Ex Parte KundraDownload PDFPatent Trial and Appeal BoardJan 24, 201713821541 (P.T.A.B. Jan. 24, 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. 13/821,541 06/26/2013 Vikas Kundra UTSC.P1065US 5797 108197 7590 01/26/2017 Parker Highlander PLLC 1120 South Capital of Texas Highway Bldg. 1, Suite 200 Austin, TX 78746 EXAMINER KELLY, ROBERT M ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 01/26/2017 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): docket @ phiplaw .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte VIKAS KUNDRA1 Appeal 2016-002000 Application 13/821,541 Technology Center 1600 Before FRANCISCO C. PRATS, RICHARD J. SMITH, and JOHN E. SCHNEIDER, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to methods of treating tumors. The Examiner rejected the claims for indefiniteness, lack of enablement, and lack of written description. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 1—3,1,9, 11, 12, 14—26, and 59-66, under 35 U.S.C. §112, second paragraph, for indefiniteness (Ans. 3—4);2 1 Appellant states that the “real party in interest for this appeal is the assignee Board of Regents, The University of Texas System.” App. Br. 3. 2 Examiner’s Answer issued December 16, 2015. Appeal 2016-002000 Application 13/821,541 (2) Claims 1—3, 7, 9, 11, 12, 14—26, and 59-66, under 35 U.S.C. §112, first paragraph, as failing to comply with the enablement requirement (Ans. 4—12); (3) Claims 1—3,1,9, 11, 12, 14—26, and 59—66, under 35 U.S.C. §112, first paragraph, as failing to provide adequate descriptive support for generic stem cells (Ans. 13—18); (4) Claims 1—3, 7, 9, 11, 12, 14—26, and 59—66, under 35 U.S.C. §112, first paragraph, as failing to provide adequate descriptive support for a generic cell engineered to localize to a tumor (Ans. 19-20); and (5) Claims 1—3, 7, 9, 11, 12, 14—26, and 59—66, under 35 U.S.C. §112, first paragraph, as failing to provide adequate descriptive support for generic administration of ligands and cells that bind to each other (Ans. 20— 21). Claim 1, the sole independent claim on appeal, illustrates the claimed subject matter and reads as follows (App. Br. 26): 1. A method of treating a tumor, comprising the steps of: a) providing stem cells, immune cells or fibroblast cells having the ability to migrate to and localize to a tumor upon parenteral administration to a subject having a tumor, wherein the cells are engineered cells that comprise an exogenous expression construct having a nucleic acid sequence encoding a somatostatin receptor, wherein the somatostatin receptor is a native somatostatin receptor or a mutant thereof, wherein the receptor comprises a ligand binding domain that is competent to bind a somatostatin receptor ligand; b) introducing the engineered cells parenterally to a subject having a tumor; and c) administering to the subject a somatostatin receptor ligand and an anti-tumor therapeutic that specifically binds the ligand and that is effective to kill the engineered cells and thereby effect a damage on the tumor, whereby the tumor is treated. 2 Appeal 2016-002000 Application 13/821,541 STANDARD OF REVIEW As stated in In 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. INDEFINITENESS The Examiner’s Rejection The Examiner finds that two recitations in the appealed claims render the claims indefinite under § 112, second paragraph. The Examiner initially contends: Claim 1 recites “binds the ligand”. There is insufficient antecedent basis to know what ligand is being referred to. To wit, is this the somatostatin ligand or the receptor or other? There is no “a ligand” prior to recitation, leaving one to wonder if it is one or the other, or yet another species, because even the receptor may be considered the ligand for the substance that binds it. Ans. 3^4. The Examiner subsequently contends: Claim 59 recites “the tumor is further defined as a solid tumor”. It is not clear what the scope is which is being claimed. Is Applicant claiming that it is a solid tumor, or that someone defined it as a solid tumor? Is Applicant claiming solid tumor versus soft-tissue tumor (e.g., connective tissue tumor?) or versus being disseminated (e.g., hematological)? The scope is simply not clear as the Artisan would not what it is, and whether it must me simply defined to be something by someone, or it must actually be a “solid tumor”. 