UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES 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.
`
`11/508,261
`
`08/23/2006
`
`Mitsuhiro Okuda
`
`061352-0136
`
`2499
`
`05/27/2010
`7590
`McDERMOTT WILL & EMERY LLP
`600 13th Street, N.W.
`Washington, DC 20005-3096
`
`EXAMINER
`
`NIEBAUER, RONALD T
`
`ART UNIT
`
`PAPER NUMBER
`
`1654
`
`MAIL DATE
`
`05/27/2010
`
`DELIVERY MODE
`
`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)
`
`1/10
`
`
`
`UNITED STATES 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.
`
`11/508,261
`
`08/23/2006
`
`Mitsuhiro Okuda
`
`061352-0136
`
`2499
`
`05/27/2010
`7590
`McDERMOTT WILL & EMERY LLP
`600 13th Street, N.W.
`Washington, DC 20005-3096
`
`EXAMINER
`
`NIEBAUER, RONALD T
`
`ART UNIT
`
`PAPER NUMBER
`
`1654
`
`MAIL DATE
`
`05/27/2010
`
`DELIVERY MODE
`
`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)
`
`1/10
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE BOARD OF PATENT APPEALS
`AND INTERFERENCES
`__________
`
`Ex parte MITSUHIRO OKUDA,
`KAZUAKI NISHIO, and ICHIRO YAMASHITA
`__________
`
`Appeal 2009-015032
`Application 11/508,261
`Technology Center 1600
`__________
`
`Decided: May 27, 2010
`__________
`
`Before ERIC GRIMES, DEMETRA J. MILLS, and LORA M. GREEN,
`Administrative Patent Judges.
`
`GRIMES, Administrative Patent Judge.
`
`
`
`
`DECISION ON APPEAL
`This is an appeal under 35 U.S.C. § 134 involving claims to a method
`of making a zinc oxide-ferritin complex, which the Examiner has rejected as
`obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
`
`
`
`2/10
`
`
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`
`STATEMENT OF THE CASE
`Claims 1-9 are on appeal. Claim 1 is the only independent claim and
`reads as follows:
`1. A process for producing a zinc-oxide protein complex comprising:
`the step a) of preparing a buffer containing a protein having a cavity
`inside thereof, zinc ion, and ammonia, wherein the protein having a cavity
`inside thereof is ferritin; and
`a step b) of adding hydrogen peroxide to the buffer so that the
`concentration of said hydrogen peroxide is 60 mM or greater and 150 mM or
`less.
`
`
`
`Issue
`
`The Examiner has rejected claims 1-9 under 35 U.S.C. § 103(a) as
`unpatentable over Yamashita ‘3861 (Ans. 3) or the combination of
`Yamashita ‘0472 and Yamashita ‘386 (id at 6).
`The Examiner finds that Yamashita ‘386 teaches “that zinc and oxides
`thereof can be introduced into apoferritin. Further, it is taught (column 6,
`lines 9-10) that H2O2 (hydrogen peroxide) is added to the solution to
`introduce metal oxide complexes into apoferritin.” (Ans. 4.) The Examiner
`acknowledges that Yamashita ‘386 does not teach the H2O2 concentration
`range recited in the claims, but concludes that “it would have been obvious
`to one skilled in the art at the time of invention to determine all optimum and
`operable conditions, because such conditions are art-recognized result-
`effective variables” (id. at 5).
`
`1 Yamashita, U.S. Patent 6,838,386 B2, Jan. 4, 2005.
`2 Yamashita, US 2004/0158047 A1, Aug. 12, 2004. The Examiner actually
`relies on Yamashita ‘047 or Yamashita (EP 1433743 A1, June 30, 2004) in
`the alternative. Since the disclosures of these references appear to be
`identical, we will discuss only Yamashita ‘047.
`
`2
`
`3/10
`
`
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`
`The Examiner finds that Yamashita ‘047 discloses a method of
`making cobalt-ferritin complexes using metal ions, apoferritin, HEPES
`buffer, and an H2O2 concentration in the range of 1 mM to 5 M (Ans. 6).
`The Examiner finds that Yamashita ‘386 discloses that “not only zinc but
`zinc oxide can be incorporated into apoferritin via the addition of hydrogen
`peroxide. Thus one would be motivated to substitute[ ] zinc oxide for zinc
`[sic, cobalt?].” (Id.). With regard to the H2O2 concentration range recited in
`the claims, the Examiner again concludes that “it would have been obvious
`to one skilled in the art at the time of invention to determine all optimum and
`operable conditions, because such conditions are art-recognized result-
`effective variables” (id. at 7).
`Appellants contend that Yamashita ‘047 would have led those skilled
`in the art to expect that apoferritin would be denatured by a H2O2
`concentration in the range recited in the claims, and that the evidence of
`record showing efficient production of a zinc oxide-ferritin complex at the
`recited H2O2 concentrations is an unexpectedly superior result that rebuts the
`evidence relied on by the Examiner (Appeal Br. 4-5). Appellants also
`contend that the range of 1 mM to 5 M in Yamashita ‘047 is a mistake and
`should read “1 mM to 5 mM” (id. at 6). Appellants have submitted
`declaratory evidence to show that Yamashita ‘047 was translated incorrectly,
`resulting in the mM-to-M error (Appendixes III to VI attached to the Appeal
`Brief).
