15270352 - (D) (P.T.A.B. Oct. 30, 2019)

Robert W. Van Holten

Patent Trials and Appeals BoardOct 30, 2019

15270352 - (D) (P.T.A.B. Oct. 30, 2019)

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. 15/270,352 09/20/2016 ROBERT W. VAN HOLTEN ETH5859USNP 1027 27777 7590 10/30/2019 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 EXAMINER LIU, TRACY ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 10/30/2019 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): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pair_jnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ROBERT W. VAN HOLTEN ____________ Appeal 2019-004365 Application 15/270,352 Technology Center 1600 ____________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, AND RACHEL H. TOWNSEND, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–15 (Appeal Br. 3). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM, however, because our rationale differs from Examiner’s, we designate our affirmance a New Ground of Rejection. 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 Ethicon, Inc, a company in the family of Johnson & Johnson companies (Appellant’s September 17, 2018 Appeal Brief (Appeal Br.) 3). Appeal 2019-004365 Application 15/270,352 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to methods and systems for reducing lipopolysaccharides on medical devices and fluids that are intended to be in contact with the human body or to be inside of the human body” (Spec.2 1). Appellant’s claims 1, 2, 6, 7, and 9 are representative and reproduced below: 1. A method for treating solutions containing one or more endotoxins at detectable levels comprising: a. adding a suspension of a stearate to said solution to reduce detectable amounts of said endotoxins; and b. optionally removing the stearate. (Appeal Br. 10.) 2. A method according to claim 1 wherein the solution is aqueous. (Id.) 6. A method for treating medical devices comprising: a) contacting the devices to a suspension of a stearate in water or in non-aqueous solvents to reduce detectable amounts of endotoxins on said medical devices. (Id.) 7. The method of claim 6, wherein said device is a suture. (Id.) 9. A method of treatment comprising contacting the tissue surface of a mammal with a stearate suspension to reduce detectable amounts of endotoxins on said mammal. (Id.) 2 Appellant’s September 20, 2016 Specification. Appeal 2019-004365 Application 15/270,352 3 Grounds of rejection before this Panel for review: Claims 1 and 4 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mapleson,3 Chen,4 Ohkawa,5 Gaffar,6 and USDA.7 Claims 2, 3, and 5 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mapleson, Chen, Ohkawa, Gaffar, Dorval,8 and USDA. Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Ahlstrom,9 Chen, Ohkawa, Gaffar, and USDA. Claims 7 and 8 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Ahlstrom, Chen, Ohkawa, Gaffar, Williams,10 and USDA. Claims 9–15 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Gaffar, Chen, Ohkawa, and USDA. ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 3 Mapleson et al., US 2001/0053366 A1, published Dec. 20, 2001. 4 Chen, WO 2016/045601 A2, published Mar. 31, 2016. 5 Ohkawa et al., US 2013/0178521 A1, published July 11, 2013. 6 Gaffar et al., US 2011/0230558 A1, published Sept. 22, 2011. 7 April F. Kates, Regulatory Affairs Consultant, American Ingredients Company, Petition for Evaluation of Substance for Inclusion on National List of Substances Allowed in Food Production and Handling, Sept. 26, 2001. 8 Dorval et al., US 5,618,539, issued Apr. 8, 1997. 9 Ahlstrom, WO 91/16410, published Oct. 31, 1991. 10 Williams et al., US 2012/0328523 A1, published Dec. 27, 2012. Appeal 2019-004365 Application 15/270,352 4 FACTUAL FINDINGS (FF) FF 1. Mapleson discloses: A method of removing bacterial endotoxin from a pharmaceutical process solution is disclosed. In one embodiment, the method comprises treating the solution with a surfactant effective to dissociate the endotoxin from a pharmaceutical drug or vaccine substance in the solution, and then filtering the solution through a molecular cut-off filter having a pore size effective to retain the pharmaceutical drug or vaccine substance but allow the dissociated bacterial endotoxin to pass therethrough. (Mapleson, Abstract; see Final Act. 3.) FF 2. Mapleson’s surfactant can be a cationic, non-ionic, zwitterionic, amphoteric or anionic surfactant, provided that it is effective to dissociate the endotoxin from the antigen whilst not adversely affecting the properties of the antigen and in particular its ability to be retained on the MWCO filter. Preferably, however, it