3 Appeal 2016-002000 Application 13/821,541 Ans. 4 Analysis As our reviewing court has explained, the “test for definiteness is whether one skilled in the art would understand the bounds of the claim when read in light of the specification.” Miles Laboratories, Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir. 1993). In the present case, as Appellant argues (App. Br. 4—5), the full recitation at issue in claim 1 recites “administering to [a] subject a somatostatin receptor ligand and an anti-tumor therapeutic that specifically binds the ligand.” Id. at 26. We agree with Appellant that, read in context, the recitation at issue at the very least clearly requires the anti-tumor therapeutic to bind to the somatostatin receptor ligand. Accordingly, because a skilled artisan would have understood the bounds of the claim when read in context, we reverse the Examiner’s indefmiteness rejection of claim 1, and its dependents. That the anti-tumor therapeutic might bind to ligands other than that required by claim 1, as the Examiner argues (see Ans. 22—23), does not render claim 1 indefinite. See In re Miller, 441 F.2d 689, 693 (CCPA 1971) (“[Bjreadth is not to be equated with indefmiteness.”). To that end, we note that claim 59 encompasses treating any tumor that a skilled artisan would define as a solid tumor. That the recitation at issue in claim 59 might be broad, however, does not demonstrate its indefmiteness. See In re Miller, 441 F.2d at 693. Accordingly, we also reverse the Examiner’s indefmiteness rejection of claim 59, and its dependents. 4 Appeal 2016-002000 Application 13/821,541 ENABLEMENT The Examiner’s Rejection The Examiner concludes that the Specification fails to enable the full scope of the subject matter claimed because the specification, while being enabling for administration of MSCs [mesenchymal stem cells] by intravenous and direct injection routes, that target tumor cells expressing VEGF, and radioactively labeled ligands for the receptor, as well as receptors that are bound to the MSCs and bind to the somatostatin ligand/analog which contains a radiolabel, and also only for allogenic or autologous transplantations, or autologous administration of tumor-derived macrocytes/monocytes, as well as the specific cell-tumor- administration combinations already established in the prior art, does not reasonably provide enablement for other, as necessitated by amendment. Ans. 4—5. The Examiner contends that, viewed in light of the Specification, practicing the full scope of the claimed subject matter would require undue experimentation. Id. at 5—7. The Examiner advances a number of references in support of that contention. Id. at 7-12. Analysis As our reviewing court has explained, the Examiner “bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification of the application.” In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993). 5 Appeal 2016-002000 Application 13/821,541 “The scope of enablement... is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Technols. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999). While the Specification must enable the skilled artisan to practice the full scope of the claimed subject matter, “[i]t is well settled that patent applicants are not required to disclose every species encompassed by their claims, even in an unpredictable art.” In re Vaeck, 947 F.2d 488, 496 (Fed. Cir. 1991). Moreover, a claim does not lack enablement merely because it encompasses inoperative embodiments. Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984). Rather, as our reviewing court has noted: [Tjhere must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill [in the art] how to make and how to use the invention as broadly as it is claimed. This means that the disclosure must adequately guide the art worker to determine, without undue experimentation, which species among all those encompassed by the claimed genus possess the disclosed utility. Vaeck, 947 F.2d at 496 (footnote omitted). In the present case, having carefully considered the positions of the Examiner and the Appellant, and the evidence advanced in support of those positions, we conclude that a preponderance of the evidence does not support the Examiner’s conclusion of lack of enablement. Claim 1 recites a method of treating a tumor. App. Br. 26. In the first step, the practitioner provides stem cells, immune cells, or fibroblast cells capable of migrating and localizing to a tumor upon parenteral administration to a tumor-harboring subject. Id. Claim 1 requires the 6 Appeal 2016-002000 Application 13/821,541 provided cells to be engineered to have an exogenous expression construct composed of a nucleic acid sequence encoding a somatostatin receptor, the somatostatin receptor being a native or mutant receptor with a ligand binding domain competent to bind a somatostatin receptor ligand. App. Br. 26. In its second step, claim 1 requires introducing the engineered cells parenterally to the tumor-harboring subject. Id. In its third step, claim 1 requires administering to the subject a somatostatin receptor ligand and an anti-tumor therapeutic that specifically binds to the ligand. Id. Claim 1 requires the somatostatin ligand-binding therapeutic to be effective to kill the engineered cells that have localized to the tumor, thereby damaging, as well as treating, the tumor. Id. As Appellant contends (App. Br. 8—10), the Specification3 provides an in vivo working example in a mouse model in which systemically administered stem cells encompassed by claim 1, and a systemically administered somatostatin ligand-binding therapeutic agent encompassed by claim 1, act to inhibit tumor growth. Specifically, as seen at 1262, nude mice were induced to exhibit palpable tumors by injecting human ovarian cancer cells (Hey A8 cells), and were subsequently given (1) intravenous administration of a radioactive agent bound through chelation to a somatostatin receptor ligand (“[90]Y- octreotate (primarily beta emitter)”)4 and (2) intracardiac (i.e. systemic) 3 In citing to the Specification, Appellant and Examiner, for the most part, cite to the published application, US 2013/0287681 A1 (published Oct. 31, 2013). We do the same for consistency. 4 Octreotate is a somatostatin analogue and, thus, is a somatostatin receptor ligand. See Spec. 134. Although not explained as straightforwardly as it might be, Appellant’s Figure 9 shows that the 90Y-octreotate used was Y90- 7 Appeal 2016-002000 Application 13/821,541 administration of stem cells engineered to express a mutant somatostatin receptor capable of binding a somatostatin ligand (HS5 human stem cells expressing the mutant somatostatin receptor SSTR2D314). The Specification discloses that “[tjumors to which HS5 cells expressing the HA-SSTR2D314 mutant homed and incorporated were growth inhibited compared to control.” Spec. 1262; see also Appellant’s Fig. 9. It may be true, as the Examiner contends (Ans. 32—38), that claim 1 encompasses stem cells beyond those exemplified in the Specification, and that claim 1 encompasses immune cells and fibroblast cells for which no working examples have been provided. Nonetheless, to the extent that certain stem cells, immune cells, and fibroblast cells were known in the art not to localize to tumor cells, those cells are expressly excluded from Appellant’s claim 1. See App. Br. 26 (claim 1 reciting “stem cells, immune cells or fibroblast cells having the ability to migrate to and localize to a tumor upon parenteral administration to a subject having a tumor”). It may be true, as the Examiner contends (Ans. 34—35), that not every type of stem cell, immune cell, or fibroblast cell capable of localizing to tumors would have worked in accordance with the invention as described. It may also be true, as the Examiner contends (id. at 38—40), that not every combination of somatostatin receptor, ligand, and ligand-binding anti-tumor therapeutic would function in every conceivable circumstance encompassed by the claims. As discussed above, however, the Specification provides a DOTATATE. Appellant’s Specification explains that Y90-DOTATATE is octreotate that contains a chelator, “DOTA,” which binds the 90Y moiety. Spec. 134. 8 Appeal 2016-002000 Application 13/821,541 working example specifically explaining how to practice the claimed invention. The Examiner does not explain sufficiently why an ordinary artisan, armed with Specification’s exemplifying disclosure, explaining how to practice the claimed invention, would have needed to experiment unduly to determine whether a particular stem cell, immune cell, or fibroblast cell encompassed by claim 1 would function in accordance with the claimed invention. That claim 1 might encompass a variety of inoperative embodiments is not evidence, by itself, that undue experimentation would have been required to practice the full scope of the claimed subject matter. See Atlas Powder v. DuPont, 750 F.2d at 1576 (a claim does not lack enablement merely because it encompasses inoperative embodiments); see also In re Anderson, 471 F.2d 1237, 1242 (CCPA 1973) (“It is always possible to put something into a combination to render it inoperative. It is not the function of the claims to exclude all such matters but to point out what the combination is.”). In sum, because the Specification includes an undisputedly enabling disclosure of an in vivo embodiment of the process recited in claim 1, and the Examiner’s evidence supports only the potential for a number of inoperative embodiments, but does not demonstrate that, as described, undue