Ex Parte Powers et alDownload PDFPatent Trial and Appeal BoardNov 29, 201713866960 (P.T.A.B. Nov. 29, 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. 13/866,960 04/19/2013 Kelly B. Powers 101672.0174P 4497 34284 7590 Rutan & Tucker, LLP 611 ANTON BLVD SUITE 1400 COSTA MESA, CA 92626 EXAMINER HIRT, ERIN E ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 12/01/2017 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): patents @ rutan. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KELLY B. POWERS, MURTAZA YUSUF AMIN, MATTHEW R. TREBELLA, JAMES L. FREASIER, and RAYMOND KERNS1 Appeal 2016-007517 Application 13/866,960 Technology Center 1600 Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to a buffered infusate for disposal in a container (e.g., a syringe) and a medical device (e.g., a syringe) containing such a buffered infusate. Claims 1—8 and 14—23 are on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as “C. R. Bard, Inc.” App. Br. 4. Appeal 2016-007517 Application 13/866,960 STATEMENT OF THE CASE The Specification states: Briefly summarized, embodiments of the present invention are directed to normal saline and other infusate aqueous solutions for infusion into the body of a patient during medical treatment. In particular, infusates are disclosed that are formulated to resist changes to the pH of the solution when subjected to sterilization procedures that employ ethylene oxide (“EO”) gas, also referred to herein as EO sterilization. EO sterilization is a common method for sterilizing various medical devices and components. Spec. 12. Claims 1, 14, and 21 are independent claims. We find claim 1 to be representative and it is reproduced below: 1. A buffered infusate suitable for disposal in a container, the container to be sterilized using ethylene oxide, the buffered infusate comprising: an aqueous solution disposed in the container, the aqueous solution suitable for infusion into a body of a patient; and a buffer component that is added to the aqueous solution to form a buffered solution, the buffer component resisting a change in pH of the buffered solution upon exposure of the buffered solution to the ethylene oxide during the sterilization of the container. App. Br. 18 (Claims App’x). The following rejections are on appeal: Claims 1,14, and 19 stand rejected under 35 U.S.C. § 103(a) over Choo2 and D’Alessio.3 Final Action 3. 2 US 2007/0293441 A1 (pub. Dec. 20, 2007) (“Choo”). 3 US 2010/0280547 A1 (pub. Nov. 4, 2010) (“D’Alessio”). 2 Appeal 2016-007517 Application 13/866,960 Claims 2—8, 20, and 21 stand rejected under 35 U.S.C. § 103(a) over Choo, D’Alessio, and Andrei.4 Id. at 5—6. Claim 15 stands rejected under 35 U.S.C. § 103(a) over Choo, D’Alessio, and Winn.5 Id. at 8. Claim 16 stands rejected under 35 U.S.C. § 103(a) over Choo, D’Alessio, andNiedospial.6 Id. at 10. Claim 17 stands rejected under 35 U.S.C. § 103(a) over Choo, D’Alessio, Niedospial, and Andrei. Id. at 12. Claim 18 stands rejected under 35 U.S.C. § 103(a) over Choo, D’Alessio, and Dempsey.7 Id. at 14. Claim 22 stands rejected under 35 U.S.C. § 103(a) over Choo, D’Alessio, Andrei, and Winter.8 Id. at 16. Claim 23 stands rejected under 35 U.S.C. § 103(a) over Choo, D’Alessio, Andrei, Winter, and DeWitt.9 Id. at 18. CLAIM INTERPRETATION Here, the Appellants’ arguments focus largely on their contention that the claimed invention requires a process of sterilization with ethylene oxide and, also, how the recited “buffer component” reacts to such a process. App. Br., inter alia, 8 (“not only does Choo fail to disclose sterilization by exposure to ethylene oxide, the buffer of Choo is not used to ‘resist[] a 4 WO 2011/162666 A1 (pub. Dec. 29, 2011) (“Andrei”). 5 US 2009/0259170 A1 (pub. Oct. 15, 2009) (“Winn”). 6 US 2003/0097096 A1 (pub. May 22, 2003) (“Niedospial”). 7 US 2007 /0292305 A1 (pub. Dec. 20, 2007) (“Dempsey”). 8 US 5,474,782 (issued Dec. 12, 1995) (“Winter”). 9 US 2006/0198868 A1 (pub. Sept. 7, 2006) (“DeWitt”). 