Carlsson, Ola et al.Download PDFPatent Trials and Appeals BoardOct 29, 201913805040 - (D) (P.T.A.B. Oct. 29, 2019) 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. 13/805,040 04/03/2013 Ola Carlsson 3724361-00029 3654 29178 7590 10/29/2019 K&L Gates LLP-Gambro P. O. BOX 1135 CHICAGO, IL 60690-1135 EXAMINER SINGH, RANDEEP ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 10/29/2019 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): uspatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte OLA CARLSSON, TORBJORN LINDEN, LENNART JONSSON, and ANDERS WIESLANDER __________ Appeal 2018-008641 Application 13/805,0401 Technology Center 1600 __________ Before FRANCISCO C. PRATS, RACHEL H. TOWNSEND, and CYNTHIA M. HARDMAN, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a dialysis acid precursor composition, a method of making it, an apparatus and a method of providing for dilution, which have been rejected as obvious. Oral argument was heard on October 22, 2019. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word “Appellant” to refer to “Applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Gambro Lundia AB. (Appeal Br. 2.) Appeal 2018-008641 Application 13/805,040 2 STATEMENT OF THE CASE Dialysis solutions, both for hemodialysis and peritoneal dialysis (“PD”), contain many electrolytes and an acid/base buffer system and optionally glucose. (Spec. 3.) “Dialysis solutions are today prepared from different types of concentrates.” (Id.) “[T]he availability of concentrated precursor compositions for further dilution and mixing with other components into a ready-for-use dialysis solution have decreased the costs and improved the environmental issues.” (Id. at 4.) There are known problems within dry precursor compositions “due to the presence of humidity within the dry precursor composition” such as “caking and lump formation of the different components” and “if glucose is present, a discoloration of the precursor” composition. (Id. at 4–5.) Appellant’s “invention concerns a dialysis acid precursor composition for use during preparation of a dialysis acid concentrate solution and for further mixing with water and a bicarbonate containing concentrate into a ready-for-use dialysis solution.” (Id. at 1.) Claims 1–3, 5–15, 17–22, and 24–26 are on appeal. Claim 1 is representative and reads as follows: 1. A dialysis acid precursor composition for use during preparation of a dialysis acid concentrate solution and for mixing with water and a bicarbonate containing concentrate into a ready-for-use dialysis solution, the dialysis acid precursor composition comprising: powder components comprising a sodium chloride powder, at least one dry acid powder, at least one magnesium salt powder, at least one calcium salt powder selected from the group consisting of calcium chloride monohydrate, anhydrous calcium chloride, calcium gluconate, and calcium α- ketoglutarate, and a glucose powder, wherein the at least one magnesium salt powder is in a quantity such that a Appeal 2018-008641 Application 13/805,040 3 concentration of 7.5-50 mM magnesium ions is provided in the dialysis acid concentrate solution, wherein the at least one magnesium salt and the glucose are present as anhydrous components in the dialysis acid precursor composition, and wherein the dialysis acid precursor composition is sealed in a moisture-resistant container with a water vapor transmission rate less than 0.3 g/m2/d at 38°C/90% RH. (Appeal Br. 23.) The following ground of rejection2 by the Examiner is before us on review: Claims 1–3, 5–15, 17–22, and 24–26 under 35 U.S.C. § 103(a) as unpatentable over Callan,3 Sugiyama,4 Stade,5 and Veltman.6 DISCUSSION The Examiner finds that Callan, Sugiyama, Stade, and Veltman “are all directed to dry dialysate compositions.” (Final Action 6.) The Examiner notes that Callan teaches a dry dialysis precursor composition in the form of a powder that includes sodium chloride, a calcium salt such as calcium chloride, a dry acid powder and a magnesium salt, as well as including glucose. (Final Action 3 (citing Callan ¶¶ 109, 21, 52, 108, 112); Ans. 4 (citing Callan ¶¶ 14–17).) The Examiner explains that Callan also teaches that the chloride salts can be “introduced simultaneous with cations selected 2 The Examiner rejected all of the pending claims on the ground of nonstatutory obviousness-type double patenting over claims 1–22 of co-pending U.S. Application No. 13/805474. The co-pending application has been abandoned. Thus the rejection is moot. 3 Callan et al., US 2004/0060865 A1, published Apr. 1, 2004. 