experimentation would have been required to practice the full scope of the claimed process, the Examiner does not persuade us that the Specification fails to adequately enable the full scope of the subject matter encompassed by claim 1. See Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) (“The enablement requirement is met if the description 9 Appeal 2016-002000 Application 13/821,541 enables any mode of making and using the invention.”) (quoting Engel Indus., Inc. v. Loclformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)). Because, for the reasons discussed, we conclude that a preponderance of the evidence of record does not support the Examiner’s conclusion that claim 1 lacks enabling support in the Specification, we reverse the Examiner’s rejection of claim 1, and its dependents, on that ground. WRITTEN DESCRIPTION- STEM CELLS, IMMUNE CELLS, FIBROBLASTS The Examiner’s Rejection The Examiner’s first rejection under the written description requirement of § 112, first paragraph, is based on a finding that the “claims are generic for ‘stem cells’, ‘immune cells’, and ‘fibroblasts’ that have the ability to migrate to and localize at a generic tumor upon parent[er]al administration.” Ans. 13. The Examiner contends that viewed in light of the Specification, as well as the knowledge in the prior art, the full scope of the cells claimed encompasses numerous embodiments, including inoperative ones, for which Appellant has not shown possession. Id. at 13—18. The Examiner summarizes the ultimate finding of written description as follows: Given the breadth of tumor types, their factors which cause migration, the evidence of immune evasion/suppression, the sheer number of cell types, and lack of cause-and-effect for the generic tumor and cell type and administration, the Artisan would not have understood Applicant to have been in possession of the invention as presently claimed. Id. at 18. 10 Appeal 2016-002000 Application 13/821,541 Analysis To meet the initial burden of establishing a prima facie case of unpatentability based on a lack of written description, the Examiner must “present[] evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). In the present case, having carefully considered the positions of the Examiner and the Appellant, and the evidence advanced in support of those positions, we agree with Appellant that a preponderance of the evidence does not support the Examiner’s finding that the claims lack adequate descriptive support. Our reviewing court has stated that, “[f]or generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including ‘the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.’” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (quoting Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005). Accordingly: A claim will not be invalidated on section 112 grounds simply because the embodiments of the specification do not contain examples explicitly covering the full scope of the claim language. That is because the patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before. Placed in that context, it is unnecessary to spell out every detail of the invention in the specification; only enough must be included to convince a person of skill in the art that the inventor possessed 11 Appeal 2016-002000 Application 13/821,541 the invention and to enable such a person to make and use the invention without undue experimentation. Falknerv. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006) (quoting LizardTech, Inc. v. Earth Resource Mapping, PTY, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005)); see also Capon v. Eshhar, 418 F.3d at 1359 (“It is not necessary that every permutation within a generally operable invention be effective in order for an inventor to obtain a generic claim, provided that the effect is sufficiently demonstrated to characterize a generic invention.”). In the present case, as discussed above, the Specification provides an in vivo working example in a mouse model in which systemically administered stem cells encompassed by claim 1, and a systemically administered somatostatin ligand-binding therapeutic agent encompassed by claim 1, act to inhibit tumor growth. See Spec. 1262. We, thus, agree with Appellant that the tumor treating effect required by Appellant’s claim 1 has been shown sufficiently to characterize, generically, the invention recited in claim 1. As discussed above also, to the extent that certain stem cells, immune cells, and fibroblast cells were known in the art not to localize to tumor cells, those cells are expressly excluded from Appellant’s claim 1. See App. Br. 26 (claim 1 reciting “stem