Purdue Research Foundation

Patent Trials and Appeals BoardSep 24, 2021

2021000750 (P.T.A.B. Sep. 24, 2021)

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. 14/132,533 12/18/2013 Philip S. Low HLO-37913 1799 35550 7590 09/24/2021 SLW / Purdue Research Foundation P.O. Box 2938 Minneapolis, MN 55402 EXAMINER CHONG, YONG SOO ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 09/24/2021 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): otcpatent@prf.org slw@blackhillsip.com uspto@slwip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte PHILIP S. LOW, FRANCESCO MICHELANGELO TURRINI, KRISTINA ROSE KESELY, and ANTONELLA PANTALEO __________ Appeal 2021-000750 Application 14/132,533 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, RACHEL H. TOWNSEND, and JAMIE T. WISZ, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge FREDMAN. Opinion Concurring filed by Administrative Patent Judge TOWNSEND. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method for inhibiting malaria parasite egress from malaria parasite-infected red blood cells by administering imatinib. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Research Foundation (see Appeal Br. 3). We consider the Specification of Dec. 18, 2013 (“Spec.”); Non-Final Office Action of Nov. 25, 2019 (“Non-Final Action”); Appeal Brief of July 17, 2020 (“Appeal Br.”); Examiner’s Answer of Sept. 10, 2020 (“Ans.”); and Reply Brief of Nov. 10, 2020 (“Reply Br.”). Appeal 2021-000750 Application 14/132,533 2 Statement of the Case Background “[M]alaria is still a major cause of mortality and morbidity, especially in third world countries” (Spec. ¶ 2). “As the malaria-inducing vector, the Plasmodium’s life cycle provides several potential targets for therapeutic intervention” (id. ¶ 5). After a mosquito transfers sporozoites, some sporozoites migrate through the bloodstream and invade hepatocytes (id.). Then the “parasite enters a phase of cell division resulting in the formation of merozoites. Eventually these liver merozoites are released back in to bloodstream” (id. ¶ 6). “These free merozoites then randomly adhere to erythrocytes . . . invade the host RBC [red blood cells] while shedding their surface coat outside the cell, and initiate their asexual phase of replication” (id.). “During this process, the RBC membrane is gradually weakened in preparation for egress of the parasite from the RBC . . . . Culmination of this egress phase occurs when the protective parasitophorous vesicle bursts within the RBC” (id. ¶ 7). The Claims Claims 1, 2, 7, 9, 10, 12, 14, 21, and 22 are on appeal. Claim 1 is an independent claim, is representative and reads as follows: 1. A method for inhibiting malaria parasite egress from malaria parasite-infected red blood cells in a subject, the method comprising: (a) administering a therapeutically effective amount of imatinib, or a salt thereof, to said subject; and (b) reducing the level of tyrosine phosphorylated band 3 of the subject’s red blood cells to a level that stabilizes the red blood cells’ membranes and prevents malaria parasite egress from malaria-infected red blood cells in the subject. Appeal 2021-000750 Application 14/132,533 3 The Rejection The Examiner rejected claims 1, 2, 7, 9, 10, 12, 14, 21, and 22 under 35 U.S.C. § 103(a) as obvious over Lagunoff,2 Parthasaradhi Reddy,3 and Dennis4 (Non-Final Act. 3–6). The issues with respect to these rejections are: (i) Does a preponderance of the evidence of record support the Examiner’s conclusion that the prior art renders the claims obvious? (ii) If so, has Appellant provided evidence of unexpected results that outweighs the evidence supporting the prima facie case of obviousness? Findings of Fact 1. Lagunoff teaches: A method for treating Plasmodium falciparum infection in a mammalian subject is provided which comprises administering to the mammalian subject a pharmaceutical composition capable of inhibiting two or more Plasmodium falciparum target proteins, in an amount effective to reduce or eliminate the Plasmodium falciparum infection or to prevent its occurrence or recurrence in the mammalian subject. In one aspect, the pharmaceutical composition includes, but is not limited to, KN62 (ID 274), u-74389g (ID 2321), daunorubicin (ID 1989), nitrotetrazolium bt (ID 2174), STI-571/ Imatinib (ID 637), or TMPyP4 (ID 2303). (Lagunoff ¶ 17; emphasis added) 2 Lagunoff et al., WO 2008/006085 A2, published Jan. 10, 2008. 3 Parthasaradhi Reddy et al., WO 2004/106326 A1, published Dec. 9, 2004. 4 Dennis et al., US 2,714,106, issued July 26, 1955. Appeal 2021-000750 Application 14/132,533 4 2. Lagunoff teaches the “mean effective dose where 50% of P. falciparum growth was inhibited (ED50) was determined from at least two or more measurements for each compound” (Lagunoff ¶ 44). 3. Lagunoff teaches: The amount of small chemical molecule inhibitors, polypeptide inhibitors, or peptidomimetic inhibitors adequate to accomplish this is defined as a “therapeutically effective dose.” The dosage schedule and amounts effective for this use, i.e., the “dosing regimen,” will depend upon a variety of factors, including the stage of the disease or condition, the severity of the disease or condition, the general state of the patient’s health, the patient’s physical status, age, pharmaceutical formulation and concentration of active agent, and the like. (Lagunoff ¶ 93). Lagunoff teaches “dosage for intravenous (IV) administration would be about 0.01 mg/hr to about 1.0 mg/hr administered over several hours . . . . Considerably higher dosages (e.g., ranging up to about 10 mg/ml) can be used” (id. ¶ 94). 