Ex Parte 8067215 et alDownload PDFPatent Trial and Appeal BoardAug 1, 201695002219 (P.T.A.B. Aug. 1, 2016) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 95/002,219 09/13/2012 8067215 10007-115RX1 3938 96039 7590 08/01/2016 Meunier Carlin & Curfman LLC 999 Peachtree Street NE Suite 1300 Atlanta, GA 30309 EXAMINER KUNZ, GARY L ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 08/01/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ SNF HOLDING COMPANY Requester and Respondent v. CIBA SPECIALITY CHEMICALS WATER TREATMENTS LIMITED Patent Owner and Appellant ____________ Appeal 2016-004385 Reexamination Control 95/002,219 Patent 8,067,215 B2 Technology Center 3900 ____________ Before CHUNG K. PAK, RICHARD M. LEBOVITZ, and RAE LYNN P. GUEST, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This is a decision on the appeal by the Patent Owner from the Patent Examiner’s decision to reject claims 1–46 as unpatentable under 35 U.S.C. §§ 102(b) and 103(a) in the above-identified inter partes reexamination of U.S. 8,067,215 B2. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 2 We affirm the Examiner’s decision that claims 1–46 are unpatentable. However, because our reasoning and bases for the rejections differ from the Examiner’s, we designate the affirmance as new grounds of rejection under 37 C.F.R. § 41.77(b). The Third Party Requester appealed the Examiner’s decision not to adopt proposed rejections under 35 U.S.C. § 103(a). Because we affirmed the rejection of all the pending claims, we did not reach the Third Party Requester’s appeal. I. BACKGROUND The patent in dispute in this appeal is U.S. Pat. No. 8,067,215 B2 (“the ’215 patent”) which issued November 29, 2011. A request for inter partes reexamination of the ’215 patent under 35 U.S.C. §§ 311–318 and 37 C.F.R. §§ 1.902–1.997 was filed September 13, 2012 by a Third Party Requester. The Requester is SNF Holding Company (“Requester”). Requester Respondent Br. 2. The real party in interest for the ’215 patent is Ciba Specialty Chemicals Water Treatments Limited (“Patent Owner”). Patent Owner (“PO”) Appeal Br. 3. An oral hearing was held June 15, 2016 with both parties in attendance. A transcript of the hearing will be entered into the record in due course. The claimed subject matter of the ’215 patent relates to processes for preparing a polymer of ethylenically unsaturated monomers, where the monomers are obtained from nitrile conversion in a biocatalyzed reaction or fermentation process. The monomers are polymerized in the presence of Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 3 fermentation broth or components of a fermentation broth. ’215 patent, col. 5, ll. 16–23. The polymer formed by the process has an intrinsic viscosity of at least 3 dl/g measured using a suspended level viscometer in 1 M sodium chloride at 25°C. An example of a monomer is acrylamide, produced from the nitrile acrylonitrile, where polymerization of the monomer results in polyacrylamide. The biocatalyst is described in the ’215 patent as capable of converting a substrate, such as a nitrile, into the desired monomer, such as acrylamide. ’215 patent, col. 5, ll. 48–51; col. 6, ll. 4–13. “Generally [the biocatalyst] would be a microorganism that is capable of generating enzymes suitable for the conversion of interest.” Id. at col. 5, ll. 49–51. For example, a microorganism producing a nitrile hydratase or a nitrilase can be utilized to catalyze the conversion of acrylonitrile to acrylamide. Id. at col. 1, ll. 31–34; col. 3, ll. 21–27. The ’215 patent teaches that the use of a biocatalyst to make the acrylamide monomer, and the subsequent production of polyacrylamide from the acrylamide monomer made by the biocatalyzed reaction, were known prior to the filing date of the ’215 patent. Id. at cols. 1–4. The ’215 patent teaches that “small amounts of . . . impurities may adversely affect the molecular structure of the polymer [made from a monomer produced in a biocatalyzed reaction] and in such circumstances would render the polymer product unsuitable for the intended application.” Id. at col. 3, ll. 41–44. As a result, the ’215 patent states that it is “standard practice to avoid the presence of contaminants in monomers to be polymerised in order to prevent changes to the intended molecular structure Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 4 and properties of the polymer.” Id. at col. 3, ll. 45–48. The patent states that contaminants that should normally be avoided include the microorganism, cellular materials from it, and components of the fermentation broth. Id. at col. 3, l. 53 to col. 4, l. 25. The ’215 patent states that “[w]e have found that it is possible to manufacture polymers having specifically designed features and properties without the need for removing either the biocatalyst or the fermentation broth.” Id. at col. 4, ll. 54–57. II. REJECTIONS Claims 1–46 are pending and stand rejected by the Examiner as follows: 1. Claims 1–11, 15, 17, 38–41, and 46 under 35 U.S.C. § 102(b) (pre- AIA) as anticipated by WO ’680.1 RAN 8. 2. Claims 1–11, 13–17, 38– 41, and 46 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of WO ’680. RAN 8, 19. 3. Claims 1–11 and 13–17 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of WO ’680, JP ’714,2 Munk3 and Kulicke.4 RAN 22. 1 Murao et al. (WO 03/080680 A1, publ. Oct. 2, 2003) (hereinafter “WO ’680”). All references to WO ’680 are to the English translation. 2 Seki (JP 10-316714 A; publ. Dec. 2, 1998) (hereinafter “JP ’714”). All references to JP ’714 are to the English translation. 3 Peter Munk et al., Some Solution Properties of Polyacrylamide, 13 Macromolecules, 871–75 (July/Aug. 1980) (hereinafter “Munk”). 4 W. M. Kulicke et al. PREPARATION, CHARACTERIZATION, SOLUTION PROPERTIES AND RHEOLOGICAL BEHAVIOUR OF POLYACRYLAMIDE, Prog. Polym. Sci., 373–468 (1982) (hereinafter “Kulicke”). Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 5 4. Claims 18–28, 33–35, 37, and 42–45 under 35 U.S.C. § 102(b) (pre-AIA) as anticipated by WO ’680 as evidenced by Kulicke and JP ’714. RAN 27. 