Ex Parte Hollander et alDownload PDFPatent Trial and Appeal BoardMar 14, 201713599045 (P.T.A.B. Mar. 14, 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. 13/599,045 08/30/2012 Scott Wayne Hollander OTSU-001/00US 310697-2002 1058 58249 7590 03/16/2017 COOLEY LLP ATTN: Patent Group 1299 Pennsylvania Avenue, NW Suite 700 Washington, DC 20004 EXAMINER PERREIRA, MELISSA JEAN ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 03/16/2017 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): zpatdcdocketing@cooley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SCOTT WAYNE HOLLANDER, JOEL ROBERT TIMBERLAKE, and MARJORY KADASH1 Appeal 2015-000345 Application 13/599,045 Technology Center 1600 Before ERIC B. GRIMES, ULRIKE W. JENKS, 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 bottle containing excipient free powdered contrast agent. The Examiner rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm the rejection for obviousness, but designate the affirmance a new ground of rejection. 1 According to Appellants, the Real Party in Interest is Otsuka Pharmaceutical Co., Ltd. App. Br. 3. Appeal 2015-000345 Application 13/599,045 STATEMENT OF THE CASE The Specification explains that “contrast agents, are [often] provided to healthcare facilities in bulk containers that can hold a large quantity of the medicament or contrast agent. . . . Typically, such concentrated materials require the use of a separate container for dilution and/or consumption of the medicament or contrast agent.” Spec. 2. The use of multiple containers for preparing the “contrast agent for oral consumption can present various undesirable results, such as, for example, improper dilution strength, separation of the medicament or contrast agent from identifying labels and/or separation of the medicament or contrast agent from instructions for use.” Id. Claims 1, 7, 8, 11—16, 20-24, and 31—43 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal, and reads as follows: 1. An apparatus, comprising: a container body defining an opening in fluid communication with an interior of the container body; a cap coupled to the container body and enclosing the opening; a unit dose of an excipient free concentrated contrast agent in powder form disposed within the interior of the container body, the unit dose of the excipient free concentrated contrast agent configured to be diluted to a select dilution strength with a volume of a liquid receivable through the opening and within the interior of the container body; and a barrier member defining an interior, the container body and the cap collectively disposed within the interior of the barrier member, the barrier member being sealed. App. Br. 17 (emphasis added). 2 Appeal 2015-000345 Application 13/599,045 Appellants request review of the Examiner’s rejection of claims 1, 7, 8, 11—16, 20-24, and 31—43 under 35 U.S.C. § 103(a) as unpatentable over Kampfe2 in view of Zamparo,3 Conyers,4 Nagashima,5 Traboulsi,6 Wagner,7 Fennimore,8 and Mitsushima.9 As Appellants do not argue the claims separately, we focus our analysis on claim 1 and claims 7, 8, 11—16, 20—24 and 31—43, stand or fall with that claim. 37 C.F.R. § 41.37 (c)(l)(iv). See Appeal Br. 5—15, see also 15 (“claim 32 is further allowable for similar reasons as discussed above for claims 1 and 38”). Findings of Fact FF1. Zamparo teaches the production of “[ijnjectable radio-opaque compositions for tissue augmentation and in particular hard tissue augmentation, and kits.” Zamparo Abstract. Zamparo’skit comprises: a) a first container comprising fibrinogen, b) a second container comprising thrombin, and c) a third container comprising a strontium salt. Id. ]Hf 21—24. “Optionally, the kit further comprises a 2 Kampfe et al., US 5,592,940, issued Jan, 14, 1997. 3 Zamparo et al, US 2010/0284919 Al, published Nov. 11, 2010. 4 Conyers et al., Antibody-Labeled Liposomes for CT Imaging of Atherosclerotic Plaques: In Vitro Investigation of an Anti-ICAM Antibody- Labeled Liposome Containing Iohexol for Molecular Imaging of Atherosclerotic Plaques via Computed Tomography, 36 Texas Heart Institute Journal, 393—403 (2009). 5 Nagashima et al., Embolization of arteriovenous malformation using freeze-dried iohexol as contrast material, 5 J. Clinical Neuroscience 80—81 (1998). 6 Traboulsi et al., US 2011/0042255 Al, published Feb. 24, 2011. 7 Wagner et al., US 2013/0056386 Al, published Mar. 7, 2013. 8 Fennimore, US 4,150,744, issued Apr. 24, 1979. 9 Mitsushima, WO 2011/136336, published Nov. 2011. 