Ex Parte Krieger

Board of Patent Appeals and Interferences

Mar 29, 2005

09148012 (B.P.A.I. Mar. 29, 2005)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MONTY KRIEGER
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Appeal No. 2004-1823
Application No. 09/148,012
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HEARD: December 9, 2004
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Before WILLIAM F. SMITH, SCHEINER, and GRIMES, Administrative Patent Judges.
WILLIAM F. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims
1-10, 12, 15, 16, and 20-22. Claim 19 is pending but has been withdrawn from
consideration by the examiner.
Claims 1 and 8 are representative of the subject matter on appeal and read as
follows:
1. A method for altering fertility or treating a reproductive disorder in a female
mammal in need of treatment thereof comprising
administering a compound altering lipoprotein, LDL, HDL or cholesterol levels in
the mammal in an amount effective to enhance or restore fertility or treat a reproductive
disorder in the mammal.
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Application No. 09/148,012
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8. The method of claim 1 wherein the mammal is a female and the compound is
administered in an amount effective to prevent normal reproductive function.
The examiner does not rely upon prior art in any of the pending rejections.
Claims 1-10, 12, 15, 16, and 20-22 stand rejected under 35 U.S.C. § 112, first
paragraph (written description). Claims 1-10, 15, 16, and 20-22 stand rejected under 35
U.S.C. § 112, first paragraph (enablement). Claims 1-10, 12, 15, 16, and 20-22 stand
rejected under 35 U.S.C. § 112, second paragraph. We vacate the examiner’s written
description and enablement rejections and reverse the indefiniteness rejection. In
addition, we make a new ground of rejection under the provisions of 37 CFR §41.50(b).
Background
SR-BI receptor is expressed principally in steroidogenic tissues and liver.
Specification, page 6. The SR-BI is stated to mediate HDL-transfer and uptake of
cholesterol. Id. Appellant states that “SR-BI might play a major role in transfer of
cholesterol from peripheral tissues, via HDL, into the liver and steroidogenic tissues,
and that increased or decreased expression in the liver or other tissues may be useful in
regulating uptake of cholesterol by cells expressing SR-BI . . . .” Id. The present
invention is summarized as follows:
SR-BI is present at relatively high levels on the membranes of
hepatocytes and steroidogenic tissues, including the adrenal gland, testes,
and ovaries, where it mediates the uptake and transport of cholesteryl
ester from high density lipoproteins. It has been demonstrated that
transgenic animals which do not produce SR-BI are healthy, with the
exception that the females are infertile. This provides evidence that
inhibition of uptake, binding or transport of cholesteryl ester to SR-BI can
be used to inhibit pregnancy. The same pathway can also be used to
decrease production of steroids, and therefore be used as a therapy for
disorders involving steroidal overproduction and disorders treated with
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Application No. 09/148,012
Page 3
drugs that decrease steroids, such as endometriosis, and breast and
prostate cancer.
Id., page 7, second paragraph.
Appellant also states that “SR-BI has now been confirmed as the principal
mediator of cholesteryl ester transport from peripheral tissues to the liver and other
steroidogenic tissues, including the adrenal gland, testes and ovaries.” id., page 10,
and “[i]nhibition of SR-BI can . . . be used to limit steroid production in steroidogenic
tissues, and serve either as a means of contraception or a means of treating disorders
associated with overproduction of steroids.” Id., page 11.
Of particular interest in this appeal are the data set forth in Example 6 which
show that deletion of SR-BI can be effective as a contraceptive. Example 6 describes
the generation of mice containing a targeted null mutation in the gene encoding SR-BI.
Specification, page 45. The mutants generated in Example 6 are stated to have “looked
normal (weight, general appearance and behavior) and the males were fertile. No
offspring from female homozygous mutants have been obtained following multiple
attempts to do so, indicating a substantial, and possibly complete, decrease in fertility in
these females.” Id., page 49. Example 7 refers to several studies conducted to
determine why the female homozygous knockout mice were infertile.