5. Claims 12 and 18–37 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of WO ’680, JP ’714, and Kulicke. RAN 33. III. CLAIM Claim 1 is illustrative of the claimed subject matter and reads as follows (underlining and brackets indicate the changes relative to the original claims): 1. A process for preparing a polymer of an ethylenically unsaturated monomer, in which the monomer is obtained from a nitrile in a biocatalysed reaction or a fermentation process, and wherein the monomer contains [cellular material and/or components of] a fermentation broth from the biocatalysed reaction or the fermentation process, forming the polymer by polymerising the ethylenically unsaturated monomer or a monomer mixture comprising the ethylenically unsaturated monomer and [cellular material and/or components of a] the fermentation broth in the presence of a redox and/or thermal initiator and the formed polymer exhibits an intrinsic viscosity of at least 3 dl/g measured using a suspended level viscometer in 1 M sodium chloride at 25°C. IV. CLAIM INTERPRETATION All the claims in this appeal comprise a polymerizing step in which “ethylenically unsaturated monomer or a monomer mixture comprising the ethylenically unsaturated monomer and . . . fermentation broth” is polymerized. The ’215 patent teaches that the fermentation broth “may include any of the typical ingredients used for culturing the microorganism Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 6 and also may include products and by-products produced by the microorganism.” ’215 patent, col. 6, ll. 44–47. The patent also teaches that the fermentation broth may include “any other organic or inorganic compounds that may be required to ensure successful growth of the specific microorganism.” Id. at col. 6, ll. 59–61. Based on this disclosure, we interpret “fermentation broth” to be a media which is suitable for culturing a microorganism. V. FINDINGS OF FACT The following findings of fact (“FF”) are pertinent to the determination of whether the claims are anticipated by, or obvious in view of, the cited prior art. A. WO ’680 FF1. Acrylamide polymers have a wide variety of applications. Examples include use as flocculants, agents for paper manufacturing, soil conditioners, agents for recovering petroleum, thickeners for drilling fluid, and polymer absorbers. An acrylamide polymer is required to have properties such that it has a very high molecular weight . . . in order to be put to use in such applications. WO ’680, 2:10–15. FF2. In general, the use of an aqueous solution with a high acrylamide content results in the formation of polymers with higher molecular weights and the generation of an aqueous solution of highly viscous polyacrylamide. Id. at 3:13–15. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 7 FF3. Acrylamide is a highly toxic substance that is designated as a deleterious substance. . . . Recently, it is preferable to decrease the amount of acrylamide used for producing polyacrylamide that is employed in a variety of industries because of the public interest in environmental issues and energy issues. Thus, the demand for the production of highly viscous polyacrylamide from an aqueous solution with a low acrylamide content is increasing. Specifically, an object of the present invention is to provide an acrylamide solution that can provide polyacrylamide with higher viscosity from an aqueous solution with a low acrylamide content and polyacrylamide produced from such acrylamide solution. Id. at 3:12–22. FF4. [The inventors] have found that an aqueous solution of acrylamide containing saccharides can provide an aqueous solution of polyacrylamide with a higher viscosity than that of polyacrylamide obtained from an aqueous solution with an equivalent acrylamide content that contains no saccharide. This has led to the completion of the present invention. They also unexpectedly found that viscosity could be dramatically enhanced with a saccharide content of as low as 100 mg/l or lower . . . . Id. at 3:24–29. FF5. (13) a process for producing an aqueous solution of acrylamide containing saccharide, wherein acrylamide is produced with the use of a biocatalyst that has nitrile hydratase activity and contains saccharide. Id. at 5:4–6. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 8 FF6. The term “aqueous solution of acrylamide” used in the present invention refers to an aqueous solution wherein acrylamide accounts for 40% to 60% by mass, and preferably 50% by mass, of such solution. When a polymerization initiator such as ammonium persulfate is added to the aqueous solution of acrylamide, acrylamide is polymerized, and an aqueous solution of polyacrylamide is then generated. Id. at 5:9–13. FF7. Examples of a saccharide-containing solution prepared with the use of an organism include a supernatant obtained via centrifugation of a suspension of organisms such as cultured microorganisms and a solution prepared from the aforementioned supernatant via purification or other means. Id. at 5:23–26. FF8. A biocatalyst that has the nitrile hydratase activity of the present invention includes an organism that naturally or artificially has nitrile hydratase activity . . . . . . . . An organism and a processed product thereof include those that have been subjected to washing or treatment with an agent according to need . . . . The “biocatalyst” used in the present invention includes an organism such as the aforementioned microorganism, a suspension containing such organism, and a processed product thereof. Id. at 7:8–9, 19–24. FF9. Alternatively, the aqueous solution of acrylamide produced from Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 9 acrylonitrile with the use of a biocatalyst, with or without purification, may also be used, in which acrylamide content is adjusted to 40% to 60% by weight. Id. at 8:11–13. FF10. When the aforementioned aqueous solution of acrylamide containing saccharide is produced from acrylonitrile with the use of a biocatalyst, . . . the biocatalyst is added in such a manner that the content thereof becomes 0.1 mg to 100 mg per liter of the aqueous solution of acrylamide after the reaction, and acrylonitrile is brought into contact with the biocatalyst to initiate the reaction. Id. at 8:14–19. FF11. The thus obtained aqueous solution of acrylamide can be subjected to a process of purification depending on the application thereof. Examples of a process for purification thereof include filtration through a filter (JP Patent Publication (Kokoku) No. 5-49273 B (1993)) and purification with the aid of air bubbles (JP Patent Application No. 11-254151). Id. at 9:4–8. FF12. The thus obtained aqueous solution of acrylamide can be used as a starting material to obtain an aqueous solution of polyacrylamide in the same manner as with the conventional method for acrylamide polymerization. . . . Such aqueous solution of polyacrylamide can be utilized in various applications, such as in a flocculant, an agent for paper manufacturing, a soil conditioner, an agent for recovering petroleum, a thickener for drilling fluid, and a polymer absorber, as an acrylamide polymer. Id. at 9:9–18. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 10 FF13. Example 1 of WO ’680 describes a supernatant comprising a saccharide produced by Rhodococcus rhodochrous J1 strain. Id. at 10:10– 12:8. The Rhodococcus “was subjected to aerobic culture in a medium (pH 7.0) that was 2% glucose, 1% urea, 0.5% peptone, 0.3% yeast extract, and 0.05% cobalt chloride (‘%’ is by mass) at 30°C.” Id. at 10:18–20. The Rhodococcus was cultured in the medium, filtered, and washed with phosphate buffer to obtain a cell suspension. Id. at 10:13–24. The cell suspension was centrifuged and the “obtained supernatant was used as a saccharide-containing solution.” Id. at 10:25–27. FF14. Example 1 further teaches: Four separate aqueous solutions of 50% acrylamide by mass (1 liter each, Mitsubishi Rayon Co., Ltd.) were provided, and 0.07 ml, 0.2 ml, 3 ml, and 4 ml of the prepared saccharide- containing solutions were independently added to each thereof to prepare aqueous solutions of acrylamide containing saccharides. Id. at 11:17–20. FF15. Example 1 further teaches: The prepared aqueous solution of acrylamide containing saccharide was diluted with distilled water to bring the acrylamide concentration to 15% by mass. Id. at 11:24–25. FF16. Example 1 further comprises adding ammonium persulfate and sodium bisulfite to initiate polymerization of the acrylamide to form the polyacrylamide. Id. at 11:27–29. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 11 FF17. Table 1 of WO ’680 shows that as the saccharide content increased, the viscosity of the aqueous polymer solution increased. Id. at 12:15–17. FF18. Example 2 of WO ’680 shows the production of acrylamide from acrylonitrile with the use of a microbial enzyme. Id. at 12:19. A cell suspension comprising saccharide was prepared as in Example 1. Id. at 12:21–23. The cell suspension was added to a flask containing an aqueous solution of sodium acrylate, acrylonitrile was fed to the flask, and acrylamide was produced until the concentration was 47%. Id. at 12:21 to 13:5. “An aqueous solution of polyacrylamide was prepared from the resulting aqueous solution of acrylamide in the same manner as in Example 1.” Id. at 13:20–21. B. JP ’714 FF19. An object of the present invention is to provide a high molecular weight acrylamide polymer capable of being dried at a high temperature without insolubilization. JP ’714, ¶ 57 FF20. Method for producing an acrylamide polymer, characterized by obtaining an acrylamide polymer by effecting aqueous solution polymerization of an acrylamide produced by an enzyme process either alone or together with another copolymerizable monomer at a concentration range of 10 to 60 wt%, and then drying the obtained acrylamide polymer at 95°C or higher. Id. at 2:8–14. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 12 FF21.5 [0013] In the present invention, an acrylamide produced using an enzyme method means an acrylamide produced by hydrating acrylonitrile by means of the catalytic activity of a nitrile- hydratase. Nitrile-hydratases are enzymes that convert nitrile compounds into the corresponding amides, and are derived from microorganisms . . . . FF22. [0014] The nitrile-hydratase can be used as a culture medium of the above-mentioned micro-organisms, resting bacteria or immobilized bacteria separated from a culture medium. The culture medium is described on page 9, lines 15–25 of JP ’714. It is used to culture the bacteria and, therefore, is a fermentation broth as that term is used in the ’215 patent. See Claim Interpretation section supra. FF23. [0015] . . . the aqueous acrylamide solution following the hydration reaction can be used without further modification, but can also be used after increasing the acrylamide concentration by means of a condensation procedure. FF24. [0016] In the present invention, acrylamide polymer means a homopolymer of acrylamide or a copolymer of acrylamide and one or more unsaturated monomers that are copolymerizable with acrylamide. FF25. [0020] In the production method of the present invention, the concentration of acrylamide in the aqueous solution during polymerization (if a homopolymer of acrylamide is used) or the 5 The bracketed numbers refer to the numbered paragraphs of JP ’714. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 13 total concentration of acrylamide and monomers co- polymerizable therewith in the aqueous solution during polymerization (if an acrylamide copolymer is used) is generally 10 to 60 wt%, and more preferably 20 to 50 wt%. If this concentration is less than 10 wt%, it is difficult to obtain an acrylamide polymer having a high molecular weight . . . . FF26. JP ’714 teaches that the polyacrylamide obtained by its methods is “a high molecular weight polymer having a viscosity of 2,000 mPa·s or higher, or even 3,000 mPa·s or higher. A viscosity of 2,000 mPa·s corresponds to an acrylamide polymer molecular weight of approximately 10,000,000.” Id. ¶ 24. FF27. A biocatalyst was obtained by isolating and washing the obtained strain, and then immobilizing on polyacrylamide gel using a normal method. Id. at 9:15–17. FF28. An aqueous solution having an acrylamide concentration of 30% was obtained by suspending the J-1 strain biocatalyst in ion exchanged water and gradually adding and stirring acrylonitrile having a pH of 7 at 5°C. Following completion of the reaction, an aqueous acrylamide solution having a concentration of 50% (sample 1) was obtained by separating the biocatalyst, carrying out filtration using a 0.45 µm filter, and then concentrating under reduced pressure. Id. at 9:27–34. FF29. A mixture obtained by adding 2 parts of 98 wt% acrylic acid to 348 parts of the 50% aqueous acrylamide solution of Sample 1 was weighed into a 1 L beaker. 