Ex Parte Zikria et alDownload PDFBoard of Patent Appeals and InterferencesFeb 9, 201111213303 (B.P.A.I. Feb. 9, 2011) 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. 11/213,303 08/29/2005 Bashir A. Zikria 9034 43399 7590 02/10/2011 EVELYN M. SOMMER 570 LEXINGTON AVENUE , 17TH FLOOR NEW YORK, NY 10022 EXAMINER OLSON, ERIC ART UNIT PAPER NUMBER 1623 MAIL DATE DELIVERY MODE 02/10/2011 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte BASHIR A. ZIKRIA and JEMAL DEAN ZIKRIA __________ Appeal 2010-010313 Application 11/213,303 Technology Center 1600 __________ Before ERIC GRIMES, MELANIE L. McCOLLUM, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of treating a human subject and a composition for treating the subject. The Patent Examiner issued a final rejection of all the claims. We have jurisdiction under 35 U.S.C. § 6(b). 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the âMAIL DATEâ (paper delivery mode) or the âNOTIFICATION DATEâ (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-010313 Application 11/213,303 2 STATEMENT OF THE CASE â[T]his invention relates to macromolecules and biochemical methods for preventing leakage of macromolecules from capillary endothelial junctions during a period of increased capillary permeability secondary to burn injury, battlefield injury, cytotoxicity, trauma, septic and hemorrhagic shock, ischemia and other toxic processes while simultaneously preventing pathology due to the activity of free radicals.â (Spec. 1.) Claims 1-11 and 13-31, which are all the pending claims, are on appeal. A copy of the claims on appeal may be found in Appellantsâ Brief at 19-26. Briefly, method claims define a method of administering an effective amount of a composition comprising at least one polysaccharide selected from a list of three, and at least one active agent selected from a list of about three dozen named agents or kinds of agents. (E.g., claim 1, App. Br. 19.) Composition claims define compositions comprising a polysaccharide selected from a list of three and an active agent selected from a list of about three dozen named agents or kinds of agents. (E.g., claim 23, App. Br. 23.) The Examiner rejected all the claims under 35 U.S.C. § 112 for lack of enablement, and rejected all the claims over prior art in several rejections grouping different claims under §§ 102(b) and 103. We reverse the rejection for lack of enablement, and affirm the rejections for anticipation and obviousness. ENABLEMENT The Examiner rejected claims 1-11 and 13-31 under 35 U.S.C. § 112, first paragraph, âbecause the specification, while being enabling for methods and compositions for treating or reducing leakage of serum proteins from capillary endothelial junctions, does not reasonably provide enablement for a Appeal 2010-010313 Application 11/213,303 3 method of prevention or prophylaxis of said condition.â (Ans. 5-9.) Appellants dispute the Examinerâs claim interpretation, and contend that âthe term âpreventâ is used in the sense of a method of treatment of human subjects to prevent leakage of molecules, not for the life of the subject but to inhibit capillary leakage and inflammatory changes before the trauma has occurred (before surgery) or to correct or reduce the leakage after the trauma has occurred (after a burn).â (App. Br. 7-8.) The claims define a â[m]ethod of treating a human subject to prevent leakage of serum proteins from capillary endothelial junctions . . . during a period of increased capillary permeability which comprises administering to a subject in need of such treatment . . . .â (Claim 1.) The defined method treats a subject âin need of such treatment.â The rejection agrees that treating or reducing leakage is enabled, or, put another way, preventing further leakage during the period of increased permeability is enabled, as is reducing the leakage from the level occurring prior to treatment. To the extent the rejection concerns âprophylaxisâ in the sense of preventing leaky junctions from developing, that concern is misdirected because the claim does not purport to prevent leaky junctions from developing. We have reviewed the rejectionâs analysis of the Wands factors (Ans. 5-9) but find it misdirected in that it concerns âprevention of a disease,â which is not the method defined in the claims. For example, the rejection directs its analysis to discussing âpreventing diseaseâ or âprevention of a disease,â and finds that âprevention in the sense used herein must be capable of stopping any occurrence of a condition at any time in the future.â (See, e.g., Ans. 6, 8.) However, the method defined in the claims is âto prevent leakage . . . during a period of increased capillary permeability which Appeal 2010-010313 Application 11/213,303 4 comprises administering to a subject in need of such treatment . . . .