Ex Parte ChristensenDownload PDFPatent Trial and Appeal BoardDec 19, 201612515563 (P.T.A.B. Dec. 19, 2016) 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. 12/515,563 06/29/2010 John Nikolaj Christensen HOI-24002/16 1897 25006 7590 12/21/2016 DTNSMORF fr SHOHT T T P EXAMINER 900 Wilshire Drive SHOMER, ISAAC Suite 300 TROY, MI 48084 ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 12/21/2016 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docket@patlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN NIKOLAJ CHRISTENSEN1 Appeal 2014-006701 Application 12/515,563 Technology Center 1600 Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and KRISTI L. R. SAWERT, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods of treating periodontitis, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE According to the Specification, “[pjeriodontitis ... is a dental disorder that results from progression of gingivitis, involving inflammation and infection of the ligaments and bones that support the teeth. 1 Appellant identifies the Real Party in Interest as John Nikolaj Christensen. (App. Br. 1.) Appeal 2014-006701 Application 12/515,563 Left untreated for years it may result[] in loss of bone supporting the teeth and final loss of teeth.” (Spec. 1:21—26.) Appellant’s “invention relates to pharmaceutical compositions for the manufacture of medicaments useful for treatment of gingivitis, periodontitis (aggressive and chronic), periodontitis as a manifestation of systemic diseases, and necrotizing periodontal diseases.” {Id. at 1:7—10.) Appellant discloses “[t]he composition according to the invention comprises at least one strontium salt and may further comprise secondary active ingredients such as a vitamin D compound.” {Id. at 1:10—12.) Claims 1,3, 7—9, 11—17, and 23 are on appeal. Claim 1 is illustrative: 1. A method for the treatment of periodontitis, wherein the periodontitis in a patient in need thereof, wherein the periodontitis is: a. aggressive or chronic and/or b. a manifestation of a systemic disease and/or c. a necrotizing periodontal disease and/or d. gingivitis said method comprising orally administering to said patient a therapeutically effective amount of a medicament comprising strontium chloride and strontium carbonate, said medicament being in the form of a tablet or capsule. (App. Br. 8 (Claims App’x).) The claims stand rejected as follows: I. Claims 1,3, 7—9, 11—17, and 23 as obvious under 35 U.S.C. § 103(a) over Christensen2 and Popoff3 (“Rejection I”). 2 Christensen, WO 2006/000224 A2, published Jan. 5, 2006. 3 Popoff et al., US 5,641,747, issued June 24, 1997. 2 Appeal 2014-006701 Application 12/515,563 II. Claims 1,3, 7—9, 11—17, and 23 as obvious under 35 U.S.C. § 103(a) over Christensen and Hartman4 (“Rejection II”). REJECTION I Issue Has the Examiner established by a preponderance of the evidence that claims 1,3, 7—9, 11—17, and 23 would have been obvious over Christensen and Popoff? Findings of Fact FF 1. The Examiner’s findings and statement of Rejection I may be found at pages 2—6 of the Examiner’s Answer. (See also Non-Final Act. at 2—6.) We adopt those findings and provide the following for emphasis. FF 2. Christensen teaches “combining two strontium salts in one pharmaceutical composition . . . and use [of the composition] as a medicament, and in particular for the treatment and prevention of bone disorders such as osteoporosis.” (Christensen Abstract.) FF 3. Christensen teaches the “composition preferably comprises strontium carbonate and strontium chlorides. Further included may be a vitamin D compound.” (Id.) Christensen further teaches [t]he invention relates to the finding that for the treatment of bone disorders it is advantageous to coordinate administration of strontium, vitamin D and calcium to stimulate calcium uptake and to assure that calcium is available for rebuilding of the bones or preventing further loss of bone tissue and/or bone density. For patients suffering from bone disorders or bone diseases the amount of strontium, vitamin D and calcium obtained from food 4 Hartman et al., US 2004/0053968 Al, published Mar. 18, 2004. 3 Appeal 2014-006701 Application 12/515,563 is not adequate and ordinary food supplements do[] not provide suitable amounts of the relevant compound. {Id. at 5:1-8.) FF 4. Christensen teaches regulation of bone re- and degeneration can lead to bone disorders or metabolic bone diseases resulting in weakening of the bones and . . . increased rate of fractures. Included are cartilage and/or bone disease and/or conditions resulting in dysregulation of cartilage and/or bone metabolism in a subject, such as e.