15270876 - (D) (P.T.A.B. Nov. 4, 2020)

Brigham Young University

Patent Trials and Appeals BoardNov 4, 2020

15270876 - (D) (P.T.A.B. Nov. 4, 2020)

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. 15/270,876 09/20/2016 Carl Genberg 19250.42.1 7593 22913 7590 11/04/2020 Workman Nydegger 60 East South Temple Suite 1000 Salt Lake City, UT 84111 EXAMINER HELM, CARALYNNE E ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 11/04/2020 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): Docketing@wnlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte CARL GENBERG, PAUL B. SAVAGE, and RONALD L. BRACKEN __________ Appeal 2020-002075 Application 15/270,876 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, TAWEN CHANG, and JAMIE T. WISZ, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134 involving claims to an implantable medical device that includes a cationic steroidal antimicrobial compound. The Examiner rejected the claims as obvious. 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 Brigham Young University Technology Transfer Office (see Appeal Br. 3). 2 We have considered the Specification of Sept. 20, 2016 (“Spec.”); Final Office Action of Dec. 4, 2018 (“Final Action”); Appeal Brief of Aug. 15, 2019 (“Appeal Br.”); Examiner’s Answer of Nov. 18, 2019 (“Ans.”); and Reply Brief of Jan. 17, 2020 (“Reply Br.”). Appeal 2020-002075 Application 15/270,876 2 Statement of the Case Background “[M]any medical devices are implanted into the subject, and may be intended either as a permanent or temporary implant. However, even when strict sterilization procedures are followed, such medical implants can be subject to microbial contamination” (Spec. ¶ 3). “When biofouling of the implant occurs, the implant must be removed from the subject. . . . Usually, the fouled implant must be replaced with a new implant, adding to medical care costs” “and can even lead to very serious and deadly conditions, such as sepsis” (id. ¶¶ 3–4). The Specification teaches “implantable medical devices incorporating one or more cationic steroidal antimicrobial (CSA) compounds to provide the medical device with effective antimicrobial properties and/or anti-inflammatory properties” (id. ¶ 9). The Claims Claims 1, 3, 5–11, 13–20, and 22–25 are on appeal. Claim 1 is representative and reads as follows: 1. An implantable medical device selected from catheter, endotracheal tube, intravenous feed line, feeder tube, drain, prosthesis component, voice prostheses, peristaltic pump, tympanostomy tube, and tracheostomy tube, the implantable medical device comprising: a structural component of the implantable medical device formed at least in part from a thermoplastic or thermoset polymeric material; and a sulfonic acid addition salt of at least one cationic steroidal antimicrobial (CSA) compound, the at least one CSA compound having a hydrophobic sterol backbone and a plurality of charged groups attached to the sterol backbone, the at least one CSA compound being incorporated into the polymeric material of the structural Appeal 2020-002075 Application 15/270,876 3 component so as to be distributed throughout the polymeric material of the structural component, wherein the implantable medical device provides antimicrobial efficacy of at least two months when the implantable medical device is implanted. The Rejections3 A. The Examiner rejected claims 1, 3, 5, 13, 14, 20, and 22–25 under U.S.C. § 103(a) as obvious over Jones,4 Kolobow,5 Savage,6 Ding,7 Elder,8 Mochizuki,9 and Zhao10 (Final Act. 4–8) B. The Examiner rejected claims 6, 7, 9, 10, and 16 under U.S.C. § 103(a) as obvious over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, and Terry11 (Final Act. 8–9). C. The Examiner rejected claims 11 and 17–19 under U.S.C. § 103(a) as obvious over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, and Griesbach12 (Final Act. 9–10). 3 The provisional obviousness-type double patenting rejection is moot in view of the abandonment of US 15/406,667 on Feb. 6, 2020. 4 Jones et al., Physicochemical Characterization of Hexetidine-Impregnated Endotracheal Tube Poly(Vinyl Chloride) and Resistance to Adherence of Respiratory Bacterial Pathogens, 19 Pharmaceutical Res. 818–24 (2002). 5 Kolobow et al., US 5,687,714, issued Nov. 18, 1997. 6 Savage, P., US 2013/0022651 A1, published Jan. 24, 2013. 7 Ding et al., US 2002/0091433 A1, published July 11, 2002. 8 Elder et al., The Utility of Sulfonate Salts in Drug Development, 99 J. Pharmaceutical Sci. 2948–61 (2010) 9 Mochizuki et al., JP 60-80457, issued Nov. 25, 1992 (Machine Translation 1–7). 10 Zhao, X, US 2007/0053788 A1, published Mar. 8, 2007. 11 Terry et al., US 6,329,488 B1, issued Dec. 11, 2001. 