Synopsis of Application of Utility Guidelines with Examples
It is assumed at this point in the analysis that the specification
has been reviewed
and an appropriate search of the claimed subject matter has been
conducted. In
determining if the recited or disclosed utility is credible, one
should consider
whether or not there currently are materials available for
achieving that utility.
If there are, the utility is credible and no rejection under 35
U.S.C. º 101
should be made.
Guidance for Various Examination Situations
I) a) For method claims that recite more than one utility and one
of those is
credible, no rejection under 35 U.S.C. º 101 should be made.
If any utility in
such a claim is not credible, e.g., the claim recites both a
credible utility and a
utility that is not credible, the presence of the utility that is
not credible should be
addressed under 35 U.S.C. º 112, first paragraph, scope of
enablement. The
same would be true for a product claim that actually recites more
than one utility.
b) For product claims that do not recite any utilities, one
credible asserted utility
is enough to meet the criteria of 35 U.S.C. º 101.
II) Cure or prevention - Utilities that constitute curing or
preventing a condition
are sometimes not credible to one of skill in the art and thus may
raise a question
under 35 U.S.C. º 101.
III) If no credible utility is asserted in the specification of
the application and
none is well established from the record, a rejection under 35
U.S.C. º 101
would be proper.
IV) Treatment - Since most diseases or conditions can be treated,
rejections
under 35 U.S.C. º 101 for treatment claims should rarely be
made.
V) Vaccines - Since they are regularly prepared to combat various
viruses and
organisms, vaccines would have a credible utility to one of skill
in the art. Thus,
vaccines, including those for HIV, should not raise a question
under 35 U.S.C. º
101.
VI). Materials to be used for research or methods of using those
materials, i.e.,
utilities that require or constitute carrying out further research
to identify or
reasonably confirm a "real world" context of use - While such a
utility may be
credible on its face, it would raise questions under 35 U.S.C.
º 101 as seen in the
decision tree on page 46 since such a research utility is not
considered a "specific
utility".
Definitions
"Specific utility" - a practical utility which defines a "real
world" context of use.
Utilities which require or constitute carrying out further research
to identify or
reasonably confirm a "real world" context of use are not "specific
utilities". For
example, both a therapeutic method of treating a known or newly
discovered
disease and an assay method for identifying compounds that
themselves have a
"specific utility" clearly define a "real world" context of use. An
assay which
measures the presence of a material which has a stated correlation
to a
predisposition to the onset of a particular disease condition would
also define a
"real world" context of use in identifying potential candidates for
preventive
measures or further monitoring. On the other hand, the following
are examples
of types of situations which require or constitute carrying out
further research to
identify or reasonably confirm a "real world" context of use and,
therefore, do
not define "specific utilities":
A. Basic research such as using a material in a method for
studying the
properties of the material itself or the mechanisms in which the
material is
involved.
B. A method of treating an unspecified, undisclosed disease or
condition.
(Note, this is an exception to the general rule that treatments of
diseases meet the criteria of 35 U.S.C. º 101.)
C. A method of assaying for or identifying a material that itself
has no
"specific utility".
D. A method of making a material that itself has no "specific
utility".
E. A claim to an intermediate product for use in making a final
product
which has no known utility.
"Well established utility" - a "specific utility" which is well
known, immediately
apparent and implied by the specification based on the disclosure
of the
properties of a material, alone or taken with the knowledge of one
skilled in the
art. "Well established utility" is not meant to mean any "throw
away" utility that
one can dream up for an invention or even a utility that would
obviously apply to
virtually every member of a very general class of materials, such
as proteins or
DNA. If this was the case, any product or apparatus, including
perpetual motion
machines, would have a "well established utility" as landfill, an
amusement
device, a toy, or a paper weight, any carbon containing molecule
would have a
"well established utility" as a fuel since it can be burned, and
any protein would
have well established utilities such as manufacturing supplements
for vitamins or
food, as protein supplements for animal food, or as an animal
poison if the
protein is toxic. This is clearly not the intention of the
statute. However, it is
noted that if such utilities are specifically asserted by applicant
in the
specification, they would meet the utility requirement of 35 U.S.C.
º 101.
The decision tree on the following page should be used in analyzing
the claims
under 35 U.S.C. º 101.
Form Paragraph
7.05.01 - UTILITY REJECTIONS UNDER 35 U.S.C. º 101 AND 35
U.S.C.
112, FIRST PARAGRAPH
Claim [1] rejected under 35 U.S.C. º 101 because the
claimed invention is
not supported by either a [2] asserted utility or a well
established utility.
[3]
Claim [4] also rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a [5] asserted
utility or a well established utility for the reasons set forth
above, one skilled in
the art clearly would not know how to use the claimed invention.
EXAMINER NOTE:
Format A:
a) Insert the same claim numbers in brackets 1 and 4.
b) Insert "specific" in inserts 2 and 5.
c) In bracket 3, insert the explanation as to why the
claimed
invention is not supported by either a specific asserted utility or
a
well established utility. Include within the insert the following
statement: "Note, because the claimed invention is not supported
by
a specific asserted utility for the reasons set forth above,
credibility
cannot be assessed."
d) Format A is to be used when there is no asserted
utility and when
there is an asserted utility but that utility is not specific.
Format B:
a) Insert the same claim numbers in brackets 1 and 4.
b) Insert "credible" in inserts 2 and 5.
c) In bracket 3, insert the explanation as to why the
claimed
invention is not supported by either a credible asserted utility or
a
well established utility.
For claims that have multiple utilities, some of which are not
specific, some of which are not credible, but none of which are
specific and credible:
a) Insert the same claim numbers in brackets 1 and 4.
b) Insert "specific asserted utility, a credible" in
inserts 2 and 5.
c) In bracket 3, insert the explanation as to why the
claimed
invention is not supported by either a specific asserted utility, a
credible asserted utility or a well established utility. Each
utility
should be addressed. Include within the insert the following
statement for those utilities which are not specific: "Note,
because
such a utility for the claimed invention is not specific for the
reasons
set forth above, credibility cannot be assessed for that utility."
1. In each case, a separate rejection under 35 U.S.C. º 112,
first
paragraph, enablement should be made using the Forman Factors and
an
undue experimentation analysis.
2. A utility that is inoperative should be treated as being not
credible since
a utility that is inoperative cannot be credible.
Example 1: Alternative Uses Claimed
Specification: The specification relates to the prevention and
treatment of
microbe X infection, a common infection, by administering compound
A.
Claim:
1. A method for preventing or treating microbe X infection
comprising
administering to an animal in need thereof an effective amount of
compound A.
2. A method for preventing microbe X infection comprising
administering
to an animal in need thereof an effective amount of compound A.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? Since each claim is directed to a specific method of
use, the utility of
each of these claims is limited to that use and the examiner should
not look to a
"well established utility" for the composition used in the claimed
method.
Consequently, the answer to the question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Yes. In fact, for claim 1 there are two
asserted utilities, i.e.,
the two alternative utilities claimed, preventing microbe X
infection or treating
microbe X infection. Since there are two asserted utilities for
claim 1, each must
be analyzed. For claim 2, the utility is preventing microbe X
infection.
3) Is the asserted utility specific? Since microbe X
infection is a known
infection, the utilities of preventing or treating the infection
clearly define a "real
world" context of use and, therefore, are specific utilities.
4) Is the asserted "specific utility" credible? Since
infections are
conventionally treatable, the answer to this question would be yes
regarding the
treatment of microbe X infection. However, the claims also recite
preventing
microbe X infection. The term infection, broadly interpreted,
merely requires
that one microorganism gain entry into the cells of a host. Since
such a
microorganism can gain entry into the cells of a host through a
multitude of
avenues, there are no compounds known that would be capable of
preventing
entry via all such avenues, and there is no evidence in the
specification or of
record which demonstrates that entry via all such avenues is
credible, that utility
would not be credible and a rejection under 35 U.S.C. º 101
would be reasonable
with respect to this utility.
Thus, the conclusion that can be reached from this analysis for
claim 1 is
that since only one utility is needed for the claim to meet the
criteria for 35
U.S.C. º 101 and the treatment of microbe X infection meets
this criteria, no
rejection under 35 U.S.C. º 101 should be made against claim
1. The presence
of the utility that is not credible in claim 1 (preventing microbe
X infection)
should be addressed under 35 U.S.C. º 112, first paragraph,
scope of
enablement. With respect to claim 2, the conclusion that can be
reached from
this analysis is that both a 35 U.S.C. º 101 rejection and a
35 U.S.C. º 112, first
paragraph, utility rejection should be made.
