Ex Parte Halle et al

Patent Trial and Appeal BoardOct 31, 2012

12540396 (P.T.A.B. Oct. 31, 2012)

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. 12/540,396 08/13/2009 Joern-Peter Halle 3042-101RE 1222 46002 7590 10/31/2012 JOYCE VON NATZMER AGRIS & VON NATZMER LLP 200 Madison Avenue Suite 1901 New York, NY 10016 EXAMINER ANGELL, JON E ART UNIT PAPER NUMBER 1635 MAIL DATE DELIVERY MODE 10/31/2012 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte JOERN-PETER HALLE, ANDREAS GOPPELT, and PETER HOF __________ Appeal 2012-006124 Application 12/540,396 Technology Center 1600 __________ Before ERIC GRIMES, LORA M. GREEN, 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 a method of diagnosing a disorder by measuring a nucleic acid level. The Examiner rejected the claims as lacking an error correctable by reissue, for improper recapture, as indefinite, and as failing to enable the full scope of the claims. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2012-006124 Application 12/540,396 2 Statement of the Case Background “The invention relates to the use of alpha 1-antichymotrypsin (ACT) polypeptides and/or nucleic acids encoding them, or of a cell which is expressing an ACT polypeptide or a nucleic acid encoding it, for diagnosis, treatment and/or prevention [of] poorly healing diabetes-associated and/or poorly healing arterial wounds” (Spec. col. 1, ll. 17-22). The Claims Claims 1-13 are on appeal. Claims 1-4 are the original claims issued in U.S. Patent 7,255,988, for which reissue is sought in the application on appeal. Claims 5-13 were added to the reissue application. Claims 1 and 5 are representative and read as follows: 1. A method of diagnosing a disorder selected from the group consisting of poorly healing diabetes-associated wounds and poorly healing arterial wounds, in a patient, the method comprising determining, in a wound sample from the patient, the level of a nucleic acid encoding a polypeptide having the sequence of SEQ ID NO: 3, wherein a level of the nucleic acid in the wound sample from the patient that is lower than the level in a control sample indicates that said patient has the disorder. 5. A method of using nucleic acids encoding an ACT polypeptide comprising: providing a nucleic acid encoding a polypeptide having the sequence of SEQ ID NO: 3 and using said nucleic acid encoding ACT polypeptide for: diagnosis, treatment and/or prevention of poorly healing diabetes-associated and/or poorly healing arterial wounds and/or production of a pharmaceutical for treatment and/or prevention of poorly healing diabetes-associated and/or poorly healing arterial wounds. Appeal 2012-006124 Application 12/540,396 3 The issues 1 A. The Examiner rejected claims 1-13 under 35 U.S.C. § 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based (Ans. 10- 12). B. The Examiner rejected claims 5-13 under 35 U.S.C. § 112, second paragraph, as indefinite (Ans. 12). C. The Examiner rejected claims 1-13 under 35 U.S.C. § 251 for being based on a reissue declaration that does not identify an error correctable by reissue (Ans. 7-10). D. The Examiner rejected claims 5-13 under 35 U.S.C. § 112, first paragraph, as failing to reasonably provide enablement for the full scope of the instant claims (Ans. 13-16). A. Improper Recapture The Examiner finds that: the new claims are broader because there is no actual diagnostic method step (i.e., the new claims do not include determining wound levels compared to control levels) while the patented claims are limited to particular determining steps. It is noted that during prosecution of the 10/135,629 application, broad claims encompassing a method without particular method steps were rejected under 35 USC 112, first and second paragraphs (see 3/28/2005 Office Action 1 We note that whether a restriction is proper is not an appealable matter, but rather a petitionable matter. The proper redress is a petition to the Group Director of the Examiner‟s Technology Center. See Manual of Patent Examining Procedure (MPEP) § 1002.02(c). Accordingly, we shall not consider Appellants‟ arguments regarding the restriction. Appeal 2012-006124 Application 12/540,396 4 and 10/18/2005 Office Action). In response to the rejection(s), Applicant amended the claims to narrow the scope by adding specific method steps, thus giving up (i.e., surrendering) the broader subject matter. (Ans. 11-12). Appellants “submit that, in agreement with the MPEP, the reported cases involving the recapture rule consistently applied the rule only in the context of prior art rejections” (Reply Br. 5). The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s conclusion that claims 5-13 represent an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based? Findings of Fact 1. Issued Claim 1 of US 7,255,988 reads as follows: 1. A method of diagnosing a disorder selected from the group consisting of poorly healing diabetes-associated wounds and poorly healing arterial wounds, in a patient, the method comprising determining, in a wound sample from the patient, the level of a nucleic acid encoding a polypeptide having the sequence of SEQ ID NO: 3, wherein a level of the nucleic acid in the wound sample from the patient that is lower than the level in a control sample indicates that said patient has the disorder. 