Ex Parte Yang et alDownload PDFPatent Trial and Appeal BoardOct 23, 201211745283 (P.T.A.B. Oct. 23, 2012) Copy Citation 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. 11/745,283 05/07/2007 Shang-Tian Yang OSUZ 200025US01 1512 27885 7590 10/23/2012 FAY SHARPE LLP 1228 Euclid Avenue, 5th Floor The Halle Building Cleveland, OH 44115 EXAMINER YANG, NELSON C ART UNIT PAPER NUMBER 1641 MAIL DATE DELIVERY MODE 10/23/2012 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 SHANG-TIAN YANG and YUNLING BAI __________ Appeal 2011-013068 Application 11/745,283 Technology Center 1600 __________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the rejection of claims directed to a method for aminating the surface of a polymeric substrate. The Patent Examiner rejected the claims for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in- part. Appeal 2011-013068 Application 11/745,283 2 STATEMENT OF THE CASE Claims 1, 2, 4-16, 25-27, and 29-32 are on appeal. Claim 1 is representative and reads as follows: 1. A method for aminating the surface of a polymeric substrate, comprising: providing a polymeric substrate having a surface; and contacting the surface with an amine solution comprising an amine- bearing polymer, the polymer having a reactive nitrogen atom in either the backbone or a pendant group, to obtain the substrate with an aminated surface; wherein the amine solution has a pH of from about 9 to about 13. The Examiner rejected the claims as follows: claims 1, 2, 5-8, 12-16, and 29-32 under 35 U.S.C. § 102(b) as anticipated by Fixe;1 claim 4 under 35 U.S.C. § 103(a) as unpatentable over Fixe and Gebhard;2 claims 9-11 under 35 U.S.C. § 103(a) as unpatentable over Fixe and Tabbani;3 and claims 25-27 under 35 U.S.C. § 103(a) as unpatentable over Fixe, Gebhard, and Tang.4 1 F. Fixe et al., Functionalization of poly(methyl methacrylate) (PMMA) as a substrate for DNA microarrays, 32 NUCLEIC ACIDS RES. No. 1 e9 (2004). 2 Matthew Stewart Gebhard et al., US 2005/0009954 A1, published Jan. 13, 2005. 3 Yacoob Tabani et al., US 2002/011743 A1, published Aug. 22, 2002. 4 Zhongliang Tang et al., US 2006/0160243 A1, filed Jan. 18, 2005, published July 20, 2006. Appeal 2011-013068 Application 11/745,283 3 ANTICIPATION The Issue Appellants contend that Fixe did not describe the claimed method because, rather than using a polymer to aminate its substrate, Fixe used hexamethylene diamine (HMD). (App. Br. 6.) The Examiner argues that HMD is a polymer. (Ans. 9-10.) According to Appellants, the Examiner’s definition of a polymer is too broad to be reasonable. (Reply Br. 2-4). The issue is whether a person of ordinary skill in the art would consider hexamethylene diamine (HMD) to be a polymer. Findings of Fact 1. Fixe described a chemical procedure to functionalize poly(methyl methacrylate) (PMMA) substrates in which a PMMA substrate “is reacted with hexamethylene diamine to yield an aminated surface for immobilizing DNA in microarrays.” (Fixe, Abstract.) 2. Fixe’s Figure 1 included reaction scheme A, reproduced here: Figure 1 (A) diagrams a reaction scheme in which “[t]he available methyl esters of the PMMA, under basic pH conditions, are reacted with an electron donor (N) present on the hexamethylenediamine, yielding primary amines on the surface.” (Fixe 2, Figure 1 legend.) 3. Fixe taught that “the plastic surface is incubated with a solution of 10% hexamethylene diamine in 100 mM borate buffer pH 11.5, for 2 h.” (Fixe 2, “Chemical modification of PMMA substrates”.) Appeal 2011-013068 Application 11/745,283 4 4. A chemical dictionary provides this definition for polymer: A macromolecule formed by the chemical union of five or more identical combining units called monomers. In most cases the number of monomers is quite large (3500 for pure cellulose) and often is not precisely known. (HAWLEY’S CONDENSED CHEMICAL DICTIONARY, 14th ed. Copyright ©2002 by John Wiley & Sons, Inc.) Principles of Law “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted). “During examination, ‘claims … are to be given their broadest reasonable interpretation consistent with the specification, and … claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.’” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Analysis The meaning of “polymer” is the only issue in dispute. Neither Appellants nor the Examiner provided a definition for “polymer.” We find that the ordinary meaning of polymer is a large molecule formed by monomer combining units. (FF 4.) Consistent with that meaning, and for the reasons explained in Appellants’ Brief and Reply Brief, we conclude that a person of ordinary skill in the art would not think that HMD is a polymer. That is, a person of ordinary skill in the art would not agree that Fixe described a method using a polymer to aminate a substrate. The rejection is Appeal 2011-013068 Application 11/745,283 5 reversed because Fixe did not describe every limitation of the claimed method. OBVIOUSNESS A. Claims 4 and 25-27 Claim 4 recites: “The method of claim 1, wherein the amine-bearing polymer is poly(ethylene imine) or poly(allylamine hydrochloride).” Claim 25 defines a surface aminating method that includes “contacting the surface with an amine solution comprising poly(ethyleneimine).” The Issue The Examiner’s position is that the substitution of polyethylene imine (PEI) for hexamethylene diamine (HMD) in Fixe’s method would have been obvious because Gebhard evidenced that the two were “equivalent in the art for reacting with functional groups on a first and second particle.” (Ans. 6 (rejection of claim 4); Ans. 8 (rejection of claims 25-27).) Appellants contend that “Gebhard does not teach that hexamethylene diamine and poly(ethylene imine) are equivalent for all purposes,” and argue that Gebhard’s teaching is limited to equivalent crosslinking agents for polymer particles in water-based paints, not a surface. (App. Br. 7.) Appellants also contend that “the present specification provides evidence that poly(ethylene imine) and hexamethylene diamine are not equivalent. See paragraphs [0095], [00971, and [0115].” (Id.) According to Appellants, the evidence shows that “surfaces modified with the poly(ethylene imine) treatment exhibited a higher binding efficiency to an antibody than surfaces modified with hexamethylene diamine,” and therefore “hexamethylene Appeal 2011-013068 Application 11/745,283 6 diamine and poly(ethylene imine) cannot be considered as equivalents in the present application.” (Id.) The issues with respect to this rejection are: whether Gebhard disclosed that, prima facie, HMD and PEI are equivalents for the purpose of aminating a polymeric surface; and, if so, whether Appellants’ evidence demonstrates HMD and PEI are not equivalents for the purpose of aminating a surface. Further Findings of Fact 5. Gebhard taught that for crosslinking polymer particles, “[s]uitable crosslinking agents include, for example, multifunctional amine compounds, oligomers, and polymers that have at least two amine groups such as hexamethylene diamine, ethylenediamine, 1,2- diaminopropane, 2-methyl-1,5-pentane diamine, 1,4-diaminobutane, 1,12-diaminododecane, 1,2-diaminocylcohexane, 1,2-phenyldiamine, diaminotoluene, polyethylene imine, . . . .” (Gebhard 14, [0110].) 6. The Specification states: The effects of the first antibody concentration and different surface treatments on the reaction rate, expressed as RFU/sec, are shown in FIGURE 5. . . . for different surfaces, the reaction rates were very different even though the same amount of the first antibody was applied, indicating that the binding efficiency for the first antibody on these different surfaces was quite different. The pristine surface yielded the least active antibody at all initial first antibody concentrations studied. For the HMD modified PMMA surface, the fluorescence signal was comparable to that of the pristine surface at low first antibody concentrations, but increased substantially as the first antibody concentration increased to 10 mg/L. For the PEI modified PMMA surface, the fluorescence signal was the highest at all initial first antibody concentrations studied. It was about 10 times higher at 1 mg/L of the first antibody concentration as compared to those from the HMD modified and pristine surfaces. Appeal 2011-013068 Application 11/745,283 7 (Spec. 17, [0095].) 7. The Specification states: FIGURES 6 and 7 show the effects of the different surface treatment methods on streptavidin binding. FIGURE 6 shows the signal given from each modified surface. Here, 10 mg/L of streptavidin and 20 mg/L of biotin-HRP were used. Compared to the HMD modified and pristine surfaces, the PEI treated surface gave - 10 times higher signal regardless of the level of the background noise, which was zero when the concentrations of streptavidin and biotin-HRP were low but increased significantly with increasing concentrations in the assay. FIGURE 7 compares the signal and signal-to-noise ratio (S/N ratio) of the PEI-treated and HMD-treated surfaces. Here, 200 mg/L of streptavidin and 200 mg/L of biotin- HRP were used. The S/N ratio from the PEI treated microchannel was ~2 times that from the HMO treated microchannel. It is thus clear that the PEI treated surface can give the highest fluorescence signal at a faster rate and a better S/N ratio. Both are critical to ELISA’s sensitivity and detection limit. (Spec. 18, [0097].) 