3 Appeal 2016-007517 Application 13/866,960 change in pH . . . during the sterilization’ as required.”), 9 (“The claims require: (1) the buffer component and aqueous solution be combined prior to sterilization, and (2) the buffer component be used to resist a change in pH of the combined solution during ethylene oxide sterilization.”), 13 (“one of ordinary skill in the art would not have changed the sterilization method of Choo into a completely different type of sterilization”); see also Reply Br. 4—5, 8 (presenting similar positions). Because Appellants’ patentability arguments are foundationally premised on a claim interpretation requiring ethylene oxide sterilization, and because the Examiner disagrees that the claimed invention is defined by any method of sterilizing (see, e.g., Final Action 20), we consider whether the claims do, indeed, include such sterilization limitations. The Patent Office applies the broadest reasonable claim interpretation standard in proceedings. Cuozzo Speed Tech., LLC v. Lee, 136 S. Ct. 2131, 2145 (2016). “[AJpparatus [or composition] claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). “‘Functional’ terminology may render a claim quite broad. By its own literal terms a claim employing such language covers any and all embodiments which perform the recited function.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). “[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int 7, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). “When the claimed compositions are not novel they are not rendered patentable by 4 Appeal 2016-007517 Application 13/866,960 recitation of properties, whether or not these properties are shown or suggested in the prior art.” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990). “If the preamble adds no limitations to those in the body of the claim, the preamble is not itself a claim limitation and is irrelevant to proper construction of the claim.” IMS Technology, Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000). “Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Here, the independent claims are directed to “[a] buffered infusate suitable for disposal in a container,” “[a] medical device containing a buffered infusate,” and “[a] buffered saline infusate suitable for disposal in a syringe.” App. Br. 18, 20, 21 (Claim App’x). Therefore, we conclude each claim on appeal is directed to a composition or an apparatus, not a method. We further conclude that, under the above-cited precedent, the appealed claims cover only structure, thus, no limitation of any claim can require a method step, i.e., sterilizing by any process. We conclude that, the claim element(s) directed to “a buffer component” and/or “a buffered solution,” are directed to, and encompass within their scope, any such buffer component or solution that would be capable of resisting a change in pH that would be caused by “the creation of [] ethylene chlorohydrins,” as identified in the Specification at paragraph 27. See FF1, infra', see also Spec, 35—47 (describing an array of suitable buffer components for producing a buffer solution, e.g., weak acids paired with their conjugate bases, weak bases paired with their conjugate acids, 5 Appeal 2016-007517 Application 13/866,960 other suitable acid/conjugate base combinations, weak acid paired with a strong base, and weak based paired with a strong acid). FINDINGS OF FACT FF1. The Specification states that, upon ethylene oxide (EO) sterilization, “the presence in the saline solution of the buffer component causes the acetic acid and acetate base constituents of the buffer component to work in mitigating the increase in pH caused by the creation of the ethylene chlorohydrins.” Spec. 127. FF2. Choo discloses that ethylene oxide is a known sterilizing system, but focuses on and teaches sterilizing an aqueous (e.g., dialysis or glucose) solution containing a buffer (e.g., citrate or acetate), with sodium and chloride, in a flexible container using pressure of at least 0.25 MPa and, optionally heating to 60°—100°C, potentially to avoid high temperatures. Choo H 3—5, 7, 37, 57, 61, 63—64, 69, 73, claims 26—29; see also Final Action 3—6, 8, 10-14, 16, 18, 21, and Answer 2—5 (discussing Choo). FF3. Further to the preceding finding of fact, Choo discloses that a composition as disclosed can be provided in a container in a single chamber, ready-to-use, and not segregated into components. Choo H 57, 71; see also Final Action 3—6, 8, 10—14, 16, 18, 21, and Answer 2—5 (discussing Choo). FF4. Choo discloses a sterilized medical solution including, inter alia, glucose, sodium, chloride, citrate, and acetate, engineered to maintain the solution’s pH at about 6.5 to about 7.5, and that a further embodiment includes sodium chloride and has a pH of 5.1. 