90008491 (P.T.A.B. Mar. 10, 2014)

Ex Parte 7034083 et al

Patent Trial and Appeal BoardMar 10, 2014

90008491 (P.T.A.B. Mar. 10, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE 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. 90/008,491 03/22/2007 7034083 KUZ-0019 6986 50571 7590 03/10/2014 THE HARRIS FIRM 922 N STREET , NW STE . 101 WASHINGTON, DC 20001 EXAMINER DIAMOND, ALAN D ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 03/10/2014 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 __________ PATENT TRIAL AND APPEAL BOARD __________ Ex parte HISAMITSU PHARMACEUTICAL CO., INC. (Inventors : TAKASHI Y. ASUKOCHI, TOSHIROYAMAGUCHI, TETSURO TATEISHI,and NARUHITO HIGO) __________ Appeal 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 Technology Center 3900 ___________ Before: RICHARD E. SCHAFER, ROMULO H. DELMENDO, and MICHAEL P. TIERNEY, Administrative Patent Judges. SCHAFER, Administrative Patent Judge. DECISION ON APPEAL This reexamination is before us to consider Patent Owner’s challenge to a Central Examination Unit (CRU) Examiner’s reliance on the Tsubota 1 reference to reject claims 1 and 3-10. Brief filed November 4, 2008, p. 18. We grant Patent Owner’s petition. I. The claimed subject matter relates to an adhesive composition comprising a polymer made of specified monomers and crosslinked with boric acid or a 1 U.S. Patent 5,049,417. Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 2 derivative of boric acid. In our original opinion (first opinion) we affirmed four rejections, all under 35 U.S.C. § 103(a): (1) Claims 1, 3, 4, 6, and 8-10 over Tsubota alone, (2) Claims 5 and 7 over the combination of Tsubota, Sakai and Coover; (3) Claims 1, 3, 4, 6, and 8-10 over the combination of Tsubota, Eckert and Biale; and (4) Claims 5 and 7 over the combination of Tsubota, Sakai, Coover, Eckert and Biale. There were two principal issues addressed in our first opinion: (1) whether the process step “substantially no water is used in production of the adhesive” distinguished the claimed adhesive from the adhesive taught by the Tsubota reference and (2) whether the Office was estopped from relying on the Tsubota reference due to the Examiner’s prior rejection using that reference during the original prosecution. Decision entered June 15, 2010, pp. 3-10. With respect to the second issue, Patent Owner argued that the Tsubota reference did not raise a substantial new question of patentability as required by 35 U.S.C. § 303(a). Brief filed November 4, 2008, pp. 18-28. That reference, according to Patent Owner, could not be used in the reexamination proceeding against the patent. Id. In our opinion issued June 15, 2010, we held that because there was no question as to the propriety of initiating the reexamination proceeding, the issue was not one of a substantial new question sufficient to initiate reexamination under § 303(a), but of the Director’s authority, as delegated to the CRU Examiner, to conduct a properly initiated reexamination proceeding pursuant to 35 U.S.C. §§ 305, 132 and 133. We therefore agreed with the CRU Examiner, that the issue was procedural and petitionable. Because the Patent Owner did not direct us to a statutory or delegated basis of jurisdiction for us to review how the Director Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 3 exercises the authority to conduct reexaminations, we held that the matter was not properly before us. Decision entered June 15, 2010, pp. 9-10. In a Federal Register Notice dated June 25, 2010, the Director delegated the authority to the Chief Administrative Patent Judge to decide certain matters related to whether a substantial new question of patentability had been raised. Clarification on the Procedure for Seeking Review of a Finding of a Substantial New Question of Patentability in Ex Parte Reexamination Proceedings, 47 Fed. Reg. 36357 (June 25, 2010). We sua sponte withdrew our decision so we could consider whether the Notice would have affected our decision. We also asked for further briefing on issues we felt would need to be decided if the Notice required us to consider the appropriateness of the use of the Tsubota reference. Decision entered June 25, 2010. Both the Patent Owner and the Examiner filed briefs. Subsequently, we issued an opinion (second opinion) that repeated our earlier holdings on petitionability and patentability. Decision entered February 22, 2011. We also held that the Notice did not delegate authority to us to review whether a particular rejection is outside the appropriate scope of a properly initiated ex parte reexamination. In our view, the Notice delegated authority only to review the initial substantial new question determination by the Examiner –a matter that was not challenged in the appeal. Id. at 9-15. The Patent Owner requested reconsideration of