Ex Parte BoydDownload PDFBoard of Patent Appeals and InterferencesApr 1, 201010282666 (B.P.A.I. Apr. 1, 2010) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte LAWRENCE M. BOYD __________ Appeal 2009-013341 Application 10/282,666 Technology Center 1600 __________ Decided: April 1, 2010 __________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods for treatment of an intervertebral disc. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2009-013341 Application 10/282,666 2 Statement of the Case Background “[T]ypically, disc degeneration and/or herniation is preceded by degeneration of the vertebral endplates. Treatment of the disc degeneration can proceed as outlined above - i.e., a discectomy followed by the introduction of some form of scaffold into the intradiscal space” (Spec. 8, ll. 1-4). According to the Specification “where the scaffold is of the type described above that seeks to restore normal disc function (at least as much as possible), patency of the endplates is of critical concern” (Spec. 8, ll. 11- 13). The Specification teaches that the “present invention contemplates a method and system for addressing the diseased vertebral endplates in anticipation of treatment for a degenerative or diseased intervertebral disc” (Spec. 9, ll. 1-3). The Claims Claims 1-8, 10, 11, 17-19, and 21-25 are on appeal. We will focus on claims 1, 19, and 22, which are representative and read as follows: 1. A method for the treatment of an intervertebral disc prior to the introduction of a disc prosthesis or graft comprising the steps of: providing a fluent material including a decalcifying agent capable of reacting with the endplate of a vertebra adjacent the disc to decalcify the endplate; removing at least a portion of the nucleus pulposus of the intervertebral disc to expose at least a portion of the endplate to the disc space; and injecting the fluent treatment material into the disc space to come into contact and react with the portion of the endplate to prepare the portion of the endplate to Appeal 2009-013341 Application 10/282,666 3 accommodate a disc prosthesis or graft subsequently introduced into the disc space. 19. The method for the treatment of an intervertebral disc according to claim 1, wherein the step of injecting a fluent treatment includes restricting the fluent treatment to a substantially enclosed volume around a portion of the endplate that is less than the entire exposed endplate. 22. The method for the treatment of an intervertebral disc according to claim 21, wherein the step of injecting a fluent treatment includes restricting the fluent treatment to a substantially enclosed volume around a portion of the exposed endplate. The prior art The Examiner relies on the following prior art references to show unpatentability: Felt et al. US 5,888,220 Mar. 30, 1999 Boyer II et al. US 2002/0120347 A1 Aug. 29, 2002 Stedman’s Medical Dictionary 87, 684 (22nd ed. 1972). The Merck Index 3480 (11th ed. 1989). Baogan et al., The relationship between cartilage end-plate calcification and disc degeneration ** an experimental study, 114 CHINESE MEDICAL J. 308- 312 (2001). The issues A. The Examiner rejected claim 19 under 35 U.S.C. § 112, first paragraph as failing to comply with the written description requirement (Ans. 6-8). Appeal 2009-013341 Application 10/282,666 4 B. The Examiner rejected claims 1-8, 10, 17-19, and 21-25 under 35 U.S.C. § 103(a) as being obvious over Felt, Stedman’s Medical Dictionary, Baogan and Boyer II (Ans. 8-11). C. The Examiner rejected claims 1-8, 10, 11, 17-19, and 21-25 under 35 U.S.C. § 103(a) as being obvious over Felt, Stedman’s Medical Dictionary, Baogan, Boyer II, and Merck Index (Ans. 11-12). D. The Examiner rejected claims 1-8, 10, 11, 17-18, and 21-25 on the ground of nonstatutory obviousness type double patenting over claims 1-4 and 17-18 of U.S. Patent 7,004,945, Baogan, Boyer II, and Merck Index (Ans. 12-16). E. The Examiner provisionally rejected claims 1-8, 10, 11, 17-18, and 21-25 on the ground of nonstatutory obviousness type double patenting over claims 37-39, 45-47, 52, 53, and 92 of U.S. Patent Application 10/667,540, Baogan, Boyer II, and Merck Index (Ans. 12-16). F. The Examiner provisionally rejected claims 1-8, 10, 11, 17-18, and 21-25 on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 5, and 14 of U.S. Patent Application 11/169,405, Baogan, Boyer II, and Merck Index (Ans. 12-16). G. The Examiner provisionally1 rejected claims 1-8, 10, 11, 17-18, and 21-25 on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 6, 8, 21, 30-32, 45, and 46 of U.S. Patent Application 11/170,382, Baogan, Boyer II, and Merck Index (Ans. 12-16). 