12 Griesbach, III, US 2009/0099531 A1, published Apr. 16, 2009. Appeal 2020-002075 Application 15/270,876 4 D. The Examiner rejected claims 6–8 under U.S.C. § 103(a) as obvious over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, Terry, and Genberg13 (Final Act. 10–12). E. The Examiner rejected claim 15 under U.S.C. § 103(a) as obvious over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, and Bucki14 (Final Act. 12–13). F. The Examiner rejected claims 17–19 under U.S.C. § 103(a) as obvious over Jones, Kolobow, Savage, Terry, and Zhao (Final Act. 13–15). G. The Examiner rejected claims 20 and 22–25 under U.S.C. § 103(a) as obvious over Jones, Kolobow, Vachon,15 Savage, Elder, and Zhao (Final Act. 15–18). H. The Examiner rejected claim 8 under U.S.C. § 112(a) as failing to comply with the written description requirement (Final Act. 2–3). A. 35 U.S.C. § 103(a) over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, and Zhao The issue with respect to this rejection16 is: Does a preponderance of the evidence of record support the Examiner’s conclusion that Jones, Kolobow, Savage, Ding, Elder, Mochizuki, and Zhao render claim 1 obvious? 13 Genberg et al., US 2013/0243823 A1, published Sept. 19, 2013. 14 Bucki et al., Resistance of the antibacterial agent ceragenin CSA-13 to inactivation by DNA or F-actin and its activity in cystic fibrosis sputum, 60 J. Antimicrobial Chemotherapy 535–45 (2007). 15 Vachon et al., US 2013/0004586 A1, published Jan. 3, 2013. 16 We note that, other than claims 6–11 and 17–19, dependent claims stand or fall with claim 1 because separate reasons for their patentability were not provided in the Appeal Brief. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2020-002075 Application 15/270,876 5 Findings of Fact 1. Jones teaches “the incorporation of a suitable antimicrobial agent into PVC prior to the manufacture of ET [endotracheal] tubes may hold benefits in combating the second-most common hospital-acquired infection, nosocomial pneumonia” (Jones 823, col. 1). Jones teaches the “incorporation of an antimicrobial agent within the constituent polymer of a medical device is an accepted approach in engaging the problem of medical device-associated infection” (Jones 818, col. 2). 2. Savage teaches “hydrogel polymers useful in the present invention include any hydrogel suitable for use in products where there is a need to minimize microbial load. For example, the hydrogels of the present invention may be hydrogels useful in making medical devices” (Savage ¶ 26). 3. Savage teaches: hydrogel materials that include a hydrogel polymer that controllably elutes a ceragenin compound from the hydrogel polymer over time. The controlled elution of the ceragenin can occur over days, weeks, or months at a release rate that is within a desired range for making the hydrogel material anti- microbial while still maintaining the desired properties of the hydrogel material. (Savage ¶ 7). 4. Savage teaches “[e]xamples of suitable hydrogel polymers include . . . silicone” (Savage ¶ 27). The Specification defines “polymeric material” as including “silicone” (Spec. ¶ 19). 5. Savage teaches: “Ceragenin compounds, also referred to herein as cationic steroidal anti-microbial compounds (CSA) . . . act as anti- microbial agents (e.g., anti-bacterials, antifungals, and anti-virals)” (Savage Appeal 2020-002075 Application 15/270,876 6 ¶¶ 23–24). Savage teaches “[s]uitable examples of ceragenins useful in producing a composition that will elute from a hydrogel include, but are not limited to . . . CSA-131” (Savage ¶ 35). Savage teaches, regarding the CSA compounds, the use of “a pharmaceutically acceptable salt thereof” (Savage ¶ 37). 6. Savage teaches “the ceragenin compound may be selected to have a hydrophobic R17 group that non-covalently bonds to the hydrophobic groups of the hydrogel to cause a relatively consistent elution over a period of days or weeks” (Savage ¶ 59). 7. Savage teaches: Examples of medical devices that can be formed from a hydrogel containing ceragenin eluting compounds or can have such a hydrogel coated thereon include but are not limited to . . . endotracheal tubes . . . The hydrogel may be coated on or form any portion of the structures of such devices and is preferably on an outer surface and more preferably on an out service that contacts tissue or a tissue air interface (when the device is implanted). (Savage ¶ 70). 8. Savage teaches “the hydrogel polymer and the ceragenin compound are selected to yield non-covalent bonding that provides a release rate of 0.1-100 μg/ml, 0.5-50 μg/ml, or 1-10 μg/ml at three days, one week, or one month” (Savage ¶ 61). 9. Elder teaches “[s]alt formation with pharmaceutically acceptable counter-ions is an extremely useful approach for the optimization or modification of the physicochemical . . . properties of ionizable drug substances” (Elder 2949, col. 2). Elder teaches the “greater ionic content of strong inorganic acid salts, for example, sulfonates . . . usually ensures that Appeal 2020-002075 Application 15/270,876 7 the salt is less plastic in nature facilitating better secondary processing” (Elder 2959, col. 2). 10. Elder teaches “sulfonates can be readily modified by introduction of bulkier and/or longer side chains, for example . . . napsylate . . . salts. This can be used to good effect in the development of controlled release . . . products where decreased solubility is an important factor” (Elder 2959, col. 2). 11. Elder teaches that an alternative name for napsylate is 1,5- Naphthalnedisulfonate (see Elder 2950, table 1). 12. Ding teaches a “release rate profile can be altered by varying the amount of active material, the coating thickness, the radial distribution of bioactive materials, the mixing method, and the crosslink density of the polymer matrix. Sufficient variation is possible such that almost any reasonable desired profile can be simulated” (Ding ¶ 71). 13. Ding teaches “[d]rug release surface coatings on stents in accordance with the present invention can release drugs over a period of time from days to months” (Ding ¶ 55). 14. Figure 9 of Ding is reproduced below: Appeal 2020-002075 Application 15/270,876 8 “FIG. 9 depicts a graphical analysis . . . for the release of dexamethasone at two different concentrations” and shows “coating layers of polymer/bioactive species combinations for long-term release” (Ding ¶¶ 70– 71). 15. Mochizuki teaches the silicone rubber of a urinary catheter made of silicone rubber in which a cationic antimicrobial agent is dispersed in a silicone rubber does not lose properties as a silicone rubber, but relatively high concentration salts such as urine and organic waste. It is based on the discovery that sustained release of antimicrobial agent in urine over a long period of time and blockage due to precipitation or deposition of calcium salt and the like are not observed. (Mochizuki 2). 16. Mochizuki teaches the “amount of the cationic antimicrobial agent to be blended into the silicone rubber in the present invention varies depending on the type and combination thereof, but is generally 0.1 to 50% by weight . . . In this case, when the content is 0.1 % by weight or less, the desired antibacterial activity is sufficiently obtained” (Mochizuki 5). 17. Kolobow teaches that “endotracheal tube 12 and catheter 14 are preferably formed of a flexible plastic, such as polyvinylchloride (PVC) or silicone rubber, which is suitable for insertion into the trachea 16 of a human 18” (Kolobow 2:59–62). 18. Zhao teaches “[t]hree primary synthetic thermoset elastomers typically are used in medical applications: polyisoprene rubber, silicone rubber, and butyl rubber” (Zhao ¶ 5). Principles of Law The Examiner has the initial burden of establishing a prima facie case Appeal 2020-002075 Application 15/270,876 9 of obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis We adopt the Examiner’s findings of fact and conclusion of law (see Final Act. 4–8, FF 1–18) and agree that Jones, Kolobow, Savage, Ding, Elder, Mochizuki, and Zhao render claim 1 obvious. We address Appellant’s arguments below. Appellant contends Ding fails to teach or suggest an implantable medical device having a CSA compound or any other active component incorporated into and dispersed throughout the polymeric material of the structural component of the medical device. The Examiner fails to show why Ding cures the deficiencies of the other references or why one of ordinary skill in the art would have been motivated to disperse the active component throughout the polymeric structural component rather than as a coating as expressly taught by Ding. (Appeal Br. 14). We find this argument unpersuasive because Ding is not cited alone for teaching the claimed elements, but the Examiner’s rejection relies upon other references including Savage. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Indeed, Savage and Jones motivate the ordinary artisan to incorporate antimicrobial compounds into the body of endotracheal tubes for “benefits in Appeal 2020-002075 Application 15/270,876 10 combating the second-most common hospital-acquired infection, nosocomial pneumonia” (FF 1, 2, 7). Savage teaches impregnation of silicone (FF 4), a thermoset polymer as per Zhao (FF 15), with CSAs including CSA-131 (FF 5) and that the device “can be formed from a hydrogel containing ceragenin eluting compounds” (FF 7). Thus, Savage teaches the use of a silicone as a structural material that includes and elutes the CSA antimicrobial agent (FF 4, 5, 7). Savage further teaches modifying the CSA with a hydrophobic compound to allow “relatively consistent elution over a period of days or weeks” (FF 6) and teaches “a release rate of 0.1-100 μg/ml . . . at three days, one week, or one month” (FF 8). Elder suggests specific sulfonic acid addition salts like 1,5-Naphthalnedisulfonate (FF 11) because they “can be used to good effect in the development of controlled release” (FF 10). Savage teaches that “controlled elution of the ceragenin can occur over days, weeks, or months at a release rate that is within a desired range” (FF 3). Thus, Savage combined with Elder and Zhao reasonably suggest implanted endotracheal tubes formed from the thermoset material, silicone rubber, impregnated with CSA with sulfonic addition salts (FF 1, 2, 4–11). Savage suggests antimicrobial efficacy of controlled elution of “months” (FF 3). The Examiner relies upon Ding to show an actual elution profile that lasted for months (FF 14) and to further demonstrate that the underlying parameters necessary to optimize release rate were known and exemplified, as Ding teaches that “[s]ufficient variation is possible such that almost any reasonable desired profile can be simulated” (FF 12). Appeal 2020-002075 Application 15/270,876 11 We therefore do not find Appellant’s argument focusing on Ding alone persuasive because Ding is utilized in combination with Savage, Elder, and Zhao, and it is that combination that suggests all the limitations of claim 1, including the use of the polymeric material as a structural component (FF 3, 7). “The test for obviousness . . . is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re Keller, 642, F.2d 413, 424 (CCPA 1977). Appellant contends that “claim 1 requires the medical device to provide ‘antimicrobial efficacy of at least two months when the implantable medical device is implanted.’ Though [release duration and antimicrobial efficacy] are related, they are not the same” (Appeal Br. 16). Appellant also contends just because a compound is actively released, in some amount, for a given duration does not necessarily mean that it will also provide antimicrobial efficacy across the entirety of that duration. Antimicrobial efficacy requires more than just some measurable presence of released antimicrobial compound. In order to actually work to kill/deactivate microbial pathogens, the antimicrobial compound must be present in amounts above the minimum inhibitory concentration (MIC) threshold, and may even need to be present in amounts above the higher minimum bactericidal concentration (MBC) threshold. (Appeal Br. 15). We find this argument unpersuasive, not only because this attorney argument is speculation without any evidentiary support (see, e.g., In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)), but also because Savage recognizes “controlled elution of the ceragenin can occur over . . . months at a release rate that is within a desired range for making the hydrogel material anti-microbial” (FF 3). Thus, the ordinary artisan would have recognized Appeal 2020-002075 Application 15/270,876 12 that retaining an amount sufficient to maintain anti-microbial activity would be the “desired range,” and Ding teaches that this is routinely optimizable because “release rate profile can be altered by varying the amount of active material, the coating thickness, the radial distribution of bioactive materials, the mixing method, and the crosslink density of the polymer matrix” (FF 12). We also agree with the Examiner’s position that the “claims do not require any particular degree of antimicrobial efficacy, they just require some efficacy for some type of bacteria” (Ans. 7). Appellant contends “[f]irst, the dexamethasone corticosteroid of Ding is not an antimicrobial compound. Second, Ding gives no indication that the corticosteroid is released in amounts that stay above MIC and/or MBC thresholds had an antimicrobial compound been used instead” (Appeal Br. 16). We find this argument unpersuasive because it fails to address the references in combination. Ding is not relied upon for the antimicrobial agent, but rather to demonstrate that release rates may be optimized to desired values (FF 12) and that release can extend to multiple months (FF 13–14). “[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellant provides no evidence rebutting the Examiner’s citation of Savage and Ding demonstrating that controlled release of compounds, including antimicrobial compounds, may be optimized to extend for multiple months (FF 3, 8, 12–14). Appellant contends the Examiner’s obviousness combination ignores the fact that Jones teaches an important interplay between PVC and hexetidine, and that these components cannot be simply swapped independently without potentially altering Appeal 2020-002075 Application 15/270,876 13 the important mechanical and surface properties of the resulting device. The Examiner is thus artificially splitting the Jones device into independent subcomponents in order to make the substitutions necessary to arrive at the claimed inventions. Such “picking and choosing” is improper because it is accomplished using “knowledge gleaned only from the applicant’s disclosure.” See In re McLaughlin, 443 F.2d 1392, 170 USPQ (CCPA 1971). (Appeal Br. 17). We do not find this argument persuasive because the Examiner’s reasoning “takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). We note “picking and choosing may be entirely proper in the making of a 103, obviousness rejection, where the applicant must be afforded an opportunity to rebut with objective evidence” In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Therefore, while we are fully aware that hindsight bias may plague determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. We agree with the Examiner that the combination of the cited prior art would predictably result in implanted endotracheal tubes formed from the thermoset material, silicone rubber, impregnated with CSA with sulfonic addition salts with antimicrobial efficacy of controlled elution of “months” (FF 1–11). Appellant provides no evidence of any secondary considerations. Appeal 2020-002075 Application 15/270,876 14 Appellant contends: Elder was cited as generally disclosing the use of sulfonic addition salts such as naphthalene disulfonic acid (NDSA) salts in making pharmaceutical compounds for oral use. Elder makes no mention of the use of sulfonic addition salts for an implantable medical device. Moreover, Elder does not teach or suggest the use of sulfonic acid addition salts for an antimicrobial compound, let alone for an antimicrobial CSA compound that is incorporated into a polymer structure of a medical device. (Appeal Br. 18). Appellant contends “‘controlled-release’ benefits of sulfonate salt in a pill/liquid pharmaceutical that is ingested (where pharmacokinetic half-lives are typically measured in hours) has no bearing as to the performance of a sulfonate salt in an implantable medical device that is not ingested (and which is implanted for months at a time)” (Appeal Br. 18–19). We find this argument unpersuasive. Savage teaches the use of a “pharmaceutically acceptable salt” of CSAs (FF 5). The ordinary artisan would have looked to prior art such as Elder, who teaches “[s]alt formation with pharmaceutically acceptable counter-ions is an extremely useful approach for the optimization” of compound properties and specifically suggests that sulfonate salts may be useful in processing and controlled release compositions (FF 9–10). The ordinary artisan in the pharmaceutical arts, a medicinal chemist, would have been aware that controlled release drugs were notoriously well known to be useful in both oral compositions and embedded in medical devices (see, e.g., FF 1 “incorporation of an antimicrobial agent within the constituent polymer of a medical device is an accepted approach in engaging the problem of medical device-associated infection”; cf. Ding ¶ 7 the “general idea of utilizing implanted stents to Appeal 2020-002075 Application 15/270,876 15 carry medicinal agents, such as thrombolytic agents, also has been proposed.”) Thus, the evidence reasonably supports the Examiner’s finding that the ordinary artisan, motivated by Savage to use pharmaceutically acceptable CSA salts for controlled release of CSA compounds in endotracheal tubes, would have looked to Elder to identify which salts would optimize the synthesis and controlled release of the CSA compounds (FF 3, 5, 7, 9, 10). These facts are analogous to Pfizer, where prior art like Elder pointed to a particular sulfonate salt and the court found the “references provide ample motivation to narrow the genus of 53 pharmaceutically-acceptable anions disclosed by Berge17 to a few, including benzene sulphonate.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1363 (Fed. Cir. 2007). And Pfizer found that selection of optimal salt was “analogous to the optimization of a range or other variable” because “the logical line of testing was to react benzene sulfonate with amlodipine to confirm the presence of a salt, and then to verify that the physicochemical properties of amlodipine besylate were adequate.” Id. at 1368. The same type of optimization reasonably applies here, where Savage teaches the use of salts of CSA compounds and Elder suggests sulfonate salts that improve drug properties (FF 3, 5, 7, 9, 10). Appellant does not identify any secondary considerations based on the selection of the salt. Appellant contends: Because Elder ranks NDSA salts as less water soluble than hydrochloride salts, and because Mochizuki already identifies 17 We note, but do not rely upon the fact that Elder cites the same Berge reference in Pfizer (see Elder 2960, reference 7). Appeal 2020-002075 Application 15/270,876 16 hydrochloride salts as being “poorly water-soluble” and therefore less desirable, the combination of Elder and Mochizuki teach away from selecting a sulfonic acid addition salt for mixing within the polymer structure of a medical device. (Appeal Br. 19). We are not persuaded. An “obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Even if we agree with Appellant that Mochizuki teaches sulfonate salts are less water-soluble, Appellant does not identify any teaching in either Mochizuki or Elder that criticizes, discredits, or otherwise discourages the use of sulfonate salts. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.”) Indeed, Mochizuki teaches “particularly preferred examples of the poorly water-soluble antibacterial agent include hydrochloride, acetate or sulfate” salts (Mochizuki 5). Thus, Mochizuki recognizes that a variety of salts are functional and teaches optimization of the amount of a cationic salt blended into silicon rubber to obtain the desired antibacterial activity (FF 16). Conclusion of Law A preponderance of the evidence of record supports the Examiner’s conclusion that Jones, Kolobow, Savage, Ding, Elder, Mochizuki, and Zhao render claim 1 obvious. Appeal 2020-002075 Application 15/270,876 17 B.