[]g. osteoporosis, osteoarthritis, osteopetrosis, osteopenia and Paget’s disease, hypercalcemia of malignancy, periodontal disease, hyperparathyroidism, periarticular erosions in rheumatoid arthritis .... {Id. at 35:16—22 (emphasis added).) Christensen teaches the “medicament according to the invention may be used for treatment or prevention of cartilage and bone diseases/disorders as mentioned above. Treatments of diseases [or] disorders include reduction of the symptoms of the diseases/disorders.” {Id. at 35:34—36:1.) FF 5. Popoff discloses that “osteoporosis, osteoarthritis, rheumatoid arthritis and periodontal disease” are “inflammation-mediated osteolytic diseases.” (Popoff Abstract.) Popoff teaches “[ijnflammation-mediated bone loss occurs in numerous diseases such as osteoporosis, periodontal disease, osteoarthritis, and rheumatoid arthritis.” {Id. at 2:15—16.) FF 6. Popoff teaches “[b]one loss in the oral cavity is [] a significant problem in the United States.” {Id. at 2:34—35.) In this regard, Popoff teaches [pjeriodontitis is characterized by loss of bone and soft tissue attachment. The response to the formation of microbial plaque 4 Appeal 2014-006701 Application 12/515,563 is an inflammation of the gingiva and the resulting breakdown of tissues. This causes the formation of an opening along the tooth surface known as the “periodontal pocket”. The bone remodeling that occurs in periodontal disease is typically localized to the alveolar bone. The mechanism of alveolar bone loss in periodontal disease is believed to be the same basic mechanism as is responsible for bone loss associated with other types of inflammatory conditions. (Id. at 2:42-51.) Analysis Appellant argues the patentability of the rejected claims as a group. We select claim 1 as representative. The Examiner finds that Christensen teaches administering medicaments comprising strontium salts to treat bone diseases or conditions including osteoporosis and periodontal disease. (Ans. 2.) Because the Examiner finds Christensen does not expressly teach use of the medicament to treat periodontitis, the Examiner turns to Popoff. {Id. at 2—3.) The Examiner finds Popoff teaches diseases characterized by excessive bone loss including osteoporosis and periodontal disease. {Id. at 3.) The Examiner finds “Popoff teaches that periodontitis is characterized by the loss of bone . . . [that] appears to be caused by chronic inflammation, and as such, the periodontitis would have been understood to have been chronic.” {Id.) The Examiner concludes “[i]t would have been prima facie obvious ... to have used the method of Christensen (of administering a composition of strontium and Vitamin D to a patient) to have treated chronic periodontitis.” {Id.) The Examiner reasons the composition of Christensen would have been “understood as being useful for [a] variety of bone-related 5 Appeal 2014-006701 Application 12/515,563 disorders with differing clinical pathways.” (Id.) According to the Examiner, “[a]s periodontitis is a disease involving bone loss, as of Popoff, ... the skilled artisan would have been motivated to have administered the composition of Christensen to a patient in need thereof for predictable treatment of periodontitis with a reasonable expectation of success.” (Id.) Appellant argues the Examiner erred because “there is no expectation of success for treating periodontitis from Christensen teaching treatment of osteoporosis or Popoff teaching that periodontitis is inflammation mediated.” (App. Br. 3; see also Reply Br. 2—3.) Appellant contends “Christensen as a whole . . . concerns treatment of osteoporosis . . . [and] diseases caused by inappropriate regulation of bone re- and degeneration.” (App. Br. 3.) Periodontitis, on the other hand, is caused by a “bacterial infection and the formation of a microbial plaque.” (Id. at 4.) Thus, Appellant argues, “the bone loss occurring in connection to periodontitis is not caused by an inappropriate regulation of bone re- and degeneration.” (Id. at 4.) As for Popoff, Appellant contends its teachings are “directed to osteopetrotic disease . . . not periodontitis.” (Id. at 4.) And, according to Appellant, “Popoff does nothing more than indicate that periodontitis involves an inflammation component, and does nothing to teach or suggest that the composition of Christensen could or should be used to treat this chronic microbially caused disease.” (Id. at 5.) In support, Appellant cites the June 19, 2013 declaration of Dr. Henrik Ancher Sorensen, MD (“Sorensen Deck”) as showing that osteoporosis and periodontitis have different underlying causes. (See Sorensen Deck 2 6 Appeal 2014-006701 Application 12/515,563 (“primary inflammation — and especially infection — is not part of the pathogenesis in osteoporosis”).) Thus, just as Appellant argues, Dr. Sorensen opines “it is not obvious that a medicament effective in treatment of osteoporosis would also have an effect in treatment of periodontitis.” {Id. at 3.) Appellant’s arguments are unpersuasive. As an initial matter, we disagree with Appellant’s narrow interpretation of claim 1. Appellant apparently construes “treatment of periodontitis” as limited to removal or reduction of the underlying bacterial infection present in periodontitis. But, as the Specification and art confirms, periodontitis also involves an inflammatory response and degradation of the alveolar bone and supporting tissues of the teeth. {See e.g., Spec. 1:21—2:4; Popoff 2:41—61.) During prosecution we