Ex Parte MaysDownload PDFPatent Trial and Appeal BoardJul 27, 201613150491 (P.T.A.B. Jul. 27, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/150,491 06/01/2011 Robert W. Mays 26294 7590 07/29/2016 TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P. 1300EASTNINTH STREET, SUITE 1700 CLEVELAND, OH 44114 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. ATY-0019US 3138 EXAMINER BEL YA VSKYI, MICHAIL A ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 07/29/2016 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): rkline@tarolli.com docketing@tarolli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD ExparteROBERTW. MAYS 1 Appeal2014-009100 Application 13/150,491 Technology Center 1600 Before JEFFREY N. FRED MAN, ULRIKE W. JENKS, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of obtaining cells having a desired potency. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as ABT Holding Company. Appeal Br. 3. Appeal2014-009100 Application 13/150,491 STATEMENT OF THE CASE Claims 1 7 and 34--3 8 are on appeal. Claim 1 7, the only independent claim, is illustrative and reads as follows: A method for obtaining cells having a desired potency for one or more of (1) preserving splenic mass in an injury, (2) increasing splenocyte proliferation in the spleen, (3) increasing T-regulatory cells, (4) increasing one or more IL-10 and IL-4, ( 5) decreasing IL-6 and/ or IL-1 B and ( 6) modulating macrophage activation, the method comprising selecting cells that have the desired potency, by assaying cells for the desired potency, and expanding cells that have the desired potency, the cells being non-embryonic, non-germ cells that express one or more of oct4, telomerase, rex-1, or rox-1 and/or can differentiate into cell types of at least two of endodermal, ectodermal, and mesodermal germ layers. The claim rejections on appeal are as follows 2 : Claims 34--37 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement (new matter). Claims 17 and 34--38 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement (enablement). 2 The Examiner provisionally rejected claims 17 and 34--38 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 14--27 of copending Application No. 13/071,801 or claims 14--25 of copending Application 13/150,481. Final Rej. 7. Appellants do not appeal from this rejection. See App. Br. 8; Ans. 11. The Examiner also rejected claims 17 and 35-38 under 35 U.S.C. § 112 (b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. Ans. 2. In the Examiner's Answer, the Examiner withdrew this objection. These issues are thus not a part of this appeal. 2 Appeal2014-009100 Application 13/150,491 Claims 17 and 34--38 under 35 U.S.C. § 102(b) as being anticipated by U.S. Patent No. 7,015,037 Bl("the '037 patent"). 3 Claims 17 and 34--38 under 35 U.S.C. § 102(e) as being anticipated by U.S. Patent No. 8,147,824 B2("the '824 patent")4 or U.S. Patent No. 8,075,811 B2("the '811 patent"). 5 NEW MATTER REJECTION Claims 34--37 recite steps requiring that cells obtained by the method of claim 17 be further assayed (claims 34 and 36) or further expanded (claims 35 and 37). The Examiner contends that original claims and the Specification required that cells be frozen and stored in a cell bank before being subjected to further assaying and/or further expansion as recited claims 34--37. Because claims 34--37 omit the cell bank storage step, the Examiner found that Appellants omitted an essential element and thus did not have possession of the invention recited in claims 34--37. Ans. 5. Appellants argue that i-fi-149, 50, 56, and 57 of the Specification provide support for the subject matter recited in claims 34--37 and that nothing in these passages requires that the cells be stored in a cell bank before being subjected to further assays and/or further expansion as recited in claims 34--37. App. Br. 12; Reply Br. 3--4. We find that Appellants have the better position. In evaluating compliance with the written description requirement, "the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had 3 Furcht et al., U.S. Patent No. 7,015,037 Bl, issued Mar. 21, 2006. 4 Maziarz et al., U.S. Patent No. 8, 147,824 B2, issued Apr. 3, 2012 5 Verfaillie et al., U.S. Patent No. 8,075,811 B2, issued Dec. 13, 2011. 3 Appeal2014-009100 Application 13/150,491 possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (citing cases). Appellants point to several instances where the Specification describes further expansion and conducting further assays. App. Br. 12. Paragraph 57 of the Specification is particularly on point. It states: With respect to methods of treatment with cells that achieve the desired effects, between the original isolation of the cells and the administration to a subject, there may be multiple (i.e., sequential) assays for the effects. This is to confirm that the cells can still achieve the effects, at desired levels, after manipulations that occur within this time frame. For example, an assay may be performed after each expansion of the cells. If cells are stored in a cell bank, they may be assayed after being released from storage. If they are frozen, they may be assayed after thawing. If the cells from a cell bank are expanded, they may be assayed after expansion. Preferably, a portion of the final cell product (that is physically administered to the subject) may be assayed. Specification i-f 57 (emphasis added). This passage makes clear that the cells may be subjected to multiple sequential assays and multiple expansions. In addition, the statements "[i]f cells are stored in a cell bank" and "[i]f they are frozen" make clear that freezing and storing are optional. See also id. i-f 56 (suggesting that storage in a cell bank is optional by stating that multiple assays are "particularly preferable where the cells have been stored for any length of time, such as in a cell bank"). Accordingly, we find that the evidence of record does not support the Examiner's conclusion that claims 34--37 represent new matter. 