Ex Parte Ishihara et al

Patent Trial and Appeal BoardNov 28, 2018

10572332 (P.T.A.B. Nov. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 10/572,332 07/11/2011 Kazuhiko Ishihara 38834 7590 11/30/2018 WESTERMAN, HATTORI, DANIELS & ADRIAN, LLP 8500 Leesburg Pike SUITE 7500 Tysons, VA 22182 UNITED ST A TES OF AMERICA 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 033036.105 7560 EXAMINER BOWERS, ERIN M ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 11/30/2018 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): patentmail@whda.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KAZUHIKO ISHIHARA, SOHEI FUNAOKA, and KANEHISA YOKOYAMA Appeal2017---007606 Application 10/572,332 Technology Center 1600 Before TA WEN CHANG, RYAN H. FLAX, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 submit this appeal under 35 U.S.C. Â§ 134(a) involving claims to a biochip. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We REVERSE. 1 Appellants identify the real parties in interest as Sumitomo Bakelite Co. Ltd. and Kazuhiko Ishihara. App. Br. 3. Appeal2017-007606 Application 10/572,332 STATEMENT OF THE CASE According to the Specification, Appellants' invention "provides a biochip having excellent detection sensitivity, the biochip suppressing nonspecific absorption or bonding of a detection target substance without coating with an absorption inhibitor." Spec. ,r 18. The Specification describes a biochip that includes a substrate, on which a macromolecular substance comprising first, second, and third units is provided. Id. ,r,r 29--21. The "first unit" includes "a phosphorylcholine group," the "second unit" contains "an active ester group," and the "third unit" contains "a butyl methacrylate group." Id.; see also id. ,r,r 122-123. Claims 1, 17, 24, 25, 40, 41, 45, 46, 52, 57-59, and 69 are on appeal. Claim 1, the only independent claim, is illustrative and is reproduced below: 1. A biochip substrate for detection or analysis of a biologically active substance comprising: a substrate having a surface; and a macromolecular substance on the substrate surface, the macromolecular substance being a copolymer of a first monomer having a phosphorylcholine group, a second monomer having an active ester group, and a third monomer having a butyl methacrylate group, wherein the active ester group has a higher activity than alkyl esters, and wherein the macromolecular substance is a 2- methacryloyloxyethyl phosphorylcholine I butyl methacrylate I p-nitrophenylcarbonyloxyethyl methacrylate copolymer. App. Br. 16 (Claims App'x) (emphasis added). 2 Appeal2017-007606 Application 10/572,332 The claims stand rejected2 under 35 U.S.C. Â§ I03(a) as obvious over Koulik, 3 Torchilin, 4 Yokoyama, 5 and ( optionally) Pluster. 6 DISCUSSION Claim 1 recites a biochip substrate with a surface, which surface includes a macromolecular substance that is a copolymer comprising first, second, and third monomers. The copolymer includes a first monomer of 2- methacryloyloxyethyl phosphorylcholine ("MPC"), a second monomer of p- nitrophenylcarbonyloxyethyl methacrylate (''p-NPMA" or "NPMA"), and a third monomer of butyl methacrylate ("BMA"). App. Br. 16; Spec. ,r,r 122- 123 (describing the copolymer and its formula). Claim 1 requires the second monomer have an active ester group and, as explained in the Specification, a p-nitrophenyl group (part of the NPMA monomer) is an active ester group. Spec. ,r 120. Regarding claim 1, the Examiner finds that Koulik teaches surfaces coated with a copolymer that includes MPC, BMA, and a functional group. Ans. 3; see, e.g., Koulik, 6:23-35 (describing the "functional group"). As noted by the Examiner, Koulik teaches that heparin is immobilized on the 2 The Examiner withdrew the rejection of claim 1 (and other claims, which are now canceled or withdrawn) underÂ§ I02(a) based on a different reference than the references cited in this appeal. Ans. 8. 3 Koulik et al., US 6,258,371 Bl, issued July 10, 2001. 4 V.P. Torchilin et al., p-Nitrophenylcarbonyl-PEG-PE-liposomes: fast and simple attachment of specific ligands, including monoclonal antibodies, to distal ends of PEG chains via p-nitrophenylcarbonyl groups, 1511 BIOCHIMICA ET BIOPHYSICA ACTA 397--411 (2001). 5 Yokoyama et al., US 2005/0176003 Al, published Aug. 11, 2005. 6 Pluster et al., US 2002/0187249 Al, published Dec. 12, 2002. 