Ex Parte Krause et alDownload PDFPatent Trial and Appeal BoardFeb 25, 201913120375 (P.T.A.B. Feb. 25, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/120,375 04/27/2011 Bernd Krause 23643 7590 02/27/2019 Barnes & Thornburg LLP (IN) 11 S. Meridian Street Indianapolis, IN 46204 UNITED ST A TES OF AMERICA 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 52759-215754 9483 EXAMINER MCNEIL, STEPHANIE AN ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 02/27/2019 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): INDocket@btlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BERND KRAUSE, MARKUS NEUBAUER, and JOACHIM LOERCHER Appeal2017-010792 1 Application 13/120,375 Technology Center 1600 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and JOHN G. NEW, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to membranes for use in cultivating cells. The Examiner entered a rejection based alternatively on anticipation or obviousness, and also entered two additional rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b)(l). We affirm-in-part. 1 Appellants state that the real party in interest is Gambro Lundia AB. Appeal Br. 3. Appeal2017-010792 Application 13/120,375 STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 1, 2, 4, 7, 8, 16, 21, 24, and 27, under 35 U.S.C. § I02(b) as anticipated by, or alternatively under 35 U.S.C. § I03(a) as obvious over Gohl2 (Ans. 2-6); (2) Claims 1-5, 7, 8, 16, 17, 21, 24, and 27, under 35 U.S.C. § I03(a) as unpatentable over Gohl and Bell3 (Ans. 6-8); and (3) Claims 1--4, 7, 8, 16, 17, and 21-29, under 35 U.S.C. § I03(a) as unpatentable over Gohl and Baurmeister4 (Ans. 8-9). Claims 1, 7, and 8, the independent claims on appeal, are illustrative and read as follows: 1. An irradiated membrane for the cultivation of cells, the membrane comprising at least one of a polysulfone, polyethersulfone and a polyarylethersulfone, and a polyvinylpyrrolidone, which has been irradiated with at least one of gamma-rays, beta-rays and an electron beam in a dose of from 70 to 175 kGy in the presence of oxygen at a concentration of 4 to 100 vol%. 7. A cell culturing device comprising an irradiated membrane comprising at least one of a polysulfone, polyethersulfone and a polyarylethersulfone, and a polyvinylpyrrolidone, which has been irradiated with at least one of gamma-rays, beta-rays and an electron beam in a dose of from 12.5 to 175 kGy in the presence of oxygen at a concentration of 4 to 100 vol%. 2 Bernd Krause et al., EP 1 875 957 Al (published Jan. 9, 2008) (hereinafter "Gohl"). 3 Carl-Martin Bell et al., US 5,543,465 (issued Aug. 6, 1996) (hereinafter "Bell"). 4 Ulrich Baurmeister et al., US 6,271,023 Bl (issued Aug. 7, 2001) (hereinafter "Baurmeister"). 2 Appeal2017-010792 Application 13/120,375 8. A device for the extracorporeal treatment of body fluids, the device comprising cells and an irradiated membrane including at least one of a lumen surf ace and an outer surface, the membrane comprising at least one of a polysulfone, polyethersulfone and a polyarylethersulfone, and a polyvinylpyrrolidone, the cells forming a confluent layer on the lumen surface or outer surface of the membrane, the membrane having been irradiated with at least one of gamma-rays, beta- rays and an electron beam in a dose of from 12.5 to 175 kGy in the presence of oxygen at a concentration of 4 to 100 vol%. Appeal Br. 38-39 (Claims App'x) (emphasis added to show claim language at issue). STANDARD OF REVIEW As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. ANTICIPATION/OBVIOUSNESS-GOHL The Examiner's Prima Facie Case The Examiner rejected claims 1, 2, 4, 7, 8, 16, 21, 24, and 27 under 35 U.S.C. § 102(b) as anticipated by, or alternatively under 35 U.S.C. § 103(a) as obvious over Gohl. Ans. 2---6. The Examiner determined that the alternative anticipation/obviousness rejection was appropriate because the rejected claims are product-by-process claims. Id. at 3-5 (citing MPEP §§ 706.02(m), 2112)). The Examiner cited Gohl as disclosing: (1) a membrane for blood filtration composed of polyethersulfone and polyvinylpyrrolidone as recited 3 Appeal2017-010792 Application 13/120,375 in the rejected claims, (2) that its membranes may be sterilized by gamma radiation, as also recited in the claims, and (3) that cells are retained on its membranes when blood filtering is performed. Id. at 3. Based on those disclosures, the