apply the broadest reasonable interpretation of the claims consistent with the specification. In re Morris, 127 F.3d at 1054 (Fed. Cir. 1997). And here, the interpretation of “treatment of periodontitis” encompasses treatment of underlying root causes of periodontitis as well as its sequelae, such as loss of bone tissue or density. {See, e.g., Spec. 5:7—8 (“The medicament of the invention has been found to be surprisingly efficient for alleviating symptoms of [chronic periodontitis, necrotizing periodontal disease, etc.].”); see also id. at 5:14—18 and 6:14— 19.) Turning to the applied art, the teachings of Christensen and Popoff are not limited to preferred embodiments — treatments of osteoporosis or osteopetrosis — as suggested by Appellant. (App. Br. 3^4.) To the contrary, when analyzing patentability under Section 103, all disclosures of 7 Appeal 2014-006701 Application 12/515,563 the prior art must be considered. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). When we consider all relevant teachings of the applied art, we agree with the Examiner that claim 1 would have been obvious over the combination of Christensen and Popoff. Christensen discloses the medicament of claim 1, and teaches that it is suitable for treating numerous bone diseases and disorders that involve “dysregulation of cartilage and/or bone metabolism.” (FF 2-4.) Among the diseases and disorders, Christensen expressly identifies osteoporosis, osteoarthritis, rheumatoid arthritis, and periodontal disease. (FF 4.) The skilled artisan would reasonably understand periodontal disease as including periodontitis. (Ans. 8 (“periodontitis is a form of periodontal disease”); FF 5—6.)5 Christensen further teaches that treatment includes reduction of the symptoms of these diseases/disorders. (Id.) Thus, read as a whole, the skilled person would understand Christensen as teaching that strontium compositions help prevent loss of bone tissue or density characteristic of these diseases/disorders by, for example, facilitating calcium uptake. (FF 3; Ans. 12.) Popoff teaches that bone loss occurs in inflammation-mediated diseases, including osteoporosis, rheumatoid arthritis, and periodontal disease, and describes the inflammatory pathway and bone loss associated with periodontitis. (FF 5.) Indeed, Popoff teaches that, in periodontitis, 5 Indeed, the art of record suggests that “periodontal disease” and the “periodontitis” that is claimed are one in the same — particularly since claim 1 encompasses everything from “gingivitis” to “necrotizing periodontal disease.” (See Hartman || 2—3 and FF 8—9 infra.) 8 Appeal 2014-006701 Application 12/515,563 “inflammatory cytokines and local mediators [] are responsible for enhanced osteoclastic resorption and inhibition of repair or new bone formation at the sites of resorption.'1'’ (Popoff 2:52—55 (emphasis added).) So, contrary to Appellant’s contentions, the prior art describes periodontitis as a condition characterized by dysregulation of bone generation and resorption — and ultimately loss of the bone tissues supporting the teeth. Whether infection plays a role in periodontitis, and whether osteoporosis and periodontitis have identical inflammatory pathways, we are unpersuaded the Examiner erred in concluding that claim 1 would have been obvious. The Examiner provided sufficient reasoning with rational underpinning explaining why the skilled artisan would have combined Christensen and Popoff. (FF 1.) As the Examiner noted, “the treatment of Christensen would have been expected to have predictably regenerated bones that were previously degenerated ... no matter what the cause of degeneration.” (Ans. 12.) See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (stating that “obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success”). Accordingly, like the Examiner, we conclude the skilled artisan would have predictably administered Christensen’s medicament to a patient with periodontitis with the reasonable expectation of “rebuilding of the bones or preventing further loss of bone tissue and/or bone density.” (FF 3.) Dr. Sorensen’s opinion that the skilled artisan would not expect a medicament effective for treatment of osteoporosis to have an effect in treatment of periodontitis presumes the “treatment” must be of the bacterial 9 Appeal 2014-006701 Application 12/515,563 infection itself. But, as discussed above, Appellant’s claims encompass more than that. Treatment of the bone loss characteristic of chronic periodontitis is still “treatment of periodontitis” as recited in claim 1. Appellant’s declaration evidence and related argument are thus not sufficiently persuasive to show that claim 1 is nonobvious. Conclusion of Law For the reasons above, we conclude the Examiner established by a preponderance of the evidence that claim 1 would have been obvious over Christensen and Popoff. Claims 3, 7—9, 11—17, and 23 have not been argued separately and thus fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). REJECTION II Issue Has the Examiner established by a preponderance of the evidence that