â (Claim 1.) The rejection does not show that a person of ordinary skill in the art would reasonably interpret â[m]ethod of treating . . . a subject in need of such treatmentâ to mean the method purports to stop âany occurrence of a condition at any time in the future.â We find that the rejection analyzed a method that is not claimed, and conclude that it did not establish a prima facie case of nonenablement for the method that is claimed. APPELLANTSâ CLAIM FOR THE BENEFIT OF AN EARLIER FILING DATE The effective filing date of the appealed claims is disputed. We address this issue before reviewing the rejections under §§ 102 and 103 because Appellants intend their argument to disqualify some of the references the Examiner used as evidence to support several of the rejections. The Issue This Application was filed Aug. 29, 2005, as a continuation-in-part of an application filed April 22, 1997. The Examiner determined that the appealed claims are not entitled to the 1997 date, âas the parent application fails to provide support under 35 USC 112, first paragraph[, for] a method or composition involving any of the second active agents recited in instant claim 1.â (Final Rej. 2.) The Examiner found that âthough the parent application offers support for the inclusion of generic antioxidants in the disclosed method, it does not provide support for the many specific compounds recited in the instant claims.â (Id.) That is, âthe few examples [listing six named compounds] given in the parent application are not sufficiently representative of the full scope of the invention to provide Appeal 2010-010313 Application 11/213,303 5 written description for all of the individual species recited in the instant claims.â (Id. at 2-3.) Appellants agree that in comparison to the parent application, âthe instant application discloses additional antioxidants.â (App. Br. 6, citing Spec. ¶ 9.) Appellants then state: â[i]t is submitted that it is the disclosure of additional antioxidants and compositions containing them that constitutes the added matter and that the basis for the same has been provided for in the parent application. The applicant is entitled to claim priority as to this common disclosure.â (Id. at 6-7.) The issues to be decided are: whether the Examiner made a prima facie case that the effective filing date of the appealed claims is Aug. 29, 2005, the filing date of the instant continuation-in-part application, not the April 22, 1997, filing date of the parent application; and if so, whether Appellants have rebutted the prima facie case by showing a descriptive basis for the so-called âadded matterâ in the parent application filed April 22, 1997. Principles of Law â[A] patent application is entitled to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.â In re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). When a patent or an application claims the benefit of an earlier filed application, the fact finder âmust determine if one skilled in the art, reading the original specification, would immediately discern the limitation at issue . . . .â Waldemar Link, GmbH & Co. v. Osteonics Corp., 32 F.3d 556, 558-59 (Fed. Appeal 2010-010313 Application 11/213,303 6 Cir. 1994). âIn other words, does the âdisclosure of the application relied upon reasonably convey to the artisan that the inventor had possession at that time of the later claimed subject matter?ââ Id., citation omitted. An Examiner may meet âthe initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claimsâ by pointing out differences between what is disclosed in the priority application and what is now claimed. In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (affirming a finding that the two chemical species disclosed in a foreign priority application were insufficient written description to support the genus claims of the corresponding U.S. application). âThe applicant for a United States patent bears the burden of establishing its entitlement to the filing date of a previously filed application.â In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir. 1993). Analysis Appellants agree with the Examiner that antioxidants and compositions disclosed and claimed in this CIP application did not appear in the parent application. We also agree with the Examiner and therefore find the Examiner met the burden of establishing a prima facie case for holding that the appealed claims have an effective filing date of Aug. 29, 2005, the filing date of this Application, and not of April 22, 1997, the filing date of the parent application. See Gosteli, 872 F.2d at 1012. Rather than offer evidence or an explanation showing that a person of ordinary skill in the art, reading the parent application, would immediately discern the additional antioxidants and compositions listed in the currently appealed claims, Appellants simply state âthe basis for the same has been Appeal 2010-010313 Application 11/213,303 7 provided for in the parent application.