is an ionic surfactant and in particular an anionic surfactant. (Mapleson ¶ 23; see Final Act. 3.) FF 3. Examiner finds that Mapleson fails to disclose a stearate surfactant (Final Act. 3; see also id. at 7 (Examiner finds that Ahlstrom does not disclose a calcium stearate surfactant); id. at 10 (Examiner finds that Gaffar does not disclose a composition comprising calcium stearate)). FF 4. Chen discloses a reagent kit comprising an anionic surfactant and a potassium salt and method of using the reagent kit to remove a bacterial endotoxin from a biological product, wherein, in use, the anionic surfactant is fully bonded with the endotoxin in the biological product to form a conjugate, then the potassium salt is added to precipitate the conjugate, the precipitate is removed by filtration to produce a biological product solution with the endotoxin removed, and then the Appeal 2019-004365 Application 15/270,352 5 biological product is separated from the biological product solution to complete the process. (Chen, Abstract; see Final Act. 3, 7, and 11.) FF 5. Chen discloses that its anionic surfactant “is insoluble in water in the presence of the potassium salt” (Chen, Claim 1; see Final Act. 3, 7, and 11). FF 6. Ohkawa discloses: potassium salts of substituted pyrrolidine derivatives, which suppress the production of an inflammatory mediator caused by intracellular signal transduction or cell activation induced by endotoxin, and crystals thereof . . . and a pharmaceutical containing any of the same, and a prophylactic and/or therapeutic agent for sepsis containing any of the same. (Ohkawa, Abstract; see Final Act. 3, 7–8, and 11.) FF 7. Ohkawa discloses “pharmaceutical preparations . . . prepared in accordance with known methods using additives such as . . . an emulsifier (for example, . . . an anionic surfactant such as sodium lauryl sulfate or calcium stearate . . . [or] a cationic surfactant)” (Ohkawa ¶ 48; see Final Act. 3, 8, and 11). FF 8. Examiner finds that the combination of Mapleson, Chen, and Ohkawa fails to suggest a suspension comprising stearate (Final Act. 4; see also id. at 8 (Examiner finds that the combination of Ahlstrom, Chen and Ohkawa fails to suggest a suspension comprising stearate)). FF 9. USDA discloses that calcium stearate is “almost insoluble in water” (USDA ¶ 9a; see Final Act. 4, 8, and 11). FF 10. Examiner finds that Gaffar discloses “a composition for the inactivation of toxins containing cationic surfactants,” wherein the “[c]ationic surfactants are effective against endotoxins” and the compositions “include aqueous and non-aqueous sterile suspensions” that Appeal 2019-004365 Application 15/270,352 6 are “suitable for parental administration” or “liquid dosage form” (Final Act. 4 (citing Gaffar, Abstract and ¶ 48); see id. at 8 (citing Gaffar ¶ 42); id. at 10 (citing Gaffar, Abstract and ¶¶ 1, 25, 36, 37, 44, 45)). FF 11. Examiner finds that the combination of Mapleson, Chen, Ohkawa, and Gaffar does not suggest an aqueous pharmaceutical composition (Final Act. 6). FF 12. Examiner finds that Dorval discloses “a non-lyophilized stabilized vaccine composition consisting essentially of a physiologically acceptable aqueous solution” (Final Act. 6 (citing Dorval 4:61 – 5:6)). FF 13. Ahlstrom discloses the precision cleaning of a medical device “with a choline-containing cleansing agent so as to remove pyrogens from the medical device” (Ahlstrom, Abstract; see Final Act. 7). FF 14. Ahlstrom discloses that “the choline can be present in a solution which may be aqueous or non-aqueous” and exemplifies “an aqueous choline solution . . . [that] includes a surfactant” (Ahlstrom 3: 18–19; id. at 4: 18–20; see Final Act. 7). FF 15. Examiner finds that the combination of Ahlstrom Chen, Ohkawa, and Gaffar does not suggest a medical device that is a suture (Final Act. 9). FF 16. Examiner finds that Williams discloses that “[t]he presence of bacterial endotoxin in . . . [a medical] product is by far the largest concern of manufacturers in achieving nonpyrogenation,” because “medical devices must be nonpyrogenic,” and, therefore, when polyhydroxybutyrate (PHA), which “has a relatively high affinity for endotoxins,” is used in medical devices, such as sutures, “the material must meet the specific requirements set for endotoxin content” (Final Act. 9 (citing Williams ¶¶ 5, 7, and 69); see also Williams ¶ 15 (acknowledging that endotoxins are pyrogens)). Appeal 2019-004365 Application 15/270,352 7 ANALYSIS The rejection over the combination of Mapleson, Chen, Ohkawa, Gaffar, and USDA: Mapleson and Chen both disclose a method of removing bacterial endotoxin from a biological or pharmaceutical