our second opinion. We reconsidered the decision but denied making any changes. Decision entered June 30, 2011. Patent Owner filed a petition seeking supervisory review under 37 CFR § 41.3 and further reconsideration under § 41.52(a). Petition filed July 14, 2011. Prior to a decision on the petition, Patent Owner filed a notice of Appeal to the Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 4 Court of Appeals for the Federal Circuit. Notice filed August 30, 2011. The appeal precluded a decision on Patent Owner’s petition. Subsequently, the Federal Circuit granted a joint motion for a remand to allow the Chief Judge to act on the petition. In re Hisamitsu Co., Inc. Appeal 2012-1025 (Fed. Cir. February 6, 2012). On February 6, 2013, the Acting Director issued a delegation of authority allowing the Chief Judge to make final agency decisions on arguments raised on appeal by the Patent Owner that a rejection made during ex parte reexamination did not raise a substantial new question of patentability. The delegation also authorizes the Chief Judge to redelegate that decision to a panel of APJs. Attachment to Petition Decision entered April 24, 2013. The Chief Judge has so delegated authority to this panel to determine whether a substantial new question issue was raised by the rejections. Petition Decision entered April 24, 2013, p. 6. Thus, the decision as to whether the Tsubota reference may be relied upon in this reexamination is now before us. II. Applicant argues that the Tsubota reference does not support a substantial new question of patentability ("SNQ"), which is required for each rejection during Reexamination under 35 U.S.C. § 303(a), because Tsubota: (1) is the identical art as was used before, (2) was previously used to show the same limitations already found patentable, (3) and is used now in the same way as it was used to for these same limitations that were previously examined, without being viewed in any discernible new light. Brief filed November 14, 2008, p. 18. The Examiner concludes that Tsubota raises an SNQ because that reference is being viewed in a “new light”: Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 5 Tsubota is being viewed in a new light because Patent Owner argued that Tsubota's adhesive has pores and the instant adhesive doesn't have pores. Subsequently, this same argument was relied upon by the Examiner in his reasons for allowance. However, there is nothing in the instant claims that excludes the presence of Tsubota's pores. Final Rejection entered January 14, 2008, p. 16. The sole issue before us is whether the rejection of the subject matter of claims 1, and 3-10 based upon the Tsubota reference raises a substantial new question of patentability? III. A. 1. Application 10/502,474, issued as the patent under reexamination. The claims were directed to an adhesive composition and to a patch (bandage or plaster) that included the adhesive. Preliminary Amendment, filed June 23, 2005, pp. 2-3. The adhesive required a polymer made of one or more hydroxyl groups containing acrylic or methacrylic monomers cross-linked with a boron compound. Id. In the first Office action the Examiner rejected all claims (claims 1-7) as anticipated by the Tsubota reference relied on in this reexamination. Office Action entered March 25, 2005, pp. 2-3. At that time Claim 1 read: An adhesive comprising a polymer containing one or more kinds of acrylic or methacrylic monomer unit, at least one of the kinds of monomer unit having a hydroxy group, and the polymer being crosslinked by a boron-containing compound. Preliminary Amendment filed July 23, 2004 (emphasis added). The Examiner found that Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 6 Tsubota et al. disclose an acrylic adhesive which is obtained from the copolymerization of 2-ethylhexyl acrylate, ethyl acrylate, N-vinyl-2-pyrrolidone, acrylic acid, and 2- hydroxyethyl acrylic acid. Tsubota et al. further disclose that “[f]or the adhesives having hydroxy groups such as 2- hydroxyethyl methacrylate, the following compounds are useful as crosslinking agents: . . boric acid . . . .” Tsubota et al. furthermore disclose that the acrylic adhesive is applied to make an adhesive plaster used in the medical field. It is noted that the water containing a crosslinking agent is applied onto the adhesive layer for crosslinking adhesive material. The amount of water left on the adhesive plaster would be trace, which reads on “substantially no water.” Thus, the present claims are anticipated by the disclosure of Tsubota. Office Action entered March 25, 2005, p. 3 (emphasis added). Patent Owner responded by amending Claim 1, the sole independent claim, by adding the additional statement that “substantially no water is used in production of the adhesive.” Amendment filed June 23, 2005, p. 2. The