1 This rejection is no longer provisional, since U.S. Patent Application 11/170,382 has now issued as U.S. Patent 7,556,650. Appeal 2009-013341 Application 10/282,666 5 H. The Examiner provisionally rejected claims 1-8, 10, 11, 17-18, and 21-25 on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 5, and 28-30 of U.S. Patent Application 11/170,577, Baogan, Boyer II, and Merck Index (Ans. 12-16). I. The Examiner provisionally rejected claims 1-6, 10, 11, 17-18, and 21-25 on the ground of nonstatutory obviousness type double patenting over claims 21, 27, 29-32 of U.S. Patent Application 11/049,820, Baogan, Boyer II, and Merck Index (Ans. 13-16). A. 35 U.S.C. § 112, first paragraph, New Matter The Examiner finds that “claim 19 has been amended such that it currently requires fluent treatment material to be injected in a manner that results in restriction of the fluent material ‘to a substantially enclosed volume around a portion of the endplate that is less than the entire exposed endplate’” (Ans. 6). The Examiner finds that this “remains a concept that is not adequately supported by the specification as originally filed” (id.). Appellant argues that “FIG. 7 illustrates one embodiment of the invention sought to be protected by claim 19. In this embodiment, a cruciate shaped tip 30 ‘provides means for focused treatment of the endplates’” (App. Br. 11). Appellant argues that the “legs 38 of the tip 30 are described as operating as ‘a dam to contain the treatment fluid and prevent the fluid from contacting portions of the endplates that are otherwise acceptable.’” (Id.) Appellant argues that the figures and drawings show the step of restricting fluent treatment to a limited volume around a limited portion of the endplate that is less than the entirety. The rejection seeks to Appeal 2009-013341 Application 10/282,666 6 add a new limitation, namely that the restriction is limited to only parts of the endplate requiring treatment. The language of claims 1 and 19 do not include this limitation. (App. Br. 12.) In view of these conflicting positions, we frame the new matter issue before us as follows: Does the evidence of record support the Examiner’s conclusion that Claim 19 fails to comply with the written description requirement as incorporating new matter? Findings of Fact (FF) 1. Claim 19 requires that in the “treatment of an intervertebral disc,” the injected fluent treatment is restricted “to a substantially enclosed volume around a portion of an endplate that is less than the entire exposed endplate” (see Claim 19). 2. The Specification teaches that “unlike the prior embodiment, the tip 30 of FIGS. 7, 8 provides means for focused treatment of the endplates. Thus, the legs 38 serve to create an essentially sealed area between the legs and the central body 34” (Spec. 24). 3. The Specification teaches that “fluid dispersed from the openings 36 will be exposed to only a specific portion of the vertebral endplates” (id.). 4. The Specification teaches that this “approach is especially useful when it is determined that only discrete portions of the endplates are diseased or damaged to a point that requires pre-treatment” (id.). 5. Figure 7 of the Specification is reproduced below: Appeal 2009-013341 Application 10/282,666 7 “FIG. 7 is an A-P view of a disc space with a cannulated distractor, shown in cross-section . . . that provides for concentrated treatment of the vertebral endplates” (Spec. 12). 6. The Specification teaches that “the openings 36 provide a fluid path to discrete portions of the opposite endplates. Alternatively, the openings can be concentrated to one side so that the fluid treatment is applied to a portion of only one endplate” (Spec. 24). Principles of Law It is the Examiner's “initial burden [to] 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 Wertheim, 541 F.2d 257, 263 (CCPA 1976). To satisfy the written description requirement, the inventor must “convey with reasonable clarity to those skilled in the art that, as of the filing Appeal 2009-013341 Application 10/282,666 8 date sought, he or she was in possession of the invention.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). “Although [the inventor] does not have to describe exactly the subject matter claimed … the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989). Analysis The Examiner finds that the “manner in which present claim 19 has been amended broadens the scope of the claim to allow for the restriction of the fluent treatment material to any portion (i.e., understood to be any portion of the exposed endplate) of the exposed endplate” (Ans. 7). The Examiner finds that the “previously presented claim was limited to that same portion of the endplate that had been exposed and treated in independent claim 1” (id.). We do not agree with the Examiner that Claim 19 represents new matter. The amendment2 to Claim 19 to restrict the fluent treatment to a portion of the “endplate that is less than the entire” exposed endplate is fully supported by the Specification. The Specification states that that “fluid dispersed from the openings 36 will be exposed