Examiner's Rejection
Claim 2 is rejected under 35 U.S.C. º 101 because the
claimed invention is
not supported by either a credible asserted utility or a well
established utility.
Specifically, claim 2 is directed to a method of preventing
microbe X
infection. However, while no art is cited, the term infection,
broadly interpreted,
merely requires that one microorganism gain entry into the cells of
a host. Since
such a microorganism can gain entry into the cells of a host
through a multitude
of avenues, there are no compounds known that would be capable of
preventing
entry via all such avenues, and there is no evidence in the
specification or of
record which demonstrates that entry via all such avenues is
credible, that utility
would not be credible. Furthermore, since the claims are directed
to methods,
the utility is limited to those recited methods and there is no
non-asserted well
established utility for such methods.
Claim 2 is also rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a credible
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Attorney Arguments with Evidence (Alternative I)
Claim 2 has been rejected by the examiner under 35 U.S.C.
º 101 and 35
U.S.C. 112, 1. The examiner asserts that a credible utility has
not been
disclosed. Reconsideration under 37 CFR 1.111 is requested.
In support of applicants' statement of utility, attached hereto
is an opinion
declaration under 37 CFR 1.132 by an expert in the art who states
that it is
known that microbe X only gains entry into the cells of a host
through the
mucosa in the nose and mouth. The expert goes on to say that
administering
compound A blocks the mechanism by which microbe X enters the cells
of the
mucosa thereby preventing infection by the microbe. The only
reasonable
conclusion that could be reached based on the declaration and the
fact that the
statements made by the examiner are unsupported is that preventing
microbe X
infection is, in fact, credible. For these reasons, the utility
rejections under 35
U.S.C. º 101 and 35 U.S.C. º 112, first paragraph, should
be withdrawn.
Examiner's Response to Attorney Arguments with Evidence
(Alternative I)
If the examiner has no documentation to support the argument
that microbe
X gains entry into the cells of a host through a multitude of
avenues so as to rebut
the opinion declaration, the examiner should withdraw the utility
rejections.
Attorney Arguments with Evidence (Alternative II)
Claim 2 has been rejected by the examiner under 35 U.S.C.
º 101 and 35
U.S.C. º 112, 1. The examiner asserts that a credible utility
has not been
disclosed. Reconsideration under 37 CFR 1.111 is requested.
In support of applicants' statement of utility, attached hereto
is a factual
declaration under 37 CFR 1.132 by an expert with examples that
unequivocally
show that microbe X only gains entry into the cells of a host
through the mucosa
in the nose and mouth. The declaration also demonstrates that
administering
compound A blocks the mechanism by which microbe X enters the cells
of the
mucosa thereby preventing infection by the microbe. The only
reasonable
conclusion that could be reached based on the declaration and the
fact that the
statements made by the examiner are unsupported is that preventing
microbe X
infection is, in fact, credible. For these reasons, the utility
rejections under 35
U.S.C. º 101 and 35 U.S.C. º 112, first paragraph, should
be withdrawn.
Examiner's Response to Attorney Arguments with Evidence
(Alternative II)
The examiner should withdraw the utility rejections.
Example 2: Prevention
Specification: The specification relates to prevention or
retardation of aging by
administering an effective amount of compound A.
Claims:
1. A method for preventing aging comprising administering to a
patient in need
thereof an effective amount of compound A.
2. A method for retarding the aging process comprising
administering to a patient
in need thereof an effective amount of compound A.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? Since each claim is directed to specific method of use,
the utility of
each claim is limited to that use and the examiner should not look
to a "well
established utility" for the composition used in the claimed
method.
Consequently, the answer to the question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? The answer is yes, i.e., a method for
preventing or retarding
aging.
3) Is the asserted utility specific? Both preventing and
retarding aging
clearly define a "real world" context of use and, therefore, are
specific utilities.
4) Is the asserted "specific utility" credible? Since no
material has been
found to date which has been shown to or would be expected to
prevent or retard
aging and there are no working examples or other evidence in the
record which
would provide credibility to these claims it would be reasonable to
conclude that
the utility would not be credible based on the record.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made.
Note, had there been an indication in the specification that
applicant's
invention is the treatment of symptoms associated with aging, such
as skin
wrinkles, then the claims should be amended to clearly state
treatment of
symptoms or effects of aging.
Examiner's Rejection
Claims 1 and 2 are rejected under 35 U.S.C. º 101 because
the claimed
invention is not supported by either a credible asserted utility or
a well
established utility.
In this rejection it is presumed that applicants intend to
prevent or retard
physiological aging and not chronological aging, since the latter
reads on the
stoppage of time, which is not credible on its face. The
preventing or retarding
of aging via systemic treatment is itself not credible on its face
in view of
contemporary knowledge in the art. No compound is currently known
which
would have these effects.
Physiological aging is a multi-faceted process which does not
involve a
single chemical or biological effect. Various theories have been
propounded (see
Lehninger et al., pages 341, 344, and 886 and Scandalios, pages 40
and 41)
including (1) loss of telomerase activity and the relationship of
telomere length
to cell death, (2) accumulation of DNA mutations, and (3) temporal
genes which
regulate the output of structural genes. In view of these
theories, one skilled in
the art would conclude that the diverse aspects of aging, e.g.
loss of muscle
tone, slowing of metabolism, greying of hair, etc. operate via
different
mechanisms. There is no reason why one skilled in the art would
expect a single
compound to prevent or retard all of these diverse aspects.
Heretofore the art has recognized only the topical treatment of
the external
manifestations of aging, e.g. skin wrinkling, as an anti-aging
utility (see USP
5340568, for example). A systemic anti-aging utility has been
alleged in USP
5157031, but that utility is neither exemplified nor claimed
therein.
Furthermore, since the claims are directed to methods, the
utility is limited
to those recited methods and there is no non-asserted well
established utility for
such methods.
Claims 1 and 2 are also rejected under 35 U.S.C. º 112,
first paragraph.
Specifically, since the claimed invention is not supported by
either a credible
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Attorney Arguments Only (Alternative I)
Claims 1 and 2 have been rejected by the examiner under 35
U.S.C.
º 101 and 35 U.S.C. º 112, 1. The examiner asserts that
a credible utility has
not been disclosed. Reconsideration under 37 CFR 1.111 is
requested.
Anti-aging is indeed a credible utility. In USP 5157031 to
Schwartz et al.,
cited by the examiner, compounds related to dehydroepiandrosterone
(DHEA)
are stated as having an anti-aging utility. Long-term treatment
with DHEA itself
is also known to delay the rate of aging. See column 1, lines
60-64 and column
2, lines 41-42. The patented compounds exhibit the same effects of
DHEA, but
are more potent and produce no estrogenic effects.
This is the same set of facts as in In re Brana, 34 USPQ 2d
1436 (Fed.
Cir. 1995). In Brana the court reversed the examiner's rejection
under 35
U.S.C. º 112, 1 because the antitumor compounds at issue
therein were
disclosed by the applicant as superior to known antitumor agents.
This inter alia
was deemed sufficient to render credible the disclosed anti-cancer
utility. See
footnote 9 wherein the examiner in Brana notes that a rejection
under 35 U.S.C.
º 101 for failure to disclose a practical utility also could
have been made.
The examiner is also reminded that a patent is presumed valid
under 35
U.S.C. 282. The examiner in the Schwartz et al. patent could have
required
cancellation of any utility which he deemed incredible (In re
Gottlieb, 140 USPQ
665 and Ex parte Hozumi, 3 USPQ 2d 1059), but he did not.
Accordingly, one
may presume that the utility disclosed in Schwartz et al. is a
valid, credible
utility.
Examiner's Response to Attorney Arguments Only (Alternative I)
Claims 1 and 2 are rejected under 35 U.S.C. º 101 because
the claimed
invention is not supported by either a credible asserted utility or
a well
established utility for the reasons of record.
Claims 1 and 2 are rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a credible
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Applicants' arguments have been considered, but are not deemed
persuasive.
The anti-aging utility of DHEA disclosed in the background
section of
Schwartz et al. is not established fact. Schwartz et al. states at
column 1, lines
60-64:
Furthermore, it is also known that the long-term treatment of
C3H mice
with DHEA may delay the rate of aging (emphasis added).