400 parts of ion exchanged water were added to this mixture, the mixture was neutralized using Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 14 caustic soda, ion exchanged water was added to give a total of 797 parts, the temperature of the liquid was adjusted to 10°C, and the solution was transferred to a 1 L Dewar flask. This solution was purged with nitrogen gas for 30 minutes, and polymerization was started after adding 1.5 parts of a 10% aqueous solution of 2,2'-azobis (2-amidinopropane) dihydrochloride, 1 part of a 0.2% aqueous solution of sodium hydrosulfite and 0.5 parts of a 0.2% aqueous solution of t-butyl hydroperoxide as polymerization initiators. Id. at 10:32 to 11:10 (¶ 29). C. Watanabe ’855 FF30. Any microorganisms capable of hydrolyzing acrylonitrile to yield acrylamide can be used in the invention irrespective of the taxonomical classification. . . . . . . . In the preparation of immobilized cells using such microorganisms, the microorganism may be used in any of the forms of a cell-containing culture medium (cultured medium), washed cell (resting cells) disrupted cells, and the like. Watanabe ’855, col. 3, ll. 8–10, 22–26. VI. DISCUSSION Claim 1 The process recited in claim 1 requires polymerizing (1) “an ethylenically unsaturated monomer, in which the monomer is obtained from a nitrile in a biocatalysed reaction or a fermentation process” or a monomer mixture comprising it in the presence of a redox and/or thermal initiator. The monomer also contains (2) “fermentation broth from the biocatalysed Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 15 reaction or the fermentation process.” The formed polymer (3) “exhibits an intrinsic viscosity of at least 3 dl/g measured using a suspended level viscometer in 1 M sodium chloride at 25°C.” The production of (1) an ethylenically unsaturated monomer in a reaction catalyzed by a biocatalyst was known prior to the filing date of the ’215 patent as established by both WO ’680 and JP ’714, as well as admissions in the ’215 patent (see cols. 1–4). Both cited patent documents describe a microorganism producing an enzyme with nitrile hydratase activity (the “biocatalyst”) (FF5, FF8, FF20, FF21, FF27) used to catalyze the conversion of acrylonitrile to acrylamide (FF10, FF18, FF28) – an ethylenically unsaturated monomer within the scope of claim 1. The acrylamide monomer is polymerized in both publications in the presence of initiators to form a polymer (FF4, FF6, FF12, FF16, FF20, FF29). The main issues in all the rejections are whether the cited publications describe (2) polymerizing monomer and fermentation broth; and (3) a polymer with an intrinsic viscosity of at least 3 dl/g. We address each of these issues below. A. Presence of fermentation broth in the process of claim 1 1. WO ’680 In claim 1 and WO ’680, the biocatalyst is added to acrylonitrile to prepare the acrylamide monomer utilized in the subsequent polymerizing step to make the polyacrylamide polymer. (Claim 1 is not limited to acrylamide.) Example 1 of WO ’680 describes the preparation of the biocatalyst. The biocatalyst Rhodococcus rhodochrous J1 is cultured in culture medium (the “fermentation broth”). FF13. Next, the Rhodococcus is Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 16 filtered and washed with phosphate buffer. Id. Consequently, it appears that the medium in which the Rhodococcus is cultured is washed away. There is no evidence before us that there is culture media remaining after the wash step of Example 1. Consequently, this example is insufficient to establish the presence of fermentation broth in the biocatalyst produced in WO ’680. WO’680 has broader disclosure describing the preparation of a microorganism as a biocatalyst for the production of acrylamide monomer. WO ’680 teaches preparation of a supernatant from cultured microorganisms, but does not specifically state whether the supernatant is a phosphate buffer as it appears to be in Example 1 or the culture media. FF7. WO ’680 also states that “the aqueous solution of acrylamide produced from acrylonitrile with the use of a biocatalyst, with or without purification, may also be used, in which acrylamide content is adjusted to 40% to 60% by weight.” FF9. It is not sufficiently clear from this statement whether “with or without purification” refers to purification of the acrylamide or biocatalyst, or both. Subsequently, purification of the acrylamide is described (FF11), suggesting that it is the acrylamide that may or may not be purified. The Examiner stated that an “acrylamide polymerization without purification of the acrylamide from the fermentation broth would contain a fermentation broth containing whole cells, fractured cells and components of cells.” RAN 9. However, the Examiner did not provide factual support for this statement. Example 1 of WO ’680 teaches that the acrylamide is produced in an aqueous solution diluted with distilled water (FF14, FF15). Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 17 WO ’680 does not describe the aqueous solution as a fermentation broth as stated by the Examiner. In sum, we conclude that the statement “with or without purification” (FF9) is insufficient in the context of the entire disclosure of WO ’680 to establish that WO ’680 describes or suggests the presence of fermentation broth in the biocatalyst used to polymerize the acrylamide into the polyacrylamide polymer. Requester contends that the “fermentation broth” can constitute the saccharide present in the supernatant obtained from the microorganisms. Requester Respondent Br. 7. However, we have not adopted this narrow definition of “fermentation broth” to mean saccharide, alone. The fermentation broth must be suitable for culturing a microorganism. Requester has not provided evidence that saccharide alone would be suitable for this purpose. Consequently, Requester’s argument is unpersuasive. Requester also refers to the presence of “fermentation broth” in Example 2 of WO ’680. Id. Example 2 describes the use of a cell suspension as in Example 1. FF18. The cell suspension was prepared after washing with phosphate buffer. FF13. There is insufficient evidence that the cell suspension still comprises the aerobic culture medium in which the cells were originally grown after the washing step. Example 2 also describes adding the cell suspension to an “aqueous solution” of sodium acrylate and acrylonitrile. FF18. As already discussed, we have not been pointed to evidence that the aqueous solution is a fermentation broth as that term is defined in the ’215 patent. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 18 In sum, we have not been directed to adequate evidence that WO ’680 describes the presence of a fermentation broth in the monomer or monomer mixture utilized in the polymerizing step. 2. JP ’714 JP ‘714 teaches that the “nitrile-hydratase can be used as a culture medium of the above-mentioned micro-organisms [the “biocatalyst” used to make the monomer], resting bacteria or immobilized bacteria separated from a culture medium.” FF22. The hydratase is used to make the acrylamide that is polymerized in subsequent steps. FF20, FF21. JP ’714 further teaches that “the aqueous acrylamide solution following the hydration reaction [enzyme reaction with the hydratase] can be used without further modification.” FF23. The “aqueous acrylamide solution following the hydration reaction” would contain the bacteria and culture medium. If used “without further modification” (FF23), the subsequent polymerization reaction to produce polyacrylamide would contain the culture medium, namely “fermentation broth,” as required by claim 1. Thus, while there is an example in JP ’714 which describes washing the microorganism (“biocatalyst”) (FF27), there is additional express disclosure in JP ’714 of using the microorganism with culture media, namely, “fermentation broth.” Patent Owner did not adequately address this more general disclosure in JP ’714 in their Appeal Brief in which a culture medium could be present in the acrylamide used to prepare the polyacrylamide. Consequently, we conclude that JP ’714 meets the limitation of claim 1 of “forming the polymer by polymerising the ethylenically unsaturated monomer or a monomer mixture Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 19 comprising the ethylenically unsaturated monomer and the fermentation broth.” 