Ex Parte Serhan et alDownload PDFBoard of Patent Appeals and InterferencesNov 23, 201010340259 (B.P.A.I. Nov. 23, 2010) 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. 10/340,259 01/10/2003 Hassan Serhan 1672-0102 6002 7590 11/23/2010 Maginot, Moore & Beck LLP Chase Tower, Suite 3250 111 Monument Circle Indianapolis, IN 46204-5109 EXAMINER STEWART, ALVIN J ART UNIT PAPER NUMBER 3774 MAIL DATE DELIVERY MODE 11/23/2010 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 HASSAN SERHAN, JAMES KURAS, CARL MCMILLIN, and MAARTEN PERSENAIRE ____________ Appeal 2009-008577 Application 10/340,259 Technology Center 3700 ____________ Before: JENNIFER D. BAHR, LINDA E. HORNER, and STEFAN STAICOVICI, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL Appeal 2009-008577 Application 10/340,259 2 STATEMENT OF THE CASE Hassan Serhan et al. (Appellants) seek our review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 21-26, 29-34, 36, and 37. We have jurisdiction under 35 U.S.C. § 6(b). SUMMARY OF DECISION We AFFIRM-IN-PART and ENTER A NEW GROUND OF REJECTION PURSUANT TO OUR AUTHORITY UNDER 37 C.F.R. § 41.50(b). INVENTION Appellants’ claimed invention relates to a spinal disc prosthesis to replace a damaged or degenerated spinal disc in a spinal column of a human. Spec. 1:3-5. Claim 21, reproduced below, is representative of the subject matter on appeal. 21. A spinal disc prosthesis, comprising: a superior plate having a superior surface that has bone ingrowth material secured thereto; and an inferior plate positioned below said superior plate, said inferior plate having an inferior surface that has bone ingrowth material secured thereto, wherein said spinal disc is configured when viewed in a plan view to define a disc perimeter, wherein said disc perimeter includes a posterior facing flat portion and a curved portion, and wherein said curved portion extends continuously from a first end of said flat portion to a second end of said flat portion, Appeal 2009-008577 Application 10/340,259 3 wherein said flat portion extends linearly for a first distance D1, wherein said spinal disc has a maximum width in the medial-lateral direction equal to a second distance D2, and wherein 0.6D2 ≥ D1 ≥ 0.3D2. REJECTIONS Appellants seek review of the following Examiner’s rejections: 1. Rejection of claims 21-26, 29-34, 36, and 37 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 2. Rejection of claims 21-26, 29-34, 36, and 37 under 35 U.S.C. § 103(a) as being unpatentable over Shinn (US 5,683,465, issued Nov. 4, 1997) and Navarro (US 5,534,030, issued Jul. 9, 1996). ISSUES The issues presented by this appeal are: 1. Does Appellants’ original disclosure convey with reasonable clarity to those skilled in the art that, as of the filing date sought, Appellants were in possession of the subject matter of independent claim 21? 2. Is the obviousness rejection of claim 21 based upon a sufficient reason with a rational underpinning to explain why a person of ordinary skill in the art would have modified Shinn’s device to include bone ingrowth material as disclosed by Navarro? Appeal 2009-008577 Application 10/340,259 4 3. Would the proposed combination of Shinn and Navarro have led a person of ordinary skill in the art to the subject matter of independent claim 21? 4. Did the Examiner find that the proposed combination discloses a superior projection extending from the superior surface of the superior plate as called for in claims 25 and 32? ANALYSIS Rejection of claims 21-26, 29-34, 36, and 37 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement For the written description rejection, Appellants argue claims 21-26, 29-34, 36, and 37 as a group. Br. 10-15. We select claim 21 as the representative claim, and claims 22-26, 29-34, 36, and 37 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii). Independent claim 21 is directed to a spinal disc prosthesis having a disc perimeter defined by a posterior facing flat portion and a curved portion, where the curved portion extends continuously from the first end of the flat portion to the second end of the flat portion. Independent claim 21 calls for the flat portion to extend linearly for a first distance D1, and the spinal disc to have a maximum width in the medial-lateral direction of a second distance D2. Independent claim 21 recites the following ratio between first distance D1 and second distance D2: 0.6D2 ≥ D1 ≥ 0.3D2. First distance D1, second distance D2, and the specified ratio between the two distances are not found in any of Appellants’ originally filed claims. Appeal 2009-008577 Application 10/340,259 5 The Examiner found that independent claim 21 does not comply with the written description requirement because the originally-filed Specification does not provide adequate written descriptive support for the limitation “0.6D2 ≥ D1 ≥ 0.3D2.” Ans. 3. The Examiner found (Ans. 3) and Appellants concede (Br. 10) that the term “0.6D2 ≥ D1 ≥ 0.3D2” does not appear in the Specification and that Appellants’ drawings are not indicated as being to scale. This does not end our inquiry. In re Smith, 481 F.2d 910, 914 (CCPA 1973) (“claimed subject matter need not be described in haec verba in the specification in order for the specification to satisfy the description requirement” (citation omitted)). The factual inquiry we apply is whether the Specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. Vas Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)). Our reviewing court has since reaffirmed this standard. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (citing with approval the standard in Vas Cath, and stating “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” (citations omitted)). Appellants’ Specification describes that the spinal disc prosthesis, viewed in plan, conforms “generally to the shape of a natural human spinal disc.” Spec. 4:1-2 (describing figure 3 as a bottom plan view of the spinal disc); 6:5-7; fig 3. Appellants’ Specification describes that perimeter 30 of Appeal 2009-008577 Application 10/340,259 6 disc 10 is defined by a flat posterior portion 32 and a curved convex portion 34 extending between opposite ends 36 and 38 of the flat posterior portion 32. Spec. 6:7-11; fig. 3; see also Br. 6. Appellants’ Specification does not explicitly describe first distance D1 or second distance D2; however, first distance D1 is depicted as extending the length of the flat posterior portion 32, and second distance D2 is depicted as corresponding to the maximum width in the medial-lateral direction of the spinal disc. Spec., passim; fig. 3.1 Beyond the description that flat posterior portion 32 and curved convex portion 34 define the perimeter of the disc 10, and that such perimeter is generally shaped like a natural human spinal disc, Appellants’ Specification does not describe any other relationship between flat posterior portion 32 and curved convex portion 34. Br. passim. More specifically, Appellants’ Specification does not describe a ratio between first distance D1 and second distance D2. Id. A person of ordinary skill in the art would understand spinal disc prosthesis 10 to have a perimeter 30 defined by a flat posterior portion 32 connected at each end to a curved convex portion 34, configured to form a shape generally like a natural human spinal disc. Further, an artisan would understand that Appellants’ Specification does not describe or depict a ratio between flat posterior portion 32 (first distance D1) and the maximum width in the medial-lateral direction (second distance D2). Given the absence of a disclosure in Appellants’ Specification regarding a ratio between first distance D1 and second distance D2, we fail to see how a person of ordinary 1 Referring to Figure 3 as amended on August 12, 2004. Appeal 2009-008577 Application 10/340,259 7 skill in the art could derive the range (i.e., 0.6D2 ≥ D1 ≥ 0.3D2) described in independent claim 21. Vas Cath Inc., 935 F.2d at 1566 (though the claimed ranges need not correspond exactly to those disclosed in the specification, the proper issue is whether one skilled in the art could derive the claimed ranges from the disclosure). We find that Appellants’ disclosure does not adequately convey with reasonable clarity to those skilled in the art that, as of the filing date sought, Appellants were in possession of a spinal disc prosthesis that includes a flat posterior portion 32 having a first distance D1, and a maximum width in the medial-lateral direction of the spinal disc having a second distance D2, configured so that 0.6D2 ≥ D1 ≥ 0.3D2. Appellants argue that Figure 3 is “accurate,” and thus may be relied upon to describe the claimed ratio between first distance D1 and second distance D2. Br. 12-14. These arguments are based on actual measurements of the figures made by Appellants. Given the lack of a description of the relationship between first distance D1 and second distance D2 in Appellants’ Specification, and given that Appellants’ drawings are not disclosed as being to scale, points conceded by Appellants (Br. 10), we are unpersuaded by these arguments. In re Wright, 569 F.2d 1124, 1127 (CCPA 1977) (“Absent any written description in the specification of quantitative values, arguments based on measurement of a drawing are of little value.”). Appellants argue that a person of ordinary skill in the art would understand Figure 3 accurately depicts the shape of disc 10 because Appellants’ Specification describes the configuration of disc 10 as Appeal 2009-008577 Application 10/340,259 8 conforming generally to the shape of a natural human spinal column. Br. 14. We agree that Appellants’ Specification describes the spinal disc prosthesis, viewed in plan, as “generally” shaped like a natural human spinal disc. Spec. 6:5-7; fig 3. However, we fail to see, and Appellants have failed to adequately articulate, how a person of ordinary skill in the art, knowing Appellants’ claimed device is broadly described as generally shaped like a natural human spinal disc, would derive the specific claimed range (i.e., 0.6D2 ≥ D1 ≥ 0.3D2). Appellants also assert a person of ordinary skill in the art would understand Figure 3 to be accurate because Figure 3 is a “plan view” of the spinal disc prosthesis and a “plan view” is commonly known as an “orthographic projection of a 3-dimensional object from the position of a horizontal plane through the object.” Br. 13. This definition of “plan view” explains that the perspective of Figure 3 is a horizontal plane through the object; however, such definition does not address the scale or accuracy of a plan view. Even if we were to accept as true Appellants’ argument (Br. 14) that Figure 3 discloses first distance D1 is 50% of the length of second distance D2, we fail to see how the disclosure