Examiner reasoned that Gohl describes a membrane having all of the structural and functional features required by the rejected claims, and that Gohl, therefore, anticipates the rejected claims. Id. at 4---6. Alternatively, the Examiner found, an ordinary artisan had motivation for, and a reasonable expectation of success in, gamma-irradiating Gohl's membrane and adding cells to Gohl's membrane, "because [Gohl] explicitly suggests all of these modifications." Id. at 6. Therefore, the Examiner concluded, "the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made." Id. Analysis-Claim 1 (and dependent claims) It is well settled that, once the Examiner establishes that a product recited in terms of its process of making is prima facie unpatentable due to anticipation, Appellants bear the burden of proving "that the prior art products do not necessarily or inherently possess the characteristics of his claimed product." In re Thorpe, 777 F.2d 695, 698 (Fed. Cir. 1985) ( quoting In re Fitzgerald, 619 F .2d 67, 70 (CCP A 1980); In re Best, 562 F.2d 1252, 1255 (CCPA 1977)). Having carefully considered all of the arguments and evidence advanced by Appellants and the Examiner, Appellants persuade us that the preponderance of the evidence does not support the Examiner's determination that Gohl anticipates claim 1. 4 Appeal2017-010792 Application 13/120,375 In the present case, as the Examiner found, and as required by Appellants' claim 1, Gohl discloses a membrane composed of polythersulfone in combination with polyvinylpyrrolidone: [ A ]ccording to the present invention there is provided a process for manufacturing of an asymmetric hollow fibre membrane, comprising the steps of extruding a polymer solution through the outer ring slit of a hollow fibre spinning nozzle, simultaneously extruding a centre fluid through the inner bore of the hollow fibre spinning nozzle, into a precipitation bath, whereby the polymer solution contains 10 to 26wt-% of polysulfone (PSU), polyethersulfone (PES) or polyarylethersulfone (PAES), 8 to 15 wt-% polyvinylpyrrolidone (PVP), 55 to 75 wt-% N-alkyl-2- pyrrolidone (NAP) and 3 to 9 wt-% water .... Gohl ,r 14. As the Examiner found, and as required by Appellants' claim 1, Gohl discloses using gamma radiation to sterilize its membrane. Id. ,r 17 ("The mechanical stability of the membrane is excellent, and it is sterilizable by steam, gamma radiation and/or ETO.") As the Examiner contends, however, product-by-process claims are evaluated as to the structure of the claimed product, as opposed to whether the prior art necessarily describes preparing the allegedly anticipating product by the same process recited in the product-by-process claim. Thorpe, 777 F .2d at 697. Thus, for a prior art product to anticipate a product recited in a product-by-process claim, the prior art product must be identical to the claimed product, including as to the structure of the claimed product. Id. In other words, "if the process by which a product is made imparts structural and functional differences distinguishing the claimed product from the prior art, then those differences are relevant as evidence of no anticipation 5 Appeal2017-010792 Application 13/120,375 although they are not explicitly part of the claim." Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345, 1354 (Fed. Cir. 2016) (internal quotations omitted). In the present case, consistent with Appellants' contention that the sterilization conditions recited in claim 1 impart a structural difference between Gohl's membrane and the membrane recited in claim 1 (see Appeal Br. 7), Appellants' Specification discloses that sterilizing membranes with different gamma radiation dosages results in membranes that are structurally and functionally different, as demonstrated by the membranes' distinct capacities to support cell growth. See, e.g., Spec. 49. Specifically, Appellants' Specification discloses that when a membrane composed of polyethersulfone and polyvinylpyrrolidone ("VTK") was gamma-irradiated at a dosage of 25 kGy in air, 5 the resulting membrane did not support consistent mesenchymal stem cell (MSC) growth in all growth phases: Id. Air-covered VTK inserts irradiated with 25 kGy showed controversial results comparing Experiments 1 and 2; in Figure 1, this membrane type performed comparable to TCPS [(tissue culture polystyrene supports6)] in the first growth phase but showed a strong decrease of MSC in the second growth phase, whereas the membrane type behaved vice versa in Experiment 2. In contrast, when a membrane composed of polyethersulfone and polyvinylpyrrolidone was gamma-irradiated at a dosage of 75 kGy in air 5 Unmodified air contains about 20.95% molar content/volume. Spec. 28. 