Ex Parte JOHANSSON et al

Patent Trials and Appeals BoardMar 26, 2019

14840653 - (D) (P.T.A.B. Mar. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/840,653 08/31/2015 2292 7590 03/28/2019 BIRCH STEW ART KOLASCH & BIRCH, LLP 8110 Gatehouse Road Suite 100 East FALLS CHURCH, VA 22042-1248 FIRST NAMED INVENTOR Jan JOHANSSON 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. 0104-0791PUS3 3460 EXAMINER MARTIN, PAUL C ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 03/28/2019 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): mailroom@bskb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAN JOHANSSON, ANNA RISING, MY HEDHAMMAR, ULRIKA JOHANSSON, and MONA WIDHE, 1 Appeal 2018-002411 Application 14/840,653 Technology Center 1600 Before ELIZABETH A. LA VIER, TA WEN CHANG, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision under 35 U.S.C. Â§ 134(a) involving claims directed to a method for the cultivation/preparation of eukaryotic cells. Claims 1-5, 8-13, and 16-18 are on appeal as finally rejected under 35 U.S.C. Â§ 103(a).2 We have jurisdiction under 35 U.S.C. Â§ 6(b ). We affirm; however, we designate the affirmed rejections as new grounds of rejection under 35 U.S.C. Â§ 103(a), pursuant to our authority under 37 C.F.R. Â§ 41.50(b). 1 Appellants identify the Real Party in Interest as "SPIBER TECHNOLOGIES AB." Br. 1. 2 Claims 19-22 are objected to as being dependent upon rejected claims, but would otherwise be allowable, according to the Examiner. Final Action 22. Appeal 2018-002411 Application 14/840,653 STATEMENT OF THE CASE Independent claim 1 is representative and is reproduced below: 1. A method for the cultivation of eukaryotic cells, comprising applying a sample of eukaryotic cells to be cultured to a cell scaffold material; and maintaining said cell scaffold material having cells applied thereto under conditions suitable for cell culture; wherein said cell scaffold material comprises a polymer of a spider silk protein consisting of from 140 to 600 amino acid residues and comprising a repetitive fragment of from 70 to 300 amino acid residues derived from the repetitive fragment of a spider silk protein; a C-terminal fragment of from 70 to 120 amino acid residues derived from the C-terminal fragment of a spider silk protein; and optionally an N-terminal fragment of from 100 to 160 ammo acid residues derived from the N-terminal fragment of a spider silk protein, wherein said spider silk protein comprises a cell-binding motif which is an oligopeptide coupled to a remainder of the spider silk protein via at least one peptide bond. Br. (Claims Appendix 1 ). 2 Appeal 2018-002411 Application 14/840,653 The following rejections are appealed: Claims 1-5, 8-13, and 16-18 stand rejected under 35 U.S.C. Â§ 103(a) over Stark3 and Bini4 . Final Action 3. Claims 1-5, 8-13, and 16-18 stand rejected under 35 U.S.C. Â§ 103(a) over Johansson5 and Bini. Id. at 7. DISCUSSION Claim Interpretation The Patent Office applies the broadest reasonable construction standard in prosecution proceedings. Cuozzo Speed Tech., LLC v. Lee, 136 S. Ct. 2131, 2145 (2016). Claim scope is not limited by claim language that suggests or makes a claim step or element optional, but does not require steps to be performed or elements to be included, or by claim language that does not limit a claim to a particular structure. See MANUAL OF PATENT EXAMINING PROCEDURE (MPEP) Â§Â§ 2111.04 and 2143.03 (9th Ed., Rev. 08.2017, Jan. 2018); see also Cadence Pharms. Inc. v. Exela PharmSci Inc., 780 F.3d 1364, 1372 (Fed. Cir. 2015) (plain meaning of claim term "optionally" means associated steps are optional, supported by specification not discussing the optional step as essential). Here, independent claims 1 and 2 recite "optionally an N-terminal fragment of from 100 to 160 ammo acid residues derived from the N- 3 Margareta Stark et al., Macroscopic Fibers Self-Assembled from Recombinant Miniature Spider Silk Proteins, 8 BIOMACROMOLECULES 1695---01 (2007) ("Stark"). 4 Elisabetta Bini et al., RGD-Functionalized Bioengineered Spider Dragline Silk Biomaterial, 7 BIOMACROMOLECULES 3139--45 (2006) ("Bini"). 5 WO 2007/078239 A2 (published July 12, 2007) ("Johansson"). 3 Appeal 2018-002411 Application 14/840,653 terminal fragment of a spider silk protein, wherein said spider silk protein comprises a cell-binding motif which is an oligopeptide coupled to a remainder of the spider silk protein via at least one peptide bond." Br. (Claim Appendix 1-2) (emphasis added). Therefore, the recited N-terminal fragment and cell-binding motif oligopeptide elements are not required- they are optional and they do not limit the claims. This interpretation is supported by Appellants' Specification, which describes the inclusion of an N-terminal fragment of from 100 to 160 amino acid residues derived from the N-terminal fragment of a spider silk protein as "one of the embodiments of the cell scaffold material" and as "[ t ]he ( optional) NT fragment." Spec. 16. Furthermore, the Specification states, "[i]n some embodiments, the cell- binding motif is an oligopeptide coupled to the rest of the spider silk protein via at least one peptide bond." Spec. 28. Therefore, the Specification makes clear that the N-terminal fragment and cell-binding motive oligopeptide are not essential. Thus, per the plain meaning of the claim term "optionally," and in view of the Specification, the recited N-terminal fragment and cell-binding motif oligopeptide are not necessarily included in the claimed cell scaffold material and we conclude this claim language does not limit the claims. The discussion below regarding the obviousness of the claims relies upon this claim construction. Obviousness "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument 4 Appeal 2018-002411 Application 14/840,653 shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Arguments made by Appellants in the Appeal Brief (no Reply Brief was submitted) have been considered in this Decision; arguments not so- presented in the Brief are waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived."). As applicable to the rejections on appeal and Appellants' arguments there-over, "[ t ]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). Put another way, "when a patent claims a structure [or method] already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." Id. "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid underÂ§ 103." Id. at 419. "[T]he question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination, not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available." In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted). The Examiner determined the claims would have been obvious over the Stark-Bini combination. Final Action 3-7, 11-22 and Answer 3-7, 11- 5 Appeal 2018-002411 Application 14/840,653 31 ( citing Stark generally, but specifically at 1697, 1700, Figs. 7, 9; citing Bini 3140, 3141, 3143, Figs. IA, 7). The Examiner also determined the claims would have been obvious over the Johansson-Bini combination. Final Action 7-22 and Answer 7-31 (citing Johansson generally, but specifically at 46-47; and citing Bini as in the first rejection). The Examiner determined that each of Stark and Johansson teaches or suggests "a method, comprising: applying mammalian (human) embryonic kidney (HEK) cells; which attach to a cell scaffold material ( 4repCT fiber) and maintaining the cells/cell scaffold material under conditions suitable for cell culture." Final Action 3; see also id. at 7. The Examiner further determined that each of Stark and Johansson teaches or suggests: that the MaSp 1 fiber comprises a polymer of a spider silk protein consisting of 269 amino acid residues and comprising a repetitive fragment of from 70 to 300 amino acid residues derived from the repetitive fragment of a spider silk protein; a C-terminal fragment of 120 amino acid residues derived from the C-terminal fragment of a spider silk protein; wherein said spider silk protein is selected from the group of proteins defined by the formula REP-CT, REP is a protein fragment having from 70 to 300 amino acid residues, wherein said fragment is L(GA)nL, wherein n is 4; each individual A segment is an amino acid sequence of from 8 to 18 amino acid residues, wherein from O of the amino acid residues are not Ala, and the remaining amino acid residues are Ala; each individual G segment is an amino acid sequence of from 12 to 30 amino acid residues, wherein at least 40% of the amino acid residues are Gly; and each individual L segment is a linker amino acid sequence of from O to 20 amino acid residues; 6 Appeal 2018-002411 Application 14/840,653 and CT is a protein fragment having 120 amino acid residues, which fragment is a C-terminal fragment derived from a spider silk protein .... Id. at 4, 8. The Examiner relies upon and cites Bini to supplement the disclosures of Stark or Johansson for its disclosure of incorporating RGD cell-binding domains in spider silk protein cell-cultivating scaffolding. Id. at 4---6, 8-10. Appellants do not contest the Examiner's determination that Stark and Johansson teach or suggest the subject matter set forth above. See Br. 8-17. We discern no error in the Examiner's related determinations. Furthermore, in view of our claim interpretation, as set forth above, we conclude that either Stark or Johansson render the subject matter of claims 1 and 2 obvious, for the rationale set forth by the Examiner. Final Action 3-7, 11-22; Answer 3-7, 11-31. In affirming an obviousness rejection, the Board may rely upon fewer than all the references cited by the Examiner. See In re May, 574 F.2d 1082, 1090 (CCPA 1978); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). We address Appellants' arguments below. Br. 8. Appellants argue: Stark and Johan[s]son require the cultivation of "difficult" cell types known in the field that requires specific and complex culture conditions ( e.g., embryonic stem cells, induced pluripotent stem cells and cells from islets of Langerhans). However, the experimental data in Bini refers merely to the growth of human mesenchymal stem cells (seep. 3143, fig 7). One of ordinary skill in the art would lack any reasonable expectation of success to arrive at independent claims 1 and 2 ( or dependent claims 8 and 16) by the combination of Stark and Bini or the combination of Johan[s]son and Bini at least because Bini is silent on the cultivation of "difficult" cell types. 