4 Sugiyama et al., US 2010/0120702, published May 13, 2010. 5 John H. Stade, US 3,560,380, issued Feb. 2, 1971. 6 Preston L. Veltman, US 4,756,838, issued July 12, 1988. Appeal 2018-008641 Application 13/805,040 4 from sodium, potassium, magnesium, and calcium, and may be in anhydrous . . . forms.” (Final Action 3 (citing Callan ¶ 108).) The Examiner also explains that Callan teaches that the glucose can be provided in anhydrous form. (Ans. 4 (citing Callan ¶ 112); Final Action 4.) The Examiner further finds that Callan teaches that “the concentration of magnesium in their compositions is less than about 100 mEq/L.” (Final Action 3 (citing Callan ¶ 46).) The Examiner further finds that “Callan teaches storage of their dry dialysis precursor compositions in hermetically-sealed packages for convenience in shipping.” (Ans. 7.) The Examiner acknowledges that Callan “do[es] not explicitly recite sealing their dialysis acid precursor compositions in a moisture-resistant container with a water vapor transmission rate less than 0.3 g/m2/day at 38 ºC/90%RH.” (Final Action 3.) The Examiner turns to Sugiyama, Stade, and Veltman and determines that this limitation would have been obvious. In particular, the Examiner finds that Sugiyama also teaches powdery preparations for dialysis and that these preparations are “packed in a suitable container capable of preventing transmission of water vapor and gases, for example, those having water vapor transmission rates of less than 1.0g/m2/24 hrs (under 40 degrees C., 90% Relative Humidity).” (Final Action 5 (citing Sugiyama ¶ 53); Ans. 7.) The Examiner also finds that Stade discloses that “dry dialysis compositions degrade, cake, and discolor due to moisture, and that this can be alleviated by storage in moisture impermeable containers and the use of anhydrous components.” (Final Action 5.) The Examiner further finds that Veltman discloses using dextrose (i.e., glucose) “in anhydrous form in dry Appeal 2018-008641 Application 13/805,040 5 dialysate mixtures for long package shelf life, wherein all components are dry, because dextrose tends to decompose and brown/discolor.” (Id. at 5–6.) The Examiner concludes that, in view of these teachings, it would have been obvious to include anhydrous forms of dextrose, sodium chloride, magnesium chloride, and calcium chloride in dry dialysate precursor compositions with a reasonable expectation of success that the precursor composition would be stable and exhibit an optimal pH for dialysis applications. (Ans. 10; Final Action 6.) The Examiner also concludes that one of ordinary skill in the art would have found it obvious to seal the glucose-containing dialysis precursor composition of Callan in a moisture- resistant container to ensure that the dialysis acid precursor composition would remain dry and alleviate degradation, caking, and discoloration due to moisture as suggested by Stade and Veltman, and to obtain long package shelf life. (Final Action 5; Ans. 7.) Regarding the limitation with respect to the use of a container with a maximal water vapor transmission rate of 0.3 g/m2/d, the Examiner finds that such would have been deemed a result effective variable in light of the teachings of Sugiyama to use a container having water vapor transmission rates of less than 1.0g/m2/24 hrs and in light of Stade and Veltman’s teaching to keep the compositions dry in storage to avoid degradation, caking and discoloration and Stade’s teaching to store the compositions in moisture impermeable containers. (Final Action 5; Ans. 7, 11.) The Examiner concludes that using a container with a maximal water vapor transmission rate of 0.3 g/m2/d would have been obvious as a matter of routine optimization. (Id.) Appeal 2018-008641 Application 13/805,040 6 We agree with the Examiner’s factual findings and conclusion that the claimed invention would have been obvious to one of ordinary skill in the art. Appellant’s argument that Callan teaches away from the claimed invention because it refers many times to mixing the ingredients with water to produce a dialysate precursor (Appeal Br. 10; Reply Br. 2–3) is not persuasive. While it is true that Callan does teach embodiments of the acid concentrate as a liquid, it nevertheless teaches that “[i]n a related embodiment, the invention provides a dry dialysate precursor composition . . . [that can be] a pellet or tablet . . . [or] a powder.” (Callan ¶ 15; see also