Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE EDWARD E. LUCK AND DENNIS M. BROWN
Appeal No. 92-2601
March 31, 1993
Application for Patent filed February 11, 1988, Serial No. 07/154,984. Reduction of Neurotoxic Effects of Cytotoxic Agents.
Bertram I. Rowland et al. for appellants
Supervisory Patent Examiner--Merrell C. Cashion, Jr.
Before Pellman, Winters and Meros
This appeal is from the examiner's decision refusing to allow claims 1 through 12, which are all of the claims in the application.
Claims 1 and 6 are representative:
1. A method of treating an intracranial, neoplastic lesion or surrounding tissue which comprises:
administering at the site of said lesion a proteinaceous composition capable of stable placement comprising a sufficient amount of a physiologically acceptable macro-molecular proteinaceous matrix material dispersed in an aqueous medium to form a flowable composition comprising a vinca alkaloid drug uniformly dispersed in said composition.
6. The method of Claim 1 wherein said composition additionally comprises a sufficient amount of a vasoconstrictor to constrict capillaries in the vicinity of said lesion.
The reference relied on by the examiner is:
Luck et al. (Luck) 4,619,913 Oct. 28, 1986
Goodman & Gilman's, The Pharmacological Basis of Therapeutics, page 1280 (1985).
The issue presented for review is whether the examiner correctly rejected claims 1 through 12 under 35 USC 102(b) as anticipated by or, in the alternative, under 35 USC 103 as unpatentable over Luck.
We shall sustain this rejection.
Anticipation of a claim under 35 USC 102 can be found only if the prior art reference discloses every element of the claim, and anticipation is a fact question subject to review under the clearly erroneous standard. Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1457, 221 USPQ 481, 485 (Fed.Cir.1984); In re King, 801 F.2d 1324, 1326, 231 USPQ 136, 138 (Fed.Cir.1986). In resolving the question of anticipation under 35 USC 102, we must decide whether Luck's total disclosure includes the subject matter of the appealed claims and whether Luck places that subject matter in the possession of a person having ordinary skill in the art. In re Preda, 401 F.2d 825, 159 USPQ 342 (CCPA1968). On the particular facts of this case, we answer those questions in the affirmative.
We first note that the Luck reference is not directed to a layman, but rather to a person having ordinary skill in the art. We presume that such hypothetical person is aware of relevant knowledge and information in the field of treating intracranial tumors. In this regard, we observe the following statement at page 1280 of Goodman and Gilman's The Pharmacological Basis of Therapeutics (1985), respecting the therapeutic use of vincristine:
*2 Beneficial responses have been reported in patients with a variety of other neoplasms, particularly ... brain tumors.
Based on that textbook teaching, we find that, at the time appellants' invention was made, a person having ordinary skill recognized and understood that vincristine achieves a beneficial response in patients having brain tumors. In so finding, we are mindful that appellants rely on The Pharmacological Basis of Therapeutics, page 1280, as "teaching away" from the instantly claimed invention. We are not constrained, however, from pointing to other portions of that reference in contravention of appellants' position. In re Hedges, 783 F.2d 1038, 228 USPQ 685 (Fed.Cir.1986).
Considering more fully the Luck reference, we find that Luck discloses vincristine (column 3, line 55) and a method of treating brain tumors (column 6, line 21). We are persuaded that a person having ordinary skill in the art would correlate these disclosures, i.e., for a person having ordinary skill in the art, Luck discloses a method of treating brain tumors by using the chemotherapeutic drug vincristine. In this regard, we further note that: (1) Claim 7 of Luck recites a relatively small Markush group of drugs, including vincristine, for use in a method of treating neoplastic lesions; and (2) Luck specifically contemplates treating neoplastic lesions in the brain, see column 2, line 32. Furthermore, based on a review of the Luck patent in its entirety, we find that the sine qua non of this patent is its disclosure of treating neoplastic lesions by using a chemotherapeutic drug uniformly dispersed in a proteinaceous aqueous dispersion, in the manner claimed by appellants and for the same principal advantage disclosed by appellants. The advantage is that "high levels of cytotoxic drugs can be employed at the site of interest, while the remainder of the host is not exposed to significant levels of the drug". See Luck, column 13, lines 37 through 39. For these reasons, we are of the firm conviction that Luck's total disclosure includes the subject matter of claim 1 on appeal and that Luck places that subject matter in the possession of a person having ordinary skill in the art. On the particular facts of this case, we find that Luck anticipates claim 1 within the meaning of 35 USC 102(b), or at least renders claim 1 obvious within the meaning of 35 USC 103.
We have treated claim 6 on appeal separately from claim 1, but our conclusion is the same. In view of the disclosure in Luck, column 4, lines 20 through 29, we find that claim 6 too is anticipated within the meaning of 35 USC 102(b), or at least obvious within the meaning of 35 USC 103. Based on appellants' "Grouping of the Claims" set forth in the Brief before the Board, page 3, first paragraph, claims 2 through 5 and 8 through 11 fall together with claim 1. Likewise, claims 7 and 12 fall together with claim 6.
*3 We have carefully considered the evidence presented in the "experimental" portion of appellants' specification, pages 11 through 15. According to appellants, the specification evidence "demonstrates that the neurotoxic effects of vinca alkaloids are significantly reduced by administering the drugs in a stable, flowable proteinaceous matrix". See the specification, page 15, lines 3 through 6. Appellants rely on this specification evidence to rebut any prima facie case of obviousness established by the Luck patent. In our judgment, however, that reliance is misplaced.
First, to the extent that Luck anticipates the subject matter sought to be patented in claims 1 through 12, the specification evidence is irrelevant. It is axiomatic that appellants may not patent what is old, and the method defined by claims 1 through 12 is old as evidenced by Luck.
Second, to the extent that Luck establishes the prima facie obviousness of the subject matter sought to be patented in claims 1 through 12, the specification evidence is insufficient to rebut the prima facie case. On the contrary, we believe that the evidence presented in appellants' specification confirms what a person having ordinary skill would have expected based on teachings found in Luck. Compare the advantages of the invention disclosed by Luck, column 13, lines 36 through 39 with the advantages of appellants' invention set forth in the specification, page 15, lines 3 through 6. As often stated by the CCPA, expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected beneficial results are evidence of unobviousness. In re Skoll, 523 F.2d 1392, 187 USPQ 481 (CCPA1975); In re Skoner, 517 F.2d 947, 186 USPQ 80 (CCPA1975); In re Gershon, 372 F.2d 535, 152 USPQ 602 (CCPA1967).
One further point warrants attention. In the Brief before the Board, page 4, appellants refer to "the package inserts provided with vincristine and vinblastine, which package inserts are of record". We note, however, the examiner's statement in the Answer, page 8, that "the package inserts were never received". Appellants' position to the contrary, notwithstanding, the package inserts are not of record and appellants may not properly rely on them as evidence of non-obviousness.
In conclusion, we sustain the examiner's rejection of claims 1 through 12 under 35 USC 102(b) as anticipated by or, alternatively, under 35 USC 103 as unpatentable over Luck. Accordingly, the examiner's decision refusing to allow those claims is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR 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
Irving R. Pellman
Sherman D. Winters
Edward J. Meros