to only a specific portion of the vertebral endplates” (Spec. 24; FF 3). The Specification recognizes that this “approach is 2 The Amendment was submitted March 12, 2007. Appeal 2009-013341 Application 10/282,666 9 especially useful when it is determined that only discrete portions of the endplates are diseased or damaged to a point that requires pre-treatment” (Spec. 24; FF 4). These teachings of the Specification represent express support for treating only discrete portions of the exposed endplate which are less than the entire exposed endplate. The Specification recognizes the difference between the embodiment where the entire exposed endplate is treated and the embodiment of Figure 7, noting that “unlike the prior embodiment, the tip 30 of FIGS. 7, 8 provides means for focused treatment of the endplates. Thus, the legs 38 serve to create an essentially sealed area between the legs and the central body 34” (Spec. 24; FF 2). Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Claim 19 fails to comply with the written description requirement as incorporating new matter. B.-D, F.-I. 35 U.S.C. § 103(a) obviousness and obviousness type double patenting rejections The Examiner relies upon Felt or the claims of the cited patents and patent applications to teach disc repair surgery (see, e.g., Ans. 8). The Examiner concludes that based on the disclosure of Baogan et al, relating the negative effects of calcification on disc health, it is submitted that it would have been obvious to one of ordinary skill in the art to apply the demineralization techniques of Boyer II et al to remove or reduce the calcification of the vertebral end- Appeal 2009-013341 Application 10/282,666 10 plates, prior to introduction of an intervertebral disc prosthesis material, as in the method of Felt (Ans. 10). Appellant argues that “there is no apparent reason to combine each of these references in the manner set forth in the rejection. Applicant further contends that even if the references are combined they fail to disclose every limitation of the rejected claims” (App. Br. 13). Appellant argues that Felt “did not exhibit any concern over the condition of the vertebral endplates, and did not suggest that the condition of the endplates may have any bearing on the subsequently introduced prosthesis. The authors of the Boagan [sic] reference did not suggest any treatments for a calcified endplate” (App. Br. 19). Appellant also argues that “[i]t is unreasonable to suggest that anyone would introduce a hazardous acidic decalcifying agent into a living being. Certainly a person of ordinary skill in this art - a physician or surgeon - would never contemplate implementing the demineralization procedures disclosed in Boyer in a living patient” (App. Br. 20). In view of these conflicting positions, we frame the obviousness issues before us as follows: (i) Does the evidence of record support the Examiner’s conclusion that it would have been obvious to “inject[] the fluent treatment material into the disc space” where the fluent material includes a decalcifying agent as required by Claim 1? (ii) Does the evidence of record support the Examiner’s conclusion that it would have been obvious to “restricting the fluent treatment to a Appeal 2009-013341 Application 10/282,666 11 substantially enclosed volume around a portion of the exposed endplate” as required by Claim 22? Findings of Fact 7. Felt teaches a method “for repairing diarthroidal and amphiarthroidal joints by minimally invasive means” (Felt, col. 4, ll. 14-16). 8. Felt teaches that a “discectomy (i.e., removal of some or all of the nucleus pulposis, leaving an outer annular shell) is performed, with optional distraction and repair of the annulus, in order to remove the destroyed nucleus material while providing an intact annular shell” (Felt, col. 4, ll. 59-63). 9. Felt teaches that a “useful balloon apparatus will include the balloon itself, together with a delivery catheter . . . and fluid or gas pressure means” (Felt, col. 6, ll. 9-12). 10. Felt teaches that after distraction of the intervertebral disc space, the “desired quantity of the curable biomaterial is delivered by minimally invasive means to the prepared site” (Felt, col. 10, ll. 12-21). 11. Baogan teaches that “there exists a positive correlation between the thickness of the calcified layer of the cartilage end-plate and the degree of the cervical disc degeneration” (Baogan 311, col. 2). 12. Baogan teaches that “calcification of the cartilage end-plate is a key initiating factor of disc degeneration” (Baogan 311, col. 2). 13. Boyer teaches that: Demineralization of cortical, cancellous, and corticocancellous bone of autograft, allograft, and xenograft Appeal 2009-013341 Application 10/282,666 12 types is known. In one form, bone powder or chips are chemically processed using an acid such as hydrochloric acid, chelating agents, electrolysis or other treatments. The demineralization treatment removes the minerals contained in the natural bone, leaving collagen fibers with bone growth factors including bone morphogenic protein (BMP). (Boyer 1 ¶ 0008; emphasis added.) 