6 Appeal 2016-007517 Application 13/866,960 Choo 63—64, 69, 73; see also Final Action 3—6, 8, 10—14, 16, 18, 21, and Answer 2—5 (discussing Choo). FF5. D’Alessio is directed to hydrogel applicators, e.g., a syringe, which can be sterilized by “exposure to ethylene oxide or hydrogen peroxide vapor,” and discloses providing “a salt solution and a water solution being combined to form a buffer solution” in such applicators. D’Alessio H 28, 30, 42, 223, 229; see also Final Action 3—6, 8, 10—14, 16, 18, 21, and Answer 2, 4—6 (discussing D’Alessio). FF6. Andrei is directed to a method or system of combining liquid flows, such as buffer flows, to achieve mixtures with desired properties where, “either at least one basic buffer component is replaced by a strong base, or at least one acidic buffer component is replaced by a strong acid,” and having “a predetermined concentration of salt,” where “[a]n important contribution to the conductivity comes from strong electrolytes, for instance Na+ and Cl' ions.” Andrei Abstr., 1:4—6, 1:23—31, 5:4—8, 9:32—33, 13:30-31; see also Final Action 5—7, 12—13, 16, 18, and Answer 4—6 (discussing Andrei). FF7. As Appellants note, Andrei states, “[f]or environmental or human safety reasons, this is preferable to combining the weak acid with a strong base (like NaOH), or a weak base with a strong acid (like HC1)”; however, Andrei also subsequently discloses exemplary buffers produced by such combinations of strong/weak acids and bases, with a non-buffering salt like sodium chloride, as being within the scope of its disclosed invention, e.g., sodium acetate and HC1 as a 7 Appeal 2016-007517 Application 13/866,960 buffer. Andrei 13:13—15, 15:34—16:3; see also Final Action 5—7, 12— 13, 16, 18, and Answer 4—6 (discussing Andrei). FF8. Andrei discloses: a specific salt concentration may be automatically prepared given stock solutions of salt solution (Salt) and acid B1 and base B2 solutions. Buffer components B1 and B2 may be a corresponding acid/base buffering substance pair, or one of them may be a strong acid or base and the other a buffering substance. A buffer component B1 or B2 may also be a mixture of two or more components. Exemplary buffers that may be produced using this liquid blending system include phosphate, acetate, citrate, tris and bis- tris buffers, mixed acetate/phosphate buffer, and mixed acetate/format/phosphate buffer, just to mention a few. To prepare, for instance, a mixed acetate/format/phosphate buffer, the acidic component B1 may be e.g. HC1 and the basic component B2 may be a mixture of e.g. sodium acetate, sodium formate and sodium phosphate. It is also assumed that the total flow qT is known and constant. It has been taken into consideration that even if the salt is not a buffer, the change in ionic strength may lead to a shift in the pKa values of the buffering substances. Typically used non-buffering salts include, for instance, sodium chloride and calcium chloride. Andrei 15:27—16:10; see also Final Action 5—7, 12—13, 16, 18, and Answer 4—6 (discussing Andrei). FF9. Andrei discloses producing buffer solutions by combining a weak acid and weak base, a strong acid and weak base, and/or a weak acid and strong base, with a set percentage of salt. Andrei, inter alia, 17:5—17; see also Final Action 5—7, 12—13, 16, 18, and Answer 4—6 (discussing Andrei). 8 Appeal 2016-007517 Application 13/866,960 FF10. Andrei discloses an exemplary buffer system composed of acetic acid and sodium acetate providing a pH of 5.0, an exemplary buffer system composed of citric acid and sodium citrate providing a pH of 3.5, and an exemplary buffer system composed of sodium phosphate monohydrate and sodium phosphate dihydrate providing a pH of 6.5. Andrei 21:14—22 (Example 1); see also Final Action 5—7, 12—13, 16, 18, and Answer 4—6 (discussing Andrei). DISCUSSION Only those arguments made by Appellants in the Appeal Brief and properly presented in the Reply Brief have been considered in this Decision. Arguments not so presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv). In analyzing patentability and determining obviousness “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the answer depends on “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 417. “If a person of ordinary skill can implement a predictable variation [of a known work], § 103 likely bars its patentability.” Id. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. 9 Appeal 2016-007517 Application 13/866,960 Id. The obviousness analysis “can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. “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.” Id. at 419. Where ... the claimed and prior art products are identical or substantially identical ... the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote omitted). Obviousness over Choo and D ’Alessio We find, in view of the above-cited precedent and noted findings of fact, the Examiner has established a prima facie case that claim 1 would have been obvious over the cited prior art combination and we agree with and adopt the Examiner’s reasoning and findings of fact. For example, Choo teaches and suggests an acetate or citrate buffer component in a saline solution provided in a sterilized container (FF2—FF4) and D’Alessio teaches and suggests that such container holding a saline and buffer solution, for example a syringe, can be sterilized by ethylene oxide vapor (FF5). 10 Appeal 2016-007517 Application 13/866,960 Appellants argue Choo does not disclose sterilization via exposure to ethylene oxide, but is directed to sterilization via high pressure. App. Br. 8. Appellants argue “[t]he claims require: (1) the buffer component and aqueous solution be combined prior to sterilization, and (2) the buffer component be used to resist a change in pH of the combined solution during ethylene oxide sterilization.” Id. at 9. Even if we treated the Appellants-argued functional language of claim 1 (e.g., “to be sterilized using ethylene oxide,” “resisting a change in pH . . . upon exposure ... to the ethylene oxide during the sterilization”) as having some structural consequence, precedent of our reviewing court teaches that writing a claim that mixes structural and functional limitations comes at a price. In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) (“[Cjhoosing to define an element functionally, i.e., by what it does, carries with it a risk.”). The price is that when the structural limitations are met by the prior art, and when the examiner “has reason to believe” that the prior art inherently teaches the functional limitation(s), the burden shifts to the patent applicant to show that the functional limitation cannot be met by the prior art. Id.; see also In re Best, 562 F.2d 1252, 125A-55 (CCPA 1977) (“[W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.”). The Examiner has determined that the buffer components and solutions of Choo and D’Alessio would have resisted a pH change in view of 11 Appeal 2016-007517 Application 13/866,960 ethylene oxide sterilization as such is the nature of buffers. See, e.g., Final Action 21 and Answer 2. We agree with the Examiner’s reasoning and determination in this regard and Appellants have not come forward with evidence that it would not be a functional property inherent to the buffers of Choo and D’Alessio to preserve pH in the presence of ethylene chlorohydrins, as would be created by ethylene oxide sterilization. Therefore, we do not find Appellants’ arguments persuasive and conclude the balance of evidence supports the Examiner’s determination of obviousness. For the reasons above, we affirm this rejection. Obviousness over Choo, D ’Alessio, and Andrei The Examiner adds Andrei to the combination of Choo and D’Alessio for its teaching of specific buffer components, e.g., acetic acid and sodium acetate, acetic acid and sodium hydroxide, and hydrochloric acid and sodium acetate, and more general buffer component classifications, e.g., a strong acid with a weak base and a weak acid with a strong base. See Final Action 6—7; see also FF6—FF10. We find, in view of the above-cited precedent and noted findings of fact, the Examiner has established a prima facie case that the claims would have been obvious over the cited prior art combination and we agree with and adopt the Examiner’s reasoning and