Ex parte Ramanthan et al.

Board of Patent Appeals and Interferences

Oct 31, 2000

08271539 (B.P.A.I. Oct. 31, 2000)

We note that the declaration (p. 2) has typed the "Full name of sole or first inventor" as "Lata1
Ramanthan" while the signature appears as "Lata Ramanathan."
Application for patent filed July 7, 1994. According to appellants, this application is a2
continuation of application 07/859,689 filed June 11, 1992, now abandoned, which is the United States
national application corresponding to international application no. PCT/US90/07289 filed December 18,
1990 under 35 U.S.C. § 371, now abandoned, which is a continuation-in-part of application no. 07/453,570
filed December 20, 1989, now abandoned.
Entry of the amendment filed July 29, 1996 (Paper No. 23) amending claim 11 was authorized by3
the examiner in the supplemental examiner's answer (Paper No. 24, mailed October 16, 1996, p. 1).
The opinion in support of the decision being entered today was not written for publication
and is not binding precedent of the Board.
Paper No. 28
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte LATA RAMANTHAN , GAIL F. SEELIG 1
and PAUL P. TROTTA
____________
Appeal No. 1997-0711
Application No. 08/271,5392
____________
ON BRIEF
____________
Before WINTERS, SPIEGEL, and MILLS, Administrative Patent Judges.
SPIEGEL, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner finally
rejecting claims 12 and 13 and refusing to allow claim 11 as amended subsequent to the
final rejection, which are all of the claims pending in this application.3
Appeal No. 1997-0711
Application No. 08/271,539
The examiner changed the statutory basis of the final rejection of claims 11 and 12 originally made4
under 35 U.S.C. § 102(b) to a rejection under 35 U.S.C. § 102(e) and withdrew the final rejection of claim 13
under 35 U.S.C. § 103 over Abrams and Kohler in favor of a rejection over Abrams, Kohler and Goding
(answer, p. 3).
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Claim 11 is illustrative and reads as follows:
11. A method for producing antibodies which specifically bind to and
inhibit the binding of human Interleukin-4 (IL-4) to receptors comprising
administering to an animal a sufficient quantity of a polypeptide consisting of
amino acid residues 61 to 82 of IL-4, wherein the animal produces
antibodies against the polypeptide, said antibodies being able to
specifically bind to human IL-4 and are able to inhibit the binding of human
IL-4 to cellular receptors.
The references relied on by the examiner are:
Abrams et al. (Abrams) 5,013,824 May 7, 1991
(filed Sep. 19, 1986)
K≈hler et al. (Kohler), "Continuous cultures of fused cells secreting antibody of predefined
specificity," Nature, Vol. 256, pp. 495-497 (August 7, 1975)
J. Goding, MONOCLONAL ANTIBODIES: PRINCIPLES AND PRACTICE, 2nd ed., pp.
198-199 (Academic Press, London, 1986)
ISSUES4
Claims 11 and 12 stand rejected under 35 U.S.C. § 102(e) as being anticipated by
Abrams. Claim 13 stands rejected under 35 U.S.C. § 103 as being unpatentable over
Abrams, Kohler and Goding.
We reverse both rejections.
Appeal No. 1997-0711
Application No. 08/271,539
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In reaching our decision in this appeal we have given careful consideration to the
appellants' specification and claims and to the respective positions articulated by the
appellants and the examiner. We make reference to the examiner's answer (Paper No.
20, mailed May 29, 1996) and to the examiner's supplemental answer (Paper No. 24,
mailed October 16, 1996) for the examiner's reasoning in support of the rejections and to
the appellants' brief (Paper No. 19, filed February 12, 1996) and to the appellants' reply
brief (Paper No. 21, filed July 29, 1996) for the appellants' arguments thereagainst.
THE INVENTION
Human Interleukin-4 (IL-4) is protein which enhances the growth and/or biological
activities of T and B lymphocytes, macrophages, mast cells and erythropoietin-stimulated
red blood cell progenitors, as well as increases in IgG and IgE production. Antagonists of
IL-4 may, therefore, be useful for treating allergies by decreasing mast cell growth and IgE
production. Antibodies have been used to antagonize the biological activity of IL-4. See
specification, p. 1, l. 14 - p. 2, l. 8.
The claimed invention is directed to a method of producing antibodies capable of
binding to IL-4 and of inhibiting the binding of IL-4 to cellular receptors, which method
comprises administering a polypeptide consisting of amino acid residues 61 to 82 of
IL-4 to an animal whereby the animal produces the desired antibodies (claim 11).
According to the specification,
Appeal No. 1997-0711
Application No. 08/271,539
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[p]referably, the immunogenicity of the polypeptides is increased by