14. Claim 1 of U.S. Patent 7,004,945 is reproduced below: Claim 1. A method for injecting a fluent material into a disc space comprising the steps of: creating a portal in the annulus fibrosis in communication with the intradiscal space; impacting a cannulated distractor into the portal, the distractor configured to distract the vertebrae adjacent the intradiscal space and to establish a disc space height between the adjacent vertebrae; and introducing the fluent material into the intradiscal space through a lumen of the cannulated distractor while the distractor maintains the established disc space height. (Claim 1, U.S. Patent 7,004, 945.) 15. Claim 1 of U.S. Patent Application 11/169,405 is reproduced below: Claim 1. A method for treating a herniated spinal disc between opposing vertebral bodies having a damaged outer annulus and an inner nucleus pulposus, comprising the steps of: providing a curable biomaterial that upon curing has properties that emulate the properties of a natural nucleus pulposus; providing access to the nucleus pulposus through the annulus; removing at least a portion of the nucleus pulposus to create an intradiscal space; Appeal 2009-013341 Application 10/282,666 13 applying a first distraction force on said opposing vertebral bodies from within said intradiscal space; applying a second distraction force on said opposing vertebral bodies externally of said intradiscal space; introducing said curable biomaterial through said annulus access directly into said intradiscal space, and maintaining said second distraction force until said biomaterial is substantially cured. (Claim 1, U.S. Patent Application 11/169,405, Amdt. 8/20/09.) 16. Claim 1 of U.S. Patent 7,556,650 is reproduced below: Claim 1. A method for treating a diseased or damaged intervertebral spinal disc having an inner nucleus pulposus and an outer annulus, comprising the steps of: providing access to the nucleus pulposus through the annulus; removing at least a portion of said nucleus pulposus to create an intradiscal space; determining the integrity of said annulus by sealably injecting a fluid under pressure directly into the intradiscal space; and then sealably introducing under pressure a curable biomaterial, different from said fluid under pressure, through said annulus access directly into said intradiscal space. (Claim 1, U.S. Patent 7,556,650.) 17. Claim 1 of U.S. Patent Application 11/170,577 is reproduced below: Claim 1. A method of treating a diseased or damaged spinal disc having an inner nucleus pulposus and an outer annulus, comprising the steps of: providing access to the nucleus pulposus through the annulus; removing at least a portion of said nucleus pulposus to create an intradiscal space; Appeal 2009-013341 Application 10/282,666 14 determining the size of said intradiscal space by substantially filling said intradiscal space with a fluid solution, removing said solution and measuring the volume of the removed solution; and then sealably introducing under pressure a quantity of a curable biomaterial, different from said fluid solution, through said annulus directly into said intradiscal space, said quantity based on said determining step. (Claim 1, U.S. Patent Application 11/170,577, Amdt. 9/21/09.) Principles of Law “Often, it will be necessary . . . to look to interrelated teachings of multiple [references] . . . and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). “[T]his analysis should be made explicit,” and it “can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” Id. An obviousness “analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. In assessing a claim’s obviousness, “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 417. “The combination of familiar Appeal 2009-013341 Application 10/282,666 15 elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. The degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “[A] reference may teach away from a use when that use would render the result inoperable.