of a single ratio of D1 being 50% of D2 demonstrates that Appellants invented a spinal disc prosthesis configured within the claimed range of 0.6D2 ≥ D1 ≥ 0.3D2. Consequently, we affirm the rejection of claim 21 for failing to meet the written description requirement. Claims 22-26, 29-34, 36, and 37 fall with claim 21. Appeal 2009-008577 Application 10/340,259 9 Rejection of claims 21-26, 29-34, 36, and 37 under 35 U.S.C. § 103(a) as being unpatentable over Shinn and Navarro Claims 21-24, 29-31, 36 and 37 For the obviousness rejection, Appellants present the same arguments for patentability of claims 21-24, 29-31, 36, and 37. Br. 15-20, 23-24, and 27. We select claim 21 as the representative claim, and claims 22-24, 29-31, 36, and 37 stand or fall with claim 21. See 37 C.F.R. § 41.37(c)(1)(vii). The Examiner found that Shinn discloses the subject matter of independent claim 21, except that Shinn “does not disclose a bone ingrowth material secured on the external part of the superior plate and the inferior plate and does not disclose the limitations having 0.6D2 ≥ D1 ≥ 0.3D2.” Ans. 3-4. The Examiner found that Navarro discloses superior and inferior plates having bone growth material (porous coating 66). Ans. 4. The Examiner concluded that it would have been obvious to add Navarro’s bone growth material to Shinn’s superior and inferior plates in order to promote the growth of bone tissue and provide a good attachment of the implant and avoid accidental displacement of the implant from the targeted location. Ans. 4-5. The Examiner also concluded that it would have been obvious to make the ratio of the first distance D1 to the second distance D2 within the range of 0.6D2>D1> 0.3D2 as a matter of design choice. Ans. 4, 6. We address these two modifications in turn. Regarding the addition of Navarro’s bone grown material (porous coating 66) to Shinn’s device, Appellants argue that the Examiner’s stated reason for the proposed modification of promoting the growth of bone tissue Appeal 2009-008577 Application 10/340,259 10 is not a sufficient rationale because a person of ordinary skill in the art “would not provide bone growth material on a device merely for the sake of growing bone.” Br. 16 (citing Office Action dated March 6, 2008; see also Ans. 3). We are not persuaded by this argument because it fails to address the rationale for the proposed modification provided by the Examiner, namely, to provide a good attachment of the implant and avoid accidental displacement of the implant from the targeted location. See Ans. 4-5.2 Regarding the obviousness of the claimed ratio of 0.6D2 ≥ D1 ≥ 0.3D2, Appellants argue that because the bone ingrowth material is used to interlock the claimed device with bone, the configuration (shape) of the disc is not merely design choice. Br. 19-20. The question is not whether the shape of the claimed spinal disc prosthesis has a function. The proper question is whether there is a difference in function between the claimed spinal disc prosthesis and Shinn’s artificial intervertebral disk prosthesis 10. See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function or give unexpected results) (citations omitted). Shinn’s artificial intervertebral disk prosthesis 10 includes a “D-shaped” profile having a posterior facing flat portion and a convex curved portion, and approximates the cross sectional profile of a human vertebra. Shinn, col. 3, ll. 49-63; figs 1-4 (disk 10 is comprised of first plate 16 and second plate 18, which are generally the same size). Consequently, 2 Appellants elected not to file a Reply Brief. Appeal 2009-008577 Application 10/340,259 11 Shinn’s disk 10 differs from the spinal prosthesis disc of claim 21 only in that Shinn does not explicitly disclose a ratio of first distance D1 to second distance D2. Given that Appellants have not established any criticality or unexpected results achieved by the claimed ratio of first distance D1 to second distance D2, this difference between Shinn’s disk and the claimed disk having a specific ratio fails to demonstrate the non-obviousness of independent claim 21. In re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996) (“[E]ven though applicant's modification results in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art, unless the claimed ranges ‘produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.’”). We fail to see, and Appellants have failed to articulate, how bone ingrowth material differs in function when used in conjunction with a disc generally shaped like a natural human spinal disc as called for in independent claim 21 as opposed to use in conjunction with a disc that approximates the cross sectional profile of a human vertebra, as disclosed in Shinn. We therefore sustain the rejection of independent claim 21. Claims 22-24, 29-31, 36, and 37 fall with claim 21. Claims 25, 26, and 32-34 Claim 25 depends from independent claim 21, and adds the limitation that a superior projection extends outwardly from the superior surface of the superior plate. Claim 26 depends from claim 25 and therefore also contains this limitation. Claim 32 depends from independent claim 29, and adds the Appeal 2009-008577 Application 10/340,259 12 limitation that a superior projection extends outwardly from the superior surface of the superior plate. Claims 33 and 34 depend, directly or indirectly, from claim 32 and therefore also