Ex parte Sehgal et al.

Board of Patent Appeals and Interferences

Aug 18, 1999

08031563 (B.P.A.I. Aug. 18, 1999)

Application for patent filed March 15, 1993. According to appellants, is application is a1
continuation of Application 07/616,727, filed November 21, 1990, now U.S. Patent No. 5,194,590,
granted March 16, 1993, which is a continuation of Application 07/315,130, filed February 23, 1989,
now abandoned, which is a continuation of Application 06/876,689, filed June 20, 1986, now U.S.
Patent No. 4,826,811, granted May 2, 1989.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 23
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte LAKSHMAN R. SEHGAL,
RICHARD E. DE WOSKIN,
GERALD S. MOSS,
STEVEN A. GOULD,
ARTHUR L. ROSEN
and HANSA SEHGAL
_____________
Appeal No. 96-0352
Application 08/031,5631
______________
HEARD: AUGUST 2, 1999
_______________
Before KIMLIN, JOHN D. SMITH and GARRIS, Administrative Patent Judges.
JOHN D. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
Appeal No. 96-0352
Application 08/031,563
2
This is an appeal pursuant to 35 U.S.C. § 134 from the final rejection of Claim 1.
The references of record relied upon or discussed in the brief and the answer are:
Scheinberg 4,049,673 Sept. 20, 1977
Chiang et al. (Chiang) 4,485,174 Nov. 27, 1984
Jacobson et al. (Jacobson) 4,711,852 Dec. 8, 1987
Bonaventura et al. (Bonaventura) 4,761,209 Aug. 2, 1988
Saunders 4,835,097 May 30, 1989
Sehgal et al. (Sehgal patent) 5,194,590 Mar. 16, 1993
Appealed claim 1 stands rejected under 35 U.S.C. § 101 as claiming the same invention as that
defined by patented claim 1 of the Sehgal patent. Alternatively, appealed claim 1 stands rejected under
the judicially created doctrine of obviousness-type double patenting as unpatentable over patented
claim 1 of the Sehgal patent. We reverse.
Patented claim 1 of the Sehgal patent reads as follows:
1. Essentially tetramer free, cross linked, polymerized hemoglobin
wherein the hemoglobin is from human blood.
Appealed claim 1, reproduced below, includes a further limitation concerning a specific amount
of methemoglobin reductase activity:
1. Essentially tetramer free, cross linked, polymerized hemoglobin
wherein the hemoglobin is from human blood and having
methemoglobin reductase enzyme activity ranging from about 1.0 to
about 2.0 units of enzyme activity.
The examiner’s 35 U.S.C. § 101 double patenting rejection is based on the examiner’s
contention that the “enzyme function” of the appealed claim is an inherent property of the
Appeal No. 96-0352
Application 08/031,563
3
product defined by the patented claim. We find that the references of record do not support the
examiner’s contention that the claimed enzyme activity is necessarily and inevitably an inherent property
of the polymerized hemoglobin defined by the patented claim.
Hemoglobin is a complex molecule contained in red blood cells and is involved in the transport
of oxygen and carbon dioxide in the blood. The hemoglobin molecule has been described as consisting
of heme (a pigment of iron in the ferrous state) and globin (a protein formed of two alpha chains and
two beta chains having 141 and 146 amino acids respectively ). See Saunders at column 1, lines 36-
42. Oxygen combines rapidly and reversibly with hemoglobin to form oxyhemoglobin, and when the
iron of the hemoglobin molecule is oxidized to the ferric state, methemoglobin is formed. See Saunders
at column 1, lines 43-47. As acknowledged by the examiner in the answer at page 9 and as taught by
Saunders at column 1, lines 47 and 48, the enzyme, methemoglobin reductase, acts to reduce the
formed methemoglobin back to oxyhemoglobin. Scheinberg also confirms that the above reactions
take place and that methemoglobin reductase enzyme is present in red blood cells. See Scheinberg at
column 4, lines 22-31.
The examiner relies on the disclosure in the Sehgal patent at column 15, lines 53-59 as factual
support for his conclusion that the patented product inherently possesses the claimed enzyme activity.
This portion of the patent refers to a specifically exemplified polymerized hemoglobin product
produced by a complex and detailed process and indicates that the methemoglobin reductase activity in