Schwartz et al. disclose anti-aging as one among many utilities,
including
treatment and/or prevention of cancer, obesity, diabetes, and
hyperlipidemia. The
claims of Schwartz et al. are process claims limited to prophylaxis
of obesity
only. The broad utility statement appears to be based on an
extrapolation from
other activities which are superior to those of DHEA. For example,
inhibition of
binding of 3H-DMBA to skin DNA and inhibition of TPA stimulation of
epidermal 3H-thymidine incorporation at doses where DHEA is
inactive led
Schwartz et al. to conclude that their compounds are more potent at
cancer
prevention than is DHEA. No actual anti-aging data are disclosed
in Schwartz et
al.
Extrapolation from a speculative statement (see quotation
above) based on
other results does not result in anything more than additional
speculation. As
such, In re Brana, 34 USPQ 2d 1436, is not on point. In Brana only
a single
utility was involved. Superiority in an established utility is
meaningful. Assumed
superiority relative to a nebulous utility based on extrapolation
of other utilities
proves little.
Patent validity and fact are two different issues. A valid
patent may issue
with only one specific credible utility among many disclosed. The
patent is no
less valid owing to the presence of the other less than credible
utilities. Failure
of the examiner in Schwartz et al. to require cancellation of
anti-aging utility does
not prove that said utility is credible.
Attorney Arguments Only (Alternative II)
Claims 1 and 2 have been rejected by the examiner under 35
U.S.C.
º 101 and 35 U.S.C. º 112, 1. The examiner asserts that
a credible utility has
not been disclosed. Reconsideration under 37 CFR 1.111 is
requested.
Applicants submit that even if anti-aging is not a credible
utility (which
applicants do not admit), applicants have nevertheless satisfied
the utility
requirement because another utility is disclosed in the
specification as filed.
Example IV discloses the instant compound A when formulated for
topical
administration is effective in retarding the wrinkling of skin.
Since only one
utility is necessary to satisfy 35 U.S.C. º 101, applicants
submit that the
examiner's rejection is in error and should be withdrawn.
Examiner's Response to Attorney Arguments Only (Alternative II)
Claims 1 and 2 are rejected under 35 U.S.C. º 101 because
the claimed
invention is not supported by either a credible asserted utility or
a well
established utility for the reasons of record.
Claims 1 and 2 are rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a credible
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Applicants' arguments have been considered, but are not deemed
persuasive.
Applicants are not claiming compounds. If compounds were being
claimed, then any disclosed utility could be attributed thereto.
However, since
method of use claims are involved herein, applicants are limited to
the utility set
forth in those claims, i.e. retarding or preventing the entire
process of aging.
Limitations from the specification may not be read into the claims,
so that the
presence of a cosmetic formulation in Example IV is of no
consequence in
overcoming the rejection under 35 U.S.C. º 101.
Claims amended so as to be drawn to a method of retarding
wrinkling of
skin by topical administration of compound A would obviate this
rejection.
Attorney Arguments with Evidence (Alternative III)
Claims 1 and 2 have been rejected by the examiner under 35
U.S.C.
º 101 and 35 U.S.C. º 112, 1. The examiner asserts that
a credible utility has
not been disclosed. Reconsideration under 37 CFR 1.111 is
requested.
In support of applicants' statement of utility, attached hereto
is a
declaration under 37 CFR 1.132 by the inventors which shows
unequivocally that
the claimed compound A markedly reduces wrinkling of the skin when
applied
topically to the human face. The effect is long-lasting as shown
in the data in
Table 1.
Applicants submit that the claims encompass topical
administration. Note
page 20 of the specification which sets forth the various modes of
administration,
including topical administration. Applicants' data in the Rule 132
declaration
evince a true retardation of skin wrinkling, evidence that the
aging process is
indeed retarded. It is not an incredible leap from retardation to
prevention. One
need only begin applying the material before the onset of wrinkling
to lead to
prevention.
Examiner's Rebuttal to Attorney Arguments with Evidence
(Alternative III)
Claims 1 and 2 are rejected under 35 U.S.C. º 101 because
the claimed
invention is not supported by either a credible asserted utility or
a well
established utility for the reasons of record.
Claims 1 and 2 are rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a credible
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Applicants' arguments and declaration under 37 CFR 1.132 have
been
considered, but are not deemed persuasive.
It is clear from applicants' specification that retardation
and/or prevention
of the entire aging process is contemplated. As noted in the first
Office action,
skin wrinkling is but a single external manifestation of the
general process of
aging. One cannot conclude from applicants' data that internal
organs have
ceased aging because wrinkling on a test subject's face has been
reduced by
cosmetic application of compound A.
It is true that applicants' specification discloses topical
administration, but
this disclosure is a general one clearly meant to apply to both of
applicants'
inventions. Since applicants' specification also includes cosmetic
formulations
for retarding skin wrinkling (see Example IV), one could fairly
conclude that
topical administration was intended for such formulations. As
such, applicants'
showing is not relevant to the claimed invention, and it is
insufficient to establish
a credible utility therefor.
Claims amended so as to be drawn to a method of retarding
wrinkling of
skin by topical administration of compound A would obviate this
rejection.
Example 3: Therapeutic Proteins
Specification: The specification discloses a protein having the
amino acid
sequence of SEQ. ID. NO. 1 and that the protein can be made by
protein
synthesis techniques well known in the art. The only disclosed
utility for the
protein is for curing Alzheimer's disease. There is no other
disclosure of any
chemical, physical, or biological properties of the protein. There
are 98 pages of
specification which disclose alternate administration techniques
and dosages that
are very specific but which are conventional techniques for protein
administration. There are no working examples which demonstrate
the
specifically asserted utility.
Claims: There is only one claim in the application, which claim
recites --The
protein consisting of the amino acid sequence set forth in SEQ. ID.
NO. 1.--
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to an activity for the protein such that another
non-asserted utility
would be well established. Additionally, there is no art of record
that discloses
or suggests any activity for the claimed protein such that another
non-asserted
utility would be well established. Consequently, the answer to the
question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Here, there is an asserted utility, i.e.,
curing Alzheimer's
disease.
3) Is the asserted utility specific? Curing Alzheimer's
disease, a well
known disease, clearly defines a "real world" context of use and,
therefore, is a
"specific utility".
4) Is the asserted "specific utility" credible? To answer
this question one
must keep in mind what one skilled in the art already knows. With
respect to
Alzheimer's disease, one skilled in the art knows that the disease
has no known
cure, no known cause or mechanism, and can not even be truly
diagnosed until a
post mortem examination is done. In view of this and the fact that
there are no
working examples and the disclosure of conventional protein
administration
techniques does not constitute evidence pointing toward
credibility, it would be
reasonable to conclude that the utility would not be credible even
based on the
evidence.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made.
Assume for the moment that a first Office action on the merits
was mailed
to applicant which included utility rejections under 35 U.S.C.
º 101 and º 112,
first paragraph, for the reasons stated above. In response,
applicant argues that
while the specifically disclosed utility may not be credible, the
claim is to a
protein and that proteins, in view of their unique chemical
structure, would have
a "well established utility" as being a source of amino acids used
for
manufacturing supplements for vitamins or food, as protein
supplements for
animal food, or as an animal poison if the protein is toxic.
Furthermore, it would
not require undue experimentation to use the protein in any one of
these manners.
Thus, applicant argues, the utility rejections under 35 U.S.C.
º 101 and º 112,
first paragraph, are not appropriate. However, such an argument
should not be
accepted. "Well established utility" is not meant to mean any
utility that one can
dream up for an invention or even a utility that would obviously
apply to virtually
every member of a very general class of materials, such as proteins
or DNA. If
this was the case, any product or apparatus, including perpetual
motion
machines, would have a "well established utility" as landfill or a
paper weight,
any carbon containing molecule would have a "well established
utility" as a fuel
since it can be burned, and any protein would have the above noted
well
established utilities. This is clearly not the intention of the
statute. A utility is
"well established" only when the disclosure of the properties of a
material, alone
or taken with the knowledge of one skilled in the art, at least
implies that the
"well established utility" was contemplated by the inventor.
At this point it is noted that while the above utilities would
not be "well
established" under the guidelines, if those utilities were
specifically asserted in
the specification, they would meet the criteria for 35 U.S.C.
º 101.