â (App. Br. 6-7.) We find this conclusory allegation insufficient to rebut the prima facie case because it is neither evidence nor explanation sufficient to show that one skilled in the art, reading the parent specification, would immediately discern the limitations at issue in the appealed claims. See Waldemar Link, 32 F.3d at 558-59. We also find Appellantsâ statement that they are entitled to claim priority âas to this common disclosureâ obscure because it does not explain what âthis common disclosureâ means. If it refers only to the six compounds the Examiner identified in the parent application that is not disputed. But Claim 1, for example, lists dozens of compounds, and there is no showing that the six compounds making up the common disclosure support the dozens now recited in the claim. We affirm the Examinerâs filing date determination. We thus agree with the Examiner that the references relied on under §§ 102 and 103 were available as evidence of the prior art as of April 29, 2005, the effective filing date of the appealed claims. ANTICIPATION The Examinerâs position is that claims 1, 2, 4, 5, 11, 17-19, 23 and 24 were anticipated under 35 U.S.C. § 102(b) by Davis.2 The Examiner gave a detailed summary of Davisâ disclosure, which taught administering compositions to reperfuse an ischemic limb. (Ans. 10-11.) The evidence supports the Examinerâs findings, and we adopt them as our own. 2 Scott Davis, WO 00/69427, published Nov. 23, 2000. Appeal 2010-010313 Application 11/213,303 8 Appellants contend that â[i]n complete contrast, the compositions of the invention are introduced by a conventional I.V. delivery to prevent or inhibit capillary leakage and inflammatory changes before the trauma has occurred or to correct or reduce the leakage and inflammatory damages after the trauma has occurred.â (App. Br. 11.) Appellants argue that an easily oxidizable energy substrate is an important component of the Davis composition, but that it is not necessary or required in their own claims. (Id.) Appellants did not argue any claim in particular, and we select claim 1 as representative. Claims 2, 4, 5, 11, 17-19, 23 and 24 were not argued separately and therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). The Examiner responds that âthe rejected method claims do not contain any limitation which would exclude the method described by Davis,â and, with regard to the composition claims, the intended use of a composition does not limit the claims. (Ans. 33-34.) We agree. The claimed method does not require intravenous administration, nor have Appellants identified another step to distinguish Davisâ method. The Examiner is correct that an intended use recited in a claim does not distinguish the claimed composition from the same composition described in the prior art. Finally, Appellantsâ claims define the composition with the transitional term âcomprising,â which means the claim is open to the inclusion of unrecited components, including an easily oxidizable energy substrate that Appellants argue is a component of Davisâ composition. As the rejection under § 102 is supported by the evidence, we affirm it. Appeal 2010-010313 Application 11/213,303 9 OBVIOUSNESS Principles of Law âIt is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.â In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980); Merck & Co., Inc. v. Biocraft Labs, Inc., 874 F.2d 804, 809 (Fed. Cir. 1989) (âGiven the prior art teaching that both amiloride and hydrochlorothiazide are natriuretic, it is to be expected that their co-administration would induce more sodium excretion than would either diuretic aloneâ); In re Diamond, 360 F.2d 214, 217 (CCPA 1966) (where the evidence showed that synergy was expected because combined drugs targeted different cellular mechanisms, and no evidence to the contrary was produced, â[w]e are not convinced of non- obviousness of the combination of the two drugs, A5MP and a glucocorticoid . . . particularly since the record supports the [PTOâs] contention that the drugs selected are two of the commonly used drugs in the treatment of such collagen diseasesâ). See also, Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 411 F.3d 1332, 1338-1339 (Fed. Cir. 2005) (affirming obviousness where motivation was found in the knowledge of those skilled in the art at the time, and where the nature of the problem also supplied a motivation); DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006) (âthe âevidenceâ of motive will likely consist of an explanation of the well-known principle or problem-solving strategy to be appliedâ). â[I]t is not necessary in order to establish a prima facie case of obviousnessâŠ. that there be a suggestion in or expectation from the prior art Appeal 2010-010313 Application 11/213,303 10 that the claimed compound or composition will have the same or a similar utility as one newly discovered by applicant.