Ex Parte Fujita et alDownload PDFPatent Trial and Appeal BoardJun 21, 201711551365 (P.T.A.B. Jun. 21, 2017) 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. 11/551,365 10/20/2006 Masato Fujita P30961 1196 7055 7590 06/23/2017 GREENBLUM & BERNSTEIN, P.L.C. 1950 ROLAND CLARKE PLACE RESTON, VA 20191 EXAMINER SALVOZA, M FRANCO G ART UNIT PAPER NUMBER 1648 NOTIFICATION DATE DELIVERY MODE 06/23/2017 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): gbpatent@gbpatent.com greenblum.bernsteinplc@gmail.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MASATO FUJITA and NORIYUKI OHNISHI1 Appeal 2016-001777 Application 11/551,365 Technology Center 1600 Before ULRIKE W. JENKS, RYAN H. FLAX, and RACHEL H. TOWNSEND, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a process of separating phospholipid vesicles with magnetic particles. The Examiner rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellants, the Real Party in Interest is JNC Corporation. Appeal Br. 2. Appeal 2016-001777 Application 11/551,365 STATEMENT OF THE CASE Claims 15—18 and 22—25 are on appeal2, and can be found in the Claims Appendix of the Appeal Brief. Claim 15 is representative of the claims on appeal, and reads as follows: 15. A process for separating a phospholipid vesicle, comprising: mixing an aqueous solution of a water-soluble cationic magnetic fine particle having an average particle size of 30 to 300 nm containing a substance having a cationic functional group, a substance having a hydroxyl group and a substance having magnetism, with a liquid containing a phospholipid vesicle, to form a water-soluble combined body of a cationic magnetic fine particle and a phospholipid vesicle; aggregating the water-soluble combined body of the cationic magnetic fine particle and the phospholipid vesicle by adding an aggregating agent, selected from at least one member of the group consisting of a polyether, a substance having a polyalkylene glycol structure in a main chain, a substance having a polyalkylene structure in a side chain, and a substance having a polyglycerin structure in a main chain, by reacting the aggregating agent with the hydroxyl group of the substance having a hydroxyl group, to form a water-insoluble composite of the cationic magnetic fine particle, the phospholipid vesicle, and the aggregating agent; separating the water-insoluble composite of the cationic magnetic fine particle, the phospholipid vesicle and the aggregating agent magnetically, wherein the water-soluble cationic magnetic fine particle comprises: a magnetic fine particle coated with the substance having a hydroxyl group, and immobilized on said coating, a substance having a cationic functional group. 2 Appellants indicate that claims 1—14, 19, and 20 are currently pending, but are withdrawn from consideration. Appeal Br. 4. 2 Appeal 2016-001777 Application 11/551,365 The Examiner rejects the claims as follows: Claims 15—18, 22, and 25 are rejected under 35 U.S.C. § 103(a) as unpatentable over Ullman. Claims 23 and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over Ullman and Sato. Obviousness over Ullman The issue is: Does the preponderance of evidence of record support the Examiner’s conclusion that Ullman renders the method of separating phospholipid vesicles with magnetic particles obvious? Findings of Fact We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art as set out in the Answer and the Final Action mailed October 27, 2014. For emphasis only, we highlight the following: FF1. Ullman teaches separating substances with magnetic beads. The method comprises combining a liquid medium containing the substance with magnetic particles, preferably dispersed as a magnetic liquid, under conditions for binding the substance to the magnetic particles and non-specifically binding and aggregating the magnetic particles where a chemical means is used to cause the suspended magnetic particles to non- specifically bind to one another. The substance to be separated will frequently be a non-magnetic particle or will be bound to a non-magnetic particle. The non specific binding is usually conveniently obtained as the result of charge interactions, which can also serve to non- specifically bind non magnetic particles to the magnetic 3 Appeal 2016-001777 Application 11/551,365 particles. For example, the non-magnetic particles and the magnetic particles can have opposite electronic charges and non-specific binding will occur spontaneously. Where the particles and the magnetic particles have the same charge, a polyionic reagent having an opposite charge can be added to the medium to cause non-specific binding between the non-magnetic particles and the magnetic particles and between the magnetic particles. After the above combination is formed, the medium is subjected to a magnetic field gradient to separate the particles from the medium. Ullman 12:59 to 13:16. FF2. Ullman teaches that: The magnetic particles can be paramagnetic, ferromagnetic, or superparamagnetic, usually paramagnetic. . . . The diameter of the particles should be small, generally in the range from about 5 nm to 1 micron, preferably from about 10 to 250 nm, more preferably from about 20 to 100 nm, most preferably colloidal. Ullman 10:17-25. FF3. Ullman teaches that “the magnetic particles will contain a core of the magnetic component with surface functional groups such as hydroxyl. . . . The surface coating can be ... a carbohydrate such as dextran, chitosan, amylose and the like, or combinations or these substances.” Ullman 10:35—43. FF4. Ullman teaches using additives in the assay. For example, “proteins may be included, such as albumins, or surfactants, particularly non ionic surfactants, binding enhancers, e.g., polyalkylene glycols, or the like.” Ullman 12:56—58. 