Ex Parte Tazaki et alDownload PDFPatent Trial and Appeal BoardDec 14, 201712665474 (P.T.A.B. Dec. 14, 2017) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/665,474 12/18/2009 Go Tazaki 35243OU S OPCT 1365 22850 7590 12/18/2017 OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P. 1940 DUKE STREET ALEXANDRIA, VA 22314 EXAMINER PRAKASH, GAUTAM ART UNIT PAPER NUMBER 1799 NOTIFICATION DATE DELIVERY MODE 12/18/2017 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 tfarrell@oblon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GO TAZAKI, TOMOKO KOSAKA, and MOTOHIRO FUKUDA Appeal 2017-002917 Application 12/665,4741 Technology Center 1700 Before PETER F. KRATZ, JEFFREY T. SMITH, and WESLEY B. DERRICK, Administrative Patent Judges. DERRICK, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134 from the Examiner’s final rejection of claims 1, 2, 4—12, 17, and 21—24. We have jurisdiction under 35 U.S.C. § 6. We AFFIRM-IN-PART. CLAIMED SUBJECT MATTER The subject matter of the claims on appeal relates to cell culture chambers including a plurality of microchambers partitioned from each other 1 Appellants identify Kuraray Co., Ltd. as the real party in interest. Appeal Br. 2. Appeal 2017-002917 Application 12/665,474 by convex portions, i.e., side walls. Specification filed December 18, 2009 (“Spec.”), Abstract. Independent claims 1 and 23 are directed to cell culture chambers wherein upper surfaces of the convex portions that partition the microchambers have short side widths of “from 10 to 15 pm” and “from 0.5 to 15 pm,” respectively. Independent claim 1 is representative 1. A cell culture chamber comprising a plurality of microchambers formed on a surface of the chamber, wherein convex portions that partition the microchambers adjacent to one another are formed such that when cells are contained in the microchambers, the convex portions prevent cells from being adhered to upper surfaces of the convex portions, and wherein each of the upper surfaces of the convex portions has a short side width of from 10 to 15 pm, and each of the convex portions has a height more than three times of the short side width, and wherein the cells are liver cells. Appeal Brief filed May 4, 2016 (“Appeal Br.”), 28. Dependent claim 4 further limits the height of each convex portions to having a height of 30 to 300 pm. Dependent claim 12, depending from claim 11, recites “an integrated layer film formed by [a] surface treatment has two or more layers comprising at least one layer of an inorganic film and at least one layer of an organic film.” Dependent claims 21 and 22 recite “the convex portions . . . [are] one stage structure^]” and require the convex portions to be of the same height. 2 Appeal 2017-002917 Application 12/665,474 THE REJECTIONS2 Claim 23 stands rejected under 35U.S.C. § 112, first paragraph for lack of enablement. Claim 23 stands rejected under 35 U.S.C. § 102(b) as anticipated by Nishi.3 Claims 1, 2, 4—12, 17, and 21—24 stand rejected under 35 U.S.C. § 103(a) as obvious over Nishi. DISCUSSION4 We have reviewed the maintained grounds of rejection set forth by the Examiner, Appellants’ arguments and proffered evidence, and the Examiner’s response. For any ground of rejection, “the Examiner bears the initial burden . . . of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We sustain the rejection of claim 23 as lacking enablement. We reverse the anticipation rejection of claim 23. We affirm the obviousness rejections of claims 1, 2, 4—11, 17, and 21—24, but reverse the rejection as to claim 12. 2 The maintained objection to claim 24 as a substantial duplicate of claim 1 (Final Act. 2; Ans. 2) is reviewable by petition (37 C.F.R. § 1.181). 3 Nishi et al., WO 2007/049576 Al, published May 3, 2007; the Examiner relies on a machine English language translation. 4 In this discussion, we refer to the Specification, the Final Office Action dated December 31, 2014 (“Final Act.”), the Appeal Brief, the Examiner’s Answer dated October 21, 2016 (“Ans.”), and the Reply Brief filed December 21, 2016 (“Reply Br.”). 