Warren P. Williamson et al.

Patent Trials and Appeals BoardJul 23, 2019

14011809 - (D) (P.T.A.B. Jul. 23, 2019)

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. 14/011,809 08/28/2013 Warren P. Williamson IV BIOP-16US 7019 146902 7590 07/23/2019 Dorton & Willis LLP 10260 Alliance Road Suite 210 Cincinnati, OH 45242 EXAMINER BARRON, SEAN C ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 07/23/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): hliao@dortonwillis.com uspto@dortonwillis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte WARREN P. WILLIAMSON IV, RICHARD W. DAPSON, and AMIT D. SHAH1 ____________ Appeal 2018-005847 Application 14/011,809 Technology Center 1600 ____________ Before RICHARD M. LEBOVITZ, ROBERT A. POLLOCK, and DAVID COTTA, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The claims in this appeal are directed to a three dimensional, self- supporting and preformed gel block. The Examiner rejected the claims under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134, Appellants appeal the Examiner’s determination that the claims are unpatentable. We have jurisdiction for the appeal under 35 U.S.C. § 6(b). The Examiner’s rejection is reversed. A new ground of rejection pursuant to 37 C.F.R. § 41.50(b) is set forth under § 102(b). 1 The Appeal Brief (“Appeal Br.” entered Dec. 7, 2017) lists BioPath Automation, LLC, as the Real Party in Interest. Appeal Br. 1. Appeal 2018-005847 Application 14/011,809 2 STATEMENT OF THE CASE Claims 9 and 21–27 stand rejected under pre-AIA 35 U.S.C. § 103(a) as obvious in view of Williamson et al. (U.S. Pat. 7,156,814 B1, issued Jan. 2, 2007) (“Williamson”) and Vom et al. (U.S. Pat. Appl. Publ’n No. 2008/0254504 A1, published Oct. 16, 2008) (“Vom”). Ans. 4 (entered Mar. 21, 2018). Claim 9, the only independent claim on appeal, is reproduced below: 9. Apparatus comprising: a three dimensional, self-supporting and preformed gel block having a predetermined geometric shape for retention and orientation of at least one tissue sample during a histopathology process including processing, embedding and microtome slicing of the tissue sample, the gel block being sectionable by a microtome to form ribbon-like sections of the gel block and tissue sample; and a package enclosing the gel block under clean, moisture- proof conditions. CLAIM INTERPRETATION Claim 9 is directed to a “preformed gel block” of a “geometric shape” and a package enclosing the gel block. The Specification defines “gel” to mean “a dilute cross-linked system, which exhibits no flow when in the steady-state” and which is “mostly fluid” but “behave[s] like [a] solid[ ] due to a three-dimensional cross-linked network within the fluid.” Spec. ¶ 41. The claim does not require the gel block to be made of a specific material as long as it possesses the properties of a gel. The Specification discloses exemplary macromolecules from which may be formed, including “gelatin, starches such as corn starch, and agars,” “proteins such as serum, albumen, or synthetic polymers like polylysine or polyols,” and “many Appeal 2018-005847 Application 14/011,809 3 carbohydrates (e.g., various gums, or cellulose and its derivatives) . . . like corn starch.” Spec. ¶ 56. The claims do not restrict the block to a particular size or geometric shape as long as it can retain and orient a tissue “during a histopathology process.” Consistently, the Specification states that “the preformed, three dimensional gel compound may be used in the form of small blocks of any desired shape, or small sheets.” Spec. ¶ 14. See also Spec. ¶ 41. The claim recites that the “block” has a shape “for retention and orientation of at least one tissue sample during a histopathology process” and that it is “sectionable by a microtome to form ribbon-like sections of the gel block and tissue sample.” For this reason, we interpret the claim to not require that the gel block, alone, is sectioned into ribbons, but that, when embedded in a sectioning material, it can be sectioned into “ribbon-like sections.” In other words, “the gel block being sectionable by a microtome to form ribbon-like sections of the gel block and tissue sample” is an intended use of the gel block after it has been embedded during “a histopathology process.” Consistent with this interpretation, the Specification describes ribbons as being formed from gel blocks which have been embedded in a material, such as paraffin, and then sectioned with a microtome. Spec. ¶ 43. REJECTION The Examiner found that Williamson describes “a sectionable tissue sample support structure.” Final Act. 3. The Examiner cited Williamson’s disclosure of a “sectionable filter stage” and of an “embedding medium” that can be “wax, paraffin, agar or polyester resin, wherein agar and polyester Appeal 2018-005847 Application 14/011,809 4 resins are read as species of hydrogels.” Id. at 3–4. The Examiner also found that “the cassette frame onto which tissue is immobilized is made from gels.” Id. at 4. The Examiner further cited Vom for its disclosure of the claimed moisture-proof packaging. Id. at 7. The Examiner’s findings are not supported by a preponderance of the evidence. Williamson describes a “sectionable cassette” that “can be cleanly sectioned into extremely thin sections using a microtome.” Williamson 7:55–61. The cassette can be or can include a sectionable filter or filter cassette. Id. at 8:8–10, 35–36. Williamson discloses that the sectionable cassette or filter “is made from a special low density thermoplastic.” Id. at 14:61–62. An example disclosed by Williamson is of a “polyethylene homopolymer.” Id. at 15:20–21. We have reviewed the disclosures in Williamson identified by the Examiner, but find no support for the finding that the