7 Appeal 2018-002411 Application 14/840,653 This argument is not persuasive. It is not clear from Appellants' arguments what a "difficult" cell type is or why supporting such cells' growth using a spider silk protein scaffold, with or without Bini's disclosed RGD cell-binding domains, would cause the skilled artisan to have any reasonable doubts as to culturing such cells with a such a scaffold, as doing so is taught by Stark and Johansson. In any event, because the claims are not limited to including cell-binding motifs, as taught by Bini, Bini's disclosure is not essential to find the claims obvious and whether Bini's cell types are the same as those of Stark and Johansson is not determinative. Moreover, we find Appellants' contention that Stark's and Johansson's disclosures are limited to culturing "embryonic stem cells, induced pluripotent stem cells and cells from islets of Langerhans" to be simply incorrect. Stark discloses growing human embryonic kidney (HEK 293) cells on spider silk protein scaffold and Johansson discloses growing embryonal mouse mast cells and human embryonic kidney (HEK 293) cells on spider silk protein scaffold. Stark 1697, 1698, 1700; Johansson 46-47. Whether such cells fall within Appellants' definition of "difficult" cells is unclear, but Stark and Johansson disclose that they were successfully cultured on spider silk scaffolds. Stark 1697, 1698, 1700; Johansson 46-47. Appellants argue that Bini discloses that when RGD is used with spider silk protein it does not enhance cell growth - differentiation was not observed. Br. 10 ( citing Bini 3140). Appellants also argue that, although Bini teaches that the use of spider silk protein scaffolds with RGD produced better cell growth results than using only plastic, it does not suggest that using RGD provides any benefit over not using the cell-binding motif, at 8 Appeal 2018-002411 Application 14/840,653 least in spider silk scaffolds. Id. Further, Appellants argue that Bini is actually teaching away from including cell binding motifs in scaffolds as taught by Stark or Johansson because Bini teaches RGD plays an insignificant role in promoting cell growth, and may perform worse than spider silk scaffolds without RGD. Id. at 11 (citing Bini 3144, Fig. 7). A "teaching away" requires a reference to actually criticize, discredit, or otherwise discourage the claimed solution. See Fulton, 391 F.3d at 1201. Although we find some merit in Appellants' argument that Bini teaches, essentially, that using RGD with spider silk protein scaffold may be a waste of time and effort and, therefore, could be found to teach away (discourage) from making such a combination, to a degree, Appellants' argument is, nonetheless, not persuasive. As discussed above, the oligopeptide/N- terminal fragment recited by claims 1 and 2 is not a required element. Therefore, even if Bini suggests that using such an oligopeptide (e.g., RGD) would not enhance performance, such a suggestion does not teach away from the claimed invention. Appellants also assert that evidence of unexpected results supports a finding of non-obviousness. Br. 12. Appellants point to Figure 20 of their Specification, which they argue shows that "the presence of cell binding motifs (i.e., WT, RGD, IKV AV, YIGSR and RGE) increased the cell[- culturing] performance ( significantly increased number of adhered islets) as compared to [culturing] without a cell binding motif (control)." Id. at 13. This is not persuasive. As discussed above, the recited inclusion of a cell-binding motif with spider silk protein scaffold is not a claim limitation. It is an optional element of the scaffold used in the claimed method. 