claim was also amended to clarify that at least one of the acrylic or methacrylic monomers has a hydroxyl group. Patent Owner argued that Tsubota’s “air-permeable adhesive tape” is produced by applying water drops and that water is essential in producing Tsubota’s “tape.” Amendment filed June 23, 2005, p. 5. Applicants argued that the “adhesive” and tapes of the invention contain substantially no water and are clearly different than Tsubota’s “air-permeable adhesive tapes.” Id at 5-6. The Examiner maintained the anticipation rejection making it final. Office Action entered July 14, 2005. He noted that the added limitation was a process step in a product claim and found that “[t]he final product disclosed by Tsubota . . . is substantially identical to the product of the present invention because the free water remaining in the final product of Tsubota . . . is in a trace amount.” Id. at p. 4. Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 7 Patent Owner responded under 37 CFR § 1.116 requesting entry of an additional amendment and consideration of a declaration under 37 CFR § 1.132. Paper filed October 28, 2005, p. 5. Patent Owner argued that the structural characteristics of Tsubota’s tape were different than the structural characteristics of Patent Owner’s tape. Id. at 7. Tsubota’s tape included pores to provide air permeability while Patent Owner’s adhesive did not. Id. In a declaration filed under 37 CFR § 1.132 one of the inventors testified that there were no pores in the tapes made following Examples 1 and 2 in the Patent Owner’s written description. Yasukochi Declaration submitted October 28, 2005, pp. 3-4. The Examiner allowed the claims relying principally on the declaration testimony: In view of the Declaration, the adhesive obtained in the present invention does not contain communicating pores while the adhesive disclosed by Tsubota et al. contains communicating pores. Thus, the present claims are patentably distinguished from the disclosure of Tsubota et al. Notice of Allowability entered December 27, 2005, p. 3. 2. Patent Owner requested this reexamination. With its request, Patent Owner submitted an amendment to Claim 1. Preliminary Amendment filed February 9, 2007, p. 2. 2 A Central Reexamination Unit (CRU) Examiner ordered reexamination and subsequently entered a rejection. Office Action entered October 3, 2007. That rejection did not rely on Tsubota. In response to the rejection, Patent Owner 2 The amendment was not entered because of informality. A corrected preliminary amendment was entered on May 10, 2007. Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 8 amended its claims arguing that the amendment overcame the rejection. Amendment filed November 30, 2007, 6-12. The CRU Examiner concluded that the rejection had been overcome. Office action entered January 14, 2008, pp. 2- 3. The Examiner also entered four rejections each relying on Tsubota, either alone or in combination with other references. Id. at 5-14. We affirmed those rejections on the merits in our earlier opinions. The CRU Examiner recognized that Tsubota had been previously relied on in the prior prosecution and explained why it was appropriate to rely on “old art” during reexamination. Id. at 14-16. The Examiner noted that the amendment to § 303(a) specified that a substantial new question is not precluded solely because the reference was previously cited or considered by the Office. Id. at 14-15. The Examiner concluded that a substantial new question was presented based on Tsubota. Id at 15. The Examiner noted that in the original prosecution Patent Owner argued and the Examiner determined that the patentable difference was the absence of communicating pores in the claimed adhesive. Id. at 16. The CRU Examiner concluded “there is nothing in the instant claims that excludes the presence of Tsubota's pores.” Viewing Tsubota in the “new light” of a different claim construction, the Examiner held that a substantial new question existed based on Tsubota. Id. at 16. B. Congress intended reexaminations to provide an important “quality check” on patents that would allow the government to remove defective and erroneously granted patents. H.R. Rep. No. 107-120 (2002); see also In re Recreative Techs. Corp., 83 F.3d 1394, 1396-97 (Fed. Cir. 1996) (“The reexamination statute's Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 9 purpose is to correct errors made by the government … and if need be to remove patents that never should have been granted.” (quoting Patlex Corp. v. Mossinghoff, 758 F.2d 594, 604 (Fed. Cir. 1985))). Congress, however, placed some checks on reexamination review by the Office. Most pertinent to Patent Owner’s position is the requirement that the Director must determine “whether a substantial new question of patentability affecting any claim of the patent concerned is raised by the request, with or without consideration of other patents or printed publications.” 