product, i.e. a solution, by contacting the product with an anionic surfactant (see FF 1, 2, 4, and 4). More particularly, Chen discloses a method of removing a bacterial endotoxin from a product by contacting the product with a composition comprising an anionic surfactant and a potassium salt (FF 4). According to Chen its anionic surfactant “is insoluble in water in the presence of the potassium salt” (FF 5). Although Mapleson and Chen disclose the use of compositions comprising an anionic surfactant, neither reference discloses stearate as the surfactant (see generally FF 3). Ohkawa, however, discloses a pharmaceutical preparation comprising, inter alia, potassium salts of substituted pyrrolidine derivatives and an anionic surfactant, such as calcium stearate, that is useful in treating biological responses that are induced by endotoxin (FF 6–7). Stated differently, Ohkawa suggests treating patients exposed to endotoxin with a composition comprising calcium stearate and a potassium salt of substituted pyrrolidine derivatives. Thus, we find no error in Examiner’s conclusion that based on the combination of Mapleson, Chen, Ohkawa, Gaffar, and USDA, it would have been prima facie obvious to a person of ordinary skill in this art, at the time Appellant’s invention was made, to have used calcium stearate as the surfactant in the method of Mapleson . . . [because] insoluble anionic surfactants are effective in removing bacterial endotoxin as taught by Chen and Appeal 2019-004365 Application 15/270,352 8 calcium stearate is a known anionic surfactant that is mostly insoluble in water as taught by Ohkawa [and USDA]. (Final Act. 4; see FF 1–9.) We further find no error in Examiner’s rationale that “[i]t would have been prima facie obvious to one of ordinary skill in the art to have the stearate in the form of a suspension . . . [because] suspensions are a suitable form for surfactants used to treat endotoxins as taught by Gaffar” (id.). Appellant contends that neither Mapleson nor Chen “describe[] the use of stearates for . . . [the removal of endotoxins]” (Appeal Br. 5). Appellant further contends that although: Ohkawa provides a generic disclosure that calcium stearate is an anionic surfactant and that a variety of surfactants, such as anionic surfactants, could potentially be used in combination with compounds, presumably in an emulsion with one or more active ingredients that are intended to reduce endotoxins, “Ohkawa fails to provide any evidence to suggest that the use of calcium stearate would be suitable for . . . [reduction of endotoxins, because] the purpose of the ‘active’ ingredient in that reference[, i.e. the potassium salts of substituted pyrrolidine derivatives,] is intended to perform that function” (id. at 6). We are not persuaded by Appellant’s contentions. The method of Appellant’s claim 1 comprises adding a suspension of a stearate to a solution containing one or more endotoxins at detectable levels to reduce detectable amounts of endotoxins (see Appeal Br. 10). As Appellant recognizes, Ohkawa discloses a method of reducing endotoxin with a composition comprising calcium stearate and another compound (id. at 6). Thus, even if Ohkawa did not recognize the activity of calcium stearate in its disclosed composition, “the discovery of a previously Appeal 2019-004365 Application 15/270,352 9 unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Similarly, as here, “merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Further still, when Ohkawa is viewed in the context of the utility of anionic surfactants to remove endotoxin, as disclosed by Mapleson and Chen, we find no error in Examiner’s conclusion that a person of ordinary skill in this art would have found it prima facie obvious to utilize calcium stearate as the anionic surfactant in Mapleson, with a reasonable expectation that it would have performed as suggested by the combination of Mapleson and Chen (see FF 1–10). The rejection over the combination of Mapleson, Chen, Ohkawa, Gaffar, Dorval, and USDA: The method of Appellant’s claim 2 depends from and further limits Appellant’s claim 1 to an aqueous solution (Appeal Br. 10). Based on the combination of Mapleson, Chen, Ohkawa, Gaffar, Dorval, and USDA, Examiner concludes that, at the time Appellant’s invention was made, “[i]t would have been prima facie obvious to one of ordinary skilled in the art to have the pharmaceutical process solution as an aqueous solution since the pharmaceutical process solution comprises a vaccine and vaccines are known to comprise an aqueous solution as taught by Dorval” (Final Act. 6; see FF 1–12). Appeal 2019-004365 Application 15/270,352 10 Having