A reading of the entire specification indicates that SR-BI plays a role in
transporting cholesterol to steroidogenic tissues and the liver. One effect from inhibiting
SR-BI activity is to lower fertility in females. Thus, inhibition of SR-BI in females is
stated to be useful as a contraceptive and indeed in Example 6 homozygous female
mice having no SR-BI activity were found to be infertile. Notably missing from the
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specification, however, is any statement that altering SR-BI levels may “enhance or
restore fertility or treat a reproductive disorder” in a female mammal. Nor is there any
statement in regard to enhancing or restoring fertility or treating a reproductive disorder
in a female mammal by broadly administering a compound altering lipoprotein, LDL,
HDL or cholesterol levels as required by claim 1 on appeal.
Discussion
We have considered the examiner’s written description and enablement
rejections but find that they are subsumed by a bigger issue involving written
description. Consequently, we make the following new ground of rejection under the
provisions of 37 CFR § 41.50(b) and will subsequently discuss the examiner’s
rejections.
1. New Ground of Rejection Under 37 CFR § 41.50(b).
Claims 1-10, 12, 15, 16, and 20-22 are rejected under 35 U.S.C. § 112, first
paragraph (written description).
In order to put the written description issue we have discovered in perspective we
will trace the evolution of claim 1 from how it read when the case was originally filed to
its present amended form.
Original claim 1 read as follows:
A method for modifying steroid production in a mammal comprising administering
a compound altering the transfer of cholesterol or cholesteryl ester from high density
lipoprotein or other lipoproteins via SR-BI to liver or steroidogenic tissues.
As seen, original claim 1 comported with the written description of this application
in regard to modifying steroid production in a mammal by administering a compound
altering the transfer of cholesterol or cholesteryl ester from high density lipoprotein or
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Application No. 09/148,012
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other lipoproteins via SR-BI to liver and steroidogenic tissues. Claim 1 was amended in
a paper received June 26, 2000, to read as follows:
A method for modifying steroid production in a mammal in need of treatment by
alteration of reproductive hormone levels comprising administering a compound altering
the transfer of cholesterol or cholesteryl ester from high density lipoprotein or other
lipoproteins [via] by specifically altering expression of or binding to cholesterol or
cholesteryl ester of SR-BI to [liver or] steroidogenic tissues producing reproductive
hormones.
Claim 1 was subsequently amended in a paper received January 5, 2001, to read
as follows:
A method for modifying steroid production in a mammal in need of treatment by
alteration of reproductive hormone levels comprising administering a compound directly
inhibiting SR-BI or a compound selectively increasing expression of SR-BI thereby
[compound] altering the transfer of cholesterol or cholesteryl ester from high density
lipoprotein or other lipoproteins by specifically altering expression of or binding to
cholesterol or cholesteryl ester of SR-BI to steroidogenic tissues producing reproductive
hormones.
Thereafter claim 1 was amended in a paper received July 17, 2001, to read as
follows:
A method for modifying steroid production in a mammal in need of treatment by
alteration of reproductive hormone levels comprising administering a compound directly
inhibiting SR-BI function or expression or a compound selectively increasing expression
of SR-BI thereby directly resulting in the selective alteration of cholesterol or cholesteryl
ester from high density lipoprotein or other lipoproteins by specifically altering
expression of or binding to cholesterol or cholesteryl ester of SR-BI to steroidogenic
tissues producing reproductive hormones, wherein the compound is selected from the
group consisting of SR-BI cDNA, SR-BI anti-sense nucleic acids,
SR-BI antibodies, and SR-BI receptor binding small molecules or proteins.
Up to this point in time, claim 1 was directed to methods for modifying steroid
production by administering compounds that affected SR-BI function. However, claim 1
was amended in a paper received February 21, 2002, to read as follows:
A method for altering fertility or treating a reproductive disorder in a mammal
comprising
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administering a compound altering lipoprotein, LDL, HDL or cholesterol levels in
the mammal.
Thus, in the blink of an eye, claim 1 became a new claim directed to a method for
altering fertility or treating a reproductive disorder in a mammal which broadly comprises
administering a compound altering lipoprotein, LDL, HDL or cholesterol levels in the
mammal that does not require affecting SR-BI function, instead of directed to methods
for modifying steroid production by altering expression of or binding to cholesterol or
cholesteryl ester of SR-BI.