6 According to the Specification, "tissue culture polystyrene (TCPS) plates . . . represent today's gold standard for cell expansion using culture flasks or cell stacks." Spec. 30. 6 Appeal2017-010792 Application 13/120,375 (i.e., conditions encompassed by Appellants' claim 1 ), the resulting membrane supported consistent mesenchymal stem cell growth in both the first and second growth phases: Id. Air-covered VTK inserts irradiated with 75 kGy showed MSC growth in both growth phases comparable or better than TCPS. Coverage of VTK membranes with water or aqueous acrylic acid solution with different concentrations during the gamma irradiation procedure resulted in similar results as air-covered VTK inserts irradiated with 75 kGy. As seen above, although Gohl describes sterilizing its polyethersulfone/polyvinylpyrrolidone membrane with precisely the type of radiation required by Appellants' claim 1 (gamma radiation), Gohl does not disclose applying a particular dosage of that radiation to the membrane. In contrast, Appellants' claim 1 recites a specific radiation dosage range, from 70 to 175 kGy (Appeal Br. 38 (Claims App'x)), not expressly described in Gohl. As discussed above, moreover, Appellants' Specification provides evidence that applying gamma radiation at a dosage within the range recited in Appellants' claim 1 produces a membrane that is structurally and functionally different from a membrane that has been sterilized by gamma radiation applied at a dosage outside the range of claim 1. See Spec. 49. Given the evidence of record that different gamma radiation dosages yield membranes that are structurally and functionally different depending on the radiation dosages, the Examiner does not persuade us that Gohl' s generic disclosure of sterilizing its membranes with gamma radiation results in a membrane that necessarily, that is inherently, has the same structure and functional properties as the membrane recited in Appellants' claim 1. See 7 Appeal2017-010792 Application 13/120,375 Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) ("The very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question." (Emphasis added)). In addition, as discussed in the Gohl Declaration 7 ( a declaration by one of the inventors listed on the Gohl reference), a skilled artisan gamma- irradiating the membranes according to the teachings in the Gohl reference would have applied a radiation dosage in accordance with the European Standard for sterilization of health care products, and would have applied a sterilization dose of either 15 kGy or 25 kGy, rather than a dosage within the range of 70 to 175 kGy recited in Appellants' claim 1. See Gohl Deel. ,r,r 9, 1 O; see id. at Exhibit A ( cited in Gohl Declaration as providing European Standard for sterilization of a medical product). Thus, in addition to the evidence, discussed above, that the Gohl' s generic disclosure of sterilizing its membranes with gamma radiation would not necessarily yield a membrane that is the same as the membrane recited in Appellants' claim 1, Appellants have advanced evidence that a skilled artisan following Gohl' s teachings would not necessarily have applied a radiation dosage, recited in claim 1, that produces the claimed membrane. We agree with Appellants, therefore, that the preponderance of the evidence does not support the Examiner's determination that Gohl describes a membrane having all of the features of the membrane recited in Appellants' claim 1. Accordingly, we reverse the Examiner's rejection of claim 1, and its dependent claims 2, 4, 16, and 21, as anticipated by Gohl. 7 Declaration under 37 C.F.R. § 1.132 of Hermann Gohl (signed Sept. 1, 2015) (hereinafter "Gohl Deel."). 