Ex Parte Yamanaka et alDownload PDFPatent Trial and Appeal BoardSep 14, 201612356769 (P.T.A.B. Sep. 14, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/356,769 0112112009 Katsuyuki Yamanaka 22850 7590 09/16/2016 OBLON, MCCLELLAND, MAIER & NEUSTADT, LLP, 1940 DUKE STREET ALEXANDRIA, VA 22314 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. 337587USO 9485 EXAMINER MACAULEY, SHERIDAN R ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 09/16/2016 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): patentdocket@oblon.com oblonpat@oblon.com ahudgens@oblon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KATSUYUKI YAMANAKA, YOUKO SUDA, KATSUSHI YAMAMOTO, YUHIRO SAKAI, and TADASHI KANEK0 1 Appeal2014-003564 Application 12/356,769 Technology Center 1600 Before DEMETRA J. MILLS, ERIC B. GRIMES, and TA WEN CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a porous cell scaffold, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. STATEMENT OF THE CASE "A scaffold having a porous structure [that] acts as a substrate seeded with cells is generally used in [] cell technology," where for instance "[ c Jells 1 Appellants identify the Real Party in Interest as GC Corporation. (Appeal Br. 2.) 1 Appeal2014-003564 Application 12/356,769 seeded in a scaffold formed to have a required shape are transplanted into a living body." (Spec. 1.) According to the Specification, "[i]t is desired to almost uniformly seed cells in the scaffold," but "it is hard to fill ... a cell suspension liquid ... to a center part of the scaffold." (Id.) Further according to the Specification, "an objective of the present invention is to provide a porous cell scaffold having a thickness of 2 mm or more, in which cells can be easily seeded in a whole small hole structure of a scaffold, high force is not applied to the cells, and an amount of cells in the scaffold can be almost accurately attached." (Id. at 3--4.) Claims 9--17 are on appeal. Claim 9 is illustrative and reproduced below: 9. A porous cell scaffold, comprising a block-shaped scaffold having a continuous hole structure with hole diameters of 5 to 3200µm and an average hole diameter of 50 to 1500 µm and having a porous body thickness of 2 mm or more; and a culture medium and cells in a whole continuous hole structure of the block-shaped scaffold. (Br. 8 (Claims App'x).) The Examiner rejects claims 9-17 under 35 U.S.C. § 103(a) as being unpatentable over Hsieh2 and Canham. 3 (Ans. 2.) DISCUSSION Issue The Examiner has rejected claims 9-17 under 35 U.S.C. § 103(a) as being unpatentable over Hsieh and Canham. The Examiner finds that Hsieh teaches "a porous cell scaffold comprising a continuous hole structure 2 Hsieh et al., US 2002/0155594 Al, published Oct. 24, 2002. 3 Canham et al., US 2005/0177247 Al, published Aug. 11, 2005. 2 Appeal2014-003564 Application 12/356,769 (continuous channels) with hole diameters of 50 to 500 microns, such as 90 or 200 microns, and an average hole diameter within the claimed range, such as 90 to 100 microns." (Ans. 2 (citation omitted).) The Examiner also finds that Hsieh teaches that "the scaffold may be block-shaped" and that "the continuous small hole structure may comprise a culture medium and cells" with "cells and ... nutrients ... distributed throughout the channels," which the Examiner finds to meet the claim limitation "a culture medium and cells in a whole continuous hole structure of the block-shaped scaffold." (Id (citations omitted).) While the Examiner finds that Hsieh does not specifically teach the thickness of the porous body, the Examiner finds that Canham teaches a scaffold with porosity similar to that of Hsieh, teaches that "the desirable thickness for a block-shaped scaffold is up to 4 mm," and "specifically teaches the use of 3 mm as the thickness of the block." (Id. at 2-3.) The Examiner concludes that a skilled artisan "would have been motivated to prepare [Hsieh's] blocks ... with the thickness taught by Canham because [both] teach ... scaffolds ... prepared in similar manners for the proliferation of cells thereon." (Id. at 3.) Appellants acknowledge that "the combination of art teaches ranges of hole diameters and body thicknesses that are close [to] and/or overlap with ... claimed ranges." (Br. 3.) However, Appellants argue that the combined cited prior art does not teach or otherwise suggest "a culture medium and cells in a whole continuous hole structure of the block-shaped scaffold." (Id.) Appellants also argue that the Examiner has not established that this limitation is necessarily present (i.e., inherent) in the prior art and 3 Appeal2014-003564 Application 12/356,769 further erred in failing to consider evidence in the record that the limitation is in fact not present in the prior art scaffold. (Id. at 6.) The issue with respect to this rejection is whether the evidence of record supports the Examiner's finding that the cited prior art teaches or suggests "a culture medium and cells in a whole continuous hole structure of the block-shaped scaffold." Findings of Fact 1. Hsieh relates to "a method and apparatus for improving the efficiency of the growth of cell and tissue cultures in vitro" through the use of a scaffold. (Hsieh Abstract.) 