Ex Parte Soskey et alDownload PDFPatent Trial and Appeal BoardMar 16, 201612383058 (P.T.A.B. Mar. 16, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/383,058 03/19/2009 87840 7590 03/17/2016 David W. Highet, VP & Chief IP Counsel Becton, Dickinson & Company (Ferrells, PLLC) 1 Becton Drive, MC-110 Franklin Lakes, NJ 07417-1880 FIRST NAMED INVENTOR Paul R. Soskey 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P-8267 5406 EXAMINER BOYER, RANDY ART UNIT PAPER NUMBER 1771 MAILDATE DELIVERY MODE 03/17/2016 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 PAUL R. SOSKEY, JEROME F. PARMER, JR., HARRIS A. GOLDBERG, DOUGLAS P. KARIM, LAXMI SAMANTARA, CARRIE A. FEENEY, and MICHELE FARRELL Appeal2014-004225 Application 12/383,058 Technology Center 1700 Before JAMES C. HOUSEL, GEORGE C. BEST, and MONTE T. SQUIRE, Administrative Patent Judges. BEST, Administrative Patent Judge. DECISION ON APPEAL The Examiner finally rejected claims 1-13, 17-23, 27-29, 31-36, 42- 46, 48, 57, 80, and 81 of Application 12/383,058 under 35 U.S.C. § 102(b) as anticipated. Final Act. (May 15, 2013). The Examiner also rejected claims 14--16, 30, and 37--41 under 35 U.S.C. § 103(a) as obvious. Id. Appellants 1 seek reversal of these rejections pursuant to 35 U.S.C. § 134(a). We have jurisdiction under 35 U.S.C. § 6(b). 1 InMat Inc. is identified as the real party in interest. App. Br. 2. Appeal2014-004225 Application 12/383,058 For the reasons set forth below, we REVERSE. BACKGROUND The '058 Application describes a plastic collection container that includes a nanocomposite barrier coating that reduces the container's gas permeability. Spec. 1. The Specification states that the shelf-life of evacuated plastic tubes that contain a liquid additive, such as those used in blood collection, is limited because of the gas permeability of the plastic material used to make the tubes. Id. Appellants describe the use of a nanocomposite barrier coating to reduce the permeability of the plastic tube. Id. at 2. Claim 1, the only independent claim on appeal, is reproduced below from the Claims Appendix of the Appeal Brief: 1. An evacuated container assembly suitable for use in connection with biological sample collection comprising: (a) a container member formed of a first polymeric material and having a sidewall defining a cavity with an inner surface as well as one or more open ends; (b) a nanocomposite barrier coating disposed on a container member surface having a thickness of up to about 30 microns and being derived from an aqueous dispersion including (i) a dispersed barrier matrix polymer; and (ii) a substantially exfoliated silicate filler having an aspect ratio of more than 50; and ( c) a sealing member disposed in the opening( s) of the container member operative to hermetically seal the cavity; wherein the cavity is evacuated and maintains a pressure below atmospheric pressure and exhibits a draw volume loss lower 2 Appeal2014-004225 Application 12/383,058 than that of a like assembly without a nanocomposite barrier film by a factor of at least 1.5. App. Br. Claims App. Al. REJECTIONS On appeal, the Examiner maintains the following rejections: 1. Claims 1-13, 17-23, 27-29, 31-36, 42--46, 48, 57, 80, and 81 are rejected under 35 U.S.C. § 102(b) as anticipated by Ahem.2 Final Act. 2. 2. Claims 14--16 and 37--41 are rejected under 35 U.S.C. § 103(a) as unpatentable over Ahem. Final Act. 5. 3. Claim 30 is rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Ahem and Serpentino. 3 Final Act. 6. DISCUSSION Rejection 1. The Examiner rejected claims 1-13, 17-23, 27-29, 31- 36, 42--46, 48, 57, 80, and 81 as anticipated by Ahem. Final Act. 2. Appellants argue for the reversal of the rejection of these claims as a group. See Appeal Br. 6-13. Accordingly, we select claim 1 as representative of this group of claims. The remaining claims subject to this rejection will stand or fall with claim 1. 37 C.F.R. § 37 C.F.R. § 41.37(c)(l)(iv) (2013). To serve as an anticipatory reference, "the reference must disclose each and every element of the claimed invention, whether it does so explicitly or inherently." In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2 US 2005/0037165 Al, published February 17, 2005. 3 US 6,077,235, issued June 20, 2000. 3 Appeal2014-004225 Application 12/383,058 2009). In this case, the Examiner erred by finding that Ahem discloses every element of claim 1. The text of the Examiner's findings of fact with regard to the rejection of claim 1 is reproduced below: With respect to claim 1, Ahem discloses an evacuated container assembly (see Ahem, Fig. 1) suitable for use with biological sample collection (see Ahem, paragraph [0008]) comprising: (a) a container formed of a first polymeric material and having a sidewall defining a cavity with an inner surface as well as an open end (see Ahem, Fig. 1; and paragraphs [0024] and [0025]); (b) a nanocomposite barrier coating disposed on a container member surface having a thickness of up to about 30 microns and being derived from a barrier matrix polymer and a substantially exfoliated silicate filler having an aspect ratio of more than 50 (see Ahem, paragraph [0027]); and (c) a sealing member disposed in the openings of the container member operative to hermetically seal the cavity (see Ahem, Fig. 2). Ahem discloses wherein the cavity may be evacuated and maintain pressure below atmospheric