â In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990) (emphasis in original). âA reference is reasonably pertinent if, even though it may be in a different field from that of the inventorâs endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventorâs attention in considering his problem.â In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). Claims grouped with claim 1 will stand or fall with claim 1. For each rejection that grouped claims together, Appellants did not argue any claims separately. For those rejections, we select claim 1 as representative, and the other claims in the group will stand or fall will claim 1. See 37 C.F.R. § 41.37(c)(1)(vii). A. The rejection of claims 25-29 under 35 U.S.C. § 103(a) as unpatentable over Davis. (Ans. 11-12.) Appellants did not request review of this rejection, and did not mention it in their Brief. (App. Br. 5, listing grounds of rejection to be reviewed, not including this rejection.) Appellants thus have waived their right for further appellate review of this rejection. We therefore do not review the rejection. Appeal 2010-010313 Application 11/213,303 11 B. The rejection of claims 1, 13, 18-21, 23, 25 and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Zikria,3 and Simpkins.4 (Ans. 12- 14.) The Examiner gave a detailed summary of the Zikria and Simpkins disclosures, and found they taught administering compositions comprising hydroxyethyl starch and estrogen compounds, respectively, to treat ischemic damage. The Examiner found that â[o]ne of ordinary skill in the art would have recognized that these two therapies were both useful for treating ischemic damage in a subject, and would therefore have been motivated to coadminister them, either as two separate compositions or as one combined pharmaceutical composition. Combining two therapies known in the prior art is well within the ordinary and routine level of skill in the art.â (Ans. 13.) The evidence supports the Examinerâs findings and we adopt them as our own. Appellants do not dispute the Examinerâs finding that treating ischemia would inherently prevent leakage, but contend â[t]here is no suggestion or motivation from the references to make the modification suggested by the Examiner.â (App. Br. 12.) The Examiner responds that the motivation to modify a reference may be for a different purpose than the inventorâs purpose, in this case, the general problem of treating ischemic damage rather than the specific problem of leakage that Appellants addressed. (Ans. 35, citing authority.) The Examinerâs position is consistent with precedent. E.g., Dillon, 919 F.2d at 693. Further, â[c]onsidering that Simpkins discloses treating the same 3 Bashir A. Zikria, US 4,994,444, issued Feb. 19, 1991. 4 James W. Simpkins, US 5,877,169, issued Mar. 2, 1999. Appeal 2010-010313 Application 11/213,303 12 conditions as Zikria, one of ordinary skill in the art would have had a clear motivation to combine and co-administer them in the expectation of an additive benefit.â (Ans. 35.) In our view, the Examinerâs original finding of motivation, and the reasoning in the response, are supported by the evidence and consistent with precedent. See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217. We therefore affirm the rejection. C. The rejection of claims 1, 13, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over Oz,5 and Simpkins. (Ans. 14-16.) The Examiner gave a detailed summary of the Oz and Simpkins disclosures, and found they taught administering compositions comprising superoxide dismutase with hydroxyethyl starch and estrogen compounds, respectively, to treat ischemic damage. The Examiner found that â[o]ne of ordinary skill in the art would have recognized that these two therapies were both useful for treating ischemic damage in a subject, and would have therefore been motivated to coadminister them, either as two separate compositions or as one combined pharmaceutical composition. Combining two therapies known in the prior art is well within the ordinary and routine level of skill in the art.â (Ans. 15.) The evidence supports the Examinerâs findings and reasoning, and we adopt them as our own. Appellants contend that âthe use of estrogen in Simpkins is duplicative of the use of HES and SOD in Oz. There would be no need to 5 Mehmet C. Oz et al., Hydroxyethyl Starch Macromolecule and Superoxide Dismutase Effects on Myocardial Reperfusion Injury, 162 AMER. J. SURGERY 59-62 (1991). Appeal 2010-010313 Application 11/213,303 13 add estrogen, certainly no suggestion or teaching that it could function as an antioxidant and be of any advantage to the combination.