Example 4: Uncharacterized Proteins
Specification: The specification discloses a protein having the
amino acid
sequence of SEQ. ID. NO. 1 and that the protein can be made by
protein
synthesis techniques well known in the art. There is no disclosed
utility and no
description of the chemical, physical, or biological properties for
the protein.
Note, the protein is the same one noted above in Example 3.
Claims: There is only one claim in the application, which claim
recites --The
protein consisting of the amino acid sequence set forth in SEQ. ID.
NO. 1.--
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to an activity for the protein such that another
non-asserted utility
would be well established. Additionally, there is no art of record
that discloses
or suggests any activity for the claimed protein such that another
non-asserted
utility would be well established. Consequently, the answer to the
question is no.
2) Has the applicant made any assertion of utility for the
invention? Here,
there is no asserted utility.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made.
Examiner's Rejection
Claim 1 is rejected under 35 U.S.C. º 101 because the
claimed invention is
not supported by either a specific asserted utility or a well
established utility.
The claimed protein is not supported by either a specific
asserted utility or
a well established utility because the specification fails to
assert any utility for the
protein and neither the specification as filed nor any art of
record disclose or
suggest any activity for the protein such that another non-asserted
utility would
be well established for the protein. Note, because the claimed
invention is not
supported by a specific asserted utility for the reasons set forth
above, credibility
cannot be assessed.
Claim 1 is also rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a specific
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Attorney Arguments Only
Claim 1 has been rejected by the examiner under 35 U.S.C.
º 101 and 35
U.S.C. º 112, 1. The examiner's position is that there is
neither an asserted
utility nor a well established utility for the claimed protein.
Reconsideration
under 37 CFR 1.111 is requested.
While the specification may not specifically assert a utility
for the claimed
protein, proteins as a general class of compounds have a well
established utility
in view of their unique chemical structure. Specifically, because
of the unique
chemical structure of the claimed protein, it has a well
established utility as being
a source of amino acids used for manufacturing supplements for
vitamins or
food, as protein supplements for animal food, or as an animal
poison if the
protein is toxic. Furthermore, it would not require undue
experimentation to use
the protein in any one of these manners. Thus, the utility
rejections under 35
U.S.C. º 101 and º 112, first paragraph, are not
appropriate and should be
withdrawn.
Examiner's Response to Attorney Arguments Only
Claim 1 is rejected under 35 U.S.C. º 101 because the
claimed invention is
not supported by either a specific asserted utility or a well
established utility
because of the reasons set forth in the previous Office action.
Claim 1 is also rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a specific
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Applicant's arguments have been fully considered but they are
not deemed
persuasive. Applicant argues that the claimed protein has a well
established
utility as being a source of amino acids used for manufacturing
supplements for
vitamins or food, as protein supplements for animal food, or as an
animal poison
if the protein is toxic. This is not persuasive. "Well
established utility" does not
mean any utility that one can dream up for an invention or even a
utility that
would obviously apply to virtually every member of a very general
class of
materials, such as proteins or DNA. If this was the case, any
product or
apparatus, including perpetual motion machines, would have a well
established
utility as landfill or a paper weight, any carbon containing
molecule would have a
well established utility as a fuel since it can be burned, and any
protein would
have the above noted well established utilities. This is clearly
not the intention of
the statute. A utility is "well established" only when the
disclosure of the
properties of a material, alone or taken with the knowledge of one
skilled in the
art, at least implies that the well established utility was
contemplated by the
inventor. Here, since there is no assertion of utility and no
properties of the
protein are disclosed or suggested, it is the examiner's
position that the claimed protein still is not supported by either
a specific asserted
utility or a well established utility.
Example 5: Partially Characterized Proteins
Specification: The specification discloses a protein having the
amino acid
sequence of SEQ. ID. NO. 1 and that the protein can be made by
protein
synthesis techniques well known in the art. There is no explicitly
disclosed
utility for the protein. However, there is an example which
demonstrates that
when the protein is contacted with whole blood, the protein will
specifically bind
with another protein X such that X can be isolated and quantified.
Note, the
protein is the same one noted above in Examples 3 and 4.
Claims: There is only one claim in the application, which claim
recites --The
protein consisting of the amino acid sequence set forth in SEQ. ID.
NO. 1.--
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? Here, the specification as filed does disclose or
provide evidence that
points to an activity for the protein, i.e., when contacted with
whole blood, it will
specifically bind to protein X to enable the isolation and
quantification of X.
Assuming that the art does not disclose anything regarding the
significance of X,
or the examiner is unaware of any such art, such that another
non-asserted utility
would be well established, then it would be reasonable to conclude
that there is
no "well established utility".
2) Has the applicant made any assertion of utility for the
invention? Here,
since there is no explicitly asserted utility, the answer would be
no.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made.
Assume for the moment that a first Office action on the merits
was mailed
to applicant which included utility rejections under 35 U.S.C.
º 101 and º 112,
first paragraph, for the reasons stated above. In response,
applicant argues that
while there may not be a specifically asserted utility, there is a
"well established
utility". To support the argument, applicant provides a copy of an
article from
Science that was published before the filing date of the
application and which
indicated that increased levels of protein X in blood correlates to
the presence of
bleeding ulcers. In other words, the article disclosed that all
patients tested who
had bleeding ulcers, as diagnosed by other procedures, also had a
protein X level
in the blood that was above a threshold amount whereas all normal
patients tested
had a protein X level in the blood that was less than the threshold
amount. Thus,
applicant argues that the example in combination with the article
implies that
there is a "well established utility" of diagnosing bleeding ulcers
so that the
ulcers can be treated accordingly and that one skilled in the art
would certainly
know how to use the claimed protein in such a utility. Such an
argument would
be acceptable and the utility rejections under 35 U.S.C. º 101
and º 112, first
paragraph, should be withdrawn.
Example 6: Therapeutic Antibodies
Specification: The specification discloses a pharmaceutical
composition
containing a carrier, a non-antibody protein X and an antibody,
said composition
being suitable for treating HIV-1 infections. The specification
further discloses a
method of treating a subject by administering to the subject an
amount of the
above noted pharmaceutical composition effective to reduce the
likelihood of the
subject's becoming infected with HIV-1. The subject may be a
newborn infant.
The subject may also be a medical practitioner. The specification
also discloses a
vaccine for HIV-1 comprising the non-antibody protein X.
The specification further discloses a method of treating an
HIV-infected
subject, which includes administering to the subject an amount of
the composition
of the invention effective to reduce the rate of spread of HIV-1
infection in the
subject.
The specification also discloses a method of decontaminating a
fluid
containing HIV-1 which comprises contacting the fluid with the
composition of
the invention under conditions such that the composition of the
invention forms a
complex with the HIV-1 therein and removing the complex so formed
from the
fluid, thereby decontaminating the fluid.
Claims: The following claims are pending in the application:
1. A composition comprising (a) a carrier, (b) a non-antibody
protein X, and (c)
an antibody, said composition being suitable for treating HIV-1
infections.
2. The composition of claim 1, wherein the carrier is a
pharmaceutically
acceptable carrier.
3. A method of treating a subject which comprises administering to
the subject
an amount of the composition of claim 2 effective to reduce the
likelihood of the
subject's becoming infected with HIV-1.
4. The method of claim 3, wherein the subject is a newborn infant.
5. The method of claim 3, wherein the subject is a medical
practitioner.
6. A pharmaceutical composition comprising an amount of the
composition of
claim 2 effective to reduce the likelihood of a subject's becoming
infected with
HIV-1.
7. A method of treating an HIV-1 infected subject, which comprises
administering to the subject an amount of the composition of claim
2 effective to
reduce the rate of spread of HIV-1 infection in the subject.
8. A pharmaceutical composition comprising an amount of the
composition of
claim 2 effective to reduce the rate of spread of HIV-1 infection
in a HIV-1-
infected subject.
9. A method of decontaminating a fluid containing HIV-1, which
comprises
contacting the fluid with the composition of claim 1 under
conditions such that
the composition of claim 1 forms a complex with the HIV-1 therein
and removing
said complex from the fluid, thereby decontaminating the fluid.
10. A method of preventing a subject from becoming infected with
HIV-1
comprising administering to the subject an amount of the
composition of claim 2
effective to prevent the subject from becoming infected with HIV-1.
11. A method of preventing a subject from becoming infected with
HIV-1 or
treating a subject with HIV-1 which comprises administering to the
subject the
composition of claim 2.
12. A vaccine for HIV-1 comprising a non-antibody protein X.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to an activity for the compositions (claims 1-2, 6, 8,
and 12) such that
another non-asserted utility would be well established.
