`
`pharmaceutical art, it is noted that each embodiment of the invention is required to be
`
`individually assessed for physiological activity by in vitro and in vivo screening to
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`7
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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 7
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`determine which methods of use exhibit the desired pharmacological activity and which
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`diseases would benefit from this activity. Thus, the specification fails to provide
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`sufficient support of the broad use of the pharmaceutical compounds of the instant
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`claims 27-31 and 40-42 for the "treating or preventing infection". As a result
`
`necessitating one of skill to perform an exhaustive search for which "treating or
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`preventing infection", can be treated or prevented by what pharmaceutical compounds
`
`of the instant claims in order to practice the claimed invention.
`
`Genentech Inc. v. Novo Nordisk NS (CA FC) 42 USPQ2d 1001, states that" a
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`patent is not a hunting license. It is not a reward for search, but compensation for its
`
`successful conclusion" and "patent protection is granted in return for an enabling
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`disclosure of an invention, not for vague intimations of general ideas that may or may
`
`not be workable".
`
`Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed
`
`above, to practice the claimed invention herein, a person of skill in the art would have to
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`engage in undue experimentation, with no assurance of success. This rejection can be
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`overcome by incorporation of the limitation "fungal infection" into claim 27 and deletion
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`of the limitation "preventing" from claim 27 respectively, would obviate the rejection.
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`5.2. Claims 27-31 and 40-42 are rejected under 35 U.S.C. 112, first paragraph,
`
`because the specification, while being enabling for pharmaceutically acceptable salts of
`
`the instant compound of claim 27, 1,3-dihydro-5-fluoro- 1-hydroxy-2, 1-benzoxaborole,
`
`does not reasonably provide enablement for the prod rug of the instant compound of
`
`8
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 8
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`claim 27, see claim 27. The specification does not enable any person skilled in the art to
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`which it pertains, or with which it is most nearly connected, to make the invention
`
`commensurate in scope with these claims. Dependent claims 28-31 and 40-42 are also
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`rejected along with claim 27 under 35 U.S.C. 112, first paragraph.
`
`In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
`
`whether a disclosure meets the enablement requirement of 35 U.S.C. 1 12, first
`
`paragraph, have been described. They are:
`
`1 . the nature of the invention,
`
`2. the state of the prior art,
`
`3. the predictability or lack thereof in the art,
`
`4. the amount of direction or guidance present,
`
`5. the presence or absence of working examples,
`
`6. the breadth of the claims,
`
`7. the quantity of experimentation needed, and
`
`8. the level of the skill in the art.
`
`The nature of the invention
`
`The nature of the invention is the intent method of use using the compound of
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`claim 27, i.e., 1,3-dihydro-5-fluoro- 1-hydroxy-2, 1-benzoxaborole, their prodrugs or
`
`pharmaceutically acceptable salts thereof.
`
`9
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 9
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`The state of the prior art and the predictability or lack thereof in the art
`
`The state of the prior art is that pro-drugs are inactive substances that are
`
`converted to a drug within the body by enzymes or other chemicals. Prodrugs can be
`
`formed by various mechanisms and vary depending on the functional groups present in
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`the parent compound, i.e. different prodrugs would arise from parent compounds
`
`containing varying functional groups, such as a carboxylic acid, ester, an alcohol or an
`
`amine, all of which would require differing mechanism.
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`The amount of direction or guidance present and the presence or absence
`
`of working examples
`
`The only direction or guidance present in the instant specification is the
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`Compound of claim 27 and their pharmaceutically acceptable salts of the compounds.
`
`There is no data present in the instant specification for the preparation of constitutional
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`prodrugs of the instant compound of claim 27.
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`The breadth of the claims
`
`The instant breadth of the rejected claims is broader than the disclosure,
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`specifically, the instant claims include any prodrugs, i.e. any compound of claim 27 with
`
`various functional groups, no matter what the chain length and any covalently bonded
`
`compound that would release the active parent compound.
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`The quantity or experimentation needed and the level of skill in the art
`
`While the level of the skill in the pharmaceutical arts is high, it would require
`
`10
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 10
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`undue experimentation of one of ordinary skill in the art to prepare any prodrug of claim
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`27 as instantly claimed since a pro-drug of the compounds of claim 27 can have varying
`
`functional groups in varying positions. It would also require undue experimentation to
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`prepare any covalently bonded compound that would release the active parent drug
`
`since pro-drugs are formed by varying mechanisms and depend on the functional
`
`groups of the parent compound. The only guidance present in the instant specification is
`
`for the compounds of claim 27 and their pharmaceutically acceptable salts thereof.
`
`There is no guidance or working examples present for constitutional prodrugs of claim
`
`27. Therefore, the claims lack enablement for all prodrugs of the compounds of claim
`
`27. This rejection can be overcome by deleting the limitation "prodrug" from the instant
`
`claims.
`
`Claim Rejections - 35 USC § 103
`
`6.
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness under 35
`
`U.S.C. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
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`2. Ascertaining the differences between the prior art and the claims at issue.
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`11
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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 11
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`3. Resolving the level of ordinary skill in the pertinent art.
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`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
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`This application currently names joint inventors. In considering patentability of
`
`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1 .56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior
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`art under 35 U.S.C. 103(a).