3 Appeal 2017-002917 Application 12/665,474 Lack of Enablement The Examiner determines that the Specification as filed does not enable sufficient scope of the cell culture chamber for culturing liver cells according to claim 23 with convex portions of widths of 0.5 pm to 15 pm. Ans. 3. We note that the claim requires each convex portion “has a height [of] more than three times of the short side width” (claim 23), which corresponds to a lower bound of merely 1.5 pm, and inadequate height is identified as allowing “cells [to] run on the convex portions” (Spec. 1 7). As noted by the Examiner (Ans. 3), Appellants do not contest the rejection (see generally Appeal Br.; Reply Br.). Accordingly, being apprised of no reversible error, we sustain the rejection. Anticipation The Examiner finds claim 23 anticipated by Nishi on the basis of, inter alia, substantial overlap between the ranges of convex portion width disclosed in Nishi with the width range of 0.5 pm to 15 pm claimed. Final Act. 4—5; Ans. 3—6. The Examiner finds Nishi discloses (1) a broad range of 1 pm to 1500 pm, (2) a separate range of less than 2 pm, and (3) a range of 4 pm to 200 pm grounded on a cell diameter of 4 pm to 5 pm and the teaching that the chamber cell is 1.0 to 40 times the size of the cell being cultured. Ans. 4—5 (citing Nishi || 39, 42, 49, 51—52, Tables 1—4). The Examiner finds claim 23 anticipated on the basis of the variety of narrower ranges within the broad range. Final Act. 4—5. The Examiner further maintains Appellants have admitted there is overlap (Ans. 4 (citing Appeal Br. 7—8)) and that Nishi “teach[es] that the size (width) of the concave portion (upper surface of the convex portions) of each chamber cell is 1.0 to 40 times the cell being cultured” (Ans. 5 (citing Appeal Br. 9)). 4 Appeal 2017-002917 Application 12/665,474 As highlighted by Appellants’ arguments, the Examiner erred in finding Nishi teaches a convex portion width of less than 2 pm or of a range of 4 pm to 200 pm. Appeal Br. 8—10; Reply Br. 2—5. We note for emphasis that the relevant text cited refers to a lower bound of 2 pm, i.e., a minimum, for the chamber formed of side walls, and not to the width dimension of the side walls themselves. See, e.g., Nishi H 39, 49. Likewise, the basis for the range of 4 pm to 200 pm is grounded on the dimensions of the chamber, i.e., the concave portion of the convex/concave pattern, of Nishi. Accordingly, the Examiner’s reliance on substantial overlap between the narrower ranges within the broad range as being sufficiently specific to constitute an anticipation is not supported on this record. Prima Facie Obviousness Appellants proffer arguments applicable to all rejected claims and separate arguments as to claim 4, claim 12, and claims 21 and 22. The Examiner relies, inter alia, on Nishi’s disclosure of a range of widths for the convex portions of its disclosed structure 1 pm to 1500 pm and of heights of 1 to 20 times the width. Ans. 3—4, 6—7; Nishi, Tables 1—4, 142. The Examiner finds the disclosed ranges to render the ranges recited in the claims prima facie obvious, inter alia, on the basis of the overlap between what is disclosed and claimed. Ans. 6—8. As to claim 4, reciting a height of the convex portion from 30 pm to 300 pm, the Examiner further finds Nishi to teach a height of 1 pm to 200 pm as preferred. Final Act. 6 (citing Nishi 151). We find Nishi also discloses broader ranges of convex portion height (parameter f). Nishi H 82—85, Table 3, Fig. 9. The Examiner further finds Nishi to “teach that it allows the cell contained in the microchamber ... to be presented in a shape or function that it expresses in 5 Appeal 2017-002917 Application 12/665,474 vivo.” Final Act. 5. We find Nishi to teach “the size of a side wall” as a relevant factor (see, e.g., Nishi 133), including as to controlling diffusion of substances produced by the cell (Nishi H 37, 41). Independent claim 1 recites a convex portion width range “of from 10 to 15 pm” that is encompassed by the disclosed width range. Likewise, the identical recited width range of claim 24—depending from independent claim 23—is also encompassed. The disclosed ranges of heights, including that grounded on the heights being 1 to 20 times the width, where disclosed widths range from 1pm to 1500 pm, encompass the “height of 30 to 300 pm” recited in claim 4 and overlap the “height more than three times of the short side width [of 10 to 15 pm]” of claims 1 and 23. Appellants contend that the Examiner has failed to establish a prima facie case of obviousness because “there are countless possible theoretical modifications of the prior art cell culture chamber parameters with no teaching that anyone [sic, any one] modification should be selected and should be successful” and the Examiner has failed to establish that the parameters are result effective variables. Appeal Br. 16—17. Appellants contend that the instant case is analogous to that in Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010). Appellants further contend that Nishi “does not describe or suggest selecting the specific claimed width of the short side of the convex portion . . . and at the same time the ratio of the height of the convex portion to its short side width of more than three times.” Appeal Br. 17; see also Reply Br. 6—7. Appellants contend that Nishi’s goal of “preserving] the shape and the original mechanism of growth ... is different from the goal of the present invention.” Reply Br. 7 (citing Nishi 115; Spec. H 7—8). 6 Appeal 2017-002917 Application 12/665,474 Appellants also contend, without explanation, that there is no reasonable expectation that the intended goal of Nishi would be met by Nishi as modified by the Examiner and that the Examiner is improperly relying on impermissible hindsight in combining various disclosures from Nishi. Reply Br. 6-7. Appellants’ arguments are unpersuasive of reversible error. As explained by our reviewing court, “[i]n cases involving overlapping ranges, we and our predecessor court have consistently held that even a slight overlap in range establishes a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (citing In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In reMalagari, 499 F.2d 1297, 1303 (CCPA 1974)). As to “the claimed ranges [that] are completely encompassed by the prior art, the conclusion is even more compelling than in cases of mere overlap.” Peterson, 315 F.3d at 1330. Appellants’ reliance on Rolls-Royce is inapposite because the Examiner’s rejection is grounded on overlapping ranges with what is disclosed and not on the obvious-to-try rationale that, in Rolls-Royce, required modification to include a feature not disclosed, namely, a forward sweep of turbine blades that “would not have presented itself as an option at all, let alone an option that would have been obvious to try.” Rolls-Royce, 603 F.3d at 1339. Appellants’ contentions as to the width of the short side of the convex portion and the ratio of the height of the convex portion to its short side width not being identified as result effective variables, or that they can be varied at the same time, are also not well founded. 7 Appeal 2017-002917 Application 12/665,474 As explained above, the disclosed width range encompasses the claimed range of “from 10 to 15 pm” and Appellants proffer no cogent argument contesting that Nishi reasonably would have been understood by the skilled artisan to teach, inter alia, that the height of the convex portion is a result effective variable as to allowing the cell to be presented in a shape or function that it expresses in vivo. Further, there is no cogent argument proffered as to how optimizing the height of the convex portion for Nishi’s purpose to control diffusion of substances produced by the cell as much as possible (Nishi || 37, 41—42), while maintaining the desired ratio of convex portion width to height of from 1 to 20 (Nishi 142), where a preferred height range, i.e., the height of crevice 14, is 1 pm to 200 pm (Nishi 51, Fig. 9), would not lead one of ordinary skill to claimed subject matter through no more than the action of the routineer. Also, an overlapping range encompassing that claimed, as relied on in the Examiner’s rejection of claims 1 and 24 for the short side width of “from 10 to 15 pm,” is sufficient to establish a prima facie case of obviousness absent a showing that the particular range is critical. See, e.g., Woodruff, 919 F.2d at 1578 (“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. These cases have consistently held that in such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” (citations omitted)). As to independent claim 23, from which claim 24 depends, it follows that the overlapping, encompassing range is sufficient to establish a prima facie case of obviousness as claim 23 necessarily encompasses the same obvious subject 8 Appeal 2017-002917 