claims 1,3, 7—9, 11—17, 19, and 23 would have been obvious over Christensen and Hartman? Findings of Fact FF 7. The Examiner’s findings and statement of Rejection II may be found at pages 6—10 of the Examiner’s Answer. (See also Non-Final Act. at 11—15.) We adopt those findings and provide the following for emphasis. FF 8. Hartman teaches Periodontal disease is a common chronic disease primarily of adults. It is characterized by inflammation and degeneration of the tissues that surround and support mammalian teeth. These include the gingiva (gums), periodontal ligament, and alveolar 10 Appeal 2014-006701 Application 12/515,563 bone. Periodontitis, the inflammation of the gingiva and eventual loss of alveolar bone, is the latest stage of this progressive disorder and is the major cause of tooth loss in older adults. . . . The rate of bone loss (resorption) depends upon the severity of the above conditions or causative factors. Symptoms of periodontitis include the development of pockets between the gingivae and the teeth; loss of attachment of the gums and bone to the teeth; alveolar bone loss; tooth mobility; and tooth loss. (Hartman 12.) FF 9. Hartman teaches [pjeriodontal disease progresses through bursts of bone destruction. The bone loss associated with periodontal disease, like that in other parts of the skeleton, results from an imbalance between bone resorption, i.e. breakdown, and bone formation. . . . Periodontitis arises most often from the activation of local immune inflammatory mechanisms and results in the release of inflammatory mediators ... In particular, PGE2 has been implicated as a key inflammatory mediator in periodontal disease and has been shown in culture to cause decreased collagen synthesis in fibroblasts and to stimulate osteoclastic bone resorption .... Individuals suffering from periodontal disease may benefit from treatment with agents that inhibit alveolar bone resorption. (Id. at 13.) Analysis We adopt as our own the Examiner’s findings, reasoning, and conclusion that claims 1,3, 7—9, 11—17, and 23 would have been obvious over Christensen and Hartman. Appellant did not separately address the rejection over Christensen and Hartman in the Appeal Brief. (See App. Br. 2—7.) In the Reply Brief, however, Appellant provides separate argument and evidence concerning 11 Appeal 2014-006701 Application 12/515,563 Hartman. (Reply Br. 2—3 (citing Thompson and Paralkar, International Orthopaedics, 31 SICOT, 767—772 (2007).) Ordinarily, and absent a showing of good cause, the Board does not consider new argument or evidence submitted for the first time in the Reply Brief. 37 C.F.R. § 41.41(b)(1) & (2). Appellant has provided no explanation why the separate argument and evidence was not presented earlier, and we therefore do not consider it here. Nevertheless, inasmuch as Appellant’s arguments with respect to the rejection of Christensen and Hartman mirror the arguments concerning Rejection I, they are unpersuasive for the reasons discussed above. Like Popoff, Hartman teaches that periodontitis is a disease or condition characterized by dysregulation of bone formation and resorption. (FF 8—9.) Irrespective of the root cause of periodontitis, periodontitis results in “loss of attachment of the gums and bone to the teeth[,] alveolar bone loss[,] tooth mobility[,] and tooth loss.” (FF 8.) And Hartman expressly teaches that “[individuals suffering from periodontal disease,” which, in context, clearly means individuals with periodontitis, “may benefit from treatment with agents that inhibit alveolar bone resorption.” (FF 9.) Against this backdrop, the Examiner’s determination that the skilled person would have predictably administered the medicament of Christensen is supported by the preponderance of the evidence. (Ans. 7.) As pointed out by the Examiner, “because periodontitis is a disease that involves bone loss, and an imbalance between bone breakdown and formation, as of Hartman . . . [and] Christensen is drawn to the treatment of diseases of dysregulation of bone metabolism in a subject...[,] the skilled artisan would have been 12 Appeal 2014-006701 Application 12/515,563 motivated to have administered the composition of Christensen to a patient suffering from periodontitis.” (Id.) In administering to this patient population, we are persuaded the skilled artisan would have reasonably expected the medicament of Christensen would help rebuild bone or mitigate bone loss characteristic of periodontitis. (FF 2—A and 8—9.) Conclusion of Law For the reasons above, we conclude the preponderance of the evidence supports the Examiner’s conclusion that claims 1,3, 7—9, 11—17, and 23 would have been obvious over Christensen and Hartman. SUMMARY We affirm the rejection of claims 1, 3, 7—9, 11—17, and 23 under 35 U.S.C. § 103(a) over Christensen and Popoff. We also affirm the rejection of claims 1, 3, 7—9, 11—17, and 23 under 35 U.S.C. § 103(a) over Christensen and Hartman. TIME PERIOD FOR RESPONSE 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 13 Copy with citationCopy as parenthetical citation