Claim 1 was subsequently amended three more times on August 13, 2002,
November 20, 2002, and May 6, 2003, as follows:
A method for altering fertility or treating a reproductive disorder in a female
mammal in need of treatment thereof comprising
administering a compound altering lipoprotein, LDL, HDL or cholesterol levels in
the mammal in an amount effective to alter fertility or treat a reproductive disorder in the
mammal. [August 13, 2002]
A method for altering fertility or treating a reproductive disorder in a female
mammal in need of treatment thereof comprising
administering a compound altering lipoprotein, LDL, HDL or cholesterol levels in
the mammal in an amount effective to alter fertility or treat a reproductive disorder in the
mammal. [November 20, 2002]
A method for altering fertility or treating a reproductive disorder in a female
mammal in need of treatment thereof comprising
administering a compound altering lipoprotein, LDL, HDL or cholesterol levels in
the mammal in an amount effective to alter enhance or restore fertility or treat a
reproductive disorder in the mammal.
[May 6, 2003]
The claimed invention has morphed over the years from a method of modifying
steroid production in a mammal by administering a compound affecting SR-BI transfer
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of cholesterol or cholesteryl ester to a method to enhance or restore fertility or treat a
reproductive disorder in a female mammal by administering a compound that alters
lipoprotein, LDL, HDL or cholesterol levels without regard to SR-BI. The original
disclosure of this application only describes a single mode of affecting fertility in a
female mammal, i.e., SR-BI knockout female mice are infertile. There is no disclosure
that fertility may be enhanced or restored as now claimed by simply altering lipoprotein,
LDL, HDL or cholesterol levels in the female mammal.
Further evidence that claim 1 is directed to an entirely new concept not described
in the original disclosure is seen by the continued presence of claim 8 in the case which
requires the compound be administered in an amount effective to prevent normal
reproductive function. This claim is entirely at odds with claim 1 as now amended
where the compound is to be administered inter alia to enhance or restore fertility.
In addition, we find no written description of a method to treat a reproductive
disorder in a female mammal by merely administering a compound altering lipoprotein,
LDL, HDL or cholesterol levels. This concept is not found in the original disclosure of
this application.
Our finding of lack of written description extends to all of the claims pending in
this appeal. Claims such as claims 2 and 3 which limit the compound used in the
claimed methods to one that alters SR-BI expression or binding of SR-BI to high density
lipoprotein are not described in the original disclosure. Again, the only disclosed mode
of action of SR-BI that affects fertility in a female mammal is that SR-BI knockout female
mice are infertile. There is no disclosure in the original application that the observed
infertility can be ameliorated or corrected in any manner by any compound effective to
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1 Miettinen et al. (Miettinen), “Abnormal lipoprotein metabolism and reversible
female infertility in HDL receptor (SR-BI)-deficient mice,” The Journal of Clinical
Investigation, Vol. 108, No. 12, pp. 1717-1722 (2001)
alter lipoprotein, LDL, HDL or cholesterol levels in any mode, including altering SR-BI
expression or binding of SR-BI to high density lipoprotein.
In considering this issue we note:
[t]he question is not whether a claimed invention is an obvious variant of
that which is disclosed in the specification. Rather, a prior application itself
must describe an invention, and do so in sufficient detail that one skilled in
the art can clearly conclude that the inventor invented the claimed
invention as of the filing date sought...It is not sufficient for purposes of the
written description requirement of Section 112 that the disclosure, when
combined with knowledge in the art, would lead one to speculate as to
modifications that the inventor might have envisioned, but failed to
disclose.
Lockwood v. American Airlines Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966
(Fed. Cir. 1997). At best, one may intuit or think it obvious that having generated
infertile SR-BI knock out female mice, the effect may be reversible if SR-BI function is
restored. However, that is not the test. Even it that was the test, claim 1 on appeal is
not directed to methods involving affecting SR-BI function. It is much broader in scope.