Additionally, there is no
art of record that discloses or suggests any activity for the
claimed compositions
such that another non-asserted utility would be well established.
With respect to
the method claims (claims 3-5, 7, and 9-11), since each of these
claims is
directed to a specific method of use, the utility of each claim is
limited to that use
and the examiner should not look to a "well established utility"
for the
composition used in each claimed method. Consequently, the answer
to the
question is no for all of the claims.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? For each of the claims presented for this
example, an
asserted utility can be found. Those utilities are (1) a
composition for treating
HIV-1 infections (claims 1-2); (2) a pharmaceutical composition for
reducing the
likelihood of a subject becoming infected with HIV-1 (claim 6);
(3) a
pharmaceutical composition for reducing the rate of spread of HIV-1
infection
(claim 8); (4) a vaccine against HIV-1 (claim 12); (5) a method
of treating a
subject to prevent the likelihood of becoming infected with HIV-1
(claims 3-5);
(6) a method of treating a subject infected with HIV-1 (claims 7
and 11); (8) a
method of decontaminating a fluid containing HIV-1 (claim 9); and
(10) a
method of preventing a subject from becoming infected with HIV-1
(claims 10
and 11).
3) Is the asserted utility specific? Since HIV-1 infection is
a known
problem, the utilities noted in 2) above clearly define a "real
world" context of
use and, therefore, are specific utilities.
4) Is the asserted "specific utility" credible? The answer to
that question
for claims 1-9, 11 (treating part) and 12 is yes in that all of
these claims are
directed to subject matter which one would believe is credible.
Those credible
utilities are listed above in 2). However, claim 10 and part of
claim 11 are
directed to a method of preventing a subject from becoming infected
with HIV-1.
The term infection, broadly interpreted, merely requires that one
such virus gain
entry into the cells of a host. Since such a virus can gain entry
into the cells of a
host through in a multitude of avenues, there are no compounds
known that
would be capable of preventing entry via all such avenues, and
there is no
evidence in the specification or of record which demonstrates that
entry via all
such avenues is credible, the utility for this claim would not be
credible.
Thus, the conclusion that can be reached from this analysis is
that no
rejection under 35 U.S.C. º 101 should be made against claims
1-9 and 12 but
that both a 35 U.S.C. º 101 rejection and a 35 U.S.C. º
112, first paragraph,
utility rejection should be made against claim 10. For claim 11,
since only one
utility is needed for the claim to meet the criteria for 35 U.S.C.
º 101 and the
treatment of HIV-1 infection meets this criteria, no rejection
under 35 U.S.C.
º 101 should be made against claim 11. The presence of the
utility that is not
credible in claim 11 (preventing HIV-1 infection) should be
addressed under 35
U.S.C. º 112, first paragraph, scope of enablement.
Example 7: Chemical therapeutics
Specification: The specification discloses compounds useful in the
inhibition of
HIV protease, the prevention or treatment of infection by the human
immunodeficiency virus (HIV) and the treatment of consequent
pathological
conditions such as AIDS. Treating AIDS or preventing or treating
infection by
HIV is defined as including, but not limited to, treating a wide
range of states of
HIV infection: AIDS, ARC (AIDS related complex), both symptomatic
and
asymptomatic, and actual or potential exposure to HIV. For
example, the
compounds of this invention are useful in treating infection by HIV
after
suspected past exposure to HIV by, e.g., blood transfusion, organ
transplant,
exchange of body fluids, bites, accidental needle stick, or
exposure to patient
blood during surgery.
An assay for inhibition of microbial expressed HIV protease and
a cell
spread assay are disclosed. Compound X, a species of the generic
invention is
tested in these assays.
Claims:
1. A compound of the formula:
A
where A is a stable 8-10 membered bicyclic aromatic heterocyclic
having 1-3
heteroatoms selected from the group consisting of P, Se and Si.
2. A composition comprising a compound of claim 1, for use in
the
treatment of AIDS, in the prevention of infection by HIV, in the
treatment of
infection of HIV, or in the inhibition of HIV protease, and a
carrier.
3. A method of treating AIDS, comprising administering to a
mammal in
need of such treatment an effective amount of a compound of claim
1.
4. A method of preventing infection by HIV, comprising
administering to
a mammal in need of such treatment an effective amount of a
compound of claim
1.
5. A method of treating infection by HIV, comprising
administering to a
mammal in need of such treatment an effective amount of a compound
of claim 1.
6. A method of inhibiting HIV protease, comprising
administering to a
mammal in need of such treatment an effective amount of a compound
of claim 1.
7. A method of delaying the onset of AIDS, comprising
administering to a
mammal in need of such treatment an effective amount of a compound
of claim 1.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to an activity for the compound and composition (claims
1-2) such that
another non-asserted utility would be well established.
Additionally, there is no
art of record that discloses or suggests any activity for the
claimed compound and
composition such that another non-asserted utility would be well
established.
With respect to the method claims (claims 3-7), since each of these
claims is
directed to a specific method of use, the utility of each claim is
limited to that use
and the examiner should not look to a "well established utility"
for the
composition used in each claimed method. Consequently, the answer
to the
question is no for all of the claims.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Looking at each of the claims presented for
this example,
you will find an asserted utility for each of them. Those
utilities are (1) methods
of treating AIDS or subjects infected with HIV (claims 3 and 5);
(2) a method of
preventing infection by HIV (claim 4); (3) a method of inhibiting
HIV protease
(claim 6); (4) a method for delaying the onset of AIDS (claim 7);
(5) a
compound for any one of (1)-(4) (claim 1); and (6) a composition
for any one of
(1)-(4) (claim 2).
3) Is the asserted utility specific? Since HIV infection is a
known
problem, the utilities noted in 2) above clearly define a "real
world" context of
use and, therefore, are specific utilities.
4) Is the asserted "specific utility" credible? The answer to
that question
for claims 1-2 (utilities other than preventing infection by HIV),
3, and 5-7 is yes
in that all of these claims are directed to subject matter which
one would believe
is credible. Those credible utilities are listed above in 2).
However, claim 4 is
directed to a method of preventing a subject from becoming infected
with HIV.
The term infection, broadly interpreted, merely requires that one
such virus gain
entry into the cells of a host. Since such a virus can gain entry
into the cells of a
host through in a multitude of avenues, there are no compounds
known that
would be capable of preventing entry via all such avenues, and
there is no
evidence in the specification or of record which demonstrates that
entry via all
such avenues is credible, the utility for this claim would not be
credible.
Thus, the conclusion that can be reached from this analysis is
that no
rejection under 35 U.S.C. º 101 should be made against claims
3 and 5-7 but that
both a 35 U.S.C. º 101 rejection and a 35 U.S.C. º 112,
first paragraph, utility
rejection should be made against claim 4. For claim 1, since it is
a product claim
that does not recite any utilities, only one credible asserted
utility is needed to
meet the criteria for 35 U.S.C. º 101. Any of the asserted
utilities, other than
preventing HIV infection, meets this criteria and, accordingly, no
rejection under
35 U.S.C. º 101 should be made against claim 1. For claim 2,
since only one
utility is needed for the claim to meet the criteria for 35 U.S.C.
º 101 and the claimed utilities, other than preventing HIV
infection, meet this
criteria, no rejection under 35 U.S.C. º 101 should be made
against claim 2. The
presence of the utility that is not credible in claim 2 (preventing
HIV
infection) should be addressed under 35 U.S.C. º 112, first
paragraph, scope of
enablement.
Example 8: "Therapeutics" Not Associated with a Disease
Specification: A compound A is disclosed to inhibit enzyme XYZ, a
well known
enzyme, in vitro. The specification states that the compound A can
be used to
treat diseases caused or exacerbated by enzyme XYZ. No actual
diseases are
named.
Claims:
1. Compound A.
2. A method of treating a disease caused or exacerbated by enzyme
XYZ
consisting of administering an effective amount of compound A to a
patient.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? With respect to claim 2, since the claim is directed to
a specific
method of use, the utility of this claim is limited to that use and
the examiner
should not look to a "well established utility" for the composition
used in the
claimed method. Consequently, the answer to the question is no for
claim 2.
