13740277 (P.T.A.B. Dec. 20, 2016)

Ex Parte Sumimoto

Patent Trial and Appeal BoardDec 20, 2016

13740277 (P.T.A.B. Dec. 20, 2016)

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. 13/740,277 01/14/2013 Haruyuki Sumimoto 1051 111545 7590 03/03/2017 Haruyuki Sumimoto Midorii 4-3-13 Hiroshima Asaminami-ku, 731-0103 JAPAN EXAMINER SCHWADRON, RONALD B ART UNIT PAPER NUMBER 1644 MAIL DATE DELIVERY MODE 03/03/2017 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) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HARUYUKI SUMIMOTO Appeal 2015-000973 Application 13/740,277 Technology Center 1600 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and JOHN E. SCHNEIDER, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellant requests rehearing of the decision entered December 20, 2016 (“Decision”). Appellant argues that we misinterpreted the claims on appeal and that, properly interpreted, the claims are not directed to a naturally occurring product or to a product disclosed in the prior art. The request for rehearing is denied. Appellant argues that the naturally occurring complexes described by Hirose and Van Neerven are limited to ones in which IgA (whether one or more than one of the IgA molecules) is bound to a single epitope of an antigen. (Req. Reh’g. 3, 6.) Appellant argues that, by contrast, the “claimed complex can block two or more than two epitopes. ... It is true that Claim 1 Appeal 2015-000973 Application 13/740,277 does not exclude an IgA/antigen complex with free epitopes but Claim 1 exclude[s] an IgA/antigen complex in nature.” (Id. at 4.) This is a new argument, since Appellant previously argued that the claimed complex was limited to one in which “there are no free epitopes on the antigen.” (Appeal Br. 5.) We would not normally consider new arguments raised for the first time in a Request for Rehearing.1 However, we will in this case since Appellant is pro se. We previously addressed the broadest reasonable interpretation of claim 1 in light of the Specification. (Decision 4—6.) We concluded that “the Specification does not describe the claimed method as requiring an immune complex in which IgA antibodies block all of the epitopes of an antigen.” (Id. at 6.) The question raised by Appellant’s new argument is whether the broadest reasonable interpretation of claim 1 requires an immune complex in which an antigen is bound by IgA molecules at two or more different epitopes. The Specification describes its composition embodiments as follows: A composition for inducing antigen-specific tolerance comprising an antigen and immunoglobulin A antibodies that are binding to the epitopes of the antigen. This means that the IgA is specific to the epitopes. Because epitopes of the antigen are blocked by IgA antibodies, IgE or IgG antibodies can not bind to the epitopes, resulting in suppression of IgE- or IgG-mediated immune responses and leading to antigen-specific tolerance. (Spec. 1 60.) The Specification also states that 1 “Any argument raised in the reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the Examiner’s answer . . . will not be considered by the Board for purposes of the present appeal, unless good cause is shown.” 37 C.F.R. § 41.41(b)(2). 2 Appeal 2015-000973 Application 13/740,277 the composition of the present invention contain not only antigen but also IgA. And the most important point of the present invention is that the IgA is specific to the epitopes of the antigen and binds to the epitopes. The composition of the present invention has never existed in this world. The effect of the present invention is to be capable of suppression of IgE- or IgG- mediated immune responses and leading to antigen-specific tolerance more effectively. {Id. 1 62.) We do not read the Specification to support Appellant’s interpretation of the claims as requiring a single antigen molecule having multiple IgA antibodies bound to different epitopes of the antigen. Rather, the Specification states that the inventive composition comprises “an antigen,” without limiting that phrase to a single antigen molecule, and “immunoglobulin A antibodies that are binding to the epitopes of the antigen.” (Spec. 1 60.) This description of the invention encompasses a composition that comprises multiple antigen molecules having IgA antibodies bound to them, either to multiple epitopes of the same antigen molecule, or to the same or different epitopes on multiple antigen molecules. Appellant’s argument also fails because it cites no evidence to support the assertion that the IgA/ovomucoid complex that naturally occurs in human breast milk, and is disclosed by Hirose, consists of IgA antibodies that all bind to the same epitope of the ovomucoid antigen. Hirose states that “ovomucoid in breast milk was only eluted in the fractions corresponding to a molecular weight of about 450 kDa, suggesting its occurrence as an immune complex with IgA.” (Hirose 1438, left col.) Hirose also states that “[t]his is the first report to show the occurrence of a 3 Appeal 2015-000973 Application 13/740,277 food allergen as an immune complex with its specific IgA in human breast milk.” (Id. at 1440, left col.) Appellant has not pointed to persuasive evidence that the description of ovomucoid “as an immune complex with its specific IgA” would be understood by those in the art to mean that the IgA antibodies in the composition are all bound to the same epitope on each ovomucoid antigen molecule. As Appellant’s Request for Rehearing recognizes, each antigen molecule has multiple antigenic epitopes. (Req. Reh’g., Fig. 1.) Thus, Hirose’s description of breast milk as containing ovomucoid “as an immune complex with its specific IgA” is reasonably interpreted to mean that the milk contains ovomucoid antigens that have IgA antibodies bound to them, but the fact that the IgA antibodies are specific for ovomucoid does not mean that they are necessarily all bound to the same epitope. As Appellant’s Reply Brief also recognizes (see, e.g., Figs. 4—8), IgA antibodies can be specific for different epitopes on the same antigen. In short, Appellant has not pointed to persuasive evidence to support the assertion that Hirose’s antibodies all bind to the same epitope. Appellant also argues that “[i]f IgA/antigen complex is administrated orally to a naive baby through breast milk, the baby’s immune system will recognize the antigen as tolerogen because a baby is naive. . . . But if these complex is administrated orally to already allergic individual against said antigen, the complex may elicit hypersensitive reactions because the allergic individual has already recognized the said antigen as immunogen.” (Req. Reh’g 5.) 4 Appeal 2015-000973 Application 13/740,277 This argument is also unpersuasive, because the claims are directed to a product, not a method. While the preamble of claim 1 may limit the composition to one that is capable of inducing antigen-specific tolerance, it does not limit the subjects in whom the tolerance is induced to those who are already allergic to that antigen. Thus, claim 1 reads on breast milk containing an immune complex (e.g., Hirose’s IgA/ovomucoid complex) that can induce immune tolerance in a naive baby. With respect to the rejection based on Van Neerven, Appellant argues that the disclosed complex is an IgGl/antigen complex. However, as discussed in the Decision, Van Neerven discloses cow milk that contains “grass allergen-specific bovine IgGl, IgA, and IgM” antibodies. (Decision 7, emphasis added. See also Van Neerven 144.) Appellant’s argument thus is not supported by the evidence in the record. SUMMARY For the reasons discussed above, we deny the Request for Rehearing. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). REHEARING DENIED 5