â (App. Br. 13.) The Examiner responds that âit is ordinary and routine in the art to combine two existing therapeutic compositions or methods in order to achieve an additive effect that is greater than that produced by either one of the compositions alone.â (Ans. 36.) The Examiner also responded that because Oz showed a method improved over a control âbut not perfectly efficacious,â a further improvement would have been expected by adding estrogen to Ozâs composition and method. (Id.) Appellants have not identified evidence in the prior art to support their contention that the use of estrogen is duplicative. More importantly, they have not identified evidence showing that those of ordinary skill in the art would have considered that estrogen use was duplicative or redundant of HES and SOD. In the absence of such evidence, we think the Examiner has the better account of the facts. The rejection is also consistent with the law. See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217. We therefore affirm the rejection. D. The rejection of claims 1, 7, 8, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Zikria, and Bouskela.6 (Ans. 16- 18.) The Examiner gave a detailed summary of the Zikria and Bouskela disclosures and concluded that â[i]t would have been obvious . . . to add the 6 Eliete Bouskela et al., Effects of Oral Administration of Purified Micronized Flavonoid Fraction on Increased Microvascular Permeability Induced by Various Agents and on Ischemia/Reperfusion in Diabetic Hamsters, 15 INT. J. MICROCIRC. 293-300 (1995). Appeal 2010-010313 Application 11/213,303 14 flavonoid composition of Bouskela to the treatment described by Zikria.â (Ans. 17.) The evidence supports the Examinerâs findings and we adopt them as our own. Appellants contend that the âBouskela reference is specific to the oral administration of a micronized flavonoid . . . .â (App. Br. 13.) According to Appellants, there is no motivation or suggestion to use flavonoids intravenously or to use them in addition to a macromolecule like HES. (App. Br. 13.) The Examiner responds that âoral and intravenous administration are both routine, conventional, predictable methods for administering an active agent and one of ordinary skill in the art would have had a reasonable expectation of success in using a small molecule therapeutic such as a flavonoid in either of these conventional methods.â (Ans. 37.) Appellantsâ argument about intravenous administration is directed to a limitation that does not appear in the claims. Appellants provide no evidence that the Examinerâs proposed combination would not have been expected to work. The Examinerâs reasoning is consistent with precedent. See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217. We therefore affirm the rejection. E. The rejection of claims 1, 7, 8, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over Oz, and Bouskela. (Ans. 18-20.) The Examiner gave a detailed summary of the Oz and Bouskela disclosures and concluded that â[i]t would have been obvious . . . to add the flavonoid composition of Bouskela to the treatment described by Oz.â (Ans. 19.) The evidence supports the Examinerâs findings. Appeal 2010-010313 Application 11/213,303 15 Appellants argue that this rejection should be reversed for the same reasons presented against the rejection over Zikria and Bouskela (App. Br. 14.) We found those arguments unpersuasive, see item D, immediately above, and find them unpersuasive here as well. We therefore affirm the rejection. F. The rejection of claim 16 under 35 U.S.C. § 103(a) as unpatentable over Davis, and Faivre.7 (Ans. 20-21.) Claim 16 limits the polysaccharide- conjugated hemoglobin of claim 1 to a member of a group including dextran-conjugated hemoglobin. The Examiner relied on the earlier findings concerning Davisâ teachings (see Ans. 10-11), and found that Davis did not teach using stroma- free hemoglobin conjugated to dextran. (Ans. 20.) However, Faivre taught using dextran-conjugated hemoglobin in a plasma substitute shown âto provide improved survival of ischemic-reperfused bowel tissue as compared to unmodified hemoglobin.â (Id.) The Examiner concluded that it would have been obvious to use dextran-conjugated hemoglobin because Faivre showed it was âespecially useful for reperfusing ischemic tissue with minimal damage.â (Id. at 21.) The evidence supports the Examinerâs findings and we adopt them as our own. Appellants contend that Faivre teaches that conjugated hemoglobin has the capacity to release oxygen, but Appellantsâ invention uses it as an antioxidant. âThe artisan would not look to Faivre . . . as Faivreâs teachings would not result in applicantâs objectives.â (App. Br. 14.) 7 B. Faivre et al., Assessment Of Dextran 10-Benzene-Tetracarboxylate- Hemoglobin, An Oxygen Carrier, Using Guinea Pig Isolated Bowel Model, 23 ART. CELLS, BLOOD SUBS., AND IMMOB. BIOTECH. 495-504 (1995). Appeal 2010-010313 Application 11/213,303 16 We agree with the Examiner that â[w]hether one of ordinary skill in the art would have been motivated to practice the claimed method for the same reason as Applicant or for a different reason is immaterial to a finding of obviousness so long as the resulting method is the same.â (Ans. 37-38.) Appellantsâ distinction between the property emphasized by Appellants and the property emphasized by Faivre does not persuade us of error. See Dillon, 919 F.2d at 693. Although Appellants contend that Faivreâs teachings would not result in Appellantsâ objectives, Appellants provide no evidence to support that argument. We are persuaded by the Examinerâs reasoning that because Davis and Faivre both provided solutions to treating ischemia using hemoglobin, and Faivre showed that dextran-conjugated hemoglobin was superior to unmodified hemoglobin, a person of skill in the art would have been motivated to use dextran-modified hemoglobin in Davisâ method. We therefore affirm the rejection. G. The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable over Davis, and Babish.8 (Ans. 21-22.) Claim 3 limits claim 1âs tocotrienol to one selected from the group consisting of alpha-, beta-, gamma-, and delta-tocotrienols. The Examiner relied on the earlier findings concerning Davisâ teachings (see Ans. 10-11), and found that Davis did not disclose a method or composition using the listed tocotrienols. (Ans. 21.) The Examiner found that Babish disclosed âa composition having a synergistic inhibitory effect on biological oxidation processe[s] involving free radicals or singlet oxygen, 8 John G. Babish et al., US 2002/0120001 A1, published Aug. 29, 2002. Appeal 2010-010313 Application 11/213,303 17 comprising a . . . tocotrienolâ and disclosed using alpha-, beta-, gamma-, or delta-tocotrienol. (Id.) Appellants contend that â[t]he Babish composition is a dietary supplement and is intended for oral, topical, transdermal, transmucosal or parenteral routes.â âThere is no teaching in Babish or Davis that would motivate the skilled artisan to make the combination proposed by the Examiner.â (App. Br. 15.) The Examiner responds that âas discussed in the rejection, Davis discloses the need for a radical scavenger. Because Babish discloses a radical scavenger, one of ordinary skill in the art would clearly be motivated to include this radical scavenger in the composition of Davis.â (Ans. 38.) We agree with the Examinerâs reasoning because it is supported by the evidence. Appellants characterize Babishâs composition as a dietary supplement, but acknowledge that Babish taught administering the composition parenterally. We cannot agree that Babish limited its method to diet supplements. See, e.g., Babish claims 25-31. We find that the Examiner provided evidence that Babish would have motivated a person skilled in the art to use one of the recited tocotrienols in Davisâ method and composition. We therefore affirm the rejection. H. The rejection of claims 1, 14, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Zikria, and Ogiso.9 (Ans. 22-24.) The Examiner gave a detailed summary of the Zikria and Ogiso disclosures and concluded that â[i]t would have been obvious . . . to add putrescine as described by Ogiso et al. to the treatment described by Zikira. 9 Seiji Ogiso et al., The Role of Polyamines in Liver Regeneration After Hepatectomy with Ischemic Injury, 27 JPN. J. SURG. 833-839 (1997). Appeal 2010-010313 Application 11/213,303 18 One of ordinary skill in the art would have recognized that putrescine is useful for the same purpose, namely protecting against ischemic tissue damage, and that [t]he combined composition would have improved utility for the treatment of hepatic ischemia-reperfusion injury. Combining two therapies known in the prior art is well within the ordinary and routine level of skill in the art.â (Ans. 23.) The evidence supports the Examinerâs findings and we adopt them as our own. Appellants contend that Ogiso has nothing to do with preventing leakage from capillary endothelial junctions while simultaneously preventing damage to surrounding tissues. â[A]ny suggestion to make the combination of reference teachings can only come from the application . . . .â (App. Br. 16.) The Examiner responds that âboth references disclose methods for treating or preventing ischemic tissue damage. Therefore one of ordinary skill in the art would have been motivated to administer [the compositions] together in order to achieve an additive effect.