3 Appeal 2015-000345 Application 13/599,045 fourth container comprising a dry, powdered iodinated contrast agent or a iodinated contrast agent in solution.” Id. 126, 131. FF2. Zamparo teaches numerous suitable iodinated contrast agents that can be included in the kit as a dry powder. Id. H20, 82—86. Zamparo’s kit contains fibrinogen and thrombin, which are mixed together first and then the resulting solution is added to the other dry components, including the dry contrast agent. See id. H 137—138. FF3. Kampfe teaches a contrast agent mixing device that contains “two containers 12 and 14 [that] are connected to a mixing chamber 20 by feed pipes.” Kampfe 7:60—61. Kampfe teaches that “a predetermined amount of concentrated contrast medium is mixed with a predetermined amount of diluent, and optionally other additives, to formulate the desired dosage form of contrast medium” for consumption by the patient. Kampfe 3:64—67. FF4. Kampfe’s device provides “a first vessel containing a concentrated flowable contrast medium.” Kampfe 7:60—61. Kampfe teaches numerous contrast media including “iohexol.” Kampfe 3:46. “These concentrates are used in the form of solutions, dispersions or as free- flowing powder and are put into appropriate concentrate containers.” 3:24—26 (emphasis added). FF5. Traboulsi teaches a prefilled beverage bottle to which “a predetermined amount of a water soluble oral contrast imaging agent [is added] to the beverage within the chamber.” Traboulsi 121. 4 Appeal 2015-000345 Application 13/599,045 FF6. Traboulsi teaches a bottle with markings, shown in Fig. 1 below: ,je Fig. 1 shows that “device 10 is a container in the form of a plastic bottle defining a substantially cylindrical body 12,” with “[a] closure in the form of a threaded cap 18 [that] is threadedly connected to the neck 14 to seal the bottle.” Id. |32. The figure shows a side elevational view “that includes a volume scale and a time scale on an externally visible surface for identifying the amount of mixture that should be consumed approximately on or before expiration of each respective time interval.” Id. |29. FF7. Traboulsi teaches that the bottle “may be provided with a dry powdered version or concentrated liquid version of the beverage requiring reconstitution with water or other liquid prior to or after the addition of the oral contrast agent.” Id. |42. 5 Appeal 2015-000345 Application 13/599,045 FF8. Fennimore teaches the use of an envelope to package a bottle. Figure 1, shown below, depicts such an envelope and bottle. Fig. 1 reproduced above shows a “laminated foil envelope 1 [that] is heat sealed along each edge at la and along the bottom at lb. An additional top seal 1 c is provided and beneath this there is a tear notch 5 in one side of the envelope.” Fennimore 3:58—61. “The envelope is preferably a metal foil/ polymer laminate, two layers of which can be heat sealed.” Id. at 3:1—3. “The envelope in the combination resists entry of oxygen and light and loss of water vapour.” Id. at 2:63—64. FF9. The Specification explains that in one embodiment the “substance 140 can contain excipients such as dispersants, disintegrants, coatings, enteric, fillers, flavors, glidants, sorbents, preservatives, sweeteners, colors, wetting agents, binders, anti-caking agents, and/or any other suitable substances to enhance dispersal, dilution, stability, taste, 6 Appeal 2015-000345 Application 13/599,045 processability, absorption, appearance, etc. of the concentrated substance 140.” Spec. 120. Principle of Law “If a person of ordinary skill can implement a predictable variation [of a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” Id. at 416 (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). Analysis The Examiner’s position is that both Kampfe and Zamparo teach using iodinated contrast agents in powder form. Ans. 3^4. At the time of the invention it would have been obvious to one ordinarily skilled in the art that a concentrated powder iodinated contrast agent (e.g. iohexol) may be provided within a container without any excipients as Kampfe et al. teaches that free- flowing powder concentrates of iodinated contrast agent are put into appropriate concentrate containers, without additives, prior to mixing with a diluent, Zamparo et al. teaches of containers containing a dry, powdered iodinated contrast agent (e.g. iodixanol, etc.) prior to mixing with constituents from other containers. Ans. 4. We agree with the Examiner’s position that Kampfe teaches a vessel containing powdered contrast agent, and Zamparo discloses a vessel containing dry powdered contrast agent as part of a kit. The Examiner relies on Traboulsi for teaching a container that meets the physical limitations as claimed. See Ans. 5. The Examiner finds that Traboulsi’s “container or device may be filled with a dry powdered version 7 Appeal 2015-000345 Application 13/599,045 or concentrated liquid version of the beverage requiring reconstitution with water or other liquid prior to or after the addition of the oral contrast agent.” Ans. 6. The Examiner finds that Traboulsi “teaches that the containers have graduations” and concludes that “one