4 Appeal2014-009100 Application 13/150,491 ENABLEMENT REJECTION The Examiner rejected claims 17 and 34--38 because "[t]here is insufficient guidance and direction as to how to assay[] cells for the desired potency, as recited in claim 17 ." Ans. 6. The Examiner found that the Specification did not teach how to obtain the desired cells prior to their being delivered in vivo, and noted Appellants' acknowledgment that there was "no assay prior to administration in the Examples because the inventor did not know that the cells had these effects .... " Id. (citing Appellants July 19, 2013 Response). The Examiner contends that ifthe inventor could not determine potency prior to administration, the person of ordinary skill in the art would similarly be unable assay for potency. Appellants argue that the Examiner failed to show why it would require undue experimentation to assay the cells as claimed and contends that pages 32-35 of the Specification set out the claimed assays. App. Br. 13. We find that Appellants have the better position. In assessing enablement, the person of ordinary skill in the art has the full benefit of the Specification. In this case, the Specification teaches and provides an example showing that the claimed cells do in fact have the claimed potency. See, e.g., Specification ff 3-5, 220, 226, 227, 250, 252. It is thus irrelevant that the inventor did not know the cells had the claimed potency prior to administration. As the Appellants correctly point out, the relevant inquiry is what the person of ordinary skill in the art, in view of the inventor's discovery, is guided to do. See App. Br. 13. Here the Examiner has not sufficiently demonstrated that Appellants disclosure fails to teach an ordinarily skilled artisan how to assay cells for the claimed potency. The Examiner does not explain why- with the benefit 5 Appeal2014-009100 Application 13/150,491 of the teaching that MAPC cells have the claimed potency- one of skill in the art would be unable to conduct assays to identify such cells without undue experimentation. See In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Indeed, the Examiner's concession that "[c]learly, one skill[ed] in the art at the time the invention was made would know how to measure splenic mass or splenocyte proliferation or etc.," Ans. 5, suggests that it might not require undue experimentation to assay the claimed cells for potency. The Examiner has not met the initial burden of weighing all the evidence related to the factors used to support a determination that disclosure fails to satisfy the enablement requirement. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988); see also the Manual of Patent Examining Procedure (MPEP) § 2164.0l(a) (indicating "[t]he examiner's analysis must consider all the evidence related to each of these factors, and any conclusion of nonenablement must be based on the evidence as a whole") and § 2164. Accordingly, we find that the evidence of record does not support the Examiner's conclusion that claims 17 and 34--38 are not enabled. ANTICIPATION REJECTIONS The Examiner rejected claims 17 and 34--38 as anticipated by each of the '037, '824, and '881 patents. Final Rej. 5-8. Each of these references teach multipotent adult progenitor cells ("MPACs"), i.e., non-embryonic, non-germ cells that express oct4, telomerase, rex-1 and rox-1. See '824 patent, col. 8. 11. 9-27; '881 patent, col. 9, 11. 44--46; '037 patent, col. 6, 11. 2---6 and 59-60. Because the disclosures of each of these references as they relate to the dispositive issues are substantially the same, we will consider these rejections together. 6 Appeal2014-009100 Application 13/150,491 The principal issue with respect to each of these rejections is whether the prior art references at issue can anticipate the claimed invention without expressly disclosing the step of "assaying cells for the desired potency" - i.e., assaying for one or more of "(1) preserving splenic mass in an injury, (2) increasing splenocyte proliferation in the spleen, (3) increasing T- regulatory cells, ( 4) increasing one or more of IL-10 and IL-4, ( 5) decreasing IL-6 and/ or IL-1 B, and ( 6) modulating macrophage activation." See claim 17. The Examiner contends that the references disclose conducting an assay for potency because each of the '037, '824, and '881 patents disclose that the MAPCs cells have oct4, telomerase, rex-1 and rox-1. Ans. 8 ("one way to assay for the desired potency is to measure expression of these genes [oct4, telomerase, rex-1, or rox-1]"); see also '824 patent, col. 8. 11. 18-27 (disclosing expression of oct4, telomerase, rex-1 and rox-1 ); '881 patent, col. 9, 11. 44--46 (same); '037 patent, col. 6, 11. 