8 Appeal2017-010792 Application 13/120,375 As noted above, the Examiner alternatively rejected claims 1, 2, 4, 16, and 21 for obviousness over Gohl. Ans. 6. The Examiner, however, identified no disclosure in Gohl suggesting the specific radiation dosage recited in Appellants' claim 1, or the specific product resulting therefrom, but instead relied on Gohl's generic disclosure of gamma-irradiating its membranes which, as discussed above, does not mention any particular radiation dosage. Because the Examiner did not identify, nor do we discern, any specific teachings in Gohl that would have taught or suggested, or resulted in, a membrane having the structure and properties of the membrane recited in Appellants' claim 1, we reverse the Examiner's rejection of claim 1, and its dependent claims 2, 4, 16, and 21, for obviousness over Gohl. Analysis-Claim 7 (and dependent claim) Having carefully considered all of the arguments and evidence advanced by Appellants and the Examiner, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's determination that Gohl anticipates claim 7. In contrast to the radiation dosage in claim 1 discussed above, Appellants' claim 7 recites a device composed of a membrane that has been irradiated at a much broader dosage, "of from 12.5 to 175 kGy." (Appeal Br. 38 (Claims App'x) (claim 7)). The gamma radiation dosage range recited in claim 7 encompasses the dosages of 25 kGy or 15 kGy recommended by the European Standard for sterilization of health care products, which the Gohl Declaration states are the dosages that would have been applied by a skilled artisan following the description of gamma-irradiation in the Gohl reference. See Gohl Deel. ,r,r 9 Appeal2017-010792 Application 13/120,375 9--10. Appellants do not persuade us, therefore, that the gamma radiation dosage recited in claim 7, used to prepare the irradiated device recited in claim 7, structurally or functionally distinguishes the cell culture device recited in claim 7 from the device described in the Gohl reference. As discussed above, Gohl' s device has the same overall structure (membrane), is undisputedly formed from the same combination of polymers, and is sterilized by the same type of radiation as the device recited in Appellants' claim 7. And as Appellants effectively concede, a skilled artisan would have understood Gohl' s description of sterilizing its membrane as applying a gamma radiation dosage encompassed by claim 7. See id. We are also unpersuaded that Appellants have established that the device recited in claim 7 is distinguishable from the device described in Gohl based on the limitation requiring the sterilization to be performed in the presence of oxygen at a concentration of 4 to 100 vol%. In addition to the Gohl Declaration, Appellants cite the Saito reference8 as evidence that Gohl's description of sterilizing its membranes would have been interpreted as disclosing gamma sterilization in the absence of oxygen, as opposed to the concentration of 4 to 100 vol%. See Appeal Br. 8-9 (incorporating by reference arguments traversing rejection of claim 1 ). While the cited portion of the Saito reference cautions against excessively high radiation dosages, Appellants do not identify in the reference any specific disclosures about excluding oxygen when performing gamma-irradiation for sterilization purposes, nor does Saito disclose 8 HIGH-PERFORMANCEMEMBRANEDIALYZERS 116 (Akira Saito et al. eds., 2011) (hereinafter "Saito"). 10 Appeal2017-010792 Application 13/120,375 anything specific about the oxygen concentrations that would have been used when following Gohl's description of sterilizing its membranes: Another major reason for the suitability of polyarylsulfone polymers for dialysis membranes is that they can be sterilized with each of the three main sterilization modes used in the medical devices industry: steam, y-rays and ethylene oxide (ETO) .... However, it must be recognized that unlike steam sterilization, both r-ray and ETO sterilization have been associated with reactions that either may modify the dialyzer materials. A high-energy input following irradiation may destroy or degrade the polymer chain and give rise to extractable oligomers. This alteration of PSu dialyzers by y- rays may lead to enhanced cytotoxicity (fig. 4) and anaphylactic reactions with ETO-sterilized dialyzers have been observed and documented. Saito 116 ( emphasis added). As to the presence of oxygen when performing sterilization by gamma-irradiation as described in the Gohl reference, the Gohl Declaration states: Generally, at the time of [sic] that Gohl was filed (July 2006), irradiation of a membrane by a person of ordinary skill in the art was done by avoiding the presence of oxygen, generally by using inert gas atmosphere