3. Watanabe ’855 Watanabe ’8556 like JP ’714 has disclosure of using the microorganisms in “the form[] of a cell-containing culture medium (cultured medium).” FF30. Consequently, for the same reasons as for JP ’714, we conclude that Watanabe ’855 meets the limitation of claim 1 of “forming the polymer by polymerising the ethylenically unsaturated monomer or a monomer mixture comprising the ethylenically unsaturated monomer and the fermentation broth.” B. “intrinsic viscosity of at least 3 dl/g” The ’215 patent discloses that the “process of the present invention is particular[ly] suitable for preparing high molecular weight water-soluble or water swellable polymers.” ’215 patent, col. 7, ll. 30–32. The patent discloses that “[p]referably the polymers are high molecular weight substantially water-soluble that exhibit an intrinsic viscosity (IV) of at least 3 dl/g (measured using a suspended level viscometer in 1M sodium chloride at 25° C.).” Id. at col. 7, ll. 33–36. The ’215 patent does not attribute a special property or result to polymers having an intrinsic viscosity of at least 3 dl/g. 6 Watanabe et al. (US 4,421,855, issued Dec. 20, 1983) (hereinafter “Watanabe ’855”). Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 20 1. WO ’680 The Examiner found that WO ’680 describes a formed polyacrylamide polymer which inherently possessed “an intrinsic viscosity of at least 3 dl/g measured using a suspended level viscometer in 1 M sodium chloride at 25°C” as recited in claim 1. RAN 11. The Examiner’s finding is not supported by a preponderance of the evidence. The Examiner stated that “when 1 mg/L – 60 mg/L of saccharide were added to the acrylamide solution, the viscosity ranged from 130,000 mPa-s to 220,000 mPa-s.” Id. However, as indicated by Patent Owner, these values are for the dynamic viscosity which is different from intrinsic viscosity. PO Appeal Br. 7. The Examiner did not establish that such values would meet the intrinsic viscosity requirement of the claim, particularly when WO ’680 teaches that the increased viscosity observed with its polyacrylamide is a result of the saccharide content. FF4, FF17. Patent Owner supported this argument with a Declaration by Bjorn Langlotz, Ph.D., a laboratory manager at BASF Advanced Materials & Systems Research. Langlotz Decl. ¶ 1. Dr. Langlotz testified: WO ‘680 references only dynamic viscosity. Thus, when WO ‘680 mentions an increased viscosity at page 12, Table 1 based on increasing saccharide content, it is referring to increasing the dynamic viscosity of the solution. This increase in dynamic viscosity of the solution described in WO ‘680 by increasing the saccharide content would have no significant effect on the intrinsic viscosity of the polyacrylamide polymer in the solution at the concentrations provided in WO ‘630 (i.e., would be within the range of experimental error). Thus, this increase in dynamic viscosity does not relate to an increase in the intrinsic viscosity of the polyacrylamide polymer. This increase in dynamic viscosity by increasing saccharide content in WO ‘680 also does Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 21 not mean that WO ‘680 is teaching an intrinsic viscosity that is as high or higher than that of the prior art. Langlotz Decl. ¶ 9. The Examiner rejected Dr. Langlotz’s argument about the saccharide content not having a significant effect on the intrinsic viscosity of the polymer, but did not provide adequate factual basis to support his position. RAN 55. Further, the definition cited by Requester defines intrinsic viscosity as reflecting “the capability of a polymer in solution to enhance the viscosity of the solution.” Requester Respondent Br., Exhibit 2. Thus, Requester’s definition of intrinsic viscosity is consistent with Dr. Langlotz’s testimony. The Examiner also found that based “upon the similarity between the processes of JP ’714 and that of WO ’680, it is reasonable to conclude that the polyacrylamide taught in WO ’680 has a similar intrinsic viscosity (2,000 mPa-s) and molecular weight (about 10 million).” RAN 23. The Examiner’s statement is not supported by a preponderance of the evidence for several independent reasons. First, WO ’680 utilized saccharides to increase the polyacrylamide’s viscosity (FF4, FF17), while JP ’714 does not. Thus, the two patent publications utilized different technologies to achieve a desired viscosity. We have not been directed to evidence that the different technologies would result in the same intrinsic viscosities. Second, the polymerization initiators utilized in the two publications are not the same. WO ’680 uses ammonium persulfate and sodium bisulfite in its example (FF16); JP ’714 describes the use of 2,2' -azobis (2- amidinopropane) dihydrochloride, sodium hydrosulfite, and t-butyl Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 22 hydroperoxide (FF29). Kulicke teaches that the type of polymerization initiator affects the molecular weight of the polymer: FF31. “The polymerization with persulfate, AIBN, and other initiators can lead to residual ions or radicals in the polymers. AIBN as initiator can be used for bulk polymerization but low molecular weight polymers are produced only.” Kulicke 378 (footnotes omitted). FF32. From the fact that under more drastical polymerization conditions – namely high amounts of a persulfate-bisulfite initiator at 70°C – branched PAAm [(polyacrylamide homopolymers)] with only a few long chain branches are produced, it is justified to conclude that linear PAAm will be formed by the mild polymerization mentioned above, see section 2.3. Table 3 presents examples of polymerization conditions, which have been used to prepare high molecular weight polymers. Id. at 379. Consequently, because of the difference