id. ¶ 21 (“In a related embodiment, the invention provides a dry acid- concentrate precursor composition comprising the above-recited components (absent the water) which, upon mixing with water, provides the aqueous acid-concentrate composition having the indicated components in the indicated concentrations.”); ¶ 72 (“The present invention also provides the same composition in a water-free form which, upon mixing with water, will form the aqueous acid-concentrate composition described above.”); ¶ 108 (“The dry PD composition, and the peritoneal dialysate prepared therefrom, is described in terms of anionic species because each anionic species may be introduced into the composition in any dry form that is physiologically acceptable and contains the anionic species of interest.”).) “[I]n a section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.’” Merck & Co. Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (second alteration in original) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976).) Callan does not Appeal 2018-008641 Application 13/805,040 7 teach away from a dry form of the precursor composition simply because it provides more detailed disclosure of the aqueous version of the composition. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (“A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path.”) We also do not find persuasive Appellant’s argument that Callan does not teach magnesium salt and glucose present as anhydrous components in a dialysis acid precursor composition comprising powder components. (Appeal Br. 10.) Callan teaches that “[t]he present invention makes an aqueous acid concentrate that may be used in the preparation of either hemodialysate or peritoneal dialysate.” (Callan ¶ 76.) But Callan also explains that the acid-concentrate precursor composition that includes chloride and citrate and sufficient physiologically-acceptable cations to provide for a neutral composition can be made as a dry composition. (Callan ¶¶ 20–22, 25.) Furthermore, Callan teaches that, for the dry PD composition, the citrate can be provided in an anhydrous form as can the chloride ions (id. ¶ 108), and that the glucose used in the acid PD precursor composition may also be provide in an anhydrous form (id. ¶ 112). Thus, we conclude that one of ordinary skill in the art would have found it obvious from the teachings in Callan to include magnesium salt and glucose in an anhydrous form in the dry acid-concentrate precursor PD composition. Moreover, we find that Stade would have provided further motivation to include all of the chloride salt elements of the acid-concentrate in their anhydrous form, because Stade teaches that use of such anhydrous grade components enables preparation of “dry hemodialysis concentrates which Appeal 2018-008641 Application 13/805,040 8 resist caking and discoloration if protected from external moisture.” (Stade 2:6–10.) We also find Veltman would have lent motivational support to provide all the components of Callan as anhydrous components, including dextrose, given its teaching of providing a non-caking dry free flowing color stable dialysis concentrate where the term “‘dry’ . . . means that there is no water present that is capable of participating in, or facilitating reaction between constituents” and the teaching that “dextrose may be added as an anhydrous material” and it is “never combined with the other components of the compositions . . . prior to the water removing step wherein said other components are rendered dry.” (Veltman 3:15–32, 8:62–65, 10:10–18.) In other words, Veltman notes the importance of having no water present at all from any component in order to preclude caking and have a color stable concentrate. We conclude that one of ordinary skill in the art would have understood this need for the absence of water to provide a shelf stable composition that does not cake would be necessary, even where the alkalizing agent was not the sodium acetate employed by Stade and Veltman, given that Sugiyama teaches a composition employing citric acid as the alkalizing agent to avoid the adverse effects known to be caused by acetate dialysis compositions (Sugiyama ¶ 8) and notes the preference of storing in a container capable of preventing transmission of water vapor and gases (id. ¶ 53) (Appeal Br. 13–14). Appellant’s argument that Callan is silent regarding vapor transmission rates (Appeal Br. 11) is not persuasive of non-obviousness. The Examiner acknowledged that Callan is silent