contain this limitation. Appellants argue that the Examiner has not made a prima facia case of obviousness regarding claims 25 and 32 because the Examiner failed to find that either reference discloses a superior projection extending from the superior surface of the superior plate. Br. 21-22, 24-25. We agree that the Examiner failed to make a finding regarding this limitation, and because there is no finding of fact for us to review, we cannot sustain the rejection of claims 25 and 32. Because claims 26, 33, and 34 depend from claims 25, and 32, respectively, the rejections of claims 26, 33, and 34 suffers from the same shortcoming. NEW GROUND OF REJECTION We enter the following new ground of rejection for claims 25, 26, and 32-34. We find that Shinn discloses a superior projection (second pins 52) extending from the superior surface (second side 18b) of the superior plate (second plate 18), where second pins 52 are adapted to enter into holes in the vertebrae. Shinn, col. 9, ll. 6-10; figs. 1, 2. We further find that Shinn discloses an inferior projection (first pins 50) extending from the inferior surface (second side 16b) of the inferior plate (first plate 16), where first pins 50 are adapted to enter into holes in the vertebrae. Shinn, col. 9, ll. 1-5; figs. 1, 2. Appeal 2009-008577 Application 10/340,259 13 For the same reasons provided by the Examiner in the rejection of claims 21 and 29, we conclude that it would have been obvious to modify Shinn’s spinal disc prosthesis, which includes Shinn’s superior and inferior projections (second pins 52 and first pins 50, respectively), with the bone growth material of Navarro (Ans. 3-6), and thus reach the subject matter of claims 25, 26, 32, 33, and 343. CONCLUSIONS 1. Appellants’ original disclosure does not convey with reasonable clarity to those skilled in the art that, as of the filing date sought, Appellants were in possession of the subject matter of independent claim 21. 2. The rejection of claim 21 is based upon a sufficient reason with a rational underpinning to explain why a person of ordinary skill in the art would have modified Shinn’s device to include bone ingrowth material as disclosed by Navarro. 3. The proposed combination of Shinn and Navarro would have led a person of ordinary skill in the art to the subject matter of independent claim 21. 3 Claim 34 depends indirectly from independent claim 29, adding the limitation that the bone ingrowth material is also secured to the inferior surface of the inferior plate. This limitation was discussed in the Examiner’s rejection (Ans. 4). However, claim 34 is subject to this new ground of rejection because it depends from claim 33, which depends in turn from claim 32, and thus includes the inferior and superior projections. Appeal 2009-008577 Application 10/340,259 14 4. The Examiner did not find that the proposed combination discloses a superior projection extending from the superior surface of the superior plate as called for in claims 25 and 32. DECISION We AFFIRM the Examiner’s decision to reject claims 21-26, 29-34, 36, and 37 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. We AFFIRM the Examiner’s decision to reject claims 21-24, 29-31, 36, and 37 under 35 U.S.C. § 103(a) as unpatentable over Shinn and Navarro. We REVERSE the Examiner’s decision to reject claims 25, 26, and 32-34 under 35 U.S.C. § 103(a) as unpatentable over Shinn and Navarro. We enter a NEW GROUND OF REJECTION for claims 25, 26, and 32-34 under 35 U.S.C. § 103(a) as unpatentable over Shinn and Navarro. Regarding the affirmed rejections, 37 C.F.R. § 41.52(a)(1) provides “Appellants may file a single request for rehearing within two months from the date of the original decision of the Board.” In addition to affirming the Examiner’s rejections of one or more claims, this decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that, TO AVOID TERMINATION OF THE APPEAL AS TO THE REJECTED CLAIMS, Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE Appeal 2009-008577 Application 10/340,259 15 DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the Examiner, in which event the proceeding will be remanded to the Examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. . . . Should Appellants elect to prosecute further before the Examiner pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek review of the Patent Office’s decision under 35 U.S.C. § 141 (Appeal to the Court of Appeals for the Federal Circuit) or under 35 U.S.C. § 145 (civil action to obtain patent) with respect to the affirmed rejections, the effective date of the affirmance is deferred until conclusion of the prosecution before the Examiner unless, as a mere incident to the limited prosecution, the affirmed rejections are overcome. If Appellants elect prosecution before the Examiner and this does not result in allowance of the application, abandonment or a second appeal, this case should be returned to the Board of Patent Appeals and Interferences for final action on the affirmed rejections, including any timely request for rehearing thereof. No time period for taking any subsequent action in connection with Appeal 2009-008577 Application 10/340,259 16 this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b) nlk Maginot, Moore & Beck LLP Chase Tower, Suite 3250 111 Monument Circle Indianapolis IN 46204-5109 Copy with citationCopy as parenthetical citation