in initiator, it cannot be presumed that the molecular weight of the polymer produced in JP ’714 would reasonably predict the molecular weight of the polymer produced by the process described in WO ’680. Third, the Examiner’s contention that WO ’680 produces “very high molecular weight polyacrylamide” is not supported by the evidence we have been directed to consider. RAN 56. WO ’680 does not describe the molecular weight of the polyacrylamide formed by its polymerization process. WO ’680 teaches that acrylamide is toxic and that “it is preferable to decrease the amount of acrylamide used for producing polyacrylamide.” FF3. To achieve this reduction in acrylamide content, WO ’680 teaches the Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 23 addition of saccharide to the polymerization solution, while maintaining a low acrylamide content. FF3–FF5. Although WO ’680 teaches that “the use of an aqueous solution with a high acrylamide content results in the formation of polymers with higher molecular weights” (FF2), we have no discussion in WO ’680 as to what the effect on molecular weight is when a lower acrylamide content is used as taught by WO ’680. Thus, the Examiner’s finding that WO ’680 produces “very high molecular weight polyacrylamide” is not necessarily consistent with the express teachings of the invention of WO ’680, which uses a lower acrylamide content. Requester contends that high molecular weight polyacrylamide is necessary for it to serve as a flocculant, one of the uses described in WO ’680 for polyacrylamide (FF1, FF12), and therefore the polyacrylamide produced in WO ’680 must have a high molecular weight. Requester Respondent Br. 4. However, this argument ignores the fact that the object of WO ’260 is to reduce the acrylamide content while maintaining the viscosity by using a saccharide. FF4. WO ’260 is silent as to molecular weight. Requester did not provide adequate evidence the molecular weight of the polymer in WO ’680 must be high, and as high as the polymer in JP ’714. In sum, we find that the Examiner erred in finding that WO ’680 necessarily discloses or suggests a polymer with the claimed intrinsic viscosity. 2. JP ’714 JP ’714 describes a high molecular weight polymer made from a “monomer [] obtained from a nitrile in a biocatalysed reaction or a fermentation process” (FF21) which has “a viscosity of 2,000 mPa·s or Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 24 higher, or even 3,000 mPa·s or higher.” FF26. JP ’214 teaches that a “viscosity of 2,000 mPa·s corresponds to an acrylamide polymer molecular weight of approximately 10,000,000.” Id. The following findings of fact establish that the formed polymer in JP ’714 having a molecular weight of approximately 10,000,000 “exhibits an intrinsic viscosity of at least 3 dl/g measured using a suspended level viscometer in 1 M sodium chloride at 25°C” as recited in claim 1. FF33. Figure 13 of Kulicke shows that as the molecular weight of the polyacrylamide polymer increases, the intrinsic viscosity also increases. The figure shows that “an intrinsic viscosity of 3 dl/g occurs at a molecular weight of about 800,000 when measured in water at 25°C.” RAN 24; Kulicke 406. FF34. Munk teaches that there is “good agreement between our dependence of the intrinsic viscosity on the molecular weight.” Munk 875 (“Conclusions”). FF35. Table III of Munk shows that as the molecular weight of the polyacrylamide polymer increases, the intrinsic viscosity of the polymer also increases. Table III shows that at 1.0 M NaCl a polyacrylamide sample having a molecular weight of 11,200,000 has an intrinsic viscosity of “1790” or 17.9 dl/g. See RAN 23, 25; Munk 874. Thus, Kulicke and Munk teach that molecular weight can be relied upon as evidence of a polyacrylamide polymer’s intrinsic viscosity. Since the molecular weight of JP ’714 is greater than 800,000, it is reasonable to find that the polymer’s intrinsic viscosity is greater than 3 dl/g (FF33) and Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 25 closer to Munk’s intrinsic viscosity of 17.9 dl/g for a polymer of molecular weight of 11,200,000 (FF35). 3. Anticipation by WO ’680 The rejection of claim 1 as anticipated by WO ’680 (Ground 1 above) is reversed because the preponderance of the evidence does not establish that WO ’680 meets the requirements of claim 1 of the presence of a fermentation broth in the monomer nor the viscosity requirement. Dependent claims 2–11, 15, 17, and 38–41 are reversed for the same reasons. (Claim 46 is addressed separately below.) 4. Obviousness based on WO ’680 The Examiner alternatively rejected independent claim 1, and dependent claims 2–11, 15, 17, and 38–41 as obvious in view of WO ’680. RAN 8. The Examiner stated that it would have been obvious to optimize the viscosity of an aqueous polyacrylamide solution by employing a higher concentration of acrylamide monomer and an increasing the amount of saccharide. Id. at 12. However, the Examiner did not provide evidence that intrinsic viscosity was recognized as a variable which the skilled worker would have desired to optimize to a value of 3 dl/g or more as required by the claim. The object of WO ’680 is described as “to provide an acrylamide solution that can provide polyacrylamide with higher viscosity from an aqueous solution with a low acrylamide content.” FF3. This is accomplished utilizing a saccharide. FF4. Consequently, contrary to statements made by the Requester (Requester Respondent Br. 14–15), the skilled worker would not have used a higher content of acrylamide monomer Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 26 which is contrary to the purpose of WO ’680 to reduce the acrylamide monomer content by the use of a saccharide. In addition to this, and independently, the Examiner did not provide a reason as to why the skilled worker would have modified WO ’680 to include fermentation broth as required by the claim. For the foregoing reasons, the obviousness rejection based on WO ’680 alone of claims 1–11, 13–17, and 38– 41 is reversed (Ground 2 above). (Claim 46 is addressed separately below.) 