4 Appeal 2016-001777 Application 11/551,365 Principle of Law Prior art’s disclosure of a multitude of combinations does not render any particular formulation less obvious. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). The obviousness “analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398,418 (2007). In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103. One of the ways in which a patent's subject matter can be proved obvious is by noting that there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patent's claims. Id. at 419-20. Analysis Upon consideration of the evidence on this record, and each of Appellants’ contentions, we find that the preponderance of evidence supports the Examiner’s conclusion that the subject matter of Appellants’ claims is unpatentable. Accordingly, we affirm the Examiner’s rejections for the reasons set forth in the Answer and Final Action, which we adopt as our own, including the Examiner’s responses to Appellants’ arguments. We address Appellants’ contentions below. 5 Appeal 2016-001777 Application 11/551,365 Appellants contend that “Ullman et al. teaches the aggregation of its particles, Appellant emphasizes that it is not by addition of polyalkylene glycols. Rather, Ullman et al. discloses aggregation in its disclosure as occurring through pH adjustment.” Reply Br. 2. We are not persuaded by this argument for at least the following reasons. As the Examiner explained “the adjustment of pH to enhance aggregation is not excluded by the claim language, which is interpreted openly for reciting the claim language ‘comprising.’” Ans. 15. In other words, the claims are open to include additional steps such as manipulating the pH. Further, Ullman is not limited to pH manipulations as the only way to effect binding between a magnetic particle and a substance. See Ans. 15. Ullman teaches using magnetic particles to separate substance from a liquid medium. See FF1—FF3. Ullman explains that the binding of a substance to a magnetic particle occurs spontaneously if the substance and particle are oppositely charged. FF1. Adjusting the pH is one way of manipulating the charge of the analyte in an assay. See Ullman 13:17—52. Ullman teaches the use of polyionic reagents to enhance the binding between particles that have the same charge. See Ullman 12:5-24, 16:17—52. These polyionic reagents can also reverse the binding between the substance and the magnetic particles of the same charge. See Ullman 16:17—52. In addition, Ullman also discloses the use binding enhancers, such as polyalkylene glycols, as an additive in the assay. FF4. We agree with the Examiner that Ullman discloses multiple ways to effect the binding between magnetic particles and the reference’s options are not limited to pH adjustments, but also include the use of polyionic reagents as well as binding enhancers. 6 Appeal 2016-001777 Application 11/551,365 Appellants contend that polyethylene glycols are taught in Ullman to be optional ingredients, and thereby are not required. See generally Appeal Br. 10—13. However, the Examiner’s rejection relies on inherency based on the inclusion of polyethylene glycol. Id. at 11 (“[t]he noted feature of the claim is only met on a theory of inherency if Ullman et al. teaches the addition of a substance in such a way as would necessarily result in the aggregation of the noted components”). We are not persuaded. Ullman specifically teaches that additives such as binding enhancers, e.g., polyalkylene glycols, can be included in the assay. FF4. Ullman further includes the use of proteins, such as albumins, or surfactants, as well as non-ionic surfactants, in the assay. FF4. Any of these additives may be included in the assay, thus, in certain embodiments of Ullman they are included. The fact that Ullman explicitly provided several choices does not make following any one of Ullman’s suggestions any less obvious. See Merck, 874 F.2d at 807. Here, Ullman gives a reason to include polyethylene glycol in the assay, because it identified this ingredient to function as a binding enhancer. FF4. The Examiner explains that “[t]he characterization of the product as a binding enhancer or aggregating agent does not change the properties or effect of polyalkylene glycol when added to substance having hydroxyl group” as suggested by Ullman. Ans. 13. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990). In other words, just because polyalkylene glycol is identified in Ullman to act as a binding enhancer does not mean that it does not simultaneously function as an aggregating agent in the same assay. 7 Appeal 2016-001777 Application 11/551,365 Appellants contend that “the addition of the recited components (polyether, polyalkylene glycol, etc.) must cause the aggregation.” Reply Br. 2—3 (“[t]he claims require that the water-soluble combined body of the cationic magnetic fine particle and the phospholipid vesicle are aggregated by adding an aggregating agent”); see Appeal Br. 9-10. In so far that Appellants are arguing about the timing when the polyalkelene glycol is added to the assay mixture in Ullman, we are also unpersuaded. Ullman places no limitations as to when the binding enhancer is added to the assay other than that it is reasonably included before the physical separation by the magnetic field. The magnetic field is applied after incubating the substance containing liquid and magnetic particles. FF1. The binding agent can be added either when the substance containing liquid is added to the magnetic particles or after mixing those two components, but before the magnetic separation. See FF1 and FF4. Because Ullman does not limit when the binding enhancer is added, we are not persuaded by Appellants’ contentions that the polyalkelene glycol could not act as an aggregating agent in Ullman’s assay. Appellants contend that Ullman “teaches pH selection as a way to promote non-specific binding and aggregation of the magnetic particles prior to separation.” Reply Br. 6. According to Appellants, the Examiner has failed to provide reasoned explanation for why the polyalkylene glycols, optionally disclosed by Ullman et al. but clearly for a purpose other than aggregation, and which even if included could be included in amounts not necessarily appropriate for aggregation, would necessarily result in aggregation of the particles when used according to the teachings of Ullman. Reply Br. 5. 8 Appeal 2016-001777 Application 11/551,365 We recognize, but are not persuaded by, Appellants’ contention that the amount of binding agent taught in Ullman would not necessarily be sufficient to achieve aggregation. Argument that a process disclosed by the prior art inherently differs from a claimed process must be supported by more than “bare assertion.” In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996). Ullman teaches that binding agents are added to improve the assay performance. FF4. Ullman’s assay separates a substance contained in a liquid medium with magnetic particles. Ullman gives a reason to add polyethylene glycol to the assay, namely to function as a binding enhancer. FF4. As discussed above, Ullman places no time limitation for the addition of the binding enhancer into the disclosed assay. In Ullman the binding enhancer is added before separating the bound magnetic particles from the solution. FF1 and FF4. The binding enhancer functions to help attach the substance to the magnetic particle. The fact that Ullman explicitly provided several choices to include in the assay does not make following any one of Ullman’s suggestions any less obvious. See Merck, 874 F.2d at 807. The Patent and Trademark Office has no laboratory in which to test the effect of polyethylene glycol as a binding agent as disclosed in Ullman’s assay versus the effect of the same compound as an aggregating agent, which is why the burden to provide such evidence is reasonably shifted to Appellants. “From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (1963). Appellants have not produced evidence to show that the polyethylene glycol disclosed in Ullman in an amount sufficient to to be a binding enhancer between the substance and the magnetic particle is not also a sufficient amount to achieve aggregation as claimed. We agree 9 Appeal 2016-001777 Application 11/551,365 with the Examiner that the prior art describes a similar process of separating substances using magnetic beads which includes the use of a binding enhancer, such as polyalkylene glycol, in a process similar to that claimed. See FF1 and FF4. Based on that similarity, we find that the burden has reasonably been shifted to Appellants to provide evidence that the amounts of polyethylene glycol needed to achieve enhanced binding activity would not be effective at achieving aggregation as claimed, which they have not provided. “Appellant notes that the Examiner is conflating the aggregating function with binding enhancements Reply Br. 7. We are not persuaded by Appellants’ contention. Here, the Examiner has identified that Ullman teaches using polyalkylene glycols in a method that separates a substance from a liquid medium using magnetic particles. Ans. 6; FF4. “[A] compound and all of its properties are inseparable.” See Papes eh, 315 at 391. There is no evidence in this record that shows the same compound behaves differently in different circumstances. Without further evidence we find that it is reasonable for the Examiner to conclude that Ullman’s polyethylene glycol functions as both a binding enhancer and an aggregating agent. We conclude that the preponderance of the evidence of record supports the Examiner’s conclusion that Ullman renders obvious the method of claim 15. We thus affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as being obvious, as claims 16—18, 22, and 25 fall with that claim, we affirm the rejection as to those claims as well. 37 C.F.R. § 41.37(c)(l)(iv). 10 Appeal 2016-001777 Application 11/551,365 Obviousness over Ullman and Sato Appellants do not provide additional arguments with respect to claims 23 and 24 other than stating that “no proper combination” of Ullman and Sato would render the claims obvious. Appeal Br. 14; see Reply Br. 8. Therefore, for the reason discussed above, and those set out in the Answer and Final Action, we find that the Examiner did not err in rejecting claims 23 and 24. SUMMARY We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) over Ullman. Claims 16—18, 22, and 25 were not separately argued and fall with claim 15. We affirm the rejection of claims 23 and 24 are under 35 U.S.C. § 103(a) as unpatentable over Ullman and Sato. 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). AFFIRMED 11 Copy with citationCopy as parenthetical citation