ordinarily skilled in the art would envision mixing a respective volume of diluent into the container comprising iohexol in a concentrated powder form.” Ans. 7. Finally, the Examiner relies on Wagner and Fennimore to teach enclosing a container with “a light tight gas-impermeable envelope to protect the iohexol composition against gases, vapors and light.” Ans. 8. We agree with the Examiner that the combination of references support a prima facie case of obviousness. Zamparo teaches a kit for mixing an injectable radio-opaque composition. FF1. The kit includes a unit dose of dry powdered contrast agent by itself in a container. FF1 and FF2. The fibrinogen and thrombin containing solution is added to the container containing the dry contrast agent. FF2. Kampfe teaches a mixing device that has a separate container that stores multiple units of a concentrated form of dry contrast agent, which remains in Kampfe’s container until a measured amount of the agent is deposited into the mixing chamber. FF3 and FF4. Kampfe teaches mixing a predetermined amount of contrast medium with a predetermined amount of diluent to reach a desired dosage form. FF3. Kampfe teaches using the contrast agent iohexol. FF4. Traboulsi teaches a bottle for mixing a contrast agent. FF5. Traboulsi’s bottle has a body and a cap, and includes graduations and a window that show how much liquid is in the bottle. FF6. Traboulsi’s bottle 8 Appeal 2015-000345 Application 13/599,045 can contain a powdered version of the beverage that requires reconstitution of the powder before or after the addition of contrast agent. FF7. Finally, Fennimore teaches a bag that can hold a bottle and protect the contents of the bottle from “oxygen and light.” FF8. We agree with the Examiner that it would have been obvious to modify Traboulsi’s device by substituting the powdered beverage in the bottle for a powdered contrast agent. See Final Act. 7 (“it would have been obvious to one ordinarily skilled in the art to supply iohexol in a concentrated powder form in the device of Traboulsi et al. as the combined references above teach excipient free concentrated iohexol powder in a container prior to mixing with a diluent (e.g. water)”). It is obvious to substitute one known element for another when the combination yields a predicable result. KSR, 550 U.S. at 416. In this case the predictable result is to arrive at a powdered contrast agent stored in a bottle that allows the powder to be reconstituted in the bottle. This predictable result is buttressed by Zamparo’s teaching of storing dry contrast agent in a container as part of a kit. Kampfe also teaches that the beverage and contrast agent components are stored separately until ready to use. Kampfe teaches iohexol as a contrast agent in the form of a flowable powder. Because Kampfe teaches that iohexol can be mixed with a beverage for consumption by a patient, it would be obvious to use this contrast agent with the bottle taught by Traboulsi. Finally, we agree with the Examiner that placing the bottle containing the contrast agent as suggested by the combination of Zamparo, Kampfe, and Traboulsi into the bag as disclosed in Fennimore (as well as Wagner) would be obvious for the purpose of protecting the contrast agent from oxygen and light. 9 Appeal 2015-000345 Application 13/599,045 Appellants contend that the Examiner picks and chooses from eight different references in an attempt to show the various recitations in claims 1,15 and 38 . . . [but still] fail[s] to show that these eight references disclose or teach each and every limitation in claims 1,15 and 38, but Appellants submit that this is a clear case of hindsight reconstruction. Appeal Br. 6. We are not persuaded by Appellants’ contention that picking and choosing among various disclosures is improper in the context of an obviousness analysis. See In reArkley, 455 F.2d 586, 587—588 (CCPA 1972). Furthermore, the argument that too many references are combined is also unavailing as it has been recognized that reliance on a “large number of references” does not, without more, weigh against the obviousness of the claimed invention. In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991) (“The criterion, however, is not the number of references, but what they would have meant to a person of ordinary skill in the field of the invention.”). We recognize that the Examiner also cites Conyers and Nagashima for teaching that iohexol can be purchased in dry powder form or produced by freeze-drying. With respect to claim 1, however, we find the teachings of Conyers and Nagashima to be cumulative to the teachings of dry powdered contrast agents shown in Kampfe and Zamparo and will not address these references further. See generally In re Bush, 296 F.2d 491, 496 (CCPA 1961) (the Board may rely on less than all of the references relied upon by Examiner). 