2. Hsieh teaches that [t]he scaffold of the invention is a porous three-dimensional member formed from an open cell polymer foam. The porous foam scaffold has a substantially continuous polymer phase with highly interconnected pores. The pores form substantially continuous channels through the polymer matrix. The channels are connected to form a substantially continuous network of channels in the polymer phase with a very high surface area suitable for cell growth. Preferably, the channels or pores are distributed throughout the polymer phase to promote diffusion of cells and cell nutrients throughout the pores. (Id. at i-f 29; see also id. at Abstract, i-fi-119, 21-23, 40.) 3. Hsieh teaches that [ t ]he dimensions of the pores must be sufficiently large to allow cells to enter the pores and to allow the exchange of nutrients to the cells through the pores. In embodiments of the invention, the pore size can range from about 50 microns to about 500 microns, and preferably about 50 microns to about 200[]microns. In one embodiment, the pores have an average diameter of about 90 microns to about 100 microns. The pores are preferably of sufficient size to support the cells during growth, while allowing an aqueous nutrient medium to flow 4 Appeal2014-003564 Application 12/356,769 through the pores and to enable the pores to release the resulting cell growth by rinsing or other cell recovery methods. The pore size can vary depending on the process used to produce the scaffold. In certain embodiments, the pores are substantially two different sizes that are interconnected to form substantially continuous channels. In other embodiments, the scaffold is formed from a continuous polymer matrix having substantially uniform size pores that are interconnected to form substantially continuous channels. (Id. at i-f 40; see also id. at Abstract, i-f 19.) 4. Hsieh teaches that its scaffold can have "any desired shape suitable for use in the bioreactor," including a block. (Id. at i-fi-141, 43.) 5. Hsieh teaches an embodiment in which a porous scaffold is disclosed within a cavity of a roller bottle and dimensioned to move within the cavity to continuously contact a cell growth supporting medium as the roller bottle is rotated during the cell growth process. (Id. at i-fi-132-33.) 6. Canham teaches "[a] process for preparing an [orthopedic] scaffold ... comprising forming shaped blocks of a bioactive material." (Canham Abstract.) 7. Canham teaches that, as used in its invention, the above- mentioned blocks "will generally be relatively small in size, for example from 1-8 mm and preferably from 1.5-5 mm across." (Id. at i-f 25; see also id. at i-f 57 (describing Fig. 1 as depicting "typical monomer blocks of ... cuboid with a 4 mm edge length") and i-f 66 (describing synthesis of "solid composite blocks [that] could then be cut to the desired thickness between 0.8 mm to 4 mm").) More particularly, Canham teaches that such blocks may comprise "cubes which are, for example 3 mm x 3mm x 3mm." (Id.) 8. Canham teaches an orthopedic scaffold having a porosity that reflects the bone it is intended to replace, e.g., "a biomimetic scaffold for 5 Appeal2014-003564 Application 12/356,769 cancellous bone [having] a thin interstitimn lattice interconnected by pores of 500-600 micron width." (Id. at i-f 9; see also id. at i-f 26.) 9. Appellants do not dispute that "the combination of art teaches ranges of hole diameters and body thicknesses that are close [to] and/ or overlap with ... claimed ranges." (Br. 3.) Principles of Law \Vhere ... the claimed and prior art products are identical or substantially identical ... the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. ln re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote omitted). _L4nalysis We find the Examiner has established a reasonable basis for concluding that the combination of cited prior art suggests "a culture medium and cells in a whole continuous hole structure" of a claimed scaffold. 4 Appellants have not disputed that the prior art suggests a scaffold having the claimed physical dimensions. (FF9; see also FF1-FF8.) 4 In addition to other arguments, the Examiner also contends that "'a culture medium and cells in a whole continuous hole structure of the block-shaped scaffold' [means] that the culture medium and cells are in a continuous pore structure of the scaffold" but does not require that the culture medium and cells be in the "entire whole continuous hole structure throughout the entirety of the scaffold." (Ans. 4--5 (emphasis original).) We do not adopt the Examiner's construction of this term in our opinion. 