during irradiation or reducing it as far as possible by using oxygen scavengers. Gohl Deel. ,r 11. The Gohl Declaration, however, does not identify any specific credible evidence supporting the assertions in the Declaration regarding the general practices as to the presence of oxygen in gamma sterilization procedures. More importantly, Appellants do not identify any specific credible evidence, in the Gohl Declaration or elsewhere in the record, supporting their contentions that gamma irradiation as described in the Gohl reference would have produced a membrane structurally or functionally different from 11 Appeal2017-010792 Application 13/120,375 the gamma-irradiated device recited in Appellants' claim 7. Specifically, even assuming that a skilled artisan would have understood the Gohl reference as describing gamma irradiation at reduced oxygen concentrations, Appellants' claim 7 encompasses a significantly reduced oxygen concentration (4 vol% (Appeal Br. 38)) as compared to the oxygen concentration of unmodified air (20.95% (Spec. 28)). Also, Appellants do not identify in the record any specific credible comparative evidence demonstrating any difference between a device produced by a process encompassed Appellants' claim 7, and the gamma-irradiated device that a skilled artisan would have understood Gohl to describe, including the generally understood low oxygen sterilization concentrations. Although not cited in Appellants' arguments in relation to the anticipation of claim 7, Appellants cite to the Yokota reference9 as evidence that high oxygen concentrations would have been expected to degrade the polymers in Gohl's membrane when the device was gamma-irradiated. See Appeal Br. 19--20 ( citing Yokota ,r,r 62, 63). Yokota, however, discloses only that the amount of oxygen in air, which as discussed above is 20.95%, breaks down the polymers that form the types of membranes taught in Gohl. See Yokota ,r 62 ("If the sterilization by way of radiation exposure is carried in an atmospheric air, excited oxygen radicals break the main chains of the polymers and decompose them." (Emphasis added)). In contrast, as noted above, Appellants' claim 7 encompasses sterilization procedures in as low as 4% oxygen, which is significantly (over 9 Hideyuki Yokota et al., EP 1 795 254 Al (published June 13, 2007) (hereinafter "Yokota"). 12 Appeal2017-010792 Application 13/120,375 five-fold) lower than the amount of oxygen in air. And as discussed above, Appellants, do not identify, nor do we discern, any specific credible evidence in Yokota or elsewhere in the record supporting the assertion that a gamma-irradiated device sterilized according to the procedures encompassed by claim 7 (including oxygen concentrations as low as 4%), differs in any way from the gamma-irradiated device that a skilled artisan would have understood Gohl to describe, including the generally understood low oxygen sterilization concentrations. In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's determination that Gohl describes a device having all of the features required by Appellants' claim 7. We, therefore, affirm the Examiner's rejection of claim 7 as anticipated by Gohl. Because we affirm the Examiner's rejection of claim 7 as anticipated by Gohl, we do not reach the Examiner's alternative obviousness rejection of claim 7. Appellants' claim 24 depends from claim 7, and recites "[ t ]he cell culturing device of claim 7, wherein the device is configured for culturing adherent cells." Appeal Br. 39 (Claims App'x). Appellants advance extensive argument explaining why the plasmapheresis procedures described in Gohl, which traps cells on the membrane, do not involve adherent cells. Id. at 12-14. We are not persuaded. Claim 24 only requires the claimed membrane to be "configured for" culturing adherent cells. Id. at 39 (Claims App'x). Appellants identify no structural element required by claim 24 that is missing from the gamma-irradiated device that a skilled artisan would have understood Gohl to describe, including the generally understood low oxygen 13 Appeal2017-010792 Application 13/120,375 sterilization concentrations. That cells might or might not adhere to Gohl' s device when used for plasmapheresis does not demonstrate that Gohl's device is incapable of being used for culturing adherent cells. To the contrary, as discussed above in relation to claim 7 from which