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1381 (Fed. Cir. 2007). Analysis Claim 1 Claim 1 is drawn to a method of treating an intervertebral disc by removal of the nucleus pulposus to expose a disc endplate and injecting a fluent material including a decalcifying agent to contact the endplate prior to introduction of a disc prosthesis or graft. The Examiner found that Felt and the claims of the cited patents and patent applications teach removal of the nucleus pulposus, exposure of an endplate, and grafting material onto the endplate, with the difference that Felt and the claims of the cited patents and patent applications do not teach the use or injection of a decalcifying agent (Ans. 8, 13). However, the Examiner found that Baogan taught that “with age, the normally Appeal 2009-013341 Application 10/282,666 16 cartilaginous vertebral end-plates undergo calcification, followed by resorption and replacement by bone. This calcification and subsequent bone formation causes a thickening of the end-plates, impeding the passage of nutrients from blood to the disc” (id. at 9). The Examiner also found that Boyer taught “[m]eans of decalcifying mineralized bone” (id.). The Examiner determined that persons of ordinary skill in the art would have had reason to apply Boyer’s technique to discs exposed during the disc surgery of Felt and the claims of the cited patents and patent applications for two reasons: (1) “to reduce calcification on the vertebral end-plates for the predictable result of restoring, or at least improving, passage of nutrients from the blood to the disc through the end-plates” (id. at 10) and (2) “demineralization of the end-plates would further expose collagen fibers in the vertebrae and expose BMPs (per teaching of Boyer II et al), both of which would enhance incorporation of the prosthesis subsequently introduced into the intervertebral space” (id. at 10). Appellant argues that “there is no apparent reason to combine each of these references in the manner set forth in the rejection. Applicant further contends that even if the references are combined they fail to disclose every limitation of the rejected claims” (App. Br. 13). Appellant argues that Felt “did not exhibit any concern over the condition of the vertebral endplates, and did not suggest that the condition of the endplates may have any bearing on the subsequently introduced prosthesis. The authors of the Boagan [sic] reference did not suggest any treatments for a calcified endplate” (App. Br. 19). Appellant argues that the “Boagan [sic] does not disclose or suggest that anything other than the known treatments is acceptable for a disc that Appeal 2009-013341 Application 10/282,666 17 has degenerated due to endplate calcification” (id. at 17). Appellant argues that “none of the art of record discloses an in situ chemical or fluent treatment of the disc endplates” (id. at 17-18). In making an obviousness determination, the Examiner is not required to identify explicit teachings in the prior art that would have led persons of ordinary skill in the art to the claimed subject matter. KSR, 550 U.S. at 418. Rather, as long as the Examiner provides a plausible reason as to why the skilled worker would have been prompted to have made the claimed invention, his burden is met. Id. In this case, although Felt and the claims of the cited patents and patent applications made no mention of the use of decalcifying agents to improve nutrient passage to the disc and to improve the incorporation of the prosthesis, the Examiner properly took “account of the inferences and creative steps that a person of ordinary skill in the art would employ,” and reasoned that the skilled worker would have found it obvious to apply Boyer’s technique of decalcifying to the disc surgery of Felt and the claims of the cited patents and patent applications (see Ans. 10). The Examiner’s determination is supported by evidence because Baogan explicitly teaches that “calcification of the cartilage end-plate is a key initiating factor of disc degeneration” (Baogan 311, col. 2; FF 12). Further, Boyer teaches means to demineralize bone for purposes of grafting (FF 13). Persons of ordinary skill in the art therefore would have reasonably extrapolated Boyer’s teaching to address the calcification concerns raised by Baogan and to improve the grafting desired by Felt and the claims of the cited patents and patent applications. Appeal 2009-013341 Application 10/282,666 18 Appellant also argues that “[i]t is unreasonable to suggest that anyone would introduce a hazardous acidic decalcifying agent into a living being. Certainly a person of ordinary skill in this art - a physician or surgeon - would never contemplate implementing the demineralization procedures disclosed in Boyer in a living patient” (App. Br. 20). However, Boyer teaches that decalcification can be performed using chelating agents (FF 13) which do not pose the hazards of hydrochloric acid. As the Examiner noted, Boyer “contemplates use of known chelating agents for demineralization of bone” (Ans. 19). Claim 22 While the Examiner withdrew the obviousness rejections over Claim 19 (see Ans. 5, 21), the Examiner did not withdraw the obviousness rejections over Claim 22, which contains the identical limitations of Claim 19, but depends from Claim 21. Appellant argues that “[n]o excerpt from the applied combination of references was cited as showing, suggesting or rendering inherent restricting the fluent treatment in the manner recited in claims 19 and 22” (App. Br. 25). The Examiner notes that “claim 19 requires that the fluent treatment be limited to a portion of the endplate ‘that is less than the entire exposed end-plate’” and that “claim 22 fails to recite such a limitation” (Ans. 21). The Examiner interprets Claim 22 to only require “restriction of the fluent treatment to a substantially enclosed volume around ‘a portion of the exposed endplate’” (Ans. 21). Appeal 2009-013341 Application 10/282,666 19 We think that Appellant has the better position. While Claim 22 is undoubtedly broader than Claim 19, Claim 22 still requires restricting the fluent treatment to a substantially enclosed volume, a limitation for which the Examiner has identified no teaching or suggestion in the prior art. Even if we accept the Examiner’s interpretation that “a portion” of the endplate encompasses the entire endplate, Claim 22 is reasonably interpreted to require that the fluid is restricted from touching the surrounding tissue, a requirement not found in Claim 21, from which Claim 22 depends. The Examiner does not identify teachings or suggestion to restrict the fluent treatment in any way whatsoever. Conclusion of Law The evidence of record supports the Examiner’s conclusion that it would have been obvious to “inject[] the fluent treatment material into the disc space” where the fluent material includes a decalcifying agent as required by Claim 1? The evidence of record does not support the Examiner’s conclusion that it would have been obvious to “restricting the fluent treatment to a substantially enclosed volume around a portion of the exposed endplate” as required by Claim 22? E. Obviousness-type double patenting rejection The Examiner provisionally rejected claims 1-8, 10, 11, 17-18, and 21-25 on the ground of nonstatutory obviousness type double patenting over claims 37-39, 45-47, 52, 53, and 92 of U.S. Patent Application 10/667,540, Appeal 2009-013341 Application 10/282,666 20 Baogan, Boyer II, and Merck Index (Ans. 12-16). This rejection is now moot, since claims 37-39, 45-47, 52, 53, and 92 of U.S. Patent Application 10/667,540 (now U.S. Patent 7,575,577) were canceled prior to issuance. SUMMARY In summary, we reverse the rejection of claim 19 under 35 U.S.C. § 112, first paragraph. We affirm the rejections of: claims 1-8, 10, 17-19, 21, and 23-25 under 35 U.S.C. § 103(a) as being obvious over Felt, Stedman’s Medical Dictionary, Baogan and Boyer II, claims 1-8, 10, 11, 17-19, 21, and 23-25 under 35 U.S.C. § 103(a) as being obvious over Felt, Stedman’s Medical Dictionary, Baogan, Boyer II, and Merck Index, claims 1-8, 10, 11, 17-18, 21, and 23-25 on the ground of nonstatutory obviousness type double patenting over claims 1-4 and 17-18 of U.S. Patent 7,004,945, Baogan, Boyer II, and Merck Index, claims 1-8, 10, 11, 17-18, 21, and 23-25 on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 5, and 14 of U.S. Patent Application 11/169,405, Baogan, Boyer II, and Merck Index, claims 1-8, 10, 11, 17-18, 21, and 23-25 on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 6, 8, 21, 30-32, 45, and 46 of U.S. Patent Application 11/170,382, Baogan, Boyer II, and Merck Index, Appeal 2009-013341 Application 10/282,666 21 claims 1-8, 10, 11, 17-18, 21, and 23-25 on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 5, and 28- 30 of U.S. Patent Application 11/170,577, Baogan, Boyer II, and Merck Index, and claims 1-6, 10, 11, 17-18, and 21, and 23-25 on the ground of nonstatutory obviousness type double patenting over claims 21, 27, 29-32 of U.S. Patent Application 11/049,820, Baogan, Boyer II, and Merck Index. We reverse the rejection of claim 22 under 35 U.S.C. § 103(a) as being obvious over Felt, Stedman’s Medical Dictionary, Baogan and Boyer II, under 35 U.S.C. § 103(a) as being obvious over Felt, Stedman’s Medical Dictionary, Baogan, Boyer II, and Merck Index, on the ground of nonstatutory obviousness type double patenting over claims 1-4 and 17-18 of U.S. Patent 7,004,945, Baogan, Boyer II, and Merck Index, on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 5, and 14 of U.S. Patent Application 11/169,405, Baogan, Boyer II, and Merck Index, on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 6, 8, 21, 30-32, 45, and 46 of U.S. Patent Application 11/170,382, Baogan, Boyer II, and Merck Index, on the ground of nonstatutory obviousness type double patenting over claims 1, 4, 5, and 28-30 of U.S. Patent Application 11/170,577, Baogan, Boyer II, and Merck Index, and Appeal 2009-013341 Application 10/282,666 22 on the ground of nonstatutory obviousness type double patenting over claims 21, 27, 29-32 of U.S. Patent Application 11/049,820, Baogan, Boyer II, and Merck Index. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006). AFFIRMED-IN-PART cdc MAGINOT, MOORE & BECK, LLP CHASE TOWER 111 MONUMENT CIRCLE SUITE 3250 INDIANAPOLIS IN 46204 Copy with citationCopy as parenthetical citation