findings of fact. Appellants renew their arguments as presented over the first obviousness rejection. App. Br. 10. As concluded above, these arguments are not persuasive. Appellants argue that claim 5 is patentable because Andrei teaches away from including a strong acid and a weak base or a weak acid and a 12 Appeal 2016-007517 Application 13/866,960 strong base and, so, the skilled artisan would not have combined Andrei with the other cited prior art to render the claim obvious. App. Br. 11. This argument is not persuasive. Although Appellants correctly identify that Andrei states that there may be reasons to avoid using strong/weak acid and base combinations for a buffer, the reference then immediately proceeds to disclose an array of just such components as encompassed by its invention. See FF6—FF10. Therefore, we conclude Andrei does not teach away from the claimed subject matter or from its combination with the other cited prior art. Appellants ague that claim 7 is patentable because it is not established where the prior art teaches to include acetic acid and sodium hydroxide as buffer components. App. Br. 11. This argument is not persuasive. Andrei specifically identifies each as a buffer component at, e.g., 13:14 and 21 (Table 2). See FF7, FF10. As indicated, above, we do not agree with Appellants that Andrei teaches away from such buffer components. Appellants argue that claim 8 is patentable because it has not been established where the prior art teaches to include hydrochloric acid and sodium acetate as buffer components. App. Br. 12. This argument is not persuasive. Andrei expressly teaches to use sodium acetate and hydrochloric acid as buffer components at page 16. FF7, FF8. As indicated, above, we do not agree with Appellants that Andrei teaches away from such buffer components. Appellants argue that claim 21 is patentable because the cited prior art combination fails to teach a buffer component with a saline solution, acetic acid, and acetate that resists pH change upon exposure to an ethylene oxide 13 Appeal 2016-007517 Application 13/866,960 sterilization, and renews the arguments over Choo and D’Alessio as discussed above. App. Br. 13. We are unpersuaded. Andrei expressly discloses a buffer solution composed of sodium acetate and acetic acid and teaches saline solution. FF6—FF10. The balance of evidence supports the Examiner’s determination of obviousness. For the reasons above, we affirm this rejection. Obviousness over Choo, D ’Alessio, and Winn The Examiner cites Winn in combination with the other prior art for teaching “sterilization using ethylene oxide via gas permeation into the medical device, specifically a syringe, wherein the ethylene oxide gas permeates through the plunger seal allowing the entire assembly to be gas sterilized (see entire document; esp. [0010]; [0029]; [0031]),” and identifies a rational underpinning for the combination. Final Action 9—10. Over this rejection, Appellants argue only that, “[f]or at least the foregoing reasons, a prima facie case of obviousness is not established by the asserted combination of Choo/D’Alessio/Winn, and dependent claim 15 is patentable over the asserted combination.” App. Br. 13—14. Because we are not persuaded by Appellants’ arguments, as discussed above, we affirm this rejection for the same reasons. Obviousness over Choo, D ’Alessio, and Niedospial The Examiner cites Niedospial in combination with the other prior art for teaching “a prefilled syringe that is filled with medical fluid where, ‘the barrel along with its contents is sterilized’, and wherein the plunger tip defines a plurality of septa (see entire document; Esp. [0109]; [0114]; Figs. 2 and 4).” Final Action 11. 