Appeal No. 96-0352
Application 08/031,563
4
the exemplified product “was essentially unchanged by the process”, and that the “starting lysate as well
as the final product” had enzyme activities in the range now claimed. We point out that the starting
lysate used to produce this product was obtained from a preferred blood source, outdated human
blood. See Sehgal patent at column 5, lines 1-5 and column 9, lines 5-25. However, it would appear
that a polymerized hemoglobin produced from a non-preferred blood source using the Sehgal process
would not necessarily possess an enzyme activity in the range claimed.
In light of the above, it is evident that patented claim 1 of the Sehgal patent is a broad claim
directed simply to a polymerized hemoglobin which may be characterized as a polymerized protein, i.e.,
a single substance, while appealed claim 1 is directed to a two-component composition, i.e., a
polymerized hemoglobin in combination with the enzyme, methemoglobin reductase in specified
amounts (the claimed enzyme activity is observed only if the enzyme is present). Accordingly, it is
evident that patented claim 1 of the Sehgal patent could be infringed without literally infringing appealed
claim 1, for example, by a polymerized hemoglobin purified of all methemoglobin reductase or by a
polymerized hemoglobin having methemoglobin reductase in concentrations such that the enzyme
activity is outside the claimed range of appealed claim 1. Applying the infringement test set forth in In
re Vogel, 422 F.2d 438, 441, 164 USPQ 619, 622 (CCPA 1970), it is apparent that “the claims do
not define identically the same invention”. Therefore, the rejection under 35 U.S.C. § 101 is reversed.
Appeal No. 96-0352
Application 08/031,563
Consistent with the practice suggested in In re Hoch, 428 F.2d 1341, 1342, n.1, 166 USPQ2
406, 407, n. 1, (CCPA 1970), these references should have been included in the examiner’s statement
of rejection. In light of the prosecution history and our disposition of this appeal, we will not exercise
our discretion to remand this application to the examiner to modify the statement of rejection.
5
We also reverse the examiner’s alternative rejection of appealed claim 1 on the grounds of
obviousness-type double patenting. The examiner contends that methemoglobin reductase enzyme is
often added to hemoglobin to maintain its structural and functional stability , and “because of prior art
knowledge that establishes the importance of methemoglobin reductase activity in the amounts claimed,"
modifications and variations of the product defined by patented claim 1 of the Sehgal patent would have
been obvious to one of ordinary skill in the art. See the answer at page 12.
We have reviewed the five references of record which are “presented to merely make of
record prior art knowledge and what the skilled worker already knows” (answer, page 12), but we2
find no explicit disclosure of the “importance of methemoglobin reductase activity” in the range claimed
here. In this regard, we point out that Scheinberg teaches that chemical reductants which function
analogously to the enzyme “need not be stoichiometrically equivalent to or greater than the quantity of
oxygen” (emphasis added) to which a hemoglobin product used to absorb carbon monoxide would be
exposed during processing or use. See this reference at column 3, line 66 to column 4, line 41. Thus,
we agree with appellants that no reference of record suggests that a polymerized hemoglobin product
as defined by the patented claim should be prepared to have the “specific enzyme activity”, i.e., “from
about 1.0 to about 2.0 units of enzyme activity”. Thus, the rejection for obviousness-type double
Appeal No. 96-0352
Application 08/031,563
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patenting cannot be sustained.The decision of the examiner is reversed.
REVERSED
EDWARD C. KIMLIN )
Administrative Patent Judge )
)
) BOARD OF PATENT
) APPEALS AND
JOHN D. SMITH ) INTERFERENCES
Administrative Patent Judge )
)
)
)
BRADLEY R. GARRIS )
Administrative Patent Judge )
JDS/dal
Appeal No. 96-0352
Application 08/031,563
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