cells, immune cells or fibroblast cells having the ability to migrate to and localize to a tumor upon parenteral administration to a subject having a tumor”). It might be true, as with the enablement rejection above, that not every type of stem cell, immune cell, or fibroblast cell capable of localizing to tumors, as required by claim 1, would have worked in accordance with the invention as described. That one may conceive of claim-encompassed 12 Appeal 2016-002000 Application 13/821,541 embodiments that might not function in accordance with the invention as described does not, however, demonstrate a lack of written description. See, e.g., Falkner v. Inglis, 448 F.3d at 1366 (application disclosure need not exemplify every embodiment encompassed by claims because “the patent specification is written for a person of skill in the art”). In the present case, although the Examiner might advance evidence of potentially inoperative embodiments, the Examiner does not advance persuasive evidence showing that a skilled artisan, viewing the claims and written disclosure in the light of the knowledge in the prior art, would have failed to recognize that Appellant adequately described, and thereby possessed, the claimed invention. In contrast, Appellant advances significant evidence showing that a skilled artisan would have understood from the Specification and prior art what subject matter encompassed by the claims would have been part of Appellant’s invention. See App. Br. 11—13 and references cited therein as support for enablement; see also id. at 19 (expressly incorporating enablement arguments in traversing written description rejection). Accordingly, for the reasons discussed, Appellant persuades us that a preponderance of the evidence does not support the Examiner’s finding of a lack of written description in this instance. We, therefore, reverse the Examiner’s rejection of claim 1, and its dependents, on this ground. WRITTEN DESCRIPTION- CELLS ENGINEERED TO LOCALIZE TO TUMORS The Examiner’s Rejection The Examiner’s second rejection under the written description requirement of § 112, first paragraph, is based on a finding that the claims, 13 Appeal 2016-002000 Application 13/821,541 “as seen by depending claim 65, are drawn to or specifically encompass a generic cell engineered to localize to migrate to, and localize within, a tumor.” Ans. 19. The reasoning underlying the Examiner’s ultimate finding of lack of written description is as follows: The specification provides broad recitation of such (p. 5), arguing that it is well within the skill of the Artisan (Id.). However, the sole example of such “engineering” is providing a viral vector with a ligand that binds to a cell type to alter its natural tropism profile (e.g., p. 65). There are absolutely NO examples of any cell type that has been modified to migrate to, and localize within, any type of tumor. The Art provides nothing. Hence, given the great number of ways of “engineering” these cells to localize, and the non-exist[e]nt showing of a single member of this large genera, the Artisan would not have understood Applicant to have been in possession of the invention at the time of filing. Ans. 19-20. Analysis As an initial matter, we note that the sole claim actually requiring modification of cells to localize to tumors is claim 65, which recites “[t]he method of claim 1, wherein the cells are cells engineered to localize to a tumor expressing an antigen or chemoattractant.” App. Br. 28. As noted above, moreover, Appellant’s Specification must be viewed not only for what it expressly describes, but for what it describes when viewed by a skilled artisan armed with all of the relevant knowledge of the prior art. See Falkner v. Inglis, 448 F.3d at 1366. In the present case, as Appellant points out, beyond the descriptive disclosure acknowledged by the Examiner (see Spec. ]Hf 246—247), a skilled 14 Appeal 2016-002000 Application 13/821,541 artisan would have known of a number of ways in which a cell could be modified so as to migrate to a tumor. See App. Br. 22—24, and references cited therein. Indeed, by acknowledging that there are a “great number of ways of ‘engineering’ these cells to localize” (Ans. 20), the Examiner appears to agree with Appellant’s assessment of the state of the prior art in this regard. We acknowledge the Examiner’s contentions that Appellant’s claims are not limited to the specific embodiments described in the references Appellant cites to show the state of the art. Ans. 48 49. Again, however, that one may conceive of claim-encompassed embodiments that might not function in accordance with the invention as