Application 12/665,474 matter of dependent claim 24 as a matter of law. In the same manner, the overlapping, encompassing ranges of convex portion height that encompass the range recited in claim 4 is sufficient to establish a prima facie case of obviousness of independent claim 1 from which claim 4 depends. Further, Appellants proffer no persuasive argument or evidence supporting the position that optimization of the width and the height would require more than the exercise of routine optimization to arrive at claimed subject matter, particularly given the preferred ratios and ranges linking the two variables discussed above. Nor do we discern any basis for reversible error in the existence of two variables—concave portion width and height. Cf. In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012) (“The mere fact that multiple result-effective variables were combined does not necessarily render their combination beyond the capability of a person having ordinary skill in the art.”). More is required to establish nonobviousness. Id. (“Evidence that the variables interacted in an unpredictable or unexpected way could render the combination nonobvious, . . . but [appellant] failed to show anything unpredictable or unexpected in the interaction of the variables.”). Appellants’ further contention that there is no reasonable expectation that the intended goal of Nishi would be met by Nishi as modified by the Examiner is not sufficiently supported on this record to persuade us of reversible error. In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument. . . cannot take the place of evidence.”). Appellants’ contention the Examiner relies on impermissible hindsight is also unpersuasive of reversible, harmful error. Having not been persuaded of any deficiency in the Examiner’s rejection grounded on 9 Appeal 2017-002917 Application 12/665,474 overlapping ranges, as discussed above, the contention of impermissible hindsight is unfounded. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”), cited with approval in KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). As to claim 12, the Examiner relies on Nishi’s disclosure that its concave-convex pattern may be subject to a surface treatment and that the surface treatment can include layers of inorganic film and organic film. Final Act. 6 (citing Nishi, claim 9, 56—58). Appellants contend, inter alia, that Nishi does not disclose or teach the claimed subject matter in which “an area having micropattems is surfaced treated, and an integrated layer film [is] formed by the surface treatment ha[ving] two or more layers comprising at least one layer of inorganic film and at least one layer of an organic film.” Appeal Br. 18. On this record, the Examiner has failed to establish claim 12 is prima facie obvious. Although Nishi teaches an organic surface treatment to a concavo-convex pattern (| 56) and methods by which the concavo-convex pattern can be formed, including etching and metal deposition (|| 57—58), there is an insufficient basis for an integrated layer film that includes both an inorganic film and an organic film in the cited disclosure as proffered by the Examiner. See, e.g., Belden v. Berk-TekLLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[OJbviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”). On this record, accordingly, the Examiner’s articulated reasoning falls short of that necessary for a prima facie case. See In re Warner, 379 F.2d 1011, 1017 10 Appeal 2017-002917 Application 12/665,474 (CCPA 1967) (“The Patent Office has the initial duty of supplying the factual basis for its rejection. It may not. . . resort to speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies in its factual basis.”); In re Sporck, 301 F.2d 686, 690 (CCPA 1962); see also Oetiker, 977 F.2d at 1445. As to claims 21 and 22, in addressing arguments raised by Appellants (Appeal Br. 18—19), the Examiner relies on, inter alia, embodiments from Nishi having a culture region surrounded by four walls (Figs. 1, 3—5, 9), including an embodiment with single stage walls (Fig. 9) (Ans. 8—9). Appellants fail to address the Examiner’s position grounded on, inter alia, Nishi’s Figure 9. See generally Reply Br.; see also Appeal Br. The arguments raised, accordingly, grounded on microchambers having two stage walls