Presens Precision Sensing GMBH v. University of Maryland Biotechnology Institute, Appeal 2015-006297

• Decision Date: 29 December 2015
• Docket Number: Appeal 2015-006297
• Parties: PRESENS PRECISION SENSING GMBH Requester and Respondent v. UNIVERSITY OF MARYLAND BIOTECHNOLOGY INSTITUTE Patent Owner and Appellant Reexamination Control 95/000, 615 Patent 6, 673, 532 B2 Technology Center 3900
• Court: Patent Trial and Appeal Board

PRESENS PRECISION SENSING GMBH Requester and Respondent v. UNIVERSITY OF MARYLAND BIOTECHNOLOGY INSTITUTE Patent Owner and Appellant

Reexamination Control 95/000, 615 Patent 6, 673, 532 B2 Technology Center 3900

Appeal No. 2015-006297

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

December 29, 2015

FILING DATE 01/13/2011

Before TOM R. SCHEINER, RICHARD M. LEBOVITZ, and RAE LYNN P. GUEST Administrative Patent Judges.

Opinion for the Board filed by LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on the appeal by the Patent Owner from the Patent Examiner's decision to finally reject claims 1, 3-6 9-11, 13-16, 19, and 20 in the above-identified inter partes reexamination of U.S. 6, 673, 532 B2. The Board's jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315. We affirm.

BACKGROUND

The patent in dispute in this appeal is 6, 673, 532 B2 ("the '532 patent") which was issued on January 6, 2004. The Patent Owner and Appellant is University of Maryland Biotechnology Institute ("Patent Owner") (Reel/Frame 13689-454). Appeal Brief ("Appeal Br.") 1 (dated November 18, 2014).

A request for inter partes reexamination of the '532 patent under 35 U.S.C. §§311-318 and 37 C.F.R §§ 1.902-1.997 was filed on January 13, 2011 ("Request"). The Requester is PreSens Precision Sensing GmbH ("Requester"), who is also the Respondent in this appeal. Respondent Brief ("Resp't Br.") 1 (dated December 16, 2014). Inter partes reexamination was ordered on March 16, 2011.

An oral hearing took place on November 13, 2015. A written transcript of the hearing will be entered into the records in due course.

REJECTIONS

The Examiner finally rejected of all the pending claims. Patent Owner appeals from the final rejection. The rejections are as follows:

1. Claims 1, 3-6, 9-11, 13-16, 19, and 20 stand rejected under 35 U.S.C. § 314(a) as enlarging the scope of the claims of the patent being reexamined. RAN^[1] 33.

2. Claims 1, 3-6, 9-11, 13-16, 19, and 20 stand rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA) first paragraph, as failing to comply with the written description requirement. RAN 35.

3. Claims 1, 3-6, 9-11, 13-16, 19, and 20 stand rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, because the specification, while being enabling for processes using bioreactors, does not reasonably provide enablement for using a cultivation vessel comprising a single continuous volume. RAN 39.

4. Claims 1, 3-6, 9-11, 13-16, 19, and 20 stand rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. RAN 41.

5. Claims 1, 3, and 4 stand rejected under pre-AIA 35 U.S.C. § 102(b) as anticipated by Weigl.^[2] RAN 13.

6. Claims 1, 3-6, 9-11, 13-16, 19, and 20 stand rejected under pre-AIA 35 U.S.C. § 103(a) as obvious in view of Weigl and Bambot.^[3] RAN 19.

7. Claims 1, 3, and 4 stand rejected under pre-AIA 35 U.S.C. § 103(a) as obvious in view of Weigl and European Patent Application 0333 253.^[4] RAN 27.

8. Claims 5, 6, 9-11, 13-16, 19, and 20 stand rejection under pre-AIA 35 U.S.C. 35 U.S.C. § 103(a) as obvious in view of Weigl and EP '253 as applied to claims 1, 3, and 4, further in view of Bambot. RAN 29.

We have not reached prior art rejections 7 and 8 because rejection 6, which is affirmed, covers all the pending claims.