6 Appeal2014-003564 Application 12/356,769 Furthermore, as the Examiner points out, Hsieh teaches that the channels or pores in the scaffold of its invention "are distributed throughout the polymer phase to promote diffusion of cells and cell nutrients throughout the pores." (FF2 (emphasis added); see also Ans. 4.) Hsieh also teaches that "the pores are preferably of sufficient size to [allow] an aqueous nutrient medium to flow through the pores." (FF3.) Citing to the Specification, Appellants argue that "it is difficult to fill the culture medium with cells to a center part of [a scaffold with the claimed small-hole structure] and in particular the whole continuous pores," because "air [existing] in the small holes of the scaffold ... hinders the holes from fully fil[l]ing with the culture medium containing cells." (Br. 4.) Appellants further argue that, because Hsieh and Canham are silent about "the problem of air that hinders fully filling the holes [of the scaffold]" and because Canham does not describe how to fill the holes in its scaffold, Hsieh and Canham can fairly be read as teaching "the conventional method of just placing the medium in the culture device." (Id.) Accordingly, Appellants argue that the cited art "neither explicitly nor inherently provide a porous cell scaffold in which a culture medium and cells in a whole continuous hole structure of the block-shaped scaffold." (Id. (emphasis original).) With respect to inherency, Appellants further argue that the Examiner has not established that the limitation regarding "a culture medium and cells in a whole continuous hole structure of the ... scaffold" is necessarily present. (Id. at 6.) We are not persuaded. As discussed above, we find that the Examiner has established a reasonable basis for finding that the claimed and the prior art scaffolds are substantially identical. Thus, the burden has shifted to 7 Appeal2014-003564 Application 12/356,769 Appellants to show that the prior art scaffolds "do not necessarily or inherently possess the characteristics of the claimed product." In re Best, 562 F.2d at 1255. Appellants do not meet that burden merely by showing that the prior art is silent about the problem alleged to be solved by the invention and that the "conventional" way of providing cells into a porous structure does not fill the pores entirely, without showing, for instance, that the particular method of culturing cells disclosed in the prior art does not result in "culture medium and cells in a whole continuous hole structure" of the scaffold. Appellants further point to Example 1 and Comparative Example 1 of the Specification, and the Yamanaka Declaration 5 regarding them, in support of the argument that the combination of Hsieh and Canham does not disclose "a culture medium and cells in a whole continuous hole structure of the block-shaped scaffold." (Br. 5-6.) We have considered these examples and the Yamanaka Declaration but do not find Appellants' arguments convmcmg. In particular, in Comparative Example 1, a scaffold was dipped in a culture medium, placed in a desiccator with reduced pressure so as to infiltrate the medium into the scaffold, and placed in a culturing plate. (Spec. 40-41.) Cells suspended in differentiating medium was then "supplied from the upside" of the scaffold, seeded, and kept to stand for two hours before the scaffold was transferred to a centrifugal tube containing differentiating medium and cultured. (Id. at 41.) While the Specification and the Yamanaka Declaration show that under this procedure cells are only 5 Declaration ofKatsuyuki Yamanaka under 37 C.F.R. § 1.132 (Feb. 10, 2012). 8 Appeal2014-003564 Application 12/356,769 found in the upper part of the scaffold rather than throughout the entire scaffold structure (id.; Yamanaka Deel. i-f 4), we agree with the Examiner that Appellants have not persuasively shown that the method of seeding and culturing cells in the scaffold disclosed in Comparative Example 1 is sufficiently related to the method disclosed in Hsieh, 6 which involves placing the scaffold in the cavity of a roller bottle that is rotated during the cell growth process. (Ans. 6; FF5.) Thus, we find that Appellants have not satisfied the burden of showing that the combination of Hsieh and Canham does not disclose a scaffold having medium and cells in a whole continuous hole structure of the scaffold. Accordingly, we affirm the Examiner's rejection of claim 9. Claims 10-17 were not separately argued and fall with claim 9. 3 7 C.F .R. § 41.37(c)(l)(iv). SUMMARY For the reasons above, we affirm the Examiner's decision rejecting claims 9--17 under 35 U.S.C. § 103(a) as unpatentable over Hsieh and Canham. 6 Appellants argue in the Appeal Brief that Example 1, Comparative Example 1, and the Yamanaka Declaration show that "the conventional way of providing cells into a porous structure does not fill the pores entirely ... and this is precisely the manner in which the prior art teaches providing cells." (Br. 5---6.) However, "[a]ttomey's argument in a brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). 9 Appeal2014-003564 Application 12/356,769 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 10 Copy with citationCopy as parenthetical citation