`
`Claims 27-31 and 40-42 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Austin et al. GAS: 124:234024 or see US 5,880, 188 in view of
`
`fungicide: definition from Answre.com.
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`Applicants claim methods of use (i.e., treating infection) in an animal using 1,3-
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`dihydro-5-fluoro-1-hydroxy-2, 1-benzoxaborole, see claim 27.
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`Determination of the scope and content of the prior art (MPEP §2141.01)
`
`Austin et al. disclose 5- and 6-fluoro or bromo-1,3-dihydro-1-hydroxy-2, 1-
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`benzoxaborole as fungicide for agriculture, see Austin et al. GAS: 124:234024.
`
`12
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 12
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`Determination of the difference between the prior art and the claims (MPEP
`
`§2141.02)
`
`The difference between instant claims and Austin et al. is that the Austin et al.
`
`using 5- and 6-fluoro or bromo-1,3-dihydro-1-hydroxy-2, 1-benzoxaborole, while the
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`instant claim is 1,3-dihydro-5-fluoro-1-hydroxy-2, 1-benzoxaborole.
`
`Fungicide: definition from Answre.com discloses fungicide can be used for
`
`agriculture or pharmaceutical industry, i.e., for human fungal infections. Austin et al.
`
`methods of use and teachings of fungicide: definition from Answre.com inherently
`
`overlap with the instant invention.
`
`Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
`One having ordinary skill in the art would find the claims 27-31 and 40-42 prima
`
`facie obvious because one would be motivated to employ the methods of use of Austin
`
`et al. and teachings of fungicide: definition from Answre.com to obtain instant methods
`
`of use using 1,3-dihydro-5-fluoro-1-hydroxy-2, 1-benzoxaborole for treating infection
`
`(i.e., fungal infection) in animals. Dependent claims 28-31 and 40-42 are also rejected
`
`along with claim 27 under 35 U.S.C. 103(a).
`
`The motivation to make the claimed compounds derived from the known
`
`compounds as fungicide of Austin et al. and teachings of Answre.com would possess
`
`similar activity (i.e., treating fungal infection) to that which is claimed in the reference.
`
`13
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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 13
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`Double Patenting
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`7.
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`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`
`and to prevent possible harassment by multiple assignees. See In re Goodman, 11
`
`F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225
`
`USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA
`
`1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington,
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`418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) may be
`
`used to overcome an actual or provisional rejection based on a nonstatutory double
`
`patenting ground provided the conflicting application or patent is shown to be commonly
`
`owned with this application. See 37 CFR 1.130(b).
`
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply
`
`with37 CFR 3.73(b).
`
`Claim 27-31 and 40-42 are provisionally rejected under the judicially created
`
`doctrine of obviousness-type double patenting as being unpatentable over claims 53-54
`
`and 58 of Baker et al. co-pending application No. 11/505,591. Although the conflicting
`
`claims are not identical, they are not patentably distinct from each other and reasons
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`are as follows.
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`14
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
`
`Page 14
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`Applicants claim methods of use (i.e., treating infection) using 1,3-dihydro-5-
`
`fluoro-1-hydroxy-2, 1-benzoxaborole, see claims 27.
`
`Baker et al. et al. '591 claim methods of use (i.e., treating microorganism) using
`
`compounds of formula (I) ors compound 1,3-dihydro-5-fluoro-1-hydroxy-2, 1-benzoxa-
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`borole, see claim 54 or 58.
`
`The difference between the instant claims and Baker et al. et al. is that the instant
`
`claims are using a compound 1,3-dihydro-5-fluoro-1-hydroxy-2, 1-benzoxaborole, while
`
`Baker et al. using compound of formula (I) or a compound 1,3-dihydro-5-fluoro-1-
`
`hydroxy-2, 1-benzoxaborole. Baker et al. methods of use inherently overlap with the
`
`instant invention.
`
`One having ordinary skill in the art would find the instant claims 27-31 and 40-42
`
`prima facie obvious because one would be motivated to employ the methods of use of
`
`BAker et al. '591
`
`to obtain the instant methods of use using a compound 1,3-dihydro-5-
`
`fluoro-1-hydroxy-2, 1-benzoxaborole or its pharmaceutical salt .
`
`The motivation to obtain the claimed catalyst derives from known Baker et al.
`
`methods of use would possess similar activity (i.e., treating fungus) to that which is
`
`claimed in the reference.
`
`This is a provisional obviousness-type double patenting rejection because the
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`conflicting claims have not in fact been patented.
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`15
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`Application/Control Number: 11/357,687
`Art Unit: 1626
`
`Conclusion
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`Page 15
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Rei-Tsang Shiao whose telephone number is (571) 272-
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`0707. The examiner can normally be reached on 8:30 AM - 5:00 PM. If attempts to
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`reach the examiner by telephone are unsuccessful, the examiner's supervisor, Joseph
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`K. McKane can be reached on (571) 272-0699. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from
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`The Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`16
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`

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`Application/Control Number: 11/357,687
`Art Unit: 1626
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`Page 16
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`/REI-TSANG SHIAO I
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`Rei-Tsang Shiao, Ph.D.
`Primary Patent Examiner
`Art Unit 1626
`
`August21,2008
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`17