CLAIM

Claim 1 is representative and reads as follow (underlining showing additions and brackets showing deletions relative to theoriginal claims):^[5]

1. A method of measuring at least two cultivation parameters in a cell culture, comprising:

(a) providing a cultivation vessel wherein the cultivation vessel comprises,

walls that define a single continuous volume or a non-planar surface that defines a single continuous volume, and

at least two types of optical chemical sensors positioned within the single continuous volume;

(b) placing a continuous culture medium within the single continuous volume of the cultivation vessel such that the continuous culture medium is in contact with at least one of the walls that define the single continuous volume of the cultivation vessel or the non-planar surface that defines the single continuous volume of the cultivation vessel wherein the optical chemical sensors are positioned such that they are in contact with the continuous culture medium;

[(a)] (c) establishing [at least one] a cell culture in the continuous culture medium [at least one bioreactor, wherein each bioreactor comprises at least two optical sensors];

[(b)] (d) exciting the [at least two] optical chemical sensors to generate emission and/or light absorption, wherein the optical chemical sensors are excited using at least one excitation source per optical chemical sensor;

[(c)] (e) detecting the emission and/or absorption generated by the [at least two] optical chemical sensors in [(b)] (d) by at least one detector for each type of optical chemical sensor used; and

[(d)] (f) analyzing the detected emission and/or absorption detected in [(c)] (e) to assess the at least two cultivation parameters measured.

1. SECTION 314 REJECTION

The claims were amended during reexamination to replace "bioreactor" with the term "culture vessel." In response to the amendment, the Examiner rejected the amended claims, and the claims which depend from them, under 35 U.S.C. § 314(a) (pre-AIA). Under Section 314(a), "no proposed amended or new claim enlarging the scope of the claims of the patent shall be permitted" in an inter partes reexamination proceeding. The Examiner stated that the term "cultivation vessel" is broader than "bioreactor" and thus impermissibly broadens the scope of the claims. RAN 33-34. To support the position that "bioreactor" is narrower than "cultivation vessel, " the Examiner cited the following passage from an article:

By definition, a bioreactor is a system in which a biological conversion is effected. . . . Quite similar to conventional chemical reactors, bioreactors differ in that they are specifically designed to influence metabolic pathways . . . Bioreactors differ from conventional chemical reactors in that they support and control biological entities. As such, bioreactor systems must be designed to provide a higher degree of control over process upsets and contaminations, since the organisms are more sensitive and less stable than chemicals.

Id. at 33-34.

The Examiner's reasoning is not supported by a preponderance of the evidence. While we recognize that "bioreactor" can be defined in the art to cover embodiments that "provide a higher degree of control over process upsets and contaminations, " we do not believe that this definition is necessarily controlling. First, we must look to the specification of the '532 patent to see whether it provides a definition or other enlightenment as to the meaning of "bioreactor" and "cultivation vessel."^[6]

Patentees can act as their own lexicographers if they '"clearly set forth a definition of the disputed claim term' other than its plain and ordinary meaning." Thornerv. Sony Computer Entm 't Am., LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).

In this case, the '532 patent - consistent with the evidence provided by the Examiner - refers to controlling the growth conditions of cultured cells in a bioreactor. '532 patent, col. 1, 11. 60-67. However, in addition, the patent contains the express statement that "The bioreactor is preferably a cultivation vessel." Id. at col. 8, 1. 58. The patent explains:

[The cultivation vessel] can be as large as a 1-, 3- or even 100-liter bioreactor or as small as a 100 ul well on a multi-well microtiter plate, or even as small as microchip, or anywhere in between. The size of the cultivation vessel will depend upon the experimental parameters, e.g., number of cell types, number of media, number of different conditions to test, etc. . . . For example, if the skilled artisan has twelve different sets of conditions to determine growth optimization for a particular cell line, then a 12-well plate could be employed. Other cultivation vessel possibilities include, but are not limited to, cuvettes, culture plates such as 6-well plates, 24-well plates, 48-well plates and 96-well plates, culture dishes, microchips, 1-liter or larger bioreactors, cell culture flasks, roller bottles, culture tubes, culture vials, e.g., 3, 4 or 5 ml vials, flexible bags, etc. Thus, any type of container can be used as a cultivation vessel.

Id. at col. 8, 1. 58 - col. 9, 1. 8.

Moreover, the patent teaches:

Depending upon their configuration within the well-plate, the wells on a well plate can function as microbioreactors or as receptacles, wherein a culture vessel such as a culture vial is placed in the receptacle and the culture vial becomes the bioreactor and the well plate becomes a bioreactor platform.

Id. at col. 9, 11. 9-13 (emphasis added).

In our view, these passages provide compelling evidence that a bioreactor can simply be a cultivation vessel. For example, the statement that the "culture vial becomes the bioreactor" clearly means that a bioreactor can be a vessel - such as a culture vial. This is also consistent with teachings in Bambot. See FF13 below ("In the bioprocess industry, spinner flasks, roller bottles and shaker flasks are commonly employed as bioreactors, and are currently not instrumented at all"). In other words, while a bioreactor can contain instruments to control conditions, it can also be a narrower embodiment in which it is just a container suitable for culturing cells.

The Examiner's point may be that bioreactor is narrower than a "cultivation vessel" because a...