found no deficiency in the combination of Mapleson, Chen, Ohkawa, Gaffar, and USDA, we are not persuaded by Appellant’s contention that Dorval does not make up for Appellant’s alleged deficiency (see Appeal Br. 7 (Appellant contends that “Dorval does not demonstrate the equivalency of anionic surfactants or the use of calcium stearate as an anionic surfactant or its use for the removal [of] endotoxins”)). The rejection over the combination of Ahlstrom, Chen, Ohkawa, Gaffar, and USDA: The method of Appellant’s claim 6 comprises contacting medical devices with a suspension of a stearate in water or in non-aqueous solvents to reduce detectable amounts of endotoxins on the medical devices (see Appeal Br. 10). Examiner relies on the combination of Chen, Ohkawa, Gaffar, and USDA as discussed above (see FF 4–11). In addition, Examiner relies on Ahlstrom to disclose the use of an aqueous choline solution that includes a surfactant to remove pyrogens, i.e. endotoxin, from a medical device (FF 13–14). Therefore, based on the combination of Ahlstrom, Chen, Ohkawa, Gaffar, and USDA, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated calcium stearate into the composition of Ahlstrom . . . [because] insoluble anionic surfactants are effective in removing bacterial endotoxin as taught by Chen and calcium stearate is a known anionic surfactant that is mostly insoluble in water as taught by Ohkawa. (Final Act. 8; see FF 4–14.) Examiner further reasons that “[i]t would have been prima facie obvious to one of ordinary skill in the art to have the stearate suspended in the aqueous solution since surfactants used to treat Appeal 2019-004365 Application 15/270,352 11 endotoxins are known to be suspended in a liquid dosage form as taught by Gaffar” (id.). Appellant recognizes that “Examiner cites Ahlstrom in place of Mapleson” (Appeal Br. 7). Nonetheless, Appellant contends that “Ahlstrom has the same deficiency as Mapleson” in that Ahlstrom “does not show the use of calcium stearate for the removal of endotoxins” and “[t]he remaining references have been discussed above and do not demonstrate the equivalency of anionic surfactants or the use of calcium stearate as an anionic surfactant or its use for the removal [of] endotoxins” (id.). We are not persuaded. As Appellant recognized, Ohkawa discloses a method of reducing endotoxin with a composition comprising calcium stearate and another compound (Appeal Br. 10). Thus, even if Ohkawa did not recognize the activity of calcium stearate in its disclosed composition, “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Similarly, as here, “merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Further still, when Ohkawa is viewed in the context of the utility of surfactants to remove endotoxin, as disclosed by Ahlstrom and Chen, we find no error in Examiner’s conclusion that a person of ordinary skill in this art would have found it prima facie obvious to utilize calcium stearate as the surfactant in Ahlstrom, with a reasonable expectation that it would have Appeal 2019-004365 Application 15/270,352 12 performed as suggested by the combination of Ahlstrom and Chen (see FF 1–10). The rejection over the combination of Ahlstrom, Chen, Ohkawa, Gaffar, Williams, and USDA: Appellant’s claim 7 depends from and further limits the medical device of Appellant’s claim 6 to a suture (see Appeal Br. 10). Based on the combination of Ahlstrom, Chen, Ohkawa, Gaffar, Williams, and USDA, Examiner concludes that, at the time Appellant’s invention was made, “[i]t would have been prima facie obvious to one of ordinary skill in the art to have treated sutures with the composition of Ahlstrom since the composition treats endotoxins and sutures are made from polyhydroxybutyrate, which comprises endotoxins as taught by Williams” (Final Act. 9; see FF 4–11 and 13–16). Having found no deficiency in the combination of Ahlstrom, Chen, Ohkawa, Gaffar, and USDA, we are not persuaded by Appellant’s contention that Williams does not make up for Appellant’s alleged deficiency (see Appeal Br. 7 (Appellant contends that “Williams[] does not demonstrate the equivalency of anionic surfactants or the use of calcium stearate as an anionic surfactant or its use for the removal [of] endotoxins”)). The rejection over the combination of Gaffar, Chen, Ohkawa, and USDA: The method of Appellant’s claim 9 comprises contacting a tissue surface of a mammal with a stearate suspension to reduce detectable amounts of endotoxins on the mammal (see Appeal Br. 10). Based on the combination of Gaffar, Chen, Ohkawa, and USDA, Examiner concludes that, at the time Appellant’s invention was made, Appeal 2019-004365 Application 