With respect to claim 1, the answer is different. Enzymes have a
"well
established utility" in the art, i.e., catalyzing certain reactions
involving the
enzyme substrate. Here, since enzyme XYZ is well known, the
substrate for the
enzyme and the reaction which the enzyme catalyzes must also be
well known,
otherwise XYZ could not properly be classified as an enzyme. Since
all of this is
well known, an inhibitor of enzyme XYZ, such as compound A, would
clearly
have a "well established utility" in controlling the
enzyme/substrate interaction in
the known reaction. Therefore, claim 1 does have a "well
established utility", no
rejection under 35 U.S.C. º 101 should be made against the
claim, and there is
no need to go further in the analysis with respect to this claim.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? The answer is yes. Claim 2 has the asserted
utility of
treating a disease caused or exacerbated by enzyme XYZ.
3) Is the asserted utility specific? Since neither the
specification nor the
art of record disclose any diseases or conditions caused or
exacerbated by
enzyme XYZ, the asserted utility in this case essentially is a
method of treating
an unspecified, undisclosed disease or condition, which does not
define a "real
world" context of use. Treating an unspecified, undisclosed
disease or condition
clearly would require or constitute carrying out further research
to identify or
reasonably confirm a "real world" context of use. Therefore, the
answer to this
question is no with respect to claim 2.
Therefore, the conclusion that can be reached from this
analysis is that no
rejection under 35 U.S.C. º 101 should be made against claim 1
but that both a
35 U.S.C. º 101, as well as 35 U.S.C. º 112, first
paragraph, utility rejection
should be made against claim 2.
Once the rejection has been made with respect to claim 2, the
applicant bears
the burden of rebutting it. Upon receiving applicant's response,
the examiner
should review the original disclosure, any evidence relied upon in
establishing
the utility rejections under 35 U.S.C. º 101 and 35 U.S.C.
º 112, first
paragraph, any amendments and any new reasoning or evidence
provided by the
applicant in support of the asserted utility.
The following situations are most probable:
(1) Applicant provides a reference, published before the
filing date of the
application, which teaches that certain diseases are associated
with enzyme XYZ.
In this case the examiner should withdraw the utility rejections
under 35 U.S.C.
º 101 and 35 U.S.C. º 112, first paragraph, for claim 2.
(2) Applicant submits an opinion declaration under 37 C.F.R.
1.132 by a
third party qualified expert which states that specific diseases
conditions are
known to the skilled artisan that are known to be either caused or
exacerbated by
enzyme XYZ. The declarant identifies specific diseases and/or
conditions. After
reviewing the record in its entirety, the Examiner should only
maintain this
rejection if evidence of more probative value than the declaration
exists which
establishes a basis for doubting the truth of the declaration.
Scientific reasoning
is not more probative than the declaration. Documentation must be
provided
which establishes the basis of doubting the statements made in the
declaration.
(3) Applicant submits a declaration under 37 C.F.R. 1.132 which
contains
a factual showing that compound A is effective in alleviating the
symptoms of
peptic ulcers. The facts are adequate to establish utility and the
rejection under
35 U.S.C. º 101 should be dropped at this time. However, the
Examiner would
find "new matter" should any change be made to the specification or
claims
which was not supported by the as-filed application. If no change
to the
specification or claims is made, any position of non-enablement
would be
maintained over the specification in this example.
Example 9: DNA Fragments
Specification: The specification discloses 4332 nucleic acid
sequences that were
obtained from a human cDNA library that was formed using human
epithelial
cells. The sequences, SEQ. ID. NOS. 1-4332, are believed by
applicant to be
fragments of full length genes. Thus, it is clear that all of the
sequences
comprise at least part of the coding sequence for a protein that is
actually
produced in the human cells. The specification discloses how to
use each of the
4332 nucleic acid sequences as a probe to obtain the full length
gene that
corresponds to the nucleic acid sequence, which full length gene
can be used to
recombinantly make the corresponding protein, which can then be
used to study
the cellular mechanisms and activities in which the protein is
involved. There is a
generic disclosure of how to recombinantly make the corresponding
protein from
each of the sequences. The sequences vary in length but include
sequences long
enough to encode functional proteins, i.e. these could be genes.
There is one
fully explained example of using SEQ. ID. NO. 22 to obtain the
corresponding
gene which is then used to produce the corresponding protein which
was isolated
and purified but has no known biological activity and was only
characterized by
its sequence. Thus, no use is disclosed for the protein other
than the possibility
of using it to study the cellular mechanisms and activities in
which the protein is
involved.
Claims: There are 4332 claims in the application with each claim
reciting
--A cDNA molecule consisting of the sequence set forth in SEQ. ID.
NO. X.--
where X is also the claim number.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to an activity for the cDNA molecules or the proteins
which can be
obtained using the cDNA molecules such that another non-asserted
utility would
be well established. Additionally, there is no art of record that
discloses or
provides any evidence that points to an activity for the cDNA
molecules or the
proteins which can be obtained using the cDNA molecules such that
another non-
asserted utility would be well established. Consequently, the
answer to the
question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Here, there is an asserted utility, i.e., each
claimed cDNA
molecule can be used as a probe to obtain the full length gene that
corresponds to
the cDNA molecule, which full length gene can be used to
recombinantly make
the corresponding protein, which can then be used to study the
cellular
mechanisms and activities in which the protein is involved.
3) Is the asserted utility specific? The answer to this
question would be
no. As seen in 2) above, the asserted utility for the claimed
cDNAs is a method
of making the corresponding protein. Thus, to determine whether or
not this
method is a "specific utility", it must be determined whether or
not the product,
i.e., the corresponding protein, has a "specific utility". Here,
the only utility
asserted for the protein is studying the properties of the protein
itself or the
mechanisms in which the protein is involved. This clearly does not
define a "real
world" context of use. Since the asserted utility for the protein
(studying the
properties of the protein itself or the mechanisms in which the
protein is
involved) does not define a "real world" context of use, a method
of making that
protein (the utility for the claimed cDNAs) also could not define a
"real world"
context of use. In fact, both utilities clearly would require or
constitute carrying
out further research to identify or reasonably confirm a "real
world" context of
use.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made.
Examiner's Rejection
Claims 1-4332 are rejected under 35 U.S.C. º 101 because
the claimed
invention is not supported by either a specific asserted utility or
a well established
utility.
The claimed cDNA compounds are not supported by a specific
asserted
utility because the specification states only that the cDNA
compounds are useful
as probes for assisting in the isolation of full-length DNA
compounds (i.e.
genes), which full-length DNA would be used to make protein. Once
the protein
is obtained, the protein would be used in conducting research to
functionally
characterize the protein. A starting material which can only be
used to produce a
final product does not have a specific asserted utility in those
instances where the
final product is not supported by a specific utility. In this case
the proteins that
are to be produced as final products resulting from processes
involving the
claimed cDNA have no asserted or otherwise identified specific
utility. The
research contemplated by Applicants to establish utility for
potential protein
products by elucidating the properties, especially the biological
activities, of the
proteins has not been specified and does not constitute a specific
utility. Note,
because the claimed invention is not supported by a specific
asserted utility for
the reasons set forth above, credibility cannot be assessed.
Neither the
specification as filed nor any art of record discloses or suggests
any property or
activity for the cDNA compounds such that another non-asserted
utility would be
well established for the compounds.
Claims 1-4332 are also rejected under 35 U.S.C. º 112,
first paragraph.
Specifically, since the claimed invention is not supported by
either a specific
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Example 10: Animals with Uncharacterized Human Genes
Specification: Kidney cells from a patient with Polycystic Kidney
Disease have
been used to make a cDNA library. From this library 8000
nucleotide
"fragments" have been sequenced but not yet used to express
proteins in a
transformed host cell nor have they been characterized in any other
way. The 50
longest fragments, SEQUENCE ID #1-50, respectively, have been used
to make
transgenic mice. None of the 50 lines of mice have developed
Polycystic Kidney
Disease to date. The asserted utility is the use of the mice to
research human
genes from diseased human kidneys. The disease is inheritable, but
chromosomal loci have not yet been identified. Neither the absence
or presence
of a specific protein has been identified with the disease
condition.
Claims: 1. A non-human animal in which all of the somatic and germ
cells
contain DNA of SEQUENCE ID #1.
2. A non-human animal in which all of the somatic and germ
cells
contain DNA of SEQUENCE ID #2.
[3. - 50. are identical in form to 1 and 2 with the
sequence number
corresponding with the claim number in each.]