on that point and relied on the teachings of Sugiyama, Stade, and Veltman for the obviousness of preventing water vapor transmission during storage so as to prevent Appeal 2018-008641 Application 13/805,040 9 degradation and that the specific rate limitation would have been obvious to optimize based on routine experimentation given Sugiyama’s teaching that “[i]t is preferable to use a container capable of preventing transmission of water vapor and gases, for example, such as having water vapor transmission rates of 1.0 g/m2/24 hrs or less” (Sugiyama ¶ 53). We agree. Stade teaches that moisture is a known problem during storage of dry dialysate precursor compositions: When the dry salts required for the hemodialysis solution are mixed and stored, even in moisture-impermeable containers, serious compatibility problems are encountered. After a time the dry concentrates become caked and discolored and undergo other deleterious chemical changes. (Stade 1:49–54.) And Stade further teaches that caking and discoloration can be resisted if the dry concentrate is “protected from external moisture.” (Id. 2:6–10.) While the foregoing is not discussed in Callan, one of ordinary skill in the art would be well aware that storage in a dry environment to prevent caking, degradation, and discoloration would be important to a dry dialysis precursor composition that is “[to be] supplied to the dialysis clinic.” (Callan ¶ 9.) Indeed, Sugiyama does not explain this either, but notes that it is “preferable to use a container capable of preventing transmission of water vapor and gases.” (Sugiyama ¶ 53.) Callan “must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). As to the claimed use of a moisture-resistant container with a water vapor transmission rate less than 0.3 g/m2/day at 38 ºC/90%RH, we note that there is a presumption of obviousness in light of Sugiyama’s teaching of the preference of using a container with a maximum water vapor transmission Appeal 2018-008641 Application 13/805,040 10 rate of 1.0 g/m2/24 hrs, “or less” (Sugiyama ¶ 53), which range of 0–1.0 g/m2/24 hrs encompasses the claimed less than 0.3 g/m2/day. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) (“[T]he existence of overlapping or encompassing ranges shifts the burden to the applicant to show that his invention would not have been obvious.”); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (“[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.”). Moreover, we disagree with Appellant that Sugiyama does not recognize water vapor transmission rate as being a result-effective variable. (Appeal Br. 13.) That is because Sugiyama provides an upper limit for the vapor transmission rate, thereby suggesting that modification to a lower rate of preventing transmission of water vapor and gases would be a result effective for preventing the known problem of caking in storage due to moisture. Appellant’s argument that Sugiyama does not “disclose or suggest powder components comprising a sodium chloride powder, at least one dry acid powder, at least one magnesium salt powder, at least one calcium salt powder selected from the group consisting of calcium chloride monohydrate, anhydrous calcium chloride, calcium gluconate, and calcium α-ketoglutarate, and a glucose powder” (Appeal Br. 12) is unavailing. As the Examiner noted, “[o]ne cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413 . . . (CCPA 1981).” (Ans. 8.) Callan teaches the claimed components being used in an anhydrous form as discussed above, and Sugiyama was relied upon for the fact that it was known in the art to Appeal 2018-008641 Application 13/805,040 11 preferably use containers for storing dry dialysis concentrates in containers that prevent vapor transmission. Appellant argues that it has demonstrated “unexpected/surprising” results with the evidence set forth in the Declaration of inventor Ola Carlsson submitted December 19, 2016 (“Carlsson Declaration”) comparing various dialysate compositions (Appeal Br. 10–11; Reply Br. 2–3) and the evidence in the Specification comparing dialysate compositions stored in containers with different vapor transmission rates (Appeal Br. 13). We do not agree. First, we note that simply providing comparative test results and stating that the results are unexpected is not sufficient to demonstrate non- obviousness. “To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). Moreover, in assessing whether a result is unexpected, we must consider what properties would have been expected. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We find the Examiner considered the evidence and did not find it probative because the Declarant did not consider all of the relevant evidence. (Ans. 5.) We agree. In rendering the ultimate conclusion as to what was unexpected, we note that inventor Carlsson does not consider the teachings of Stade and Veltman: It is my understanding that the Office Action has rejected independent Claims 1, 8, 13, and 20 under 35 U.S.C. § 103(a) as being unpatentable over U.S. Patent Publication No. 2011/0172583 to Callan et al (“Callan”) in view of U.S. Patent Appeal 2018-008641 Application 13/805,040 12 Publication No. 2010/0120702 to Sugiyama et al. (“Sugiyama”). (Carlsson Declaration ¶ 5.) And as discussed above, Stade teaches that moisture in the dry concentrate is known to cause caking and discoloration and Stade even noted that commercially available anhydrous sodium acetate was not dry enough to prevent caking (Stade 1:55–61). Stade teaches that the salts of sodium, magnesium, calcium and potassium, and that dextrose be provided as anhydrous components to ensure as little moisture as possible, i.e., less than 0.75% by weight. (See, e.g., Stade 2:35–56.) Furthermore, as the Examiner explained, “Veltman discloses that dextrose (i.e., glucose) is used in anhydrous form in dry dialysate mixtures for long package shelf life, wherein all other components are rendered dry, because dextrose tends to decompose and brown/discolor (see column 10, lines 10-18 and column 28 lines 21–-38).” (Ans. 5.) These teachings combined with Callan’s teaching that the dry acid PD composition can be made with all anhydrous components was not considered by inventor Carlsson at all in assessing the unexpectedness of the storage stability of the claimed composition. Thus, the fact that inventor Carlsson concluded that there was significantly improved storage stability in certain of the compositions does not consider the fact that the art suggests stability of Callan’s dry acid PD composition where all ingredients are provided as anhydrous components. Furthermore, we do not disagree that the comparative testing appears to show that two year stability is achieved even when KCl, NaCl and CaCl2 are not anhydrous but MgCl2, citric acid and glucose are anhydrous. (See Carlsson Declaration ¶ 9, No. 2 and No. 7 and ¶ 11.) However, the claimed composition does not exclude the use of anhydrous forms of KCl, NaCl and Appeal 2018-008641 Application 13/805,040 13 CaCl2 salts, and as just discussed, the art suggests the stability of a composition where all the ingredients present are anhydrous. As for the comparative data in the Specification concerning the moisture resistant containers, we note that the comparison between a container with a transmission rate of 0.3 g/m2/day and of one with 2.7 g/m2//day is not a comparison of the closest prior art since Sugiyama teaches storage stability in a container with a transmission rate of less than 1.0 g/m2/day. Appellant’s assertion that one of ordinary skill in the art would understand that if Composition 3 were enclosed in the sealed plastic bag of Sugiyama, brown lump formation would be delayed at best to slightly less than 3 months, (Appeal Br. 13) is a bare assertion not grounded in scientific discussion or evidence. “Attorney’s argument in a brief cannot take the place of evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). After considering all the evidence before us, we conclude that Appellant has not provided sufficient evidence to show the non-obviousness of the claimed subject matter. In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984); In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976). Thus, Appellant does not persuade us that the Examiner erred in rejecting claim 1 for obviousness. Claims 2, 3, 5–7, 9–11, and 24–26 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appellant purports to argue the remaining claims on appeal (claim 8, 12–15, and 17–22) separately (see Appeal Br. Section III. D–F). However, the arguments are identical to those Appellant asserted for independent Appeal 2018-008641 Application 13/805,040 14 claim 1. We do not find those arguments persuasive for the reasons just discussed. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 5–15, 17–22, 24– 26 103(a) Callan, Sugiyama, Stade, Veltman 1–3, 5–15, 17–22, 24– 26 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 Copy with citationCopy as parenthetical citation