8. The Specification states: The interaction between the first antibody and the different PMMA surfaces can be attributed to the spacer effect. FIGURE 8 shows the effect of the different amine molecules PEI, PAH, HMD, and DAP on the enzyme reaction rate. In these experiments, 1 mg/L first antibody, 1 mg/L antigen, and 10 mg/L second antibody were used. The PMMA surfaces treated with the two polymers bound ~10 times more active antibodies than those treated with the two small diamine molecules. Clearly, the two amine-bearing polymers were better than the small diamine molecules for antibody binding because the spacer function of polymers can preserve most of the biological activity of the bound protein molecules. The spacer effect allowed the proteins of the antibody to stay away from the PMMA surface, thus preserving more activity than those bound closer to the surface. (Id., [0098].) Appeal 2011-013068 Application 11/745,283 8 Analysis Claims 4 and 25 define methods for aminating the surface of a polymeric substrate. In Fixe, the polymeric surface is on a slide or sheet, and in Gebhard the polymeric surface is on a particle. Gebhard evidences that HMD and PEI are both diamines. (FF 5.) In Fixe, one of the two amine groups on HMD reacts with PMMA, to leave the second amine group exposed, thus aminating the surface. (FF 2.) In Gebhard, one of the two amine groups on HMD attaches to the surface of a particle, thus aminating that surface in the same sense that Fixe aminates a surface, and the second amine group attaches to the surface of another particle, thus crosslinking the particles. According to Gebhard, HMD and PEI may be used equivalently for the purpose. This evidence of chemical equivalence is prima facie sufficient to show that PEI would have been expected to aminate a PMMA surface in the same manner that HMD does. On the first issue, we agree with the Examiner. Appellants contend that the Specification evidences the non- equivalence of HMD and PEI for aminating a substrate. The Specification evidences that when an aminated surface is used as a substrate for immobilizing an antibody or for streptavidin, the immobilized antibody or streptavidin will behave differently depending on the length of the crosslinker. (FF 6, 7.) The Specification explains that antibody binding efficiency is higher on the PEI treated surface. (FF 6.) It is said that PEI, being longer than HMD, provides a beneficial spacer effect. (FF 8.) This evidence does not show a difference in the amination result whether HMD or PEI is used, and on the evidence presented, HMD and PEI function equivalently to produce an aminated surface. As in Fixe’s method Appeal 2011-013068 Application 11/745,283 9 using only HMD, the surface becomes aminated. There is no explanation showing that the differential antibody fluorescence results obtained are due to non-equivalent amination by HMD or PEI. Instead, the comparative evidence concerns results obtained when the aminated surfaces are used in subsequent steps including binding an antibody or streptavidin to a surface, and measuring fluorescence. That is, the evidence concerns differences resulting when different products (HMD and PEI aminated surfaces) are used in a method of binding an antibody or streptavidin (but not DNA as in the prior art). The claims are not directed to the products or the methods discussed in the comparative examples, and the examples do not concern differences in the effectiveness of HMD or PEI for aminating a surface. The argument that the Specification’s evidence demonstrates non-equivalence of HMD and PEI for purposes of aminating a surface is not persuasive because the evidence doesn’t show any differences in surface amination. Claims 26 and 27 have not been argued separately and therefore fall with claim 25. 37 C.F.R. § 41.37(c)(1)(vii). B. Claims 9-11 The obviousness rejection of claims 9-11 is premised on the finding, set out in the anticipation rejection, that Fixe described using a polymer to aminate a substrate. That finding is not supported by the evidence. See “ANTICIPATION,” above. The obviousness rejection must be reversed because it did not properly account for the “polymer” limitation. Appeal 2011-013068 Application 11/745,283 10 SUMMARY We reverse the rejection of claims 1, 2, 5-8, 12-16, and 29-32 under 35 U.S.C. § 102(b) as anticipated by Fixe. We affirm the rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable over Fixe and Gebhard. We reverse the rejection of claims 9-11 under 35 U.S.C. § 103(a) as unpatentable over Fixe and Tabbani. We affirm the rejection of claims 25-27 under 35 U.S.C. § 103(a) as unpatentable over Fixe, Gebhard, and Tang. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). 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