14 Appeal 2016-007517 Application 13/866,960 Over this rejection, Appellants argue only that, “[f]or at least the foregoing reasons, a prima facie case of obviousness is not established by the asserted combination of Choo/D’Alessio/Niedospial, and dependent claim 16 is patentable over the asserted combination.” App. Br. 14. Because we are not persuaded by Appellants’ arguments, as discussed above, we affirm this rejection for the same reasons. Obviousness over Choo, D ’Alessio, Niedospial, and Andrei Each of these references has been discussed above. The Examiner combines them for the same or similar reasons, as has been discussed above. Over this rejection, Appellants argue only that, “[f]or at least the foregoing reasons, a prima facie case of obviousness is not established by the asserted combination of Choo/D’Alessio/Niedospial/Andrei, and dependent claim 17 is patentable over the asserted combination.” App. Br. 14. Because we are not persuaded by Appellants’ arguments, as discussed above, we affirm this rejection for the same reasons. Obviousness over Choo, D ’Alessio, and Dempsey The Examiner cites Dempsey in combination with the other prior art for teaching: sterilization procedures for packaged and unpackaged medical devices comprising insertion of the medical device into an ethylene oxide gas environment for a time, temperature, and humidity sufficient to sterilize the medical device in less than about 500 minutes, e.g. about 200-500 minutes, at a temperature of about 135 °F, specifically 10 °C to about 95 °C, and at about 60% relative humidity (see entire document; esp. [0015]; [0010]; [0058-0059]; [0062]; Claims 1 and 5) and identifies a rational underpinning for the combination. Final Action 15— 16. 15 Appeal 2016-007517 Application 13/866,960 Over this rejection, Appellants argue only that, “[f]or at least the foregoing reasons, a prima facie case of obviousness is not established by the asserted combination of Choo/D’Alessio/Dempsey, and dependent claim 18 is patentable over the asserted combination.” App. Br. 15. Because we are not persuaded by Appellants’ arguments, as discussed above, we affirm this rejection for the same reasons. Obviousness over Choo, D ’Alessio, Andrei, and Winter The Examiner cites Winter in combination with the other prior art for teaching “a providing an aqueous solution which is a normal saline solution including 0.9% saline by weight in an aqueous solution (see entire document; esp. Col. 2, In. 66-Col. 3, In. 9; Col 2, In. 31-44),” and identifies a rational underpinning for the combination. Final Action 17. Over this rejection, Appellants argue only that, “[f]or at least the foregoing reasons, a prima facie case of obviousness is not established by the asserted combination of Choo/D’Alessio/Andrei/Winter, and dependent claim 22 is patentable over the asserted combination.” App. Br. 15. Because we are not persuaded by Appellants’ arguments, as discussed above, we affirm this rejection for the same reasons. Obviousness over Choo, D Alessio, Andrei, Winter, andDeWitt The Examiner cites DeWitt in combination with the other prior art for teaching “a buffered solution wherein about 1L of the solution includes in water, about 8.7g NaCl, 0.68g NaCCECEE, and about 1.67ml of 1M acetic acid, specifically 9g NaCl, 0.704g NaCCECEE, and 1.6ml of 1M acetic acid (see entire document; esp. [0304-0305]; [0062]),” and identifies a rational 16 Appeal 2016-007517 Application 13/866,960 underpinning for the combination. Final Action 18—19 (subscript formatting added). Over this rejection, Appellants argue only that, “[f]or at least the foregoing reasons, a prima facie case of obviousness is not established by the asserted combination of Choo/D’Alessio/Andrei/Winter/Dewitt, and dependent claim 23 is patentable over the asserted combination.” App. Br. 16. Because we are not persuaded by Appellants’ arguments, as discussed above, we affirm this rejection for the same reasons. SUMMARY The obviousness rejection of claims 1, 14, and 19 over Choo and D’Alessio is affirmed. The obviousness rejection of claims 2—8, 20, and 21 over Choo, D’Alessio, and Andrei is affirmed. The obviousness rejection of claim 15 over Choo, D’Alessio, and Winn is affirmed. The obviousness rejection of claim 16 over Choo, D’Alessio, and Niedospial is affirmed. The obviousness rejection of claim 17 over Choo, D’Alessio, Niedospial, and Andrei is affirmed. The obviousness rejection of claim 18 over Choo, D’Alessio, and Dempsey is affirmed. The obviousness rejection of claim 22 over Choo, D’Alessio, Andrei, and Winter is affirmed. The obviousness rejection of claim 23 over Choo, D’Alessio, Andrei, Winter, and DeWitt is affirmed. 17 Appeal 2016-007517 Application 13/866,960 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 18 Copy with citationCopy as parenthetical citation