`The issue with respect to both rejections is: Have Appellants shown
`that the H2O2 concentration range recited in claim 1 provides results that are
`superior to what would have been expected based on the prior art?
`
`3
`
`4/10
`
`
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`Findings of Fact
`1. Yamashita ‘386 discloses a method of introducing iron into
`apoferritin by mixing HEPES buffer, apoferritin, and iron ammonium sulfate
`(Yamashita ‘386, col. 5, ll. 13-17).
`2. Yamashita ‘386 discloses that “the concentration of iron
`ammonium sulfate . . . is preferably in the range of 5 to 10 mmol/L” (id. at
`col. 5, ll. 21-23).
`3. Yamashita ‘386 discloses that “the technology of introducing
`chromium, manganese, cobalt, nickel, aluminum, tungsten, zinc, and oxides
`thereof into apoferritin has already been reported” (id. at col. 6, ll. 2-5).
`4. Yamashita ‘386 discloses that “in the case of cobalt, inorganic
`atoms can be introduced into apoferritin by merely adding apoferritin to an
`ammonium solution of cobalt sulfate, adjusting the pH value to around 8.0,
`and then adding a small amount of H2O2 solution” (id. at col. 6, ll. 6-10).
`5. Yamashita ‘047 discloses a “method for producing a cobalt-protein
`complex” (Yamashita ‘047 at 2, ¶ 17); the protein may be apoferritin (id. at
`2, ¶ 21).
`6. Yamashita ‘047 discloses that “a reaction solution is prepared by
`mixing a HEPES buffer solution, an apoferritin solution and Co2+ ion
`solution” (id. at 3, ¶ 42). “Next, . . . an oxidizing agent (e.g., H2O2) is added
`to the reaction solution” (id. at 3, ¶ 43).
`7. Yamashita ‘047 discloses that the “concentration of apoferritin in
`the reaction solution is adjusted to be in a range from 0.1 to 1 mg/ml (about
`0.2-2 µM). More specifically, it is preferably about 0.5 mg/ml (1 µM).” (Id.
`at 3, ¶ 48).
`
`4
`
`5/10
`
`
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`
`8. Yamashita ‘047 discloses that the “Co2+ ion concentration may be
`about 1000 to 5000 times more than . . . preferably 2000 to 3000 more than
`that of the apoferritin concentration. . . . For example, when the apoferritin
`concentration is 0.5 mg/ml (about 1 µM), Co2+ ions are added at a
`concentration of 2-3 mM.” (Id. at 3, ¶¶ 49-50.)
`9. Yamashita ‘047 discloses that, in the oxidizing step, “hydrogen
`peroxide . . . in an equal quantity or a ½ quantity of that of cobalt ion is
`added to the reaction solution. For example, when the concentration of Co2+
`ion is 2 mM, H2O2 is added to the reaction solution so that the final
`concentration of H2O2 is in a range from 1 mM to 2 mM.” (Id. at 4, ¶ 52.)
`10. Yamashita ‘047 discloses that “there may be cases in which
`apoferritin is denatured by addition of a hydrogen peroxide solution.
`Therefore, adding a salt is effective to stabilize apoferritin.” (Id. at 4, ¶ 53.)
`11. Yamashita ‘047 discloses that apoferritin and H2O2 are used at a
`ratio between 1:1000 and 1:5000 (id. at 4, Table 2). Yamashita ‘047 states
`that this corresponds to a H2O2 concentration of 1 mM to 5M for an
`apoferritin concentration of 1 µM (id.).
`12. The Specification states that “in case of formation of the cobalt-
`protein complex, hydrogen peroxide is essential, although it cannot be
`introduced at a high concentration. The concentration is presumed to be 5
`mM.” (Spec. 11.)
`13. The Specification provides evidence that zinc oxide-ferritin
`complexes form at H2O2 concentrations between 60 mM and 150 mM but
`not at a H2O2 concentration of 40 mM or 200 mM (id. at 14).
`
`5
`
`6/10
`
`
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`
`14. Appellants have provided declaratory evidence showing the
`results of combining different concentrations of H2O2 with apoferritin, zinc
`acetate, and ammonium (Declaration under 37 C.F.R. § 1.132, filed Feb. 8,
`2008). The declaration states that at 40 mM H2O2, “[m]ost of the ferritin
`remained as apoferritin” (id. at ¶ 8), that at 60 mM or 150 mM H2O2, the
`zinc oxide-ferritin yield was approximately 20% (id. at ¶¶ 9, 11); that at 100
`mM H2O2, the yield of zinc oxide-ferritin was 80% or higher (id. at ¶ 10);
`and that at 200 mM H2O2, the apoferritin was denatured and no zinc oxide-
`ferritin was formed (id. at ¶ 12).