3 Appeal2017-007606 Application 10/572,332 coating through this functional group. Ans. 3. According to the Examiner, Koulik also teaches a polyethylene glycol methacrylate monomer. Ans. 3. Although Koulik teaches a polymer comprising MPC, BMA, and a functional group for attachment of biomolecules (e.g., heparin), the Examiner finds that Koulik does "not teach an active ester or an active ester in the form of a p-nitrophenyl group." Id. at 4. Thus, the Examiner acknowledges that Koulik does not teach a coating with a copolymer that includes the second monomer (p-NPMA) as required by claim 1. The Examiner turns to Torchilin in combination with Koulik for suggestion of this claim element. The Examiner finds that Torchilin "teach[es] p-nitrophenylcarbonyl- polyethylene glycol (an active ester) which is suitable for attachment of biomolecules, such as ligands and monoclonal antibodies." Id.; see also Torchilin, Abstract ( describing a "new amphiphilic PEG derivative," described as pNP-PEG-DOPE, which "could serve as a very convenient tool for protein attachment to the distal ends of liposome-grafted PEG chains."). The Examiner finds that Torchilin does "not teach a p- nitrophenylcarbonyl- polyethylene glycol methacrylate unit." Ans. 4. But, according to the Examiner, Koulik teaches a PEG methacrylate unit and, therefore, "it would have been obvious to utilize a p-nitrophenylcarbonyl- polyethylene glycol unit because it would have been obvious ... to combine one known element (i.e., p-nitrophenylcarbonyl-polyethylene glycol as taught by Torchilin et al.) with another known element (i.e., polyethylene glycol methacrylate as taught by Koulik et al.)." Ans. 4. The Examiner reasons that "[ o ]ne would have been motivated to utilize p- nitrophenylcarbonyl- polyethylene glycol because Torchilin et al. teach that 4 Appeal2017-007606 Application 10/572,332 p-nitrophenylcarbonyl readily binds amino-group containing compounds and beneficially forms a stable non-toxic bond." Id. at 5 (reasoning it would be obvious to "apply[] a known technique (p-nitrophenyl (PNP) activation ... to a known device (PEG support) ready for improvement"). The Examiner cites Yokoyama as teaching a polyolefin biochip and an organosiloxane coating (relevant to claims 17, 25, and 46). Ans. 5-6. And the Examiner cites Pluster as teaching a use of methacrylates in coatings on biochips. Id. at 6. Appellants argue that claim 1 is nonobvious over the asserted art for at least three reasons. First, Appellants argue the Examiner's proposed modification of Koulik would impermissibly change Koulik's principle of operation by changing Koulik's functional group from a compound that includes a primary amino group to one with an active ester group. App. Br. 11. Appellants contend Koulik' s purpose is development of blood- compatible, anti-thrombogenic coatings for medical articles, which Koulik does by including in its coating composition a functional group that includes a primary amino that couples to a bioactive molecule - particularly heparin. Id.; Reply Br. 2 ("[T]he Koulik inventors thus developed a new coating with MPC, heparin, and a primary amino group as the functional group to immobilize the heparin."). Second, Appellants argue none of the cited references actually disclose p-NPMA, and hence the Examiner's prior art combination would not have created a reasonable expectation of success in designing a biochip as claimed. App. Br. 12-13. Third, Appellants contend, the Examiner's rejection is based on improper hindsight because nothing in the cited art taught or suggested the specific MPC/BMA/p-NPMA biochip coating as claimed. Id. at 13-14. 5 Appeal2017-007606 Application 10/572,332 We are persuaded the Examiner did not meet the burden to show, by a preponderance of the evidence on this record, that claim 1 would have been obvious over the asserted prior art. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (The Examiner "bears the initial burden ... of presenting a prima facie case of unpatentability."). The mere fact that various features of the cited references could be combined, does not mean that they predictably would have been combined. Sufficient evidence and/or persuasive reasoning for the combination must be provided in the record. And, where a proposed combination or modification would render the prior art invention being modified unsuitable for its intended purpose, there is generally no sufficient reason or motivation for making such a modification - and the modification is not obvious as a result. See In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984); In re Ratti, 270 F.2d 810,813 (CCPA 1959); MPEP Â§ 2143.01. Insofar as the Examiner is proposing to modify Koulik' s copolymer coating to include a monomer having an active ester group (p-NPMA) in place of Koulik's "functional group," we are unpersuaded the ordinarily skilled person would have made that modification. 