â (Ans. 38.) We agree with the Examiner that the reason for combining the teachings of the prior art is based in the prior art itself. The Examinerâs reasoning is consistent with precedent. See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217. The motivation to modify a known method may be for a different purpose than the inventorâs purpose, in this case, the goal of treating or preventing ischemic damage rather than the specific problem of leakage that Appellants addressed. E.g., Dillon, 919 F.2d at 693. The Examinerâs position is consistent with precedent. We therefore affirm the rejection. Appeal 2010-010313 Application 11/213,303 19 I. The rejection of claims 1, 14, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over Oz and Ogiso. (Ans. 24-26.) The Examiner gave a detailed summary of the Oz and Ogiso disclosures and concluded that â[i]t would have been obvious . . . to add putrescine as described by Ogiso et al. to the treatment described by Oz et al. One of ordinary skill in the art would have recognized that putrescine is useful for the same purpose, namely protecting against ischemic tissue damage, and that [t]he combined composition would have improved utility for the treatment of hepatic ischemia-reperfusion injury. Combining two therapies known in the prior art is well within the ordinary and routine level of skill in the art.â (Ans. 25.) The evidence supports the Examinerâs findings and we adopt them as our own. Appellants contend that â[n]either reference is related to the invention directed at preventing capillary leakage by administering a macromolecule (HES, glycogen, dextran) and an antioxidant.â (App. Br. 16.) âThe artisan would not make the combination as suggested by the Examiner without knowing of what the applicants had done.â (App. Br. 17.) The motivation to modify a known method may be for a different purpose than the inventorâs purpose, in this case, the goal of treating or preventing ischemic damage rather than the specific problem of leakage that Appellants addressed. E.g., Dillon, 919 F.2d at 693. The Examinerâs position is consistent with precedent. We therefore affirm the rejection. Appeal 2010-010313 Application 11/213,303 20 J. The rejection of claims 1, 6, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) over Zikria and Hirashima.10 (Ans. 26-28.) The Examiner gave a detailed summary of the Zikria and Hirashima disclosures and concluded that â[i]t would have been obvious . . . to add the selenoprotein of Hirashima et al. to the treatment described by Zikria. One of ordinary skill in the art would have recognized that selenoprotein P as described by Hirashima et al. is useful for the same purpose as the invention of Zikria, namely protecting against ischemic tissue damage, and that [t]he combined composition would have improved utility for the treatment of ischemia-reperfusion injury. Combining two therapies known in the prior art is well within the ordinary and routine level of skill in the art.â (Ans. 27.) The evidence supports the Examinerâs findings and we adopt them as our own. Appellants contend that the âthere is no suggestion or motivation for the modification in the references so as to approximate the applicantâs invention but not with true success either as concerns the composition or the method.â (App. Br. 17.) We agree with the Examiner that the reason for combining the teachings of the prior art is based in the prior art itself. The Examinerâs reasoning is consistent with precedent. See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217. 10 Hirashima et al., JP 2002-060346A, published Feb. 2002. Appeal 2010-010313 Application 11/213,303 21 K. The rejection of claims 1, 6, and 17-31 under 35 U.S.C. § 103(a) over Oz, and Hirashima. (Ans. 28-29.) The Examiner gave a detailed summary of the Oz and Hirashima disclosures and concluded that â[i]t would have been obvious . . . to add the selenoprotein of Hirashima et al. to the treatment described by Oz et al. One of ordinary skill in the art would have recognized that selenoprotein P as described by Hirashima et al. is useful for the same purpose as the invention of Oz, namely protecting against ischemic tissue damage, and that [t]he combined composition would have improved utility for the treatment of ischemia-reperfusion injury. Combining two therapies known in the prior art is well within the ordinary and routine level of skill in the art.â (Ans. 28- 29.) The evidence supports the Examinerâs findings and we adopt them as our own. Appellants contend that the âthere is no suggestion or motivation for the modification in the references so as to approximate the applicantâs invention but not with true success either as concerns the composition or the method.