9 Appeal 2018-002411 Application 14/840,653 Therefore, the asserted unexpected results are not commensurate in scope with the claims. See In re Dill, 604 F.2d 1356, 1361 (CCPA 1979). Furthermore, Appellants do not explain what the expected result was and do not provide a comparison with the closest prior art, which also renders the asserted evidence not persuasive of non-obviousness. See Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014) ("To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention."). Appellants argue that dependent claims 8 and 16, which depend from claims 1 and 2, further define the claimed "oligopeptide [as] coupled to an N-terminal fragment of from 100 to 160 amino acid residues derived from the N-terminal fragment of a spider silk protein." Br. 9 ( emphasis added). This argument is not persuasive because the oligopeptide/N-terminal fragment recited by claims 1 and 2, even as further defined by claims 8 and 16, is not a required element of the claimed invention; as discussed above, it is merely optional. The language of claims 8 and 16 do not change this. Thus, claims 8 and 16 fall with claims 1 and 2. Appellants argue dependent claims 3, 4, 11, and 12 are patentable because they further define the subject matter of claims 1 and 2 such that the recited "eukaryotic cells" are "mammalian cells," and then further that the cells are "selected from the group consisting of stem cells and cells from islets of Langerhans." Br. 14. This is not persuasive. The discussion above pertaining to claim interpretation is applicable here. Further, both Stark and 10 Appeal 2018-002411 Application 14/840,653 Johansson teach culturing mammalian cells (HEK cells) as recited by claims 3 and 11, as discussed above, making claims 3 and 11 obvious. Moreover, here, the disclosure of Bini is applicable, even if the reference does not suggest that including RGD would have necessarily been advantageous, because Bini teaches that spider silk protein scaffold (not identical, but similar to that taught in Stark and Johansson) has advantages in culturing the growth of human bone marrow derived mesenchymal stem cells (hMSCs) because it is superior to using tissue culture plastic, which are stem cells as claimed. See Bini 3139 (Abstract). Thus, Bini and Stark or Bini and Johansson teach and suggest the subject matter of claims 4 and 12, which would also have been obvious. Appellants argue dependent claims 5 and 13 are patentable because the spider silk protein of Bini is distinct from the protein of claims 1 and 2, from which these claims depend. Br. 14. This argument is not persuasive. As discussed above, Bini's teachings are not required for establishing that claims 1 and 2 would have been obvious and, in any event, Bini was not cited by the Examiner for its disclosure of the specific spider silk protein claimed- Stark and Johansson were cited for this. "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references .... [The reference] ... must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Thus, Appellants' attacks on Bini for its lacking disclosure, otherwise provided by other cited prior art, is not persuasive. Therefore, claims 5 and 13 fall with claims 1 and 2. 11 Appeal 2018-002411 Application 14/840,653 Appellants argue dependent claims 9 and 1 7, which depend from claims 1 and 2, respectively, further define the oligopeptide as having a certain amino acid sequence. Br. 15-16. This is not persuasive. As discussed above, we interpret claims 1 and 2 to not require the recited oligopeptide; it is merely optional. Claims 9 and 17 do not change this. Likewise, Appellants' asserted evidence of some unexpected results using RGD, as recited in these dependent claims (still optional), is not persuasive for the reasons discussed above in relation to the independent claims. Claims 9 and 17 fall with claims 1 and 2. Appellants argue dependent claims 10 and 18, which depend from claims 1 and 2, define the cell scaffold material as being a film, foam, fiber, or fiber-mesh, and argue that they are patentable for the same reasons the independent claims 1 and 2 are patentable. Br. 16. This is not persuasive for the same reasons set forth above regarding the obviousness of claims 1 and 2. Furthermore, Stark and Johansson each teaches that their spider silk protein scaffold includes fibers, as claimed here. Stark 1695 (Abstract); Johansson 46-47. Claims 10 and 18 fall with claims 1 and 2. For the reasons set forth above, we affirm the Examiner's obviousness rejections of the appealed claims. Appellants' arguments do not persuade us that the Examiner erred in his determinations or that the claims are, otherwise, nonobvious. Because our conclusions on obviousness differ somewhat from the Examiner's determinations, particularly in interpreting the language of the claims and regarding the importance of the Bini reference in combination with Stark and Johansson, we designate our affirmance of the obviousness rejections as new grounds. 12 Appeal 2018-002411 Application 14/840,653 SUMMARY The obviousness rejections under 35 U.S.C. Â§ 103(a) are each affirmed. TIME PERIOD FOR RESPONSE This Decision contains new grounds of rejection pursuant to 37 C.F.R. Â§ 4I.50(b ), which provides, "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 37 C.F.R. Â§ 41. 50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amend- ment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under Â§41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in MPEP Â§ 1214.01. 13 Appeal 2018-002411 Application 14/840,653 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED; 37 C.F.R. Â§ 4I.50(b) 14