7 Reading the reference as a whole, Koulik's principle of operation is not as broad as the Examiner 7 If that is not the modification intended or proposed by the Examiner (i.e., replacement of Koulik's functional group with a group from Torchilin), the Examiner did not clarify the record in the face of Appellants' arguments on this point. Quite the opposite, the Examiner responded that Koulik' s principle of operation is broader than that argued by Appellants and, further, stated that "any modification of a primary reference with a secondary reference necessarily involves at least some small change to the mode of operation of the primary reference." Ans. 9. 6 Appeal2017-007606 Application 10/572,332 asserts: "the attachment of biomolecules to the surfaces of medical article through copolymer coatings." Ans. 9. To the contrary, the object and principle of operation of Koulik is (more narrowly) the development of coatings for medical articles ( devices such as stents) that are blood compatible and avoid the attachment of plasma proteins ( coagulation factors, immunoglobulins, etc.) on the article when in contact with blood. See Koulik, 1:5-2:46. The principle of operation of Koulik relies on coatings that are resistant to clotting and undesirable immune responses when in use. This is repeatedly described, exemplified, and claimed in Koulik with specific coatings having a functional group that is a monomer with a primary amino group that couples to the anticoagulant heparin. See, e.g., Koulik 2:28--46, 9:60-10:46, 13:48-14:24. Koulik describes suitable functional groups as monomers that include a primary amino group. Id. at 6:27-36. And the Examiner has not provided a persuasive reason why the skilled artisan would use a different functional group (with an active ester) or, on this record, explained how Koulik' s coating composition would still function as intended if it was modified in that way. The Examiner also fails to explain sufficiently and persuasively how the combination of Koulik and Torchilin ( with or without Yokoyama and Pluster) would have resulted in the specific macromolecular copolymer claimed having all three of its recited parts: MPC/BMA/p-NPMA. The Examiner mentions a teaching in Koulik of polyethylene glycol (PEG) methacrylate. Ans. 3. As Appellants point out, however, "Koulik teaches PEG methacrylate as an alternative for MPC in Koulik' s hydrophilic block" - one of the three blocks (hydrophilic, hydrophobic, functional) that are used in Koulik's coatings. App. Br. 14; see Koulik, 5:64---6:12. If the 7 Appeal2017-007606 Application 10/572,332 Examiner is suggesting the ordinarily skilled person would have used PEG methacrylate as the hydrophilic block instead of MPC, the resulting copolymer would lack MPC and, thus, not satisfy the claim. If the Examiner is proposing that both MPC and a PEG methacrylate would have been used, the Examiner did not make that position clear. And, with no art cited on the record here that discloses claim 1 's second monomer, p-NPMA, if the Examiner is suggesting the ordinarily skilled person would have made that compound based on Torchilin's teaching of a specific p-nitrophenycarbonyl PEG derivative grafted to liposomes and Koulik's mention of a PEG methacrylate, and used it with MPC and BMA in a coating, we are unpersuaded on this record that such a combination or modification would have occurred absent hindsight using the Appellants' Specification for direction. For the reasons above, the preponderance of the evidence does not support the Examiner's conclusion of obviousness. Accordingly, we reverse the rejection of claim 1 and dependent claims 17, 24, 25, 40, 41, 45, 46, 52, 57-59, and 69. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) ("[D]ependent claims are nonobvious if the independent claims from which they depend are nonobvious."). SUMMARY We reverse the rejections for obviousness on appeal. REVERSED 8