described does not demonstrate a lack of written description. See, e.g., Capon v. Eshhar, 418 F.3d at 1359 (“It is not necessary that every permutation within a generally operable invention be effective in order for an inventor to obtain a generic claim, provided that the effect is sufficiently demonstrated to characterize a generic invention.”). Thus, on the current record, the Examiner does not advance persuasive evidence suggesting that an ordinary artisan would have failed to recognize that, when read in light of the knowledge in the prior art, Appellant was in possession of cells engineered as required by claim 65, that would be generally operable within the spirit of the claimed invention. In contrast, Appellant’s Specification, as well as the prior art advanced by Appellant, support a finding that an ordinary artisan would have understood Appellant as having invented a process using cells engineered as required by claim 65, and would have been able to make such cells, based on the knowledge in the prior art. 15 Appeal 2016-002000 Application 13/821,541 Accordingly, for the reasons discussed, Appellant persuades us that a preponderance of the evidence does not support the Examiner’s finding of a lack of written description in this instance. We, therefore, reverse the Examiner’s rejection of claim 1, and its dependents, on this ground. WRITTEN DESCRIPTION- LIGANDS AND THERAPEUTICS THAT BIND TO EACH OTHER The Examiner’s Rejection The Examiner’s third and final rejection under the written description requirement of § 112, first paragraph, is based on a finding that the claims “are generic for administrations of ligands and therapeutics that bind each other, but are not coupled to each other, and for any timing of administration, as seen by the amendment in Claim 1.” Ans. 20. In reasoning that such subject matter lacks written description, the Examiner states as follows: The specification only describes that these are “coupled” to each other, which the Artisan would understand to be a chemical linkage (covalent bond), and not separate. E.g., page 3. At no point is an example provided of separate administrations, or non-covalently-linked entities. The Art fails to make this clear for this invention. Hence, the Artisan would not have understood Applicant to have been in possession of the invention as claimed at the time of filing. Ans. 21. Analysis The step at issue in this ground of rejection requires “administering to the subject a somatostatin receptor ligand and an anti-tumor therapeutic that specifically binds the ligand and that is effective to kill the engineered cells 16 Appeal 2016-002000 Application 13/821,541 and thereby effect a damage on the tumor, whereby the tumor is treated.” App. Br. 26 (claim 1). As noted above, as to this step, Appellant’s in vivo working example describes administering 90Y-octreotate, which is a radioactive somatostatin analogue which contains a chelator that binds to the 90Y atom, and thus is a somatostatin receptor ligand to which the anti-tumor therapeutic, the radioactive 90Y, is actually bound. See Spec. 1262. As Appellant argues, the Specification explains more generally that therapeutic radionuclides can be bound to somatostatin receptor ligands using chelators. Id. at 134 (“The ligand may further comprise a chelator molecule, such as . . . DOT A ... or . . . DTPA .... In particular embodiments, the ligand may be [90YDOTA]- octreotate or [177Lu-DOTA]-octreotate.”). Given these disclosures, we conclude that an ordinary artisan, giving claim 1 its broadest reasonable interpretation consistent with the Specification, would have understood the administration step to involve the co-administration of the somatostatin ligand and an agent that is bound to the ligand. That is, we agree with Appellant that “delivery of the three-way complex (receptor ligand - chelator - radionuclide) is consistent with it being ‘a somatostatin receptor ligand and an anti-tumor therapeutic that specifically binds the ligand’” (Reply Br. 10) as recited in claim 1. Accordingly, because the Examiner’s written description rejection is based on interpreting claim 1 as encompassing separate administration of the somatostatin ligand and its therapeutic agent binding partner, whereas an ordinary artisan, for the reasons discussed, would not have considered that interpretation reasonable in light of Appellant’s Specification, we reverse the Examiner’s rejection in this instance as well. 17 Appeal 2016-002000 Application 13/821,541 SUMMARY For the reasons discussed, we reverse each of the Examiner’s rejections. REVERSED 18 Copy with citationCopy as parenthetical citation