claim 24 depends, Gohl's device, on this record, has all of the structural and functional features required by the rejected claims. Because Appellants identify no structural element required by claim 24 that is missing from the gamma-irradiated device that a skilled artisan would have understood Gohl to describe, including the generally understood low oxygen sterilization concentrations, Appellants do not persuade us that the Examiner erred in maintaining the rejection of claim 24 as anticipated by Gohl. We, therefore, affirm the Examiner's rejection of claim 24 as anticipated by Gohl. Because we affirm the Examiner's rejection of claim 24 as anticipated by Gohl, we do not reach the Examiner's alternative obviousness rejection of claim 24. Analysis-Claim 8 (and dependent claim) Having carefully considered all of the arguments and evidence advanced by Appellants and the Examiner, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's determination that Gohl anticipates claim 8. Claim 8 recites a device similar to the device recited in claim 7, discussed above, the device including a confluent layer of cells on an inner or outer lumen surface of a membrane composed of the same polymers required by claims 1 and 7 discussed above, and irradiated under the same conditions discussed above in relation to claim 7, including a radiation 14 Appeal2017-010792 Application 13/120,375 dosage of from 12.5 to 175 kGy in the presence of oxygen at a concentration of 4 to 100 vol%. Appeal Br. 38-39 (Claims App'x). As to claim 8 's requirement for a layer of confluent cells on the membrane surface, the Examiner determined that "this limitation is interpreted as referring to use of the claimed product, and not to a structural property of the claimed product." Ans. 6. Appellants do not assert error in the Examiner's claim interpretation, but instead reiterate their arguments that Gohl's device is distinguishable from the claimed device, based on the radiation dosage range and oxygen concentration range recited in claim 8. See Appeal Br. 9-10. As discussed above, however, the radiation dosage range of from 12.5 to 175 kGy recited in Appellants' claim 8 encompasses the dosages of 25 kGy or 15 kGy, which the Gohl Declaration states are the dosages that would have been applied by a skilled artisan following the description of gamma-irradiation in the Gohl reference. See Gohl Deel. ,r,r 9-10. As also discussed above, Appellants do not identify in the record any specific credible evidence, comparative or otherwise, demonstrating any difference between a device produced by a process encompassed Appellants' claim 8, and the gamma-irradiated device that a skilled artisan would have understood Gohl to describe, including the generally understood low oxygen sterilization concentrations. Appellants do not persuade us, therefore, that the limitation as to the oxygen concentration during sterilization serves to distinguish the device recited in claim 8 from the device that Gohl described to a skilled artisan. We, therefore, affirm the Examiner's rejection of claim 8 as anticipated by Gohl. 15 Appeal2017-010792 Application 13/120,375 Claim 27 recites "[t]he device of claim 8, wherein the cells are adherent cells." Appeal Br. 40 (Claims App'x). Appellants' Specification states that, "[ a ]dherent cells are defined, in the context of the present invention, as cells attaching to a substrate which are to be maintained, expanded, differentiated, stored, etc." Spec. 18. As the Examiner found, Gohl discloses that, when performing plasma separation, blood cells are "retained by the membrane." Gohl ,r 53. Thus, giving the term "adherent cells" its broadest reasonable interpretation consistent with the Specification, Appellants' claim 27 encompasses the device described in Gohl when it is used to perform plasma separation, because the cells retained on the membrane, at the very least, can be stored, which is all that Appellants' definition of adherent cells requires. Accordingly, even assuming that plasma separation procedures ultimately require removal of cells from the membrane as Appellants contend, that fact does not negate the fact that the Appellants' claim 27 encompasses the device with the retained cells described by Gohl, under the proper claim interpretation standard. Because Appellants do not persuade us, therefore, that the Examiner erred in maintaining the anticipation