-D., F. U.S.C. § 103(a) further including Terry Appellant separately address claims 6–11 and 17–19 in these rejections, contending that the “cited art does not teach or suggest a medical device that includes one or more CSA compounds distributed throughout the polymeric device structure and, in addition, a lubricious coating that also includes one or more CSA compounds” (Appeal Br. 20). Appellant contends the “coating of Terry does not include a CSA compound or any other antimicrobial agent, but the Examiner cites to Savage and argues that it would have been obvious to add the CSA compounds of Savage to the coating of Terry” (id.). Appellant contends: The Examiner’s position is illogical. It cannot be true that “there is no example [of adding an antimicrobial to a lubricious coating] in the cited prior art,” yet simultaneously be true that the choice to add CSA compounds to the coating of Terry is “consistent with” the cited references regarding where to place CSA compounds. (id.). We do not find this argument persuasive because Savage teaches the “hydrogel may be coated on or form any portion of the structures of such devices” (FF 7). That is, Savage recognizes that CSA compounds may be either coated on or form portions of device structures, including endotracheal tube devices (FF 7). Terry teaches regarding medical devices such as endotracheal tubes, that it “is necessary for the surface of these medical devices to have a low coefficient of friction to prevent injury, irritation, or inflammation to the patient and to facilitate medical and surgical procedures” (Terry 1:21–26). In particular, Terry teaches “[t]here is also a need in the art for a coating having improved durability and uniformity which retains its lubricity and will adhere to medical devices Appeal 2020-002075 Application 15/270,876 18 made from silicone” (Terry 3:30–32). Griesbach teaches “[i]n addition to use as a lubricious coating, the coatings may be used to impart antibacterial and anti-microbial properties to the medical device” (Griesbach ¶ 32). We therefore agree with the Examiner that the ordinary artisan would have had reason to use a lubricious coating on the silicone endotracheal tube of Savage in order to have a low coefficient of friction. In addition, the ordinary artisan would have found it obvious, based on Savage’s teaching that CSA antimicrobial compounds may be in a device or in a device coating and Griesbach’s teaching that a coating may have antimicrobial compounds to incorporate CSA compounds in both the structure and coating of an endotracheal tube because combining two known useful delivery modes into a single device would have reasonably been obvious. In re Kerkhoven, 626 F.2d 846 (CCPA 1980). Consistent with Ding, the ordinary artisan would have used both modes in order to optimize the elution profile as desired (FF 12). E. and G. U.S.C. § 103(a) Appellant does not separately argue these obviousness rejections, instead relying upon their arguments to overcome the combination of the primary combination of references. We do not find those arguments persuasive for the reasons given above. The Examiner provides sound fact- based reasoning for combining these references and we also find that the further combinations renders the rejected claims obvious for the reasons given by the Examiner (see Final Act. 12–13, 15–18). Appeal 2020-002075 Application 15/270,876 19 H. U.S.C. § 112, first paragraph Appellant does not dispute the rejection of the claim 8 as failing to comply with the written description requirement (see Appeal Br. generally). We therefore summarily affirm the written description rejection (see Final Act. 2–3). See Manual of Patent Examining Procedure § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, that ground of rejection will be summarily sustained by the Board.”) SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 5, 13, 14, 20, 22–25 103 Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao 1, 3, 5, 13, 14, 20, 22– 25 6, 7, 9, 10, 16 103 Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, Terry 6, 7, 9, 10, 16 11, 17–19 103 Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, Griesbach 11, 17–19 6–8 103 Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, Terry, Genberg 6–8 15 103 Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, Bucki 15 Appeal 2020-002075 Application 15/270,876 20 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 17–19 103 Jones, Kolobow, Savage, Terry, Zhao 17–19 20, 22–25 103 Jones, Kolobow, Vachon, Savage, Elder, Zhao 20, 22–25 8 112(a) Written Description 8 Overall Outcome 1, 3, 5–11, 13–20, 22– 25 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