2---6 and 59---60 (same). Appellants contend that the Examiner "incorrectly assumes that assessing the claimed cells for the claimed genes is the same as assessing the claimed cells for effects (1)-(6)." App. Br. 15. Appellants assert that it is irrelevant whether MP A Cs inherently have the desired potency because the references do not disclose conducting the assay. Appellants argue: The Examiner takes the position that the '037 patent teaches obtaining cells having (inherently) a potency for the claimed effects. That may be so. But this reference does not disclose that multi-potent adult progenitor cells (MAPCs) have the claimed effects or suggest conducting an assay for the claimed effects. An assay is required by the claims. This is not disclosed in the '037 patent. It is not disclosed because it was not known at the time that the cells could have these effects. App. Br. 14. 7 Appeal2014-009100 Application 13/150,491 The facts of this case are similar in relevant respects to those in In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed. Cir. 2002). In that case, certain of the claims at issue required "'identifying seeds which produce cniciferous sprouts ... containing high Phase 2 enzyme-inducing potential."' Id. at 1349 (emphasis added). Facing prior art that disclosed "growing and eating sprouts," id. at 1346, patentee argued that "the prior a.rt/ails to meet the 'identifying' steps of the claims because it does not specify which cultivars should be sprouted." Id. at 1351 (emphasis added). The Court found that high Phase 2 enzyme-inducing activity was inherent in certain sprouts and that the patentee had not "invented a new kind of sprout" but rather "recognized that some sprouts are rich in glucosino1ates and high in Phase 2 enzyme-inducing activity while other sprouts are not." Id. at 1350. The Court rejected patentee's argument that the prior mi did not anticipate because it did not include an "identifying" step as follows: [A]l1 of the appropriate cultivars that are identified in Brassica's patent are in the public domain. '895 patent, col. 10, 11. 43-65. Brassica cannot credibly maintain that no one has heretofore grown and eaten one of the many suitable cultivars identified by its patents. It is unnecessary for purposes of anticipation for the persons sprouting these particular cultivars to have realized that they were sprouting something rich in glucosinolates and high in Phase 2 enzyme-inducing potential. Id. at 1351 (emphasis added). Here, as in Cruc(/erous .S!Jrout, patentee has not invented a new composition of matter but rather recognized the properties of something that already existed. The step of "assaying the cells for the desired potency" here parallels the step of '"identifying seeds which produce cruciferous sprouts ... 8 Appeal2014-009100 Application 13/150,491 containing high Phase 2 enzyme-inducing potential"' in Cruc(ferous Sprout. As in Cruciferous .":Jprout, the step of "assaying" does nothing more than require recognition of an inherent property and thus does not lend patentability to the claimed method. Id. The instant facts are even rnore supportive of anticipation because in Cruciferous Sprout, there was no recognition of any property of the cruciferous sprout seeds associated with the desired function. In the instant case, each of the prior art patents necessarily performs assays to demonstrate expression of oct4, telomerase, rex-1 and rox-1 in the cells at issue. The inherent selection and expansion of cells identified as expressing these genes reasonably satisfies the assaying and expanding steps. Appellants argue that the Examiner has presented insufficient evidence of inherency. App. Br. 15-16 ("Examiner has presented no relationship between any of these genes [ oct4, telomerase, rex-1 and rox-1] and effects 1-6. "); see also Reply Br. 5. The limitation at issue here, however, simply recites previously undiscovered properties of MP A Cs. Absent evidence to the contrary, it is reasonable to assume that all MP ACs have such properties. To the extent they do not, we think the burden is more appropriately placed on the Appellant to demonstrate the absence of inherency. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) ("Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, 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 9 Appeal2014-009100 Application 13/150,491 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."). Appellants fail to point to any evidence in the record that MP ACs exist that do not have the potency effects 1---6. In the absence of such evidence, or other evidence demonstrating that the claimed potency is not inherent in "non-embryonic, non-germ cells that express one or more of oct4, telomerase, rex-1, or rox-1 and/or can differentiate into cell types of at least two of endodermal, ectodermal and mesodermal germ layers," we affirm the Examiner's rejection of claims 17 and 34--38 as anticipated. In sum, for the reasons discussed, Appellants' arguments do not persuade us that a preponderance of the evidence fails to support the Examiner's prima facie case of anticipation as to claim 17. Because they were not argued separately, claims 34--38 fall with claim 17. 37 C.F.R. § 41.37(c)(l)(iv). SUMMARY For these reasons and those set forth in the Examiner's Answer and Final Rejection, the Examiner's final decision to reject claims 17 and 34--38 is affirmed. No time period for taking any subsequent action in connection with this appeal maybe extended under 37 C.F.R. § 1.136(a) (1). 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