rejection of claim 27 over Gohl, we affirm that rejection. Because we affirm the Examiner's rejection of claims 8 and 27 as anticipated by Gohl, we do not reach the Examiner's alternative obviousness rejection of claims 8 and 27. OBVIOUSNESS-- GOHL AND BELL In rejecting claims 1-5, 7, 8, 16, 17, 21, 24, and 27 for obviousness over Gohl and Bell, the Examiner relied on Gohl for the teachings discussed above as to claims 1, 2, 4, 7, 8, 16, 21, 24, and 27, and cited Bell as evidence 16 Appeal2017-010792 Application 13/120,375 that it would have been obvious to include a polyamide in Gohl' s membrane as recited in Appellants' claim 3, and also cited Bell as evidence that it would have been obvious to cast Gohl's membrane in the form of a flat sheet, as recited in Appellants' claim 5. See Ans. 6-8. Claims 3 and 5 both depend from claim 1. Appeal Br. 38. Because the Examiner does not identify any teaching in Bell that remedies Gohl' s deficiencies discussed above in relation to claim 1, we reverse this rejection as to claim 1, and its dependent claims 2-5, 16, 17, and 21. As to claims 7 and 8, and their dependent claims 24 and 27, however, Appellants only argue that Bell fails to remedy the deficiencies of Gohl as to those claims, and also that the prior art teaches away from the claimed invention. Appeal Br. 33-35. As discussed above, however, we are not persuaded that Gohl fails to describe a device having all of the features required by claims 7, 8, 24, and 27. In addition, Appellants fail to cite any evidentiary support, or provide any explanation, for their contention that the prior art teaches away from the claimed invention. We, therefore, affirm the Examiner's rejection of claims 7, 8, 24, and 27 for obviousness over Gohl and Bell. OBVIOUSNESS-- GOHL AND BAURMEISTER In rejecting claims 1--4, 7, 8, 16, 17, and 21-29 for obviousness over Gohl and Baurmeister, the Examiner relied on Gohl for the teachings discussed above as to claims 1, 2, 4, 7, 8, 16, 21, 24, and 27, and cited Baurmeister as evidence that it would have been obvious to include a polyamide in Gohl's membrane as recited in Appellants' claim 3, and also cited Baurmeister as evidence that it would have been obvious to use Gohl' s 17 Appeal2017-010792 Application 13/120,375 membrane as a substrate for hepatocytes, as recited in Appellants' claims 22, 23, 25, 26, 28, and 29. See Ans. 8-9. Claims 3, 22, and 23 all depend from claim 1. Appeal Br. 38, 39 (Claims App'x). Because the Examiner does not identify any teaching in Baurmeister that remedies Gohl's deficiencies discussed above in relation to claim 1, we reverse this rejection as to claim 1, and its dependent claims 2- 4, 16, 17, and 21-23. As to claims 7 and 8, and their dependent claims 24--29, however, Appellants only argue that Baurmeister fails to remedy the deficiencies of Gohl as to those claims, and also that the prior art teaches away from the claimed invention. Appeal Br. 36-37. As discussed above, however, we are not persuaded that Gohl fails to describe a device having all of the features required by claims 7, 8, 24, and 27. In addition, Appellants fail to cite any evidentiary support, or provide any explanation, for their contention that the prior art teaches away from the claimed invention. We, therefore, affirm the Examiner's rejection of claims 7, 8, and 24--29 for obviousness over Gohl and Baurmeister. SUMMARY We reverse the Examiner's rejection of claims 1, 2, 4, 16, and 21 as anticipated Gohl. We also reverse the Examiner's rejection of claims 1, 2, 4, 16, and 21 for obviousness over Gohl. We affirm the Examiner's rejection of claims 7, 8, 24, and 27 as anticipated by Gohl. We do not reach the Examiner's alternative rejection of claims 7, 8, 24, and 27 for obviousness over Gohl. 18 Appeal2017-010792 Application 13/120,375 We reverse the Examiner's rejection of claims 1-5, 16, 17, and 21 for obviousness over Gohl and Bell. We affirm the Examiner's rejection of claims 7, 8, 24, and 27 for obviousness over Gohl and Bell. We reverse the Examiner's rejection of claims 1--4, 16, 17, and 21-23 for obviousness over Gohl and Baurmeister. We affirm the Examiner's rejection of claims 7, 8, and 24--29 for obviousness over Gohl and Baurmeister. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l ). See 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED-IN-PART 19 Copy with citationCopy as parenthetical citation