15/270,352 13 it would have been prima facie obvious to one of ordinary skill in the art to have incorporated calcium stearate into the composition of Gaffar . . . since insoluble anionic surfactants are effective in removing bacterial endotoxin as taught by Chen and calcium stearate is a known anionic surfactant that is mostly insoluble in water as taught by Ohkawa. . . . In regards to the composition having cationic surfactants and calcium stearate for inhibiting endotoxins, generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. (Final Act. 11; see FF 4–11 and 16.) See In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (“it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.”); In re Susi, 440 F.2d 442, 445 (CCPA 1971)(“the combination, for the same purpose, of one additive explicitly disclosed in the prior art and another suggested by the prior art would at least prima facie obvious”). Appellant contends that “Gaffar has the same deficiency as Mapleson” in that Gaffar “does not show the use of calcium stearate for the removal of endotoxins” and “[t]he remaining references do not demonstrate the equivalency of anionic surfactants or the use of calcium stearate as an anionic surfactant or its use for the removal [of] endotoxins” (Appeal Br. 7). We are not persuaded. As Appellant recognized, Ohkawa discloses a method of reducing endotoxin with a composition comprising calcium stearate and another compound (id. at 10). Thus, even if Ohkawa did not recognize the activity of calcium stearate in its disclosed composition, “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old Appeal 2019-004365 Application 15/270,352 14 composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Similarly, as here, “merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Further still, when Ohkawa is viewed in the context of the utility of surfactants to remove endotoxin, as disclosed by Gaffar and Chen, we find no error in Examiner’s conclusion that a person of ordinary skill in this art would have found it prima facie obvious to utilize an anionic surfactant, as discussed by Chen and Ohkawa, such as calcium stearate, as disclosed by Chen, in addition to a cationic surfactant, as disclosed by Gaffar and Ohkawa, for the expected combined benefit of removing endotoxin from a mammalian tissue (see FF 4–11 and 16). See In re Kerkhoven, 626 F.2d at 850; In re Susi, 440 F.2d at 445. CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mapleson, Chen, Ohkawa, Gaffar, and USDA is affirmed. Claim 4 is not separately argued and falls with claim 1. As discussed above, because our rationale differs from Examiner’s we designate our affirmance a new ground of rejection. The rejection of claim 2 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mapleson, Chen, Ohkawa, Gaffar, Dorval, and USDA is affirmed. Claims 3 and 5 are not separately argued and fall with Appeal 2019-004365 Application 15/270,352 15 claim 2. As discussed above, because our rationale differs from Examiner’s we designate our affirmance a new ground of rejection. The rejection of claim 6 under 35 U.S.C. § 103(a) as unpatentable over the combination of Ahlstrom, Chen, Ohkawa, Gaffar, and USDA is affirmed. As discussed above, because our rationale differs from Examiner’s we designate our affirmance a new ground of rejection. The rejection of claim 7 under 35 U.S.C. § 103(a) as unpatentable over the combination of Ahlstrom, Chen, Ohkawa, Gaffar, Williams, and USDA is affirmed. Claim 8 is not separately argued and falls with claim 7. As discussed above, because our rationale differs from Examiner’s we designate our affirmance a new ground of rejection. The rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable over the combination of Gaffar, Chen, Ohkawa, and USDA is affirmed. Claims 10–15 are not separately argued and fall with claim 9. As discussed above, because our rationale differs from Examiner’s we designate our affirmance a new ground of rejection. Appeal 2019-004365 Application 15/270,352 16 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed New Ground 1, 4 103 Mapleson, Chen, Ohkawa, Gaffar, USDA 1, 4 1, 4 2, 3, 5 103 Mapleson, Chen, Ohkawa, Gaffar, Dorval, USDA 2, 3, 5 2, 3, 5 6 103 Ahlstrom, Chen, Ohkawa, Gaffar, USDA 6 6 7, 8 103 Ahlstrom, Chen, Ohkawa, Gaffar, Williams, USDA 7, 8 7, 8 9–15 Gaffar, Chen, Ohkawa, USDA 9–15 9–15 Overall Outcome 1–15 1–15 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). Appeal 2019-004365 Application 15/270,352 17 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 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. . . . 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; 37 C.F.R. § 41.50(b)