`
`Principles of Law
`When determining obviousness, “the prior art as a whole must be
`considered. The teachings are to be viewed as they would have been viewed
`by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir.
`1986).
`“[T]he meaning of a prior art reference requires analysis of the
`understanding of an artisan of ordinary skill.” Finisar Corp. v. DirecTV
`Group, Inc., 523 F.3d 1323, 1336 (Fed. Cir. 2008).
`“One way for a patent applicant to rebut a prima facie case of
`obviousness is to make a showing of ‘unexpected results,’ i.e., to show that
`the claimed invention exhibits some superior property or advantage that a
`person of ordinary skill in the relevant art would have found surprising or
`unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995).
`
`6
`
`7/10
`
`
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`Analysis
`Yamashita ‘386 discloses a method of making a cobalt-ferritin
`complex by mixing apoferritin with an ammonium solution of cobalt sulfate
`and adding a “small amount” of a hydrogen peroxide solution (FF 4).
`Yamashita ‘386 also discloses that “the technology of introducing . . . cobalt,
`. . . zinc, and oxides thereof into apoferritin has already been reported” (FF
`3), although it does not expressly state that methods using zinc are similar to
`those using cobalt.
`Yamashita ‘047 discloses a method of making cobalt-ferritin
`complexes by mixing HEPES buffer, apoferritin, and Co2+ ions, and then
`adding H2O2 (FF 6). Yamashita ‘047 discloses that the concentration of
`Co2+ ions is preferably 2000-3000 times that of the apoferritin (FF 8) and the
`concentration of H2O2 should be equal to or half that of the Co2+ ions (FF 9).
`Yamashita ‘047 states that the concentration of apoferritin is preferably 1
`µM, in which case the concentration of Co2+ ions would be 2-3 mM, and that
`for a Co2+ ion concentration of 2 mM, the H2O2 concentration would be 1-2
`mM (FFs 7-9).
`Yamashita ‘047 also discloses that the concentration of H2O2 is 1000-
`5000 times that of the apoferritin (FF 11). The same table states that when
`apoferritin is used at 1 µM, H2O2 is used at a concentration of 1 mM to 5M
`(id.). Based on the totality of Yamashita ‘047, however, those of skill in the
`art would recognize that the “5M” in Table 2 of Yamashita ‘047 is a
`typographical error, and that “5 mM” was intended, because (a) 1 µM is
`equivalent to 10-6 M, and 5000 x 10-6 M = 5 x 10-3 M, or 5 mM, and (b) a
`concentration of 5 M is over a thousand-fold higher than the other
`
`7
`
`8/10
`
`
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`concentrations discussed by Yamashita ‘047, which are consistently in the
`millimolar range or below.3
`Thus, Yamashita ‘047 provides evidence that a skilled worker would
`have interpreted Yamashita ‘386’s disclosure of “adding a small amount of
`H2O2 solution” (FF 4) to mean an amount of H2O2 on the order of 1-5 mM,
`rather than the 60-150 mM required by the claims on appeal.
`Yamashita ‘047 also states that “there may be cases in which
`apoferritin is denatured by addition of a hydrogen peroxide solution” and
`that adding a salt will stabilize the apoferritin (FF 10). A skilled worker
`would recognize that the disclosure of this potential problem, and its
`solution, applies to the reaction described in Yamashita ‘047; i.e., a reaction
`using 1-5 mM H2O2. The instant Specification and Appellants’ declaration,
`however, present evidence that H2O2 concentrations of 60-150 mM not only
`do not denature apoferritin but effectively form ferritin-zinc oxide
`complexes (FFs 13, 14). We agree with Appellants that the results presented
`in the Specification and declaration are unexpectedly superior to what would
`have been expected based on the cited prior art.
`
`
`3 Appellants have presented evidence to show that the “5M” in Yamashita
`‘047 was the result of a translating error, and that “5 mM” was intended (see
`Appeal Br. 6). Whether a prior art reference says what was intended by its
`author is not the issue, however: it says what is written, regardless of what
`its author intended. On the other hand, if the reference contains a
`typographical error that would be readily apparent to a skilled worker, then
`the skilled worker would understand the reference to mean something other
`than what it actually says. Such is the case here.
`
`8
`
`9/10
`
`
`
`Appeal 2009-015032
`Application 11/508,261
`
`
`Conclusion of Law
`Appellants have shown that the H2O2 concentration range recited in
`claim 1 provides results that are superior to what would have been expected
`based on the prior art.
`
`
`
`SUMMARY
`We reverse the rejection of claims 1-9 based on Yamashita ‘386 and
`the rejection of claims 1-9 based on Yamashita ‘047 combined with
`Yamashita ‘386.
`
`REVERSED
`
`
`
`
`lp
`
`
`MCDERMOTT WILL & EMERY LLP
`600 13TH STREET, N.W.
`WASHINGTON DC 20005-3096
`
`
`9
`
`10/10
`
`
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