cassette “is made from gels.” Ans. 5; Final Act. 4. The Examiner did not establish that thermoplastic or polyethylene homopolymer is a “gel” as that term would be properly construed in light of the Specification (see above). The Examiner relied upon Williamson’s disclosure of embedding materials made from hydrogels as meeting the “gel” requirement of claim 9. Ans. 4–5; Final Act. 3–4. We do not agree. Williamson discloses gels, including agars, but does not describe them in block form. Williamson discloses them as a surface treatment or being sprayed on the tissue or sectionable filter. Williamson 15:30–34; 20:55–65. The Examiner did not establish that the surface or spray treatment with a gel would result in a gel block and that such gel would be made into “a package enclosing the gel block under clean, moisture-proof conditions” as required by all the rejected Appeal 2018-005847 Application 14/011,809 5 claims. The gel treatments described in Williamson are applied to the tissues prior to sectioning (id.) and therefore are not preformed blocks. Vom does not make up for this deficiency. Because the Examiner did not establish that Williamson describes a “self-supporting and preformed gel block having a predetermined geometric shape for retention and orientation of at least one tissue sample,” the rejection of independent claim 9 and dependent claims 21–27 is reversed. NEW GROUNDS OF REJECTION The following new grounds of rejection are set forth pursuant to 37 C.F.R. § 41.50(b): 1. Anticipation by “Petri Plate Production” Claim 9 is rejected under 35 U.S.C. § 102(b) (pre-AIA) as anticipated by “Petri Plate Production,” Hardy Diagnostics, published Aug. 9, 2010 (https://www.youtube.com/watch?v=s0OfmPGk294, last accessed June 18, 2019) (listed on Form PTO-892 attached to this Decision).2 Claim 9 reads on a gel block of agar that is capable of “being sectionable by a microtome to form ribbon-like sections of the gel block and tissue sample” after histopathology processing that includes an embedding step. “Petri Plate Production” describes the production of petri plates comprising media which are packaged into sealed moisture-proof packaging. “Petri Plate Production” does not expressly describe that the plates are made 2 A still capture of one frame of the video showing packaged petri plates is attached to this Decision (“Petri Plate Production Capture”) and listed on Form PTO-892. Appeal 2018-005847 Application 14/011,809 6 from agar, but, as evidenced by the comments, one of ordinary skill in the art would understand that the poured media comprises agar.3 The Specification discloses that the claimed gel can be produced from agar (Spec. ¶ 56), the same material described in “Petri Plate Production.” The agar on the petri plate is “a three dimensional, self-supporting and preformed gel block having a predetermined geometric shape” as required by claim 9. It is in the form of a sheet. The Specification specifically discloses that the block may be a sheet. Spec. ¶ 14. As to the claimed requirement that the gel block is capable of being sectioned after embedding, because the agar material from which the block in “Petri Plate Production” is made is the same material which can be used to make the block in claim 9 (see Spec. ¶ 56 discussed above), it is reasonable to believe that it would be sectionable as claimed. Once “the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (citation omitted). For these reasons, we find that “Petri Plate Production” anticipates claim 9. As to dependent claims 21–27, we leave it to the Examiner to determine whether these claims are anticipated by “Petri Plate Production” or obvious based on it, alone, or combined with additional prior art references. 3 Petri Plate Production Comments. Listed on Form PTO-892. Appeal 2018-005847 Application 14/011,809 7 2. Anticipation by “Hakuto Kanten Jelly Candy” Claim 9 is rejected under 35 U.S.C. § 102(b) (pre-AIA) as anticipated by “Japanese Snack Reviews: Hakuto Kanten Jelly Candy,” published Feb. 16, 2009 (http://japanesesnackreviews.blogspot.com/2009/02/hakuto-kanten- jelly-candy-peach.html, last accessed June 18, 2019) (listed on Form PTO- 892). Claim 9 reads on a gel block of agar that is “sectionable by a microtome to form ribbon-like sections of the gel block and tissue sample” after histopathology processing that includes an embedding step. “Hakuto Kanten Jelly Candy” describes packaged jelly candy made from agar. The Specification discloses that the claimed gel can be produced from agar (Spec. ¶ 56), the same material described in “Hakuto Kanten Jelly Candy.” As to the claimed requirement that the gel block is capable of being sectioned after embedding, because the agar material from which the block in “Hakuto Kanten Jelly Candy” is made is the same material which can be used to make the block in claim 9, it is reasonable to believe that it would be sectionable as claimed. Once “the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (citation omitted). For these reasons, we find that “Hakuto Kanten Jelly Candy” anticipates claim 9. As to dependent claims 21–27, we leave it to the Examiner to determine whether these claims are anticipated by “Hakuto Kanten Jelly Appeal 2018-005847 Application 14/011,809 8 Candy” or obvious based on it, alone, or combined with additional prior art references. TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground 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 prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under §41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the MPEP § 1214.01. Appeal 2018-005847 Application 14/011,809 9 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). See 37 C.F.R. §§ 41.50(f), 41.52(b). REVERSED; 37 C.F.R. § 41.50(b)