51. A method of screening for potential causative
agents which trigger or exacerbate Polycystic Kidney Disease
comprising
administering a selected agent to a non-human animal of any one of
claims 1 -50
and observing the kidney of said animal for abundant cyst
formation.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to a property of the claimed animals (claims 1-50) such
that another
non-asserted utility would be well established. Additionally,
there is no art of
record that discloses or provides any evidence that points to a
property of the
claimed animals (claims 1-50) such that another non-asserted
utility would be
well established. With respect to claim 51, since it is directed
to a specific
method of use, the utility of this claim is limited to that use and
the examiner
should not look to a "well established utility" for the composition
used in the
claimed method. Consequently, the answer to the question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Here, there is an asserted utility, i.e.,
generally to use the
animals to research human genes from diseased human kidneys and
specifically
to use the animals in a method for screening for potential
causative agents which
trigger or exacerbate Polycystic Kidney Disease.
3) Is the asserted utility specific? The answer to this
question would be
yes. The utility of generally using the animals to research human
genes from
diseased human kidneys clearly does not define a "real world"
context of use but
would require or constitute further research to identify or
reasonably confirm
such a context of use. However, the screening method utility,
which identifies
potential causative agents which trigger or exacerbate Polycystic
Kidney Disease,
is a "specific utility" since it defines a "real world" context of
use.
4) Is the asserted "specific utility" credible? Since the
state of the art is
such that one has no reason to expect abundant cyst formation in
any of the
animals involved in the screening method, the answer to this
question is no,
based on the current record.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made.
Examiner's Rejection
Claims 1-51 are rejected under 35 U.S.C. º 101 because the
claimed
invention is not supported by either a credible asserted utility or
a well
established utility.
Neither the specification as filed nor any art of record
discloses or suggests
any specific property or activity for the animals such that a
utility would be well
established for the animals.
With regard to the asserted use of the animals as disease
models, the action
of the human DNA compounds on the animals is not specifically known
and the
mere assertion that abundant cyst formation will be observable in
any of the
claimed animals would not be accepted by one skilled in the art as
being
reasonable or credible in view of the contemporary knowledge in the
art. As
discussed by Cable et al. (a 1995 reference) (Note, this reference
is fictitious),
while extensive studies have been conducted, the only clear results
are from
Mendelian studies of families which exhibit the disease. These
studies indicate
that the disease is inheritable and dominant, as opposed to
recessive, via
statistical analysis. No study has clearly indicated that a single
DNA component
is involved. No chromosomal loci has been identified. The
possibility of a
regulatory mechanism being involved has not been ruled out by any
of the studies
conducted to date. No specific protein or abnormal level of a
specific protein has
been associated with the disease. The expectation that any of the
claimed animals
will exhibit the abundant cyst formation based on the presence of a
single,
unidentified DNA compound is not credible. Nothing in the current
record alters
this assessment of the state of the art at the time of filing.
Claims 1-51 are also rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a credible
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
Attorney Arguments Only (Alternative I)
Claims 1-51 have been rejected by the examiner under 35 U.S.C.
º 101
and 35 U.S.C. º 112, 1. The examiner asserts that a credible
utility has not
been disclosed. Reconsideration under 37 CFR 1.111 is requested.
The use of these animals to study DNA and polycystic kidney
disease via
observing abundant cyst formation is credible. This utility is
directly analogous
to that of US Patent # 4,736,866 to Leder et al. in which human DNA
compounds associated with tumor formation are contained in the
genomes of non-
human animals and these animals are used to study the human DNA
compounds
and tumor formation as well as tumor treatment. Obviously, such an
important
medical research utility as exists for the current claimed
invention is a patentable
utility. The claimed animals contain DNA compounds which are
associated with
human cells which exhibit the specific disease, just as they were
in the Leder et
al. patent. It is more than credible that the cells which exhibit
the disease will
contain the faulty DNA and that the claimed animals will likely
exhibit the
disease due to the presence of DNA from diseased cells.
Examiner's Response to Attorney Arguments Only (Alternative I)
Claims 1-51 are rejected under 35 U.S.C. º 101 because the
claimed
invention is not supported by either a credible asserted utility or
a well
established utility for the reasons of record.
Claims 1-51 are rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a credible
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the invention.
Applicants analogize the current specification, animals and
intended
utilities to those of Leder et al. US Patent # 4,736,866. The
situations are in
fact not analogous. The specific embodiment of the specific MYC
oncogene in
the Leder et al. patent involved a well-established oncogene.
There is no
question in the art that the particular DNA compound had been
directly
associated with tumor formation in humans. Moreover, the specific
mice
exhibited in the Leder et al. specification exhibit tumor
formation. This is not a
point of speculation in that fact pattern.
Applicants have not provided any evidence to counter the Cable
et al.
reference and its characterization of the state of the art with
regard to DNA
compounds and the human polycystic kidney disease. It does not
directly follow
that a diseased cell will necessarily contain "culprit" DNA as
asserted by
Applicants. This is particularly true of cDNA compounds as used
herein, where
no protein effect is associated with the disease. Thus, even if
one were to accept
the premise that the diseased cell must contain the genetic flaw,
focusing on
cDNA necessarily excludes the greater part of DNA contained in the
diseased
cell. Applicants' arguments have been considered, but are not
deemed
persuasive.
Attorney Arguments with Evidence (Alternative II)
Claims 1-51 have been rejected by the examiner under 35 U.S.C.
º 101
and 35 U.S.C. º 112, 1. The examiner asserts that a credible
utility has not
been disclosed. Reconsideration under 37 CFR 1.111 is requested.
In support of applicant's statement of utility, attached hereto
is a
declaration submitted under 37 CFR 1.132 by the inventors which
exhibits a
mouse corresponding to the animal of claim 38 which has exhibited
abundant cyst
formation. This effect has been confirmed as evidenced in the
declaration, by the
production of three additional founder mice which carry DNA
Sequence ID #38
as a transgene and have exhibited abundant cyst formation. In
addition, these
mice have been cross-bred and some of their progeny exhibit the
abundant cyst
formation as well. (For purposes of this example, it is presumed
that the
evidenced is factual as stated here.)
Based on this evidence clearly the use of the claimed animals
to screen for
agents which trigger or exacerbate the disease condition is
credible.
Examiner's Response to Attorney Arguments with Evidence
(Alternative II)
The examiner should withdraw the rejections based on lack of
credible
utility in light of this evidence.
Example 11: Receptors
Specification: The specification discloses a protein isolated from
a cell
membrane preparation which is the binding partner for protein X but
does not
characterize the isolated protein regarding its biological function
or any disease
or body condition that is associated with the isolated protein.
Based solely on the
facts that the protein was isolated from a cell membrane and it
binds to protein X,
applicant characterizes the isolated protein as receptor A. The
function of
protein X has also not been identified. There is disclosed a
binding assay for
determining other materials which bind to the receptor by adding
the material to
the complex of receptor A and protein X and determining the amount
of
inhibition of the binding of the complex as an indication that the
material will
bind to the receptor and thus be a therapeutic drug to effect
control over the
receptor. Also disclosed is the production of a monoclonal
antibody which
specifically binds to receptor A. There are no working examples
using any
materials to demonstrate such inhibition of binding, to assay the
receptor or to
identify of any other material which binds to the receptor. The
utility disclosed is
for identifying materials which bind the receptor and the potential
use of such
materials as therapeutics.
Claims:
1. Isolated receptor A.
2. A method of identifying materials which bind to receptor A
comprising:
a) forming a complex of receptor A and protein X in a liquid;
b) adding a material to be screened to said complex
c) determining the amount of binding of said complex wherein an
inhibition of
said binding is an indication that said material binds to said
receptor.
3. A monoclonal antibody which specifically binds to receptor A.
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts. For this fact situation, each claim will be analyzed
separately.
Claim 1:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to a property of the claimed receptor such that another
non-asserted
utility would be well established. Additionally, there is no art
of record that
discloses or provides any evidence that points to a property of the
claimed
receptor such that another non-asserted utility would be well
established.
Consequently, the answer to the question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Here, there is an asserted utility for the
claimed invention. In
fact, for claim 1 there are two asserted utilities, i.e. a) a
method of identifying
materials which bind to receptor A, and b) a method of making a
monoclonal
antibody.
3) Is the asserted utility specific? The answer to this
question in each case
is no. The method in 2a) above essentially is a method of
identifying a material,
i.e., those materials which bind to receptor A. Thus, to determine
whether or
not this method is a "specific utility", it must be determined
whether or not the
material that binds to receptor A itself has a "specific utility".