10 Appeal 2015-000345 Application 13/599,045 Excipient free powdered contrast agent Appellants contend that none of the references “teach a unit dose of an excipient free powder contrast agent disposed within a container.” Appeal Br. 7, see also 13. The Examiner’s position is that Kampfe discloses excipient free contrast agent. See Ans. 11. We begin with claim construction of the phrase “excipient free” powder contrast agent, giving the claims their broadest reasonable interpretation consistent with the Specification. In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). According to the Specification, excipients include for example dispersants, disintegrants, coatings, enteric, fillers, and flavors among others. FF9. Given this definition of excipient it is understood that an excipient is something that is added to the active agent in order to impart a desirable feature to the active agent. Therefore, we interpret excipient free to be a composition that does not contain any of the listed ingredients identified as suitable for mixing with the active agent. FF9. The broadest reasonable interpretation of “excipient free” powdered contrast agent as read in light of the Specification is that nothing can be added to the contrast agent, however, the contrast agent could still encompass any contaminates that are part of the production, synthesis, and isolation of the contrast agent. The Examiner finds that “the contrast agent that is free of excipients and additives as dry powdered iodinated contrast agent is taught in the prior art without additives, for example Kampfe et al. teaches that additives are optional.” Ans. 11. We agree with the Examiner that Kampfe teaches excipient free contrast agents, such as iohexol. Specifically, we find that the contrast agents listed in Kampfe are not limited in any way. FF4; see 11 Appeal 2015-000345 Application 13/599,045 Kampfe 3:45—53. In other words, Kampfe does not limit the iohexol,10 or any other taught contrast media, to particular brands or compositions. Because iohexol is available as an analytical agent there is no reason to believe that the iohexol referenced in Kampfe includes excipients. Because iohexol in Kampfe is not limited, it is reasonable to conclude that the iohexol disclosed in Kampfe includes excipient free compositions of the contrast agent. Accordingly, we are not persuaded by Appellants’ contention that excipient free iohexol is not taught by the cited art. Contrast agent in a container Appellants contend that “Traboulsi does not disclose or suggest that at any point the bottle can contain only contrast agent.” Appeal Br. 10, see also 12; Reply Br. 10. Appellants contend that the “language makes clear that Traboulsi contemplates that the container could be provided with a concentrated version of the beverage, not the contrast agent.” Appeal Br. 12. We are not persuaded. The Examiner explains that “[t]he device [of Traboulsi] is a bottle, [having] a closure for a treaded [sic] cap connected to the neck of the bottle to seal it. The device comprises graduations and labels for providing conventional information, product ingredients, etc.” Ans. 13. Traboulsi also discloses that powdered content can be stored in the bottle. FF7. Zamparo teaches a kit for producing a contrast agent containing composition that has components in a separate container. FF1. Zamparo 10 For example, iohexol is sold as an analytical standard that does not contain any of the listed excipients, http://www.sigmaaldrich.com/catalog/product/sial/74147?lang=en®ion= US#, last visited March 2, 2017. 12 Appeal 2015-000345 Application 13/599,045 teaches that the diluent is added to the container with the powdered contrast agent. FF2. Although Zamparo’s exemplified containers are syringes, the teaching of adding the diluent to the powder contrast agent is similarly applicable to containers that are larger, such as the bottles taught in Traboulsi. Traboulsi teaches the production of a contrast beverage by adding the contrast agent to the beverage in the bottle. See FF5—FF7. Traboulsi also discloses that the beverage can be stored in the bottle as a dry powder that can later be reconstituted. FF7. Both Kampfe and Zamparo teach that the contrast agents can be in a dry powder form that is mixed with a diluent. FF2 and FF3. Zamparo also teaches that the dry powder contrast agent is in a separate container as part of the kit. FF1. Substituting the dry powdered beverage with dry powdered contrast agent in Traboulsi’s bottle would have been obvious in light of these disclosures about containment of dry powders in various sized containers prior to the addition of diluent. The “substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR, 550 U.S. at 416. In this case, substituting a dose of dry powdered contrast agent in the bottle