4. Table 5 of Lagunoff is reproduced in part below: “Table 5 shows the results for the 16 inhibitors that were tested. Four inhibitors were found to have very strong binding (e.g., KN62, U-74389G, Daunorubicin, and Nitrotetrazolium) Two inhibitors have moderate binding (e.g., Imatinib (Gleevec) and TmPyP4). Based on this study, these six drugs Appeal 2021-000750 Application 14/132,533 5 work against malaria” (Lagunoff ¶ 105). 5. The Examiner finds that Lagunoff does not “disclose specifically imatinib mesylate” (Non-Final Act. 4). 6. Parthasaradhi Reddy teaches “a sufficiently stable non- hygroscopic amorphous form of imatinib mesylate hydrate. So, amorphous form of imatinib mesylate hydrate can be utilized to prepare stable pharmaceutical dosage forms having good dissolution properties” (Parthasaradhi Reddy 2:2–5). 7. Dennis teaches: “Chloroquine . . . has been found to be a highly effective drug for the treatment of hepatic amebiasis, as well as malaria” (Dennis 1:27–30). Principles of Law The Examiner has the initial burden of establishing a prima facie case obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis We adopt the Examiner’s findings of fact and conclusion of law (see Non-Final Act. 3–6, FF 1–7) and agree that the combination of Lagunoff, Parthasaradhi Reddy, and Dennis renders the claims obvious. We address Appellant’s arguments below. Claim Interpretation We begin with claim construction because before a claim is properly interpreted, its scope cannot be compared to the prior art. During Appeal 2021-000750 Application 14/132,533 6 prosecution, we interpret terms in a claim using the broadest reasonable interpretation in light of the Specification. In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997). Claim 1 is composed of a preamble and two steps. The preamble recites the intended use for active compound imatinib, step (a) recites administration of imatinib, and step (b) recites the results that flow from administration of imatinib. We address each claim element separately. As to the preamble: If, however, the body of the claim fully and intrinsically sets forth the complete invention, including all of its limitations, and the preamble offers no distinct definition of any of the claimed invention's limitations, but rather merely states, for example, the purpose or intended use of the invention, then the preamble is of no significance to claim construction because it cannot be said to constitute or explain a claim limitation. Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). A “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). The preamble of claim 1 recites a “method for inhibiting malaria parasite egress from malaria parasite-infected red blood cells in a subject.” This method is achieved by step (a) of claim 1 which recites “administering a therapeutically effective amount of imatinib, or a salt thereof, to said subject.” Thus, the preamble recites an intended new use for the administration of imatinib, that is, to result in inhibiting malaria parasite egress. The preamble does not, itself, impose any specific limitations on claim 1, but rather simply establishes the use obtained by the imatinib administration step. Therefore, the preamble Appeal 2021-000750 Application 14/132,533 7 does not limit claim 1. As to step (a), this step requires administration of a “therapeutically effective amount of imatinib.” Claim 1. The Specification acknowledges that such doses are routinely optimizable, noting “[a]n ordinarily skilled physician or veterinarian can readily determine and prescribe the effective amount of the drug required to treat, for example, to prevent, inhibit (fully or partially) or arrest the progress of the disease” (Spec. ¶ 285). The Specification also teaches that “suitable daily dosages are for example between about 2-4000 mg administered orally” (id. ¶ 286). Thus, step (a) is reasonably understood as requiring administration of amounts of imatinib between 2 and 4000 mg daily as determined by a physician. As to step (b), this step recites the inherent result of the administration of imatinib which is “reducing the level of tyrosine phosphorylated band 3 of the subject’s red blood cells to a level that stabilizes the red blood cells’ membranes and prevents malaria parasite egress from malaria-infected red blood cells.” Claim 1. The Federal Circuit has “repeatedly held that ‘[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.’” In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) (citing Bristol-Myers Squibb Co. v. Ben Venue Labs. Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). The court explained that “[i]t matters not that those of ordinary skill heretofore may not have recognized the[ ] inherent characteristics of the [prior art].” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1350 (Fed. Cir. 2002)). Therefore, as step (b) of claim 1 is entirely drawn to the newly discovered result that administration of an effective dose of imatinib results in stabilization of the blood cell’s membranes to prevent malaria egress, we Appeal 2021-000750 Application 14/132,533 8 find this result does not impose a limitation on claim 1 because this result is an inherent property that results from administration of an effective amount of imatinib. Therefore after completing claim construction, we determine that the proper interpretation of claim 1 simply requires administration of an effective amount of imatinib with the other recitations being either intended use of the method or inherent properties of administration of imatinib. Prima Facie Obviousness Appellant contends that one of ordinary skill in the art, upon reading Lagunoff, whether alone or in further combination with Reddy (Dennis being irrelevant as directed to chloroquine), would not reasonably expect that use of the candidate compounds identified by Lagunoff would inhibit protein targets on the infectious parasite P. falciparum in vivo, let alone reduce the level of tyrosine phosphorylated band 3 protein – the most abundant protein in red blood cells - to inhibit (claim 1 and dependent claims thereon), or reduce the incidence of (claim 10 and dependent claims thereon) egress of a malarial parasite from infected red blood cells as claimed. (Appeal Br. 10). We find this argument unpersuasive based on our claim interpretation above. Lagunoff specifically directs the ordinary artisan to treat malaria with one of six compounds, with imatinib specifically listed (FF 1, 4) and with a drug dosage of 10 mg/ml (FF 3) that is within the 2 to 4000 mg dosage recited in the Specification as being a suitable daily dosage (Spec. ¶ 286). In “cases involving overlapping ranges, [courts] 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); In re Appeal 2021-000750 Application 14/132,533 9 Slayter, 276 F.2d 408, 411 (CCPA 1960) (“It is well settled that a generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.”). Indeed, Lagunoff states regarding imatinib and the other five drugs that “[b]ased on this study, these six drugs work against malaria” (FF 4). And although Lagunoff does not identify the inherent process by which imatinib functions to treat malaria, recitation of a newly discovered inherent property of stabilizing red blood cell membranes resulting from administration of the compound imatinib does not patentably distinguish from prior art teaching administration of imatinib in the dosage range identified by Appellant’s Specification as being effective to achieve the claimed therapeutic result. In King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1270 (Fed. Cir. 2010), one of the claims covered “a method of increasing the oral bioavailability of metaxalone” by “administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.” The court found that according to the patent itself, “the natural result of taking metaxalone with food is an increase in the bioavailability of the drug,” and that “[t]he prior art discloses taking metaxalone with food,” so the preamble was “inherently anticipated.” Id. at 1275–76. Similarly, in Cruciferous Sprout, the claims at issue included “[a] method of preparing a food product rich in glucosinolates, comprising germinated cruciferous seeds . . . and harvesting sprouts prior to the 2–leaf stage, to form a food product comprising a plurality of sprouts.” Cruciferous Sprout, 301 F.3d at 1345. The Court agreed that “rich in glucosinolates” is a claim limitation, but found the claims inherently Appeal 2021-000750 Application 14/132,533 10 anticipated because the patentee merely recognized properties that “necessarily have existed as long as sprouts themselves.” Id. at 1347, 1350. Appellant contends Lagunoff teaches an approximately 3% success rate – screening of 2,687 drug and drug-like compounds resulted in the discovery of 87 compounds with activity less than or equal to 10 micromolar. Screening of another 2,160 compounds resulted in the discovery of 72 compounds with greater than 70% growth inhibition at one micromolar concentration. (Appeal Br. 12). Appellant contends “the take-away message is that HTS is even worse than single-target computational screening” (id. at 13). We find this argument unpersuasive because Lagunoff, in ¶¶ 41–45, is contrasting the results of two prior art HTS studies by Chong and Weisman with the multitarget computational screening results in Lagunoff itself. Lagunoff does not find a 3% success rate for his process, but rather states “[o]verall, the success rate of approximately 38% of multitarget computational screening is significantly higher than the rates of approximately 3% produced by the two experimental HTS studies for identifying antimalarial inhibitors” (Lagunoff ¶ 42). Thus, Lagunoff asserts that the success rate is 38%. As to the underlying issue of a reasonable expectation of success, an obviousness finding is “appropriate where the prior art ‘contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.”’ In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988). That is the situation at hand. Lagunoff provides a detailed enabling Appeal 2021-000750 Application 14/132,533 11 methodology for using imatinib in treatment of malaria, including at least one dosage that is within the range that Appellant’s Specification teaches achieves the claimed therapeutic effect (FF 1–3). Lagunoff suggests, and even claims, the use of imatinib for treatment of malaria (see Lagunoff, claims 8, 13). Lastly, Lagunoff provides evidence of success and states regarding imatinib and the five other recited drugs that “[b]ased on this study, these six drugs work against malaria” (FF 4). Appellant provides no specific evidence showing that the ordinary artisan would lack a reasonable expectation of success of administering an amount of imatinib in an amount that would treat malaria. And “[o]bviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” Kubin, 561 F.3d at 1360 (emphasis omitted) (citing O’Farrell, 853 F.2d at 903–904). As we have already noted, that Lagunoff does not recognize that the treatment would include “reducing the level of tyrosine phosphorylated band 3 of the subject’s red blood cells to a level that stabilizes the red blood cells’ membranes and prevents malaria parasite egress from malaria-infected red blood cells in the subject” does not establish error in the rejection. The court has “repeatedly held that ‘[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.’” Montgomery, 677 F.3d at 1381. “It matters not that those of ordinary skill heretofore may not have recognized the[ ] inherent characteristics of the [prior art].” Cruciferous Sprout, 301 F.3d at 1350. We note that Appellant recites the limitations of claims 10, 12, 14, and 22 (see Appeal Br. 16) but does not provide any specific arguments as to why these claims would not have been obvious over the cited prior art. “A Appeal 2021-000750 Application 14/132,533 12 statement which merely points out what a claim recites will not be considered an argument for separate patentability of the claim.” 37 C.F.R. § 41.37(c)(1)(iv). We, therefore, find these claims obvious for the reasons given above and for the reasons given by the Examiner. Appellant contends “the Examiner has relied on conclusory statements, which are only possible with impermissible hindsight based on Appellant’s disclosure” (Appeal Br. 17). We are not persuaded. Although we are fully aware that hindsight bias may plague determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. Here, where Lagunoff identifies and claims imatinib as one of six drugs that work against malaria (FF 1–4), it would have been predictable to treat malaria with imatinib and obtain any of the resulting inherent consequences including those recited in claim 1. Secondary Considerations Appellant asserts “Appellant’s findings are surprising and unexpected in view of Lagunoff, taken alone or in further combination with Reddy (Dennis being irrelevant as directed to chlorquinone). By screening imatinib for binding to multiple P. falciparum proteins only to discover the binding to be ‘moderate/uncertain,’ Lagunoff evidenced the absence of a reasonable expectation of success.” We are not persuaded. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (emphasis omitted) (citation Appeal 2021-000750 Application 14/132,533 13 omitted). However, other than statements by attorney (see, e.g., Appeal Br. 16), Appellant points to no evidence that treatment of malaria by imatinib was unexpected after Lagunoff’s disclosure. And although the inherent result regarding stabilization of red blood cells may have been unknown and therefore unexpected, we have already explained that newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent. Conclusions of Law (i) A preponderance of the evidence of record supports the Examiner’s conclusion that the prior art renders the claims obvious. (ii) Appellant has not provided evidence of unexpected results that, when weighed with the prima facie obviousness analysis, support a finding that the claims would have been unobvious. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 7, 9, 10, 12, 14, 21, 22 103 Lagunoff, Parthasaradhi Reddy, Dennis 1, 2, 7, 9, 10, 12, 14, 21, 22 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Appeal 2021-000750 Application 14/132,533 14 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PHILIP S. LOW, FRANCESCO MICHELANGELO TURRINI, KRISTINA ROSE KESELY, and ANTONELLA PANTALEO __________ Appeal 2021-000750 Application 14/132,533 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, RACHEL H. TOWNSEND, and JAMIE T. WISZ, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge, Concurring. CONCURRING OPINION I concur in the decision to affirm the Examiner’s obviousness rejection, but arrive at that conclusion based on a different claim construction. Claim 1 is an independent claim, is representative and reads as follows: 1. A method for inhibiting malaria parasite egress from malaria parasite-infected red blood cells in a subject, the method comprising: (a) administering a therapeutically effective amount of imatinib, or a salt thereof, to said subject; and Appeal 2021-000750 Application 14/132,533 15 (b) reducing the level of tyrosine phosphorylated band 3 of the subject’s red blood cells to a level that stabilizes the red blood cells’ membranes and prevents malaria parasite egress from malaria-infected red blood cells in the subject. Although there is “no ‘litmus test’ for determining whether a preamble is limiting,” the Federal Circuit has “generally construed statements of intended purpose” in “methods of using a composition for a specific purpose” that involve “a single step of administering an effective amount of a composition” as limiting. Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340, 1342–43 (Fed. Cir. 2021). In Lilly, the Court noted: In contrast to apparatus and composition claims, claims to methods of using such apparatuses or compositions are not directed to what the method “is,” but rather they typically rely entirely on what the method “does.” And what a method does is usually recited in its preamble. Accordingly, our claim construction analysis of statements of intended purpose in methods of using apparatuses or compositions has tended to result in a conclusion that such preamble language is limiting. See, e.g., Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003); Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003); but cf. Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375-76 (Fed. Cir. 2001) (holding preamble language non-limiting in method of treatment claims containing two steps, the second of which was administering a compound). Id. at 1341. The Court found that in the following claim 1. A method for treating headache in an individual, comprising: administering to the individual an effective amount of a humanized monoclonal anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody. . . Appeal 2021-000750 Application 14/132,533 16 the preamble was a statement of intentional purpose for which the method must be performed. Id. at 1336, 1342. The Court found that there was a “heavy emphasis” in the Specification of treating such a vasomotor symptom and the claim language by reciting “a step of administering an ‘effective amount’” of particular compound where “the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount’” was provided in the preamble. Id. at 1342–43. Appellant’s claim 1 is similar. It does not recite numerical amounts or ranges of imatinib to be administered, but rather requires “a therapeutically effective amount.” Appellant’s Specification provides the following in defining this phrase: The terms “pharmaceutically effective amount,” “therapeutically effective amount,” or “therapeutically effective dose” refers to the amount of the subject compound that will elicit the biological or medical response of a tissue, system, animal or human that is being sought by the researcher, veterinarian, medical doctor or other clinician. The term “therapeutically effective amount” includes that amount of a compound that, when administered, is sufficient to prevent development of, or alleviate to some extent, one or more of the symptoms of the condition or disorder being treated. The therapeutically effective amount may vary depending on the compound, the disorder or condition and its severity. (Spec. ¶ 87.) Appellant thus defines this phrase in terms of “elicit[ing a] biological or medical response” being sought by a “researcher, veterinarian, medical doctor or other clinician” and of “prevent[ing] development of, or Appeal 2021-000750 Application 14/132,533 17 alleviat[ing] to some extent, one or more of the symptoms of the condition or disorder being treated.” Step (b) of claim 1 recites the biological response that is to be elicited, namely “reducing the level of tyrosine phosphorylated band 3” of the red blood cells of the subject whose red blood cells are “malaria parasite-infected” to a level that stabilizes the membrane of the red blood cell and prevents malaria egress therefrom. The prevention response is what is recited in the claim preamble. Although this reduction of tyrosine phosphorylated band 3 to achieve certain functional results may be a result of the administration of imatinib, as my colleagues note, the functional result is nevertheless the metric by which one practicing the claim is to determine whether the amount administered is a “therapeutically effective amount.” In light of the foregoing, I would conclude that the preamble and step (b) are limiting.5 Nevertheless, I agree with my colleagues that the effective result of preventing malaria parasite egress from malaria-infected red blood cells required by the claimed method as well as the remaining effect recited in step (b) are inherent results of the method taught by Lagunoff, which teaches treating malaria with one of six compounds, with imatinib specifically listed and with a drug dosage of 10 mg/ml. My colleagues explain that Lagunoff provides a detailed enabling methodology for using imatinib in treatment of 5 The claims construction analysis in Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001) is not controlling at least for the reason that independent claim 1 does not recite a specific dosage range. In BMS, the claims required a particular range of taxol be administered over a specified period of time, and the Court found that the intended purpose of the preamble did not result in a manipulative difference to that step of administration. Id. at 1375–76. Appeal 2021-000750 Application 14/132,533 18 malaria, including at least one dosage that is within the range that Appellant’s Specification teaches achieves the claimed therapeutic effect. “It is well settled that a generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.” In re Slayter, 276 F.2d 408, 411 (CCPA 1960). Moreover, “[i]t matters not that those of ordinary skill heretofore may not have recognized the[ ] inherent characteristics of the [prior art].” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1350 (Fed. Cir. 2002). Thus, for the foregoing reasons, I concur in the result.