In response to the examiner’s rejections, appellant relies upon Miettinen.1
Present appellant Monty Krieger is listed as a co-author in Miettinen. We have
considered Miettinen and find that it is not relevant since it was published in 2001, after
the September 4, 1998, filing date of this application. Furthermore, even if Miettinen is
to be considered in determining the patentability of the claims, if anything, it supports
our new ground of rejection since Miettinen states:
It is estimated that for 10-20% of women with infertility problems, the
underlying causes are unknown. We are not aware of any reports
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exploring the potential etiology of abnormal lipoprotein structure or
metabolism in these patients, although a few studies have examined the
potential role of lipoproteins in female infertility associated with endocrine
disturbances such as polycystic ovarian syndrome.
Page 1721 (reference citations omitted). As of 2001, appellant is admitting that for the
10-20% of women having infertility problems of unknown cause, it was not known that
altering their lipid level broadly as set forth in claim 1 on appeal would enhance or
restore their fertility. If anything, Miettinen establishes that appellant was not in
possession of the concepts now claimed as of the filing date of this application.
2. Examiner’s Written Description and Enablement Rejections.
In reviewing the examiner’s reasoning in support of these rejections as it appears
in the Examiner’s Answer, we find the examiner was concerned about the compounds
encompassed by the claims on appeal as well as appropriate dosages to be used in the
claimed methods. See, e.g., Examiner’s Answer, page 3. While the examiner makes
valid points in making these rejections, we believe the examiner overlooked the
overriding issue in this case outlined above in the new ground of rejection. We are not
prepared to say that the examiner’s rejections are incorrect, just that the issues raised
by the examiner are premature until appellant can establish that the claims as drafted
enjoy written descriptive support in the original disclosure of this application.
Under these circumstances, it is appropriate that we vacate the examiner’s
enablement and written description rejections. If prosecution is to be continued in this
application, we believe appellant will need to amend the claims so that they are limited
to subject matter that was clearly described in the original disclosure of this application.
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2 Issues concerning written descriptive support for amended claims would be
minimized if appellant would comply with the requirements of 37 CFR § 1.75(d)(1) when
presenting the amended claims.
At that point in time, the examiner will be in a better position to assess the written
description and enablement issues raised in the extant rejections.2
3. Rejection Under 35 U.S.C. § 112, Second Paragraph.
The only reason given by the examiner in support of this rejection is that the
claims are “incomplete for omitting essential steps, such omission amounting to a gap
between the steps. . . . The omitted steps are: the recitation of a treatment regimen
including a dose of the claimed compound to be administered and the length of time to
administer the compound.” Examiner’ Answer, page 8. We reverse this rejection.
Claim 1 does recite a treatment regimen as well as a dose and length of time that
the compound is to be administered in that claim 1 requires administering the specified
compound in an amount effective to enhance or restore fertility or to treat a reproductive
disorder. The dosage and the time period in which the compound is administered are
those which are “effective” as required by claim 1 on appeal. What the examiner does
not appreciate is that claim 1 is functional in nature. Normally that means that claim 1 is
broad in scope, not indefinite under 35 U.S.C. § 112, second paragraph.
The examiner has not identified in what manner a person of skill in the art would
have difficulty in ascertaining the metes and bounds of claim 1 on appeal. Under these
circumstances, we reverse the rejection under 35 U.S.C. § 112, second paragraph.
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Time Period For Response
This decision contains a new ground of rejection pursuant to 37 CFR § 41.50(b)
(effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz.
Pat. Office 21 (September 7, 2004)). 37 CFR § 41.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial review."
37 CFR § 41.50(b) also provides that the appellant, WITHIN TWO MONTHS
FROM THE DATE OF THE DECISION, must exercise one of the following two options
with respect to the new ground of rejection to avoid termination of the appeal as to the
rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or
both, and have the matter reconsidered by the examiner, in which event
the proceeding will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record. . . .
VACATED-IN-PART; REVERSED-IN-PART; 37 CFR § 41.50(b)
)
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Toni R. Scheiner )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Eric Grimes )
Administrative Patent Judge )
Appeal No. 2004-1823
Application No. 09/148,012
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