2. Original claim 1 of US application 10/135,629 reads as follows: A method of diagnosing a disorder selected from the group consisting of poorly healing diabetes-associated wounds, and poorly healing arterial wounds, in a patient, the method comprising determining in a sample from the patient, a level of at least one compound selected from the group consisting of an ACT polypeptide having an amino acid sequence Appeal 2012-006124 Application 12/540,396 5 according to SEQ ID No. 1 to SEQ ID No.4, and a nucleic acid coding for the polypeptide, the level of the polypeptide or the nucleic acid in the sample from the patient that differs from the level in a control sample indicating that said patient has the disorder. 3. The non-final rejection of March 28, 2005 rejected the full scope of claim 1 under 35 U.S.C. § 112, first paragraph since “the only result which can be indicative that the wound is a poor healing wound is when the level of ACT expression is less than a control (wherein the control is ACT expression in wound tissue [o]f a normal subject)” (Nonfinal Rej. 10/135,629, 3/28/2005 at 9). The non-final rejection of March 28, 2005 also rejected claim 1 under 35 U.S.C. § 112, second paragraph as indefinite “for omitting essential steps, such omission amounting to a gap between the steps” (Nonfinal Rej. 10/135,629, 3/28/2005 at 4). 4. The Amendment filed in response to the March 28, 2005 non- final rejection amended claim 1 to require “wherein a level of the nucleic acid in the wound sample from the patient that is lower than the level in a control sample indicates that said patient has the disorder” (Amendment filed Aug. 1, 2005, page 2). Appellants argued at the time that the Examiner‟s rejection under 35 U.S.C. § 112, second paragraph, should be withdrawn because “the claim requires that the nucleic acid level in the patient wound sample be compared with the nucleic acid level of a control sample and that a decreased level of nucleic acid in the patient sample is diagnostic of a poorly healing diabetes-associated or arterial wound” (id. at 8). Appeal 2012-006124 Application 12/540,396 6 Principles of Law The recapture rule “prevents a patentee from regaining through reissue the subject matter that he surrendered in an effort to obtain allowance of the original claims.” In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997). Application of the recapture rule is a three step process …. The first step is to determine whether and in what aspect the reissue claims are broader than the patent claims…. [A] reissue claim that deletes a limitation or element from the patent claims is broader with respect to the modified limitation…. Next, the court must determine whether the broader aspects of the reissue claims relate to surrendered subject matter…. To determine whether an applicant surrendered particular subject matter, we look to the prosecution history for arguments and changes to the claims made in an effort to overcome a prior art rejection…. [In] the third step of the recapture analysis … the court must determine whether the surrendered subject matter has crept into the reissue claim. In re Mostafazadeh, 643 F.3d 1353, 1358 (Fed. Cir. 2010) (internal citations and quotation marks omitted). “In discussing this third step, it is important to distinguish among the original claims (i.e., the claims before the surrender), the patented claims (i.e., the claims allowed after surrender), and the reissue claims.” Id. Thus, “recapture may be avoided under this final step of the analysis if the reissue claims „materially narrow‟ the claims relative to the original claims such that full or substantial recapture of the subject matter surrendered during prosecution is avoided.” Id. (quoting N. Am. Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 1349 (Fed. Cir. 2005). Appeal 2012-006124 Application 12/540,396 7 Analysis We begin by noting that claims 1-4, the originally issued claims of the „988 patent, are not subject to this rejection because there is no recapture of any subject matter in these claims. We agree with the Examiner that reissue claim 5 is broader than the original patent claims because reissue claim 5 lacks the “is lower than” limitation found in issued claim 1 (FF 1-2). That is, claim 5 lacks the limitation in issued claim 1 “wherein a level of the nucleic acid in the wound sample from the patient that is lower than the level in a control sample indicates that said patient has the disorder” (FF 1; emphasis added). We also agree with the Examiner that the “is lower than” limitation was added in response to rejections under 35 U.S.C. § 112, first and/or second paragraph in the non-final rejection of March 28, 2005 (FF 3-4). Lastly, we agree with the Examiner that “applicant did not materially narrow the claims in other respects” (Ans. 12). Appellants “submit that, in agreement with the MPEP, the reported cases involving the recapture rule consistently applied the rule only in the context of prior art rejections” (Reply Br. 5). We are not persuaded. In Ex parte Russo, 2007 WL 433615 (BPAI 2007), the Board (in a non-precedential opinion) addressed the argument that “recapture cannot apply apart from a prior art rejection.” Id. at *4. The Board found that: we adopt as our holding what appears to be dicta in MBO Laboratories, Inc. v. Becton, Dickinson & Company, No. 2006-1062, slip. op. at 12-13 (Fed. Cir. Jan. 24, 2007): Appeal 2012-006124 Application 12/540,396 8 The recapture rule is a limitation on the ability of patentees to broaden their patents after issuance. ….Section 251 is “remedial in nature, based on fundamental principles of equity and fairness, and should be construed liberally.” However, the remedial function of the statute is limited. Material which has been surrendered in order to obtain issuance cannot be reclaimed via Section 251: … It is critical to avoid allowing surrendered matter to creep back into the issued patent, since competitors and the public are on notice of the surrender and may have come to rely on the consequent limitations on claim scope. … The recapture rule thus serves the same policy as does the doctrine of prosecution history estoppel: both operate, albeit in different ways, to prevent a patentee from encroaching back into territory that had previously been committed to the public. (citations omitted.) As a matter of law, we conclude that a recapture rejection may be based on a lack of enablement rejection made during prosecution of the application into the patent sought to be reissued. Id. at *4-*5. We agree with Russo that the policy rationale of notice which underlies the recapture rule supports the conclusion that the prohibition on recapture should not be limited to prior art rejections, but should apply to claim amendments made to overcome enablement and indefiniteness rejections as well. Conclusion of Law The evidence of record supports the Examiner‟s conclusion that claims 5-13 represent an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. However, the Examiner‟s rejection of claims 1-4 on this Appeal 2012-006124 Application 12/540,396 9 basis is reversed. Claims 1-4 are the claims issued in the „988 patent and therefore do not attempt to recapture surrendered subject matter. B. 35 U.S.C. § 112, second paragraph The Examiner finds that “[c]laims 5-13 provide[ ] for the use of nucleic acids encoding an ACT polypeptide; however, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass” (Ans. 12). The Examiner finds that a “claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Furthermore, the „metes and bounds‟ of the elected diagnostic method are unclear since „use‟ does not proscribe [sic] the screening steps that are within the scope of the invention” (Ans. 12). Appellants contend that “the person skilled in the art would understand what is claimed, including the diagnostic uses of the nucleic acid encoding SEQ ID NO: 3, upon review of the specification.” (App. Br. 12). Appellants “submit, in view of the specific nucleic acid sequence set forth in the claims and the specific uses for which they are employed together with the common knowledge how they are employed to perform these uses and the skill in the art, that the rejected claims meet these requirements” (App. Br. 12). The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s conclusion that claims 5-13 are indefinite? Findings of Fact 5. Claim 5 has no active steps other than “providing a nucleic acid” and “using said nucleic acid”. Appeal 2012-006124 Application 12/540,396 10 Principles of Law A claim is indefinite if, when read in light of the specification, it does not reasonably apprise those skilled in the art of the scope of the invention. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003) (citations omitted). During prosecution of an application before the USPTO, the threshold standard of ambiguity for indefiniteness is lower than it might be during litigation of an issued patent. Ex parte Miyazaki, 89 USPQ2d 1207, 1212 (BPAI 2008) (precedential). “[I]f a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim . . . indefinite.” Id. at 1211. Analysis The Examiner finds that a “claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced” (Ans. 12). We agree. Claim 5 details no steps which explain how the diagnosis, treatment and/or prevention of the specified wounds would be performed by “using” a nucleic acid of SEQ ID NO: 3, nor does claim 5 detail any steps for the production of a pharmaceutical for treatment or prevention by “using” the same nucleic acid. “Providing” a nucleic acid, the only other active step recited in claim 5, does not result in any of the outcomes recited in claim 5. Without such positive steps, the ordinary artisan cannot determine which diagnosis, treatment, prevention or pharmaceutical production methods are encompassed by the claims. See Ex parte Erlich, 3 USPQ2d 1011,1017 (Bd. Pat. App. & Int. 1986) (“While … Appeal 2012-006124 Application 12/540,396 11 the claims need not recite all of the operating details, we do find that a method claim should at least recite a positive, active step(s) so that the claim will „set out and circumscribe a particular area with a reasonable degree of precision and particularity,‟ and make it clear what subject matter [the] claims encompass, as well as making clear the subject matter from which others would be precluded.”) (citations omitted.) Conclusion of Law The evidence of record supports the Examiner‟s conclusion that claims 5-13 are indefinite. C. 35 U.S.C. § 251 for lack of defect or error In the instant case, Appellants stated that the error was that “the submission of linking claims, which are broad enough to read on or link the invention elected with the invention not elected, was omitted. Although Applicant/Patentee reserves the right to present additional, different broadening claims in connection with this application, new independent claims 5 and 12 have been presented which recite a scope which is broader in certain respects than originally issued independent claim 1” (Reissue Dec. 1, Aug. 13, 2010). As discussed above, we conclude that claims 5-13 are indefinite because speculation is required to determine the meaning of the terms employed and assumptions are required as to the intended scope of the claims. Because the scope of the claims is unclear, it is also unclear whether the claims are properly interpreted as linking claims, as argued by Appellants, or whether the claims simply represent an attempt to avoid the copendency requirement of 35 U.S.C. § 120. Appeal 2012-006124 Application 12/540,396 12 We therefore do not reach the merits of the Examiner‟s rejection of claims 5-13 under 35 U.S.C. § 251 since the claims cannot be properly interpreted. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (holding that the Examiner and the Board were wrong in relying on what, at best, were speculative assumptions as to the meaning of the claims and in basing a prior-art rejection thereon). The reasoning in In re Steele is reasonably applicable to the appealed rejections under 35 U.S.C. § 251 because reaching a decision regarding this issue requires that we first determine whether the claims are properly understood as linking claims or instead as simple joinder of multiple, patentably distinct inventions. D. 35 U.S.C. § 112, first paragraph, scope of enablement As discussed above, claims 5-13 are indefinite because speculation is required to determine the meaning of the terms employed and assumptions are required as to the intended scope of the claims. Because the scope of the claims is unclear, it is also unclear what claim scope must be enabled in order to satisfy 35 U.S.C. § 112, first paragraph. We therefore do not reach the merits of the Examiner‟s rejection of claims 5-13 under 35 U.S.C. § 112, first paragraph, for lack of enablement. See In re Steele, 305 F.2d at 862 (holding that the Examiner and the Board were wrong in relying on what, at best, were speculative assumptions as to the meaning of the claims and in basing a prior-art rejection thereon). The reasoning in In re Steele is applicable to rejections under 35 U.S.C. § 112, first paragraph, for enablement because reaching decisions regarding these issues requires that we first understand the metes and bounds of the claims. Appeal 2012-006124 Application 12/540,396 13 SUMMARY In summary, we affirm the rejection of claim 5 under 35 U.S.C. § 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii), we also affirm the rejection of claims 6-13 as these claims were not argued separately. We reverse this ground of rejection as applied to originally issued claims 1-4. We affirm the rejection of claim 5 under 35 U.S.C. § 112, second paragraph, as indefinite. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii), we also affirm the rejection of claims 6-13 as these claims were not argued separately. We do not reach the rejection of claims 5-13 under 35 U.S.C. § 251, first paragraph, as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. We do not reach the rejection of claims 5-13 under 35 U.S.C. § 112, first paragraph, as failing to reasonably provide enablement for the full scope of the instant claims. 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-IN-PART alw