of Traboulsi produces the predictable result that the powder can be mixed with a diluent in the container as taught by Zamparo. The question of obviousness cannot be approached on the basis that an artisan having ordinary skill would have known only what was read in the references, because such artisan must be presumed to know something about the art apart from what the references disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). Moreover, the law presumes skill on the part of the artisan rather than the converse. See In re Sovich, 769 F.2d 738, 742-43 13 Appeal 2015-000345 Application 13/599,045 (Fed. Cir. 1985). Based on the disclosure in the combination of references (FF1—FF7), in conjunction with the knowledge of the ordinarily skilled artisan we agree with the Examiner’s conclusion that it would have been obvious to one ordinarily skilled in the art to supply iohexol in a concentrated powder form in the device of Traboulsi et al. as the combined references teach excipient free concentrated iohexol powder in a container prior to mixing with a diluent (e.g. water) from a second container and Traboulsi et al. teaches that the container or device with graduations may be used for mixing an oral imaging agent with a beverage and diluent to generate an oral contrast agent solution wherein the concentrated powdered contrast agent is contained within the bottle prior to dilution. Therefore, one ordinarily skilled in the art would envision mixing a respective volume of diluent into the container comprising iohexol in a concentrated powder form. Ans. 13. Unit dose Appellants contend that “[t]he Examiner fails to show that any of the cited references disclose or suggest a ‘unit dose’ as recited in the claims.” Reply Br. 8. We are not persuaded. We understand that a “unit dose” is the amount of contrast agent necessary for administration to a patient. As explained above, Zamparo teaches a kit for the production of a contrast agent containing composition that can be administered to a patient. FF1 and FF2. Here, the components in Zamparo’s kit are stored in separate containers and just before use they are then sequentially mixed in those containers to produce the final mixed composition. Most importantly Zamparo teaches adding the diluent to the dry powder components in the kit. Because Zamparo’s containers are syringes and are taught to be coupled to each other so the contents can be thoroughly mixed, it is reasonable to 14 Appeal 2015-000345 Application 13/599,045 conclude that each of the components in each container represents a unit dose of the respective components. Zamparo 122—131,1129 (“both bipartite syringe bodies are attached to a two-way connecting device and the contents are mixed by squeezing them through the injection needle attached to the connecting device”). We find that Zamparo teaches a unit dose of contrast agent stored in a container. We conclude that the evidence cited by the Examiner supports a prima facie case of obviousness with respect to claim 1, and Appellants have not provided sufficient evidence of secondary considerations that outweighs the evidence supporting the prima facie case. As Appellants do not argue the claims separately, claims 7, 8, 11—16, 20-24, 31, and 33—43 fall with claim 1. Claim 32 Appellants contend that “none of the Cited References disclose or suggest ‘the dilutable contrast agent [being] free of excipients and additives’ as recited in claim 32.” Appeal Br. 15. As discussed above, the Examiner relies on Kampfe to disclose excipient free contrast agent. We note that Kampfe does not limit the iohexol, or other taught contrast media, to particular brands or compositions. Therefore, it is reasonable to conclude that iohexol disclosed in Kampfe includes excipient free compositions of the contrast agent, as these agents are known to be available as analytical standards and are not limited to particular commercially available compositions. Accordingly, we are not persuaded by Appellants’ contention that excipient free iohexol is not taught by the cited art. 15 Appeal 2015-000345 Application 13/599,045 SUMMARY We affirm the rejection of claims 1 and 32 under 35 U.S.C. § 103(a) as unpatentable over Kampfe, Zamparo, Conyers, Nagashima, Traboulsi, Wagner, Fennimore, and Mitsushima. Because claims 7, 8, 11—16, 20-24, 31, and 33—43 were not argued separately they fall with claim 1. Although we affirm the Examiner’s rejection, we designate the affirmance a new ground of rejection because our rationale differs slightly from that of the Examiner. TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 CFR § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 CFR § 41.50(b) also provides that the appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. . . . 37 C.F.R. §41.500?) 16 Copy with citationCopy as parenthetical citation