Here, the only
utility asserted for the identified materials is a therapeutic to
effect control over
receptor A. Since neither the specification nor the art of record
disclose any
diseases or conditions associated with receptor A, the asserted
utility in this case
essentially is a method of treating an unspecified, undisclosed
disease or
condition, which does not define a "real world" context of use.
Treating an
unspecified, undisclosed disease or condition clearly would require
or constitute
carrying out further research to identify or reasonably confirm a
"real world"
context of use. Since the asserted utility for the identified
materials does not
define a "real world" context of use, a method of identifying such
materials also
could not define a "real world" context of use.
The method in 2b) above essentially is a method of making a
material, i.e.,
a monoclonal antibody. Thus, to determine whether or not this
method is a
"specific utility", it must be determined whether or not the
monoclonal antibody
itself has a "specific utility". Here, there is an asserted
utility for the monoclonal
antibody even though it is not explicit, i.e., as a therapeutic
drug to effect control
over the receptor. However, since neither the specification nor
the art of record
disclose any diseases or conditions associated with receptor A, the
asserted utility
in this case essentially is a method of treating an unspecified,
undisclosed disease
or condition, which does not define a "real world" context of use.
Treating an
unspecified, undisclosed disease or condition clearly would require
or constitute
carrying out further research to identify or reasonably confirm a
"real world"
context of use. Since the asserted utility for the product
(monoclonal antibody)
does not define a "real world" context of use, a method of making
such a product
also could not define a "real world" context of use.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made on claim 1.
Claim 2:
1) Based on the record, is there a "well established utility"
for the claimed
invention? Since the claim is directed to a specific method of
use, the utility of
this claim is limited to that use and the examiner should not look
to a "well
established utility" for the composition used in the claimed
method.
Consequently, the answer to the question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Here, there is an asserted utility for the
claimed invention,
i.e., a method of identifying materials which bind to receptor A.
3) Is the asserted utility specific? The answer to this
question is no.
Specifically, the method essentially is a method of identifying a
material, i.e.,
those materials which bind to receptor A. Thus, to determine
whether or not this
method is a "specific utility", it must be determined whether or
not the material
that binds to receptor A itself has a "specific utility". Here,
the only utility
asserted for the identified materials is a therapeutic to effect
control over receptor
A. Since neither the specification nor the art of record disclose
any diseases or
conditions associated with receptor A, the asserted utility in this
case essentially
is a method of treating an unspecified, undisclosed disease or
condition, which
does not define a "real world" context of use. Treating an
unspecified,
undisclosed disease or condition clearly would require or
constitute carrying out
further research to identify or reasonably confirm a "real world"
context of use.
Since the asserted utility for the identified materials does not
define a "real
world" context of use, a method of identifying such materials also
could not
define a "real world" context of use.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made on claim 2.
Claim 3:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to a property of the claimed monoclonal antibody such
that another
non-asserted utility would be well established. Additionally,
there is no art of
record that discloses or provides any evidence that points to a
property of the
claimed monoclonal antibody such that another non-asserted utility
would be well
established. Consequently, the answer to the question is no.
2) Has applicant made any assertion of utility for the
specifically claimed
invention? Here, there is no explicitly asserted utility for the
claimed monoclonal
antibody. However, as stated in the analysis of claim 1 above,
there is an
asserted utility for the monoclonal antibody even though it is not
explicit, i.e., as
a therapeutic drug to effect control over the receptor.
3) Is the asserted utility specific? The answer to this
question is no.
Specifically, since neither the specification nor the art of record
disclose any
diseases or conditions associated with receptor A, the asserted
utility in this case
essentially is a method of treating an unspecified, undisclosed
disease or
condition, which does not define a "real world" context of use.
Treating an
unspecified, undisclosed disease or condition clearly would require
or constitute
carrying out further research to identify or reasonably confirm a
"real world"
context of use.
Thus, in any case, the conclusion that can be reached from this
analysis is
that both a 35 U.S.C. º 101 rejection and a 35 U.S.C. º
112, first paragraph,
utility rejection should be made on claim 3.
Let us assume for the moment that the specification also
discloses that
receptor A is present in the cell membranes of melanoma cells but
not on the cell
membranes of normal skin cells. Assume also that the examiner has
found and
made of record an old journal article indicating that it is
desirable to selectively
detect melanoma cells as opposed to normal skin cells so as to
diagnose that type
of cancer. Does this change the above analysis?
For each of the claims, the above analysis changes right from
the first
question: Based on the record, is there a "well established
utility" for the
claimed invention? The answer to this question would change to yes
in each
case. Specifically, based on this record, there is a "well
established utility" for
the products of claims 1 and 3. The "well established utility" for
the receptor A
is a method of making a monoclonal antibody and the "well
established utility"
for the monoclonal antibody is for use in diagnosing melanoma.
Such utilities are
"well established" because the disclosure of the properties of the
receptor and
antibody taken together with the knowledge of one skilled in the
art at least
implies that these utilities were contemplated. With respect to
claim 2, since
there is now evidence of record providing a correlation between
this method and
diagnosing melanoma, i.e., materials identified by the method, such
as the
monoclonal antibody, can be used to diagnose melanoma, this method
now has a
"well established utility".
Therefore, the conclusion that can be reached with this fact
pattern is that
utility rejections under 35 U.S.C º 101 rejection and a 35
U.S.C. º 112, first
paragraph, should not be made against claims 1-3.
Example 12: Large Chemical Groups
Specification: The specification discloses a large genus of
chemical compounds
having the formula:
R1 R2
A - B
R3 R4
The specification teaches the chemical synthesis methods necessary
to make the
compounds but does not disclose any chemically similar compounds.
The
specification provides several paragraphs describing basic
experimental methods
with known materials and suggests testing the claimed compounds in
the same
methods so as to ascertain the physical, chemical and biological
properties of the
claimed compounds. The only utility mentioned in the specification
is that the
compounds could be used for biomedical research once the physical,
chemical
and biological properties of the compounds have been determined.
Claims:
1. Compounds having the formula:
R1 R2
A - B
R3 R4
Analysis: The following analysis includes the questions that need
to be asked
according to the guidelines and the answers to those questions
based on the above
facts:
1) Based on the record, is there a "well established utility"
for the claimed
invention? The specification as filed does not disclose or provide
any evidence
that points to a property or activity of the claimed compounds such
that another
non-asserted utility would be well established. Additionally, the
art of record
does not disclose or provide any evidence that points to a property
or activity of
the claimed compounds such that another non-asserted utility would
be well
established. Consequently, the answer to the question is no.
2) Has the applicant made any assertion of utility for the
specifically
claimed invention? Here, there is an asserted utility, i.e., the
claimed
compounds can be used in biomedical research once the physical,
chemical and
biological properties of the compounds have been determined.
3) Is the asserted utility specific? The answer to this
question would be
no. Biomedical research and even experimental methods for
determining the
physical, chemical, and biological properties of the compounds
themselves are
unspecified and do not define a "real world" context of use. Such
utilities clearly
would require or constitute carrying out further research to
identify or reasonably
confirm a "real world" context in which the compounds could be
used.
Thus, the conclusion that can be reached from this analysis is
that both a
35 U.S.C. º 101 rejection and a 35 U.S.C. º 112, first
paragraph, utility
rejection should be made.
Examiner's Rejection
Claim 1 is rejected under 35 U.S.C. º 101 because the
claimed invention is
not supported by either a specific asserted utility or a well
established utility.
The claimed compounds are not supported by either a specific
asserted
utility or a well established utility because the specification
states only that the
compounds are useful for biomedical research, and neither the
specification as
filed nor any art of record discloses or suggests any property or
activity for the
compounds such that another non-asserted utility would be well
established for
the compounds. The biomedical research contemplated by applicants
is
unspecified. It will take place at some future time, only when the
properties of
the claimed compounds have been elucidated by the experimental
methods
disclosed in applicants' specification. Absent a disclosure of
those properties, the
asserted utility of biomedical research lacks specificity. Note,
because the
claimed invention is not supported by a specific asserted utility
for the reasons set
forth above, credibility cannot be assessed.
Claim 1 is also rejected under 35 U.S.C. º 112, first
paragraph.
Specifically, since the claimed invention is not supported by
either a specific
asserted utility or a well established utility for the reasons set
forth above, one
skilled in the art clearly would not know how to use the claimed
invention.
--42