that do not fully surround the bottom of the chamber (Appeal Br. 18—19 (citing Nishi, Figs. 1, 6—7)), are not persuasive of reversible error. For these reasons, we find the Examiner’s prima facie case of obviousness well-founded for each of the claims on appeal except for claim 12 as discussed above. Unexpected Results Appellants maintain that the present record establishes the claimed invention achieves surprising, unexpected results. Appeal Br. 19-20. Having considered the proffered evidence, we do not find it sufficient to rebut the prima facie case. It is well established that Appellants bear the burden of showing that the claimed invention imparts unexpected results. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). To meet this burden, Appellants must show that the results actually would have been unexpected, and that the unexpected 11 Appeal 2017-002917 Application 12/665,474 results are reasonably commensurate with the scope of protection sought by the claim on appeal. In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983); In re Clemens, 622 F.2d 1029, 1035 (CCPA 1980); Klosak, 455 F.2d at 1080. As to the results being unexpected, Appellants do not direct us to any statement in the Specification or elsewhere attesting to the unexpected nature of the results or to any persuasive evidence that the results would have been unexpected at the time of the invention. See generally Appeal Br.; Reply Br. Proffering the Specification’s recitation of the result (Spec. 144) as being an “unexpected result” (Appeal Br. 19—20), is not sufficient to bear Appellants’ burden. See, e.g., Geisler, 116 F.3d at 1471 (“Geisler made no such assertion [that results were unexpected] in his application. Nor did Geisler submit any such statement through other evidentiary submissions, such as an affidavit or declaration under Rule 132 ... . Instead, the only reference to unexpected results was a statement by Geisler’s counsel. . . that Geisler’s results were ‘surprising.’”). Likewise, as to Appellants’ reliance on Examples 1 and 2 (Appeal Br. 20—21 (citing Spec. ^fl[ 39-45, Figs. 7— 10)), it is not enough that the claimed chamber has advantages over what is conventional in the art. As to the results being commensurate with the claims, Appellants fail to sufficiently explain how, or if, the tests performed comparing inventive and reference chambers establish unexpected results over the breadth of the claims on appeal. Appeal Br. 19-23; Reply Br. 8—10. The testing is limited to Example 1 having a short side width of 10 pm and height of 50 pm and Example 2 having a short side width of 15 pm and height of 50 pm. A silicon dioxide film is also used in both Examples. Spec. H 43, 46. The width (and height) encompassed by independent claim 23 is not manifestly 12 Appeal 2017-002917 Application 12/665,474 commensurate with the tested range. The height encompassed by the further claims is likewise not manifestly commensurate with the single data point of 50 pm. Appellants direct us to no evidence or persuasive argument why the results obtained with these structures coated with silicon dioxide film would similarly be expected for structures without coating, or that one of ordinary skill in the art would expect them over the claimed range. See Pearson, 494 F.2d at 1405. For these reasons, Appellants have not shown evidence of unexpected results commensurate with the scope of the claims. See In re Harris, 409 F.3d 1339, 1343 (Fed. Cir. 2005) (holding that the applicant must show unexpected results covering the scope of the claimed range or narrow the claims). On balance, the record of evidence weighs most heavily in favor of the Examiner’s conclusion of obviousness as to all claims on appeal except for claim 12. DECISION The Examiner’s rejection of claim 23 under 35 U.S.C. § 112, first paragraph for lack of enablement is AFFIRMED. The Examiner’s rejection of claim 23 under 35 U.S.C. § 102(b) is REVERSED. The Examiner’s rejection of claims 1,2, 4—11, 17, and 21—24 under 35 U.S.C. § 103(a) for obviousness is AFFIRMED. The Examiner’s rejection of claim 12 under 35 U.S.C. § 103(a) for obviousness is REVERSED. 13 Appeal 2017-002917 Application 12/665,474 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)(iv). AFFIRMED-IN-PART 14 Copy with citationCopy as parenthetical citation