combination with an adjuvant and/or by conversion to a larger form prior to
immunization (p. 11, ll. 28-30)
or
[t]he immunogenicity of the polypeptides can also be enhanced by cross-
linking or by coupling to an immunogenic carrier molecule .... Cross-linking
or conjugation to a carrier molecule may be required because small
polypeptides sometimes act as haptens (molecules which are capable of
specifically binding to an antibody but incapable of eliciting antibody
production, i.e., they are not immunogenic). Conjugation of such
polypeptides to an immunogenic carrier molecule renders the fragments
immunogenic through what is commonly known as the "carrier effect."
[P. 12, ll. 11-22.]
Production of the desired antibodies is determined using a two-part screening procedure,
i.e., (1) an ELISA analysis using the immunizing polypeptide and IL-4 as antigens and (2) a
radioligand receptor binding analysis which measures the inhibition of the specific binding
of I-IL-4 to cellular receptors (specification, p. 16, ll. 21-26).125
The specification exemplifies immunizing rabbits by intradermal administration of a
combination of polypeptide No. 7 (i.e., amino acid residues 61 to 82 of IL-4), pertussis
vaccine and Freund's complete adjuvant (p. 21) and ELISA and radioligand analyses of
the obtained antiserum (i.e., antiserum 343-6 IgG fraction) (pp. 22-24).
OPINION
All of the appealed claims require a method comprising administration of "a
polypeptide consisting of amino acid residues 61 to 82 of IL-4" (emphasis added). The
Appeal No. 1997-0711
Application No. 08/271,539
Indeed, the examiner has failed to acknowledge or address appellants' argument that the5
polypeptide of amended claim 11 was not coupled to anything (see e.g., supplemental answer, p. 1,
"Applicants' arguments [in the reply brief] in traversal of the art rejections are identical to those advanced in
the Brief.").
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transitional phrase "consisting of" excludes any elements, step, or ingredient not specified
in the claim. See In re Gray, 53 F.2d 520, 521, 11 USPQ 255, 256 (CCPA 1931) and Ex
parte Davis, 80 USPQ 448, 450 (Bd. App. 1949). Thus, while we interpret claim 11 as
being open to the administration of other ingredients in addition to the recited polypeptide,
e.g., an adjuvant, the recited polypeptide is limited to only the specified amino acid
residues. The examiner has not pointed out, and we do not find where, Abrams discloses
or suggests that antibodies can be elicited by administration of IL-4-derived polypeptides
per se. Rather, Abrams specifically discloses and exemplifies conjugating the5
polypeptide to an immunogenic carrier molecule (see e.g., c. 4, ll. 8-22; c. 8, ll. 31-33;
EXAMPLES I-VIII). Moreover, Abrams fails to disclose or suggest that the carrier
molecule can be deleted, e.g., replaced with an adjuvant to increase to the immunogenicity
of the polypeptide. Therefore, in view of the amended claim language, we agree with
appellants that claim 11 is not anticipated by Abrams because
Abrams et al. have coupled the polypeptide Lys - Phe to myoglobin, while61 82
[in] the present invention the polypeptide is not coupled to anything
(emphasis in the original, reply brief, p. 4, para. 1).
Appeal No. 1997-0711
Application No. 08/271,539
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The rejection of claims 11 and 12 under § 102(e) as anticipated by Abrams is
reversed. Since the limitation of administration of "a polypeptide consisting of amino acid
residues 61 to 82 of IL-4" is not disclosed or suggested by Kohler or Goding, the
rejection of claim 13 under § 103 is not sustainable. In re Fine, 837 F.2d 1071, 1074,
5 USPQ2d 1596, 1598 (Fed. Cir. 1988).
OTHER MATTERS
We note that the three references, BV, BW and BX, listed on PTO-1449, page 5, of
the Information Disclosure Statement filed August 6, 1992 in parent application
07/859,689, have not been either initialed or lined out by the examiner.
CONCLUSION
To summarize, the decision of the examiner to reject claims 11 and 12 under
35 U.S.C. § 102(e) as being anticipated by Abrams and to reject claim 13 under
35 U.S.C. § 103 as being unpatentable over Abrams, Kohler and Goding is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
Appeal No. 1997-0711
Application No. 08/271,539
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CAROL A. SPIEGEL ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
DEMETRA J. MILLS )
Administrative Patent Judge )
Appeal No. 1997-0711
Application No. 08/271,539
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PAUL G. LUNN
SCHERING-PLOUGH CORPORATION
ONE GIRALDA FARMS
MADISON, NJ 07940-1000
APPEAL NO. 1997-0711 - JUDGE SPIEGEL
APPLICATION NO. 08/271,539
APJ SPIEGEL
APJ MILLS
APJ WINTERS
DECISION: REVERSED
Prepared By:
DRAFT TYPED: 26 Apr 02
FINAL TYPED: