Excelsior Medical Corp. V. Ivera Medical Corp.

• Decision Date: 09 May 2016
• Docket Number: Appeal 2015-003842
• Parties: EXCELSIOR MEDICAL CORPORATION Requester v. IVERA MEDICAL CORPORATION Patent Owner and Appellant Reexamination Control 95/002, 085 Patent 7, 780, 794 Cl Technology Center 3900
• Court: United States Patent and Trademark Office. United States Patent and Trademark Office, Patent Trial and Appeal Board

EXCELSIOR MEDICAL CORPORATION Requester v. IVERA MEDICAL CORPORATION Patent Owner and Appellant

Reexamination Control 95/002, 085 Patent 7, 780, 794 Cl Technology Center 3900

Appeal 2015-003842

United States Patent and Trademark Office, Patent Trial and Appeal Board

May 9, 2016

FILING DATE: 08/17/2012

Before MARKNAGUMO, JEFFREY B. ROBERTSON, and RAE LYNN P. GUEST Administrative Patent Judges.

DECISION ON APPEAL

ROBERTSON, Administrative Patent Judge.

Patent Owner Ivera Medical Corporation ("Patent Owner") appeals under 35 U.S.C. §§ 134(b) and 315(a) (pre-AIA) the Examiner's decision to reject claims 12-18 20, 21, 23, and 24.^[1] Third-Party Requester Excelsior Medical Corporation (hereinafter "Requester") urges that the Examiner's decision must be affirmed.^[2] We have jurisdiction under 35 U.S.C. §§ 134(b) and 315(a) (pre-AIA). We reverse the Examiner's decision to reject claims 12-18, 20, 21, 23, and 24.

STATEMENT OF THE CASE

Requester requested inter partes reexamination of United States Patent 7, 780, 794 CI (hereinafter the "'794 Patent") on August 17, 2012. The '794 Patent was subject to ex parte reexamination (Control 90/009 951, filed on October 3, 2011), which resulted in the patentability of original claims 1-11 and 13-24 being confirmed and the patentability of claim 12 being confirmed as a result of an amendment. (See Ex Parte Reexamination Certificate Issued under 35 U.S.C. § 307, issued on June 26, 2012.) U.S. Patent No. 7, 985, 302 CI (hereinafter the "'302 Patent"), which was filed as a continuation of the '794 Patent, was subject to ex parte reexamination (Control 90/009, 950, filed on October 3, 2011), which resulted in the patentability of original claims 1-6 and 8-17 being confirmed, the patentability of claim 7 being confirmed as a result of an amendment, and new claims 18-25 being added and determined to be patentable. (See Ex Parte Reexamination Certificate Issued under 35 U.S.C. § 307, issued on May 22, 2012.) The '302 Patent is the subject of inter partes reexamination Control No. 95/002, 086, and also on appeal to PTAB (Appeal No. 2015-004765). U.S. Patent No. 8, 206, 514 B2, which was filed as a continuation of the '302 Patent, is the subject of inter partes reexamination Control No. 95/002, 087, and also on appeal to PTAB (Appeal No. 2015-003760). (See App. Br. 1.) Decisions in Appeal No. 2015-004765 and Appeal No. 2015-003760 are being mailed concurrently herewith.

We heard oral argument from Patent Owner in the three above mentioned appeals concurrently on July 8, 2015, a transcript of which was entered into the electronic record on July 30, 2015.

We are also informed that the '794 Patent is related to or the subject of the following proceedings styled: Ivera Medical Corp. v. Excelsior Medical Corp.; Ivera Medical Corp. v. Hospira, Inc.; and Ivera Medical Corp. v. Catheter Connections, Inc. (App. Br. 1.) We have been informed that in a consolidated order dated April 29, 2014, the District Court of the Southern District of California granted Defendants' Motion for Summary Judgment of Invalidity of claims 12, 13, 15, 16, 18, 20, and 21 of the '794 Patent, claims 1-21 of the '302 Patent, and claims 1-8, 11-18, 20-25, and 27 of the '514 Patent over prior art that is at issue in the current reexamination. (App. Br., Ex. 25, at 3-4, and 15.)

We observe that the Court of Appeal for the Federal Circuit reversed the District Court's entry of summary judgment of invalidity and remanded the proceeding to the District Court. Ivera Medical Corp. v. Hospira, Inc., 801 F.3d 1336, 1346 (Fed. Cir. 2015).

The '794 Patent

The '794 Patent relates to a cleaning device, system, and method, where the cleaning device includes a cap having an inner cavity and an opening to receive a site of a medical device, the cap also including a compressible material containing a cleaning agent. (Col. 2, ll. 9-19.) The '794 Patent describes that the cap 10 includes a housing 4 having internal threads 3, the internal threads being "sized and arranged to accommodate luer threads, i.e. standardized male threads" and further describes that when the cap is kept secured to a medical implement, "the cleaning agent in cap 10 will evaporate overtime." (Col. 4, ll. 56-60 col. 6, ll. 7-10; Figs. 1-4.) In some embodiments, the cap may either be configured with a threaded ring 106 that is adapted to receive the site of a medical implement, which threaded ring may also include or create a small vent aperture or opening to allow evaporation of a cleaning agent in the cap. (Col. 6, ll. 26-43; Figs. 5-11.) The '794 Patent discloses also that in an alternative embodiment, holes 164 can be included in the cleaning device to promote evaporation of the cleaning agent. (Col. 8, ll. 11-21; Fig. 14.)

Claims 20 and 23, which are illustrative of the appealed subject matter, read as follows:

20. A cleaning device for a medical implement, the cleaning device comprising:

a cap having an opening to an inner cavity, the opening for receiving a site of the medical implement;

a threading at a periphery of the opening to the inner cavity;

a compressible cleaning material that contains a cleaning agent, the compressible cleaning material at least partially secured in the inner cavity and adapted to swab and clean the site of the medical implement with the cleaning agent;

at least one second opening proximate the opening to the inner cavity to allow evaporation of the cleaning agent from the inner cavity and to inhibit a vacuum in the cap when the opening receives the site of the medical implement; and

a removable seal attached to the cap at the opening to cover the opening and the second opening, and to maintain the compressible cleaning material and cleaning agent within the inner cavity prior to receipt of the site of the medical implement.

23. A cleaning device for a medical implement, the cleaning device comprising:

a cap having an opening to an inner cavity, the opening being sized for receiving a site of the medical implement;

a compressible cleaning material that contains a cleaning agent, the compressible cleaning material at least partially secured in the inner cavity and adapted to swab and clean the site of the medical implement with the cleaning agent;

means for venting the cleaning agent from the compressible cleaning material and the inner cavity, the means for venting being created between the cap and the site of the medical implement when the site of the medical implement is received in the opening of the cap; and

a removable seal attached to the cap at the opening to cover the opening and to maintain the compressible cleaning material and cleaning agent within the inner cavity prior to receipt of the site of the medical implement.

(App. Br. Claims App'x.)

Patent Owner contests the Examiner's decision to reject the claims as follows:

I. Claim 23 is rejected under 35 U.S.C. § 103(a) as being unpatentable over White (U.S. Patent No. 5, 242, 425, issued September 7, 1993) in view of Hoang (US 2007/0112333 A1, filed November 17, 2005, published May 17, 2007) as evidenced by the Rice Declaration (Declaration of James G. Rice, Ph.D. in Support of Inter Partes Request for Reexamination of U.S. Patent No. 7, 780, 794, executed on August 16, 2012) (Ground 1);

II. Claim 23 is rejected under 35 U.S.C. § 102(e) as being anticipated by Anderson (U.S. Patent No. 8, 167, 847 B2, issued May 1, 2012) (Ground 2);

III. Claim 23 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Anderson in view of White (Ground 4);

IV. Claim 23 is rejected under 35 U.S.C. § 102(e) as being anticipated by Hoang as evidenced by the Rice Declaration (Ground 5);

V. Claim 23 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Tennican (WO 2007/137056 A2, published November 29, 2007) in view of ISO Luer (International Standard, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. Reference number ISO 594-2: 1998(E) (International Organization for Standardization) (1998)) (Ground 7);

VI. Claims 12-18, 20, 21, 23, and 24 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Hoang in view of Buchman (U.S. Patent No. 7, 922, 701 B2, issued April 12, 2011) (Ground 8); and

VII. Claims 12, 13, 15, 16, 18, 20, 21, and 23 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Hoang in view of Chin-Loy (U.S. Patent No. 5, 954, 957, issued September 21, 1999) (Ground 9).

Claim Interpretation

"Means for venting "

Patent Owner contends that the Examiner did not properly interpret the phrase "means for venting" recited in claim 23, because the Examiner did not identify the corresponding structure in the Specification of the '794 Patent, which is required under 35 U.S.C. § 112, 6th paragraph (pre-AIA). (App. Br. 5.)

Specifically, Patent Owner takes issue with the Examiner's position that the '794 Patent describes that a corresponding structure to the "means for venting" set forth in claim 23 includes a cap having standardized luer threads. (RAN 26-27, citing column 4, lines 54-60, column 6, lines 3-10 and Figures 1-4.)

Patent Owner contends that the structure corresponding to the "venting" function recited in the claim requires "(1) an aperture or opening that is formed between the cap and a ring disposed within the cap (6:33-48), (2) holes formed in the cap (8:11-21), and (3) equivalents thereof." (App. Br. 3.) We observe that the Federal Circuit identified two embodiments in the '794 Patent corresponding to openings that permit venting of the interior of the cap: a threaded ring that can create a small vent aperture or opening relative to the inner wall of the cap (citing '794 Patent, Fig. 6 and col. 6, ll. 37-43); and holes that are formed in the...