pressure (see Ahem, paragraph [0056]). Ahern does not explicitly disclose wherein the cavity exhibits a draw volume loss lower than half of a like assembly without a nanocomposite barrier film by a factor of at least 1.5. However, such limitation does not in any way structurally distinguish the claimed apparatus from that of Ahem. The patent law is clear that claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. See MPEP § 2114. Final Act. 3. The Examiner's Answer expands upon this rejection: [Here], the claims at issue are directed to an article per se. In this regard, Examiner notes that the apparatus or article of Ahem is structurally identical to that claimed and uses the same materials of construction. To be clear, in both Ahem and the claimed article/apparatus, there is a nanocomposite barrier coating in contact with the surface of a container member. 4 Appeal2014-004225 Application 12/383,058 Thus, it would reasonably appear that an article having the same structure as that claimed and made of the same materials as that claimed would necessarily (inherently) possess the same characteristics as that claimed - namely, exhibiting a draw volume loss lower than that of a like assembly without a nanocomposite barrier film by a factor of at least 1.5. When an examiner has reason to believe that the functional language asserted to be critical for establishing novelty in claimed subject matter may in fact be an inherent characteristic of the prior art, the burden of proof is shifted to Applicant to prove that the subject matter not shown in the prior art does not possess the characteristics relied upon. See MPEP § 2112(V) (citing In re Fitzgerald, 619 F.2d 67, 70 (CCPA 1980)). Answer4. It is true that structural claims, such as claims directed to an article or apparatus, must be distinguished from the prior art in terms of structure. In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). This principle, however, is not a blanket license to disregard functional limitations or product-by-process limitations in a claim. In this case, the Examiner has relied too heavily upon this proposition of law. As always, we begin by looking to the language of the claim. During prosecution, the words used in an applicant's claim are given their "broadest reasonable meaning ... in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant's specification." In re Morris, 127 F.3d 1048, 1054--55 (Fed. Cir. 1997). In this case, claim 1 requires "a nanocomposite barrier coating disposed on a container member surface having a thickness of up to about 30 microns." The ordinary meaning of the term "coating" as it is used in Appellants' Specification and claims is "a layer of one substance covering 5 Appeal2014-004225 Application 12/383,058 another." Coat I Definition of Coat by Merriam-Webster, Merriam- Webster.com, http://www.Merriam-Webster.com/dictionary/coat. Ahem describes a blood collection to comprising a polymeric core material encapsulated within a second polymeric material. Ahem i-f 25 ("For example, FIGS. 5 and 6 show tube wall 14a having a core layer 52 surrounded by outer skin layer 54 and inner skin layer 56."). Although the Examiner does not specifically so state, the proper interpretation of the term coating requires that either the inner skin layer or the outer skin layer of Ahem's blood collection tube corresponds to the claimed "nanocomposite barrier coating." The Examiner correctly found that Ahem describes the use of nanocomposites containing small amounts of clay, including montmorillonite, in the inner and outer skin layers. Final Act. 3 (citing Ahem i-f 27). This portion of Ahem does not describe the thickness of either of the skin layers. Ahem's i-f 52-which is not cited in the anticipation rejection at hand, even though it is cited elsewhere in the Final Action- describes the skin layers in Ahem' s blood collection tube as being about 8 to about 40 mils (about 203 to about 1016 µm) thick. 4 Neither i-f 27 nor i-f 52 of Ahem describe the skin layer of the blood collection tube as having a thickness of 30 µm or less. 4 We note that Ahem states that "[t]he containers of the invention are capable of being formed in any desired size." Ahem i-f 52. In connection with the obviousness rejection of claims 14--16, the Examiner apparently interprets this teaching as a disclosure that "the container size as well as the coating thickness is variable as desired." Final Act. 6. We disagree with the Examiner's finding in this regard. The cited portion of Ahem contains no suggestion that either of the skin layers can have a thickness of 30 µm or less. 6 Appeal2014-004225 Application 12/383,058 An anticipatory reference "must disclose each and every element of the claimed invention." In re Gleave, 560 F.3d at 1334. As discussed above, the Examiner's finding that Ahem describes the use of a nanocomposite barrier coating that is 3 0 µm or less in thickness is incorrect. We, therefore, reverse the rejection of claim 1 as anticipated by Ahem. Rejections 2 and 3. The obviousness rejections of claims 14--16, 30, and 37--41 are based upon the same findings of fact and reasoning as the anticipation rejection discussed above. We, therefore, also reverse these rejections. CONCLUSION For the reasons set forth above, we reverse the rejection of claims 1- 23, 27--46, 48, 57, 80, and 81. REVERSED 7 Copy with citationCopy as parenthetical citation