Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE JOSEPH H. PHILLIPS, LEWIS L. LANIER, ATHENA HUEY-JIUAN DING,
ELIZABETH EVANS, DAVID W. BUCK AND LORI RHODES
Appeal No. 92-3045
April 27, 1993
Application for Patent filed January 21, 1988, Serial No. 07/146,745. Leu 23: Monoclonal Antibody For Monitoring Leukocyte Activation.
Robert M. Hallenbeck et al. for appellants
Supervisory Patent Examiner--John Doll
Examiner--Robert D. Budens
Before Pellman, Goolkasian and W. Smith
This is an appeal from the final rejection of claims 26 and 27, all the claims remaining in the application. These claims read as follows:
26. A hybridoma deposited as ATCC HB-9627.
27. A monoclonal antibody produced by a hybridoma deposited as ATCC HB-9627.
The reference relied upon by the examiner is: Hara et al. (Hara), "Human T Cell Activation", J. Exp. Med., Vol. 164, pages 1988-2005 (Dec. 1986).
Claims 26 and 27 stand rejected under 35 U.S.C. § 102(b) as anticipated by or, alternatively, under 35 U.S.C. § 103 as unpatentable over Hara.
We have carefully considered the respective positions of appellants and the examiner and find ourselves in agreement with the position of the examiner. In view of the thorough and complete exposition of the rejection and response to appellants' arguments set forth by the examiner in the Examiner's Answer, we shall adopt the reasoning set forth in the Examiner's Answer as our own and add the following comments for emphasis.
The present invention is summarized in the opening paragraph of the specification as follows:
This invention relates to a monoclonal antibody (MAb) useful in monitoring leukocyte activation, and more particularly, relates to a monoclonal antibody that will bind Leu 23, an antigen that appears on natural killer (NK) cells, on a subset of low bouyant density (LBD) T lymphocytes rapidly after such cells are activated with Interleukin-2 (IL-2) and on certain T lymphocytes after stimulation of the T cell antigen receptor complex.
Hara discloses a hybridoma which produces a monoclonal antibody which recognizes the EA-1 antigen on activated T cells. Appellants admit on page 2 of the Appeal Brief that the Leu 23 antigen of the present invention and the EA-1 antigen of Hara have been clustered as falling in the CD-69 grouping. Based on this grouping and the similarity in the activated cells on which the respective antigens are found, the examiner has concluded that the respective antigens which are recognized by the monoclonal antibody of the present invention and Hara can reasonably be considered the same or substantially similar. From this, the examiner concluded that it is proper to shift the burden to appellants to establish through objective evidence that the respective hybridomas and monoclonal antibodies do differ in an unobvious manner, citing In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA1977) in support. We agree.
*2 Appellants argue that it is "extraordinarily unlikely" that the two hybridomas and the monoclonal antibodies produced thereby would be the same. In support of this argument, appellants note that different immunogens were used in the present invention and Hara. Appellants also rely upon Knapp [FN1] as evidence that it is possible to make different antibodies against a single antigen without ever making identical clones. Appellants also argue that their review of the available literature does not indicate that the clone EA-1 of Hara is "commercially available anywhere" and that it is "equally unlikely" that appellants could follow the method disclosed in Hara and duplicate the EA-1 clone since they do not have a comparison product.
Appellants' reliance upon Knapp, at best, indicates that there might be a difference between the claimed subject matter and the hybridoma and monoclonal antibody disclosed by Hara. However, we do not find that this in and of itself is a sufficient rebuttal of the rejections. There is no evidence of record which establishes that the respective antigens do, in fact, differ or the significance of such a difference. As set forth in Best, supra, the Patent and Trademark Office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference in the first instance between the respective products, i.e., the claims are directed to new materials, and that such a difference would have been considered unexpected by one of ordinary skill in the art, i.e. the claimed subject matter, if new, is unobvious. This is appellants' burden. Rather than speculate about possible differences, appellants should have presented factual evidence which establishes that actual, unobvious differences exist between the respective materials.
Nor are we persuaded by appellants' arguments that EA-1 is not commercially available and the unlikelihood of them duplicating the work of Hara. Appellants have not placed in this record any evidence which establishes that they communicated with the authors of the Hara reference in an attempt to obtain the relevant material described in their reference. Nor have appellants made of record any evidence setting forth attempts to duplicate the work described in the Hara reference. Attorneys' arguments in an Appeal Brief can not take the place of such evidence.
For the reasons set forth above and those in the Examiner's Answer, the decision of the examiner is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See the final rule notice, 54 F.R. 29548 (July 13, 1989), 1105 O.G. 5 (August 1, 1989).
BOARD OF PATENT APPEALS AND INTERFERENCES
John T. Goolkasian
William F. Smith
FN1. Knapp, "White Cell Differentiation Antigens", Leucocyte Typing IV, Oxford University Press, pages 331-337, (1989).