â (App. Br. 17.) We agree with the Examiner that the reason for combining the teachings of the prior art is based in the prior art itself. The Examinerâs reasoning is consistent with precedent. See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217. Appeal 2010-010313 Application 11/213,303 22 L. The rejection of claims 1, 5, 9, 10, 12, 19-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Feola,11 and Cliffton.12 (Ans. 29- 31.) The Examiner found that Feola disclosed a blood substitute that comprised cross-linked hemoglobin, dextran or hydroxyethyl starch, and an electrolytic solution, but not including ellagic acid. (Ans. 30.) Cliffton disclosed that ellagic acid induced hypercoaguability, and that it decreased traumatic bleeding in rats after tail amputation. (Id.) The Examiner concluded that it would have been obvious âto add ellagic acid to the blood substitute of Feola et al.â because both compositions âare already useful for administering to subjects suffering from traumatic bleeding, and are therefore also useful in a composition for administration to a subject suffering from traumatic bleeding that can both replace lost blood and reduce further blood loss.â (Id.) Appellants contend that âFeola teaches a blood substitute which is of a very different composition with a very different objective than the composition of the invention. Cliffton similarly has nothing to do with the invention and is directed to the prevention of traumatic bleeding by ellagic acid in animals.â (App. Br. 18.) â[T]he references are inappropriate and their combination does not teach or suggest the invention as claimed.â (Id.) Feola provided a composition said to be âeffective in sustaining life after severe hemorrhage.â (Feola, col. 1, ll. 15-19.) According to Feola, severe hemorrhage endangers life because âthe drop in circulating blood 11 Mario Feola et al., US 5,439,882, issued Aug. 8, 1995. 12 E.E. Cliffton et al., Prevention of Traumatic Bleeding by Ellagic Acid in Rats, 120 PROC. SOC. EXP. BIO. MED. 179-180 (1965). Appeal 2010-010313 Application 11/213,303 23 volume reduces tissue perfusion and produces ischemia.â (Id. at col. 1, ll. 23-26.) Cliffton disclosed that â[i]ntravenous injection of ellagic acid causes marked statistically significant decrease in bleeding after amputation of the tail in the rat.â (Cliffton, Summary, 180.) We cannot agree with Appellantsâ contention that Feolaâs treatment of hemorrhage and ischemia had a very different objective than the invention. As Appellants describe it, their own invention is directed to preventing leakage during conditions associated with trauma, hemorrhagic shock, and ischemia. (Spec. 1.) Feola was also directed at treating hemorrhage and ischemia, and Cliffton was directed to reducing hemorrhage. We find that the Feola and Cliffton teachings were reasonably combined for the reason the Examiner stated. See Clay, 966 F.2d at 659. The motivation to modify a known method may be for a different purpose than the inventorâs purpose, in this case, Feolaâs goal of treating or preventing ischemic damage rather than the specific problem of leakage that Appellants addressed. E.g., Dillon, 919 F.2d at 693. If Clifftonâs ellagic acid had been added to Feolaâs composition, the result would have been the composition Appellants now claim. We agree with the Examiner that the evidence supports concluding it would have been obvious to do so, and it would have been obvious to use the combined composition in Feolaâs method, the method that Appellants now claim. SUMMARY We reverse the rejection of claims 1-11 and 13-31 under 35 U.S.C. § 112, first paragraph. We affirm the following rejections: Appeal 2010-010313 Application 11/213,303 24 claims 1, 2, 4, 5, 11, 17-19, 23 and 24 under 35 U.S.C. § 102(b) as anticipated by Davis; claims 1, 13, 18-21, 23, 25 and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Zikria and Simpkins; claims 1, 13, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over Oz and Simpkins; claims 1, 7, 8, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Zikria and Bouskela; claims 1, 7, 8, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over Oz and Bouskela; claim 16 under 35 U.S.C. § 103(a) as unpatentable over Davis and Faivre; claim 3 under 35 U.S.C. § 103(a) as unpatentable over Davis and Babish; claims 1, 14, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Zikria and Ogiso; claims 1, 14, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over Oz and Ogiso; claims 1, 6, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) over Zikria and Hirashima; claims 1, 6, and 17-31 under 35 U.S.C. § 103(a) over Oz and Hirashima; and claims 1, 5, 9, 10, 12, 19-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as unpatentable over Feola and Cliffton. Appeal 2010-010313 Application 11/213,303 25 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 alw EVELYN M. SOMMER 570 LEXINGTON AVENUE , 17TH FLOOR NEW YORK, NY 10022 Copy with citationCopy as parenthetical citation