5. Obviousness based on WO ’680, JP ’714, Munk, and Kulicke The Examiner rejected claims 1–11 and 13–17 as obvious in view of WO ’680, JP ’714, Munk, and Kulicke. RAN 22. The Examiner stated that WO ’680 “does not expressly disclose the intrinsic viscosity of the polymerized acrylamide product synthesized by the process of claim 1,” but found that the “secondary references – JP ’714, Munk, and Kulicke – address this issue of intrinsic viscosity of the final polymerized acrylamide product.” RAN 23. The Examiner argues that, based on JP ’714, Munk, and Kulicke, “WO ’680 must have a molecular weight of about 0.8 - 11 million daltons” and “must” have the required minimum intrinsic viscosity of at least 3 dl/g. Id. at 25. For the reasons already discussed, we conclude that the Examiner erred finding that WO ’680’s polyacrylamide would necessarily possess the intrinsic viscosity of the polymer of claim 1. The Examiner did not provide a reason as to why the skilled worker would have desired this value. Furthermore, we find that the basis of the obviousness rejection is not clear because the Examiner did not provide a reason as to why claim 1 would Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 27 have been obvious to one of ordinary skill in the art; rather, the Examiner appeared to rely on the same arguments set forth for the anticipation rejection. See RAN 22. Despite the error in the rejection, we shall sustain the rejection of claims 1–11 and 13–17 as obvious in view of WO ’680, JP ’714, Munk, and Kulicke, but, as explained below, for different reasons from the Examiner. Accordingly, we designate the rejection as a new ground of rejection under 37 C.F.R. § 41.77(b). We also further rely on Watanabe ’855 as evidence, in addition to JP ’714, that it would have been obvious to have utilized fermentation broth in the polymerization step. As explained above, the evidence in the record establishes that JP ’714 describes a polymer having a molecular weight of approximately 10,000,000, which is understood to “exhibit[] an intrinsic viscosity of at least 3 dl/g measured using a suspended level viscometer in 1 M sodium chloride at 25°C” as evidenced by Munk and Kulicke (FF33–FF35) and as recited in claim 1. JP ’714 describes production of high molecular weight acrylamide polymer as an object of its invention. FF19. Thus, even to the extent that JP ’714’s polymer does not possess the recited intrinsic value, there would have been reason to make high molecular polymers which are known to have high intrinsic viscosity as taught in Munk and Kulicke. FF33–FF35. Munk and Kulicke provide explicit evidence acrylamide polymers with such high molecular weight also have intrinsic viscosities well above the claimed value of 3 dl/g. As discussed supra at page 19, the’215 patent does not attribute a special property or result to polymers having an intrinsic viscosity of at least 3 dl/g. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 28 With respect to the requirement of claim 1 that fermentation broth is present during the polymerizing step, both JP ’714 and Watanabe ’855 describe fermentation broth in the microorganisms used to catalyze the fermentation process. See discussion above; FF22, FF30. The Examiner did not reject certain dependent claims under the obviousness rejection, which had been found to have been anticipated by, or obvious in view of, WO ’680, alone. These claims are claims 38–41. See Rejections 1 and 2, supra (rejecting these claims as anticipated or obvious based on WO ’680). The Examiner explained why these claims were described by WO ’680. RAN 17–18. We therefore add these claims to this obviousness rejection. As explained above, JP ’714 discloses an example molecular weight such that the intrinsic viscosity value falls within the ranges recited specifically in claims 39 and 40, as evidenced by Munk and Kulicke. FF33–FF35. In sum, we affirm the rejection of 1–11 and 13–17 as obvious in view of WO ’680, JP ’714, Munk and Kulicke (Ground 3), but designate it as a new ground of rejection under 37 C.F.R. § 41.77(b). Claims 38–41 are also rejected on the same basis. Watanabe ’855 is added to the rejection as additional evidence. Claim 18 A. Anticipation rejection Claim 18 is similar to the process of claim 1, but uses a monomer mixture comprising a first ethylenically unsaturated monomer and a second ethylenically unsaturated monomer. The Examiner made the finding that the Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 29 disclosure in WO ’680 of acrylamide and polyacrylamide includes copolymers as evidenced by JP ’714 and Kulicke. RAN 28. The Examiner’s evidence is not persuasive. The claim requires first and second ethylenically unsaturated monomers. The Examiner has not established that the terms acrylamide and polyacrylamide recited in WO ’680 “necessarily” mean two different (i.e., first and second) ethylenically unsaturated monomers. A “prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005). When inherency is a basis of anticipation, it “may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal citation and quotation marks omitted). The Examiner also stated that the terms denote a family of monomers, which include cationic and ionic monomers. RAN 28–29. Anticipation can be established when a small genus is disclosed and each member can be at once envisaged. In re Petering, 301 F.2d 676, 681 (CCPA 1962). The Examiner has not explained why a person of ordinary skill in the art would have immediately envisaged utilizing the specifically recited ethylenically unsaturated monomers recited in the claim. For example, the Examiner has not identified the members of the monomer family to know the family’s size and complexity. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 30 Accordingly, we cannot sustain the anticipation rejection of claim 18 and dependent claims 19–28, 33–35, 37, and 42–45 (Ground 4). B. Obviousness rejection The Examiner rejected claims 12 and 18–37 as obvious in view of WO ’680, JP ’714, and Kulicke. The rejected claims are drawn to a polymerization process utilizing a mixture of monomers. The Examiner found that JP ’714 describes a process of polymerizing one or more unsaturated monomers to form polyacrylamide. RAN 34–35; FF24, FF25. The Examiner’s finding is supported by factual evidence. Id. Patent Owner has not identified an error in the Examiner’s findings. See PO Appeal Br. 36. Accordingly, the rejection is affirmed (Ground 5). However, for the same reason as for Ground 3, we designate the rejection as a new ground of rejection under 37 C.F.R. § 41.77(b) and add Watanabe ’855 as additional evidence. Claims 42–45 are added to the rejection. Claims 42 further recites an enzyme which is described by JP ’714. FF20, FF21, FF22. Claims 43 and 44 further recite intrinsic viscosities which are described in JP ’714 as evidenced by Munk and Kulicke. See supra at pp. 24–25. Claim 45 recites that the formed polymer is water-soluble which is a characteristic of polyacrylamide described by both WO ’680 and JP ’714. See RAN 33; FF25. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 31 Claim 46 A. Anticipation and obviousness rejections based on WO ’680 alone Claim 46 is similar to claim 1, but rather than reciting the presence of fermentation broth, it recites that monomer or monomer mixture comprises “the components of the fermentation broth.” The saccharide, biocatalyst microorganism, and/or biocatalyst nitrile hydratase are components of a fermentation broth and are present in the polymerization flask of WO ’680 (RAN 18–19). Thus, WO ’680 meets the limitation of the claim. However, the anticipation and obviousness rejections (Grounds 1 and 2) cannot be sustained because the required intrinsic viscosity of claim 46 is not met by WO ’680 as explained above. B. Obviousness based on WO ’680 in combination with JP ’714, Kulicke, and Munk Claim 46 was not rejected as obvious based on WO ’680 in combination with JP ’714, Kulicke, and Munk. We find this to be an error since claim 46 is even broader than claim 1, which was rejected on this basis, differing in the requirement that components of a fermentation broth are present in the polymerizing step, rather than the fermentation broth itself. Consequently, we set forth a new ground of rejection under 37 C.F.R § 41.77(b) of claim 46 as obvious in view of WO ’680, JP ’714, Munk, Kulicke, and Watanabe ’855. VII. ANTICIPATION BY JP ’714 We set forth a new ground of rejection 37 C.F.R § 41.77(b) of independent claims 1, 18, and 46 under 35 U.S.C. § 102(b) (pre-AIA) as Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 32 anticipated by JP ’714. We leave it to the Examiner to determine whether any of the claims which depend from the independent claims are anticipated by JP ’714. JP ’714 describes the claimed process of polymerizing ethically unsaturated monomers utilizing monomers made by a biocatalyst. FF21, FF23, FF24, FF25, FF28, FF29. The biocatalyst used to make the monomer can be used in the polymerization process as a “culture medium” (FF22, FF23), and thus meets the limitation of the claims that requires the presence of fermentation broth, or a component of it, in the step of polymerizing the monomer to form a polymer. As discussed above, the polymers produced in JP ’714 also meet the requirement of the claims of an intrinsic viscosity of at least 3 dl/g, as evidenced by Munk and Kulicke. FF33–FF35. VIII. SUMMARY Grounds of Rejection 1, 2, and 4 are reversed. Grounds of Rejection 3 and 5 are affirmed but are designated as new grounds of rejection under 37 C.F.R. § 41.77(b). New evidence has been added to each. The new grounds are as follows: 3. Claims 1–11, 13–17, and 38–41 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of WO ’680, JP ’714, Munk, Kulicke, and Watanabe ’855. 5. Claims 12, 18–37, and 42–45 under 35 U.S.C. § 103(a) (pre- AIA) as obvious in view of WO ’680, JP ’714, Munk, Kulicke, and Watanabe ’855. Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 33 6. Claim 46 is rejected under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of WO ’680, JP ’714, Munk, Kulicke, and Watanabe ’855. This is a new ground of rejection under 37 C.F.R. § 41.77(b). 7. Claims 1, 18, and 46 are rejected under 35 U.S.C. § 102(b) (pre-AIA) as anticipated by JP ’714. This is a new ground of rejection under 37 C.F.R. § 41.77(b). NEW GROUNDS OF REJECTION This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.77(b) which provides that “[a]ny decision which includes a new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Correspondingly, no portion of the decision is final for purposes of judicial review. A requester may also request rehearing under 37 C.F.R. § 41.79, if appropriate; however, the Board may elect to defer issuing any decision on such request for rehearing until such time that a final decision on appeal has been issued by the Board. For further guidance on new grounds of rejection, see 37 C.F.R. § 41.77(b)–(g). The decision may become final after it has returned to the Board. 37 C.F.R. § 41.77(f). 37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN ONE MONTH FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. The owner may file a response requesting reopening of prosecution before the examiner. Such a response must be either an amendment of the claims so rejected or new evidence relating to the claims so rejected, or both. (2) Request rehearing. The owner may request that the proceeding be reheard under § 41.79 by the Board upon the same record. . . . Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 34 Any request to reopen prosecution before the examiner under 37 C.F.R. § 41.77(b)(1) shall be limited in scope to the “claims so rejected.” Accordingly, a request to reopen prosecution is limited to issues raised by the new ground(s) of rejection entered by the Board. A request to reopen prosecution that includes issues other than those raised by the new ground(s) is unlikely to be granted. Furthermore, should the patent owner seek to substitute claims, there is a presumption that only one substitute claim would be needed to replace a cancelled claim. A requester may file comments in reply to a patent owner response. 37 C.F.R. § 41.77(c). Requester comments under 37 C.F.R. § 41.77(c) shall be limited in scope to the issues raised by the Board’s opinion reflecting its decision to reject the claims and the patent owner’s response under paragraph 37 C.F.R. § 41.77(b)(1). A newly proposed rejection is not permitted as a matter of right. A newly proposed rejection may be appropriate if it is presented to address an amendment and/or new evidence properly submitted by the patent owner, and is presented with a brief explanation as to why the newly proposed rejection is now necessary and why it could not have been presented earlier. Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for all patent owner responses and requester comments, is required. The examiner, after the Board’s entry of a patent owner response and requester comments, will issue a determination under 37 C.F.R. § 41.77(d) as to whether the Board’s rejection is maintained or has been overcome. The proceeding will then be returned to the Board together with any comments and reply submitted by the owner and/or requester under 37 C.F.R. § 41.77(e) for reconsideration and issuance of a new decision by the Board as provided by 37 C.F.R. § 41.77(f). AFFIRMED; 37 C.F.R. § 41.77(b) Appeal 2016-004385 Patent 8,067,215 B2 Reexamination Control 95/002,219 35 Patent Owner: BASF Corporation Patent Department 500 White Plains Road P.O. Box 2005 Tarrytown, NY 10591 Third Party Requester: DICKSTEIN SHAPIRO LLP 1825 EYE STREET NW WASHINGTON, DC 20006-5403 Copy with citationCopy as parenthetical citation