35 U.S.C. § 303(a). The substantial new question requirement “guard[s] against simply repeating the prior examination on the same issues and arguments . . . .” Recreative, 83 F.3d at 1396- 97. The substantial new question requirement bars “reconsideration of any argument already decided by the office, whether during the original examination or an earlier reexamination.” H.R. Rep. No. 96-1307(I), at 3, 7 (1980). Prior to the amendment of § 303 in 2002, the evaluation whether a substantial new question was raised presumed that the Examiner had considered every possible patentability issue related to the references cited in the original prosecution. In re Swanson, 540 F.3d 1368, 1380; In re Portola Packaging, 110 F.3d 786, 790 (Fed. Cir. 1997). However, § 303(a) as amended, specifies that “[t]he existence of a substantial new question of patentability is not precluded by the fact that a patent or printed publication was previously cited by or to the Office or considered by the Office.” 35 U.S.C.§303(a)(2002). Section 303(a) as it now reads requires a more context- specific approach that is based on an analysis of what the PTO actually did. Swanson, id. The 2002 amendment removed the focus of the new question inquiry from whether the reference was previously considered, and returns it to whether the particular question of patentability presented by the reference in reexamination Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 10 was previously evaluated by the PTO. Thus, a “substantial new question of patentability” relates to issues that have not previously been considered by the PTO. In re NTP Inc., 654 F.3d 1268, 1275 (Fed. Cir. 2011); Swanson, 540 F.3d at 1379. C. Reviewing the original prosecution, we hold that the issue of claim construction as to the scope of the claimed subject matter relating to the presence and absence of pores was necessarily considered in the original examination. The original examiner specifically stated in the statement of reasons for allowance: In view of the Declaration, the adhesive obtained in the present invention does not contain communicating pores while the adhesive disclosed by Tsubota et al. contains communicating pores. Thus, the present claims are patentably distinguished from the disclosure of Tsubota et al. Application 10/502,474, Notice of Allowability entered December 27, 2005, p. 3. We hold that in making this determination, the original Examiner necessarily considered the issue of claim scope concluding that the claims excluded the presence of pores. While claim construction is a matter of law that is considered de novo and without deference, in our view, this principal does not supersede the limitation on revisiting a specific issue that was previously decided. On the record before us, the scope of the claims as including or excluding pores is simply not a new issue. The Tsubota reference is relied on for the same teachings as in the original prosecution. Only the determination as to the scope of the claims is different. 3 That is, a mere difference in the opinions between the CRU Examiner 3 We do not hold that a new claim construction can never be relied upon to view a reference in a new light. We hold only that based upon the record in this case, the Appeal No 2011-000986 Reexamination Control No. 90/008,491 Patent 7,034,083 11 and the original Examiner on the same question (whether the claims exclude the pores) does not raise a substantial new question within the meaning of 35 U.S.C. § 303(a). The substantial new question requirement precludes revisiting the same issue on the same facts and arguments that were overcome in the original prosecution. The substantial new question requirement “guard[s] against simply repeating the prior examination on the same issues and arguments.” Swanson, 540 F.3d at 1380 quoting Recreative, 83 F.3d at 1396-97. ORDER Patent Owner’s petition asserting that a substantial new question of patentability was not raised by the Tsubota reference is granted. Our opinions entered February 22 and June 30, 2011, are withdrawn. This reexamination is remanded to the Central Reexamination Unit for action not inconsistent with this opinion. 4 REMANDED THE HARRIS FIRM 922 N STREET, NW STE . 101 WASHINGTON DC 20001 original examiner necessarily considered the issue of whether the claimed subject matter excluded the presence of pores. 4 In its Brief filed October 12, 2010, Patent Owner requested a remand to allow amendment of its claims. Whether amendment will be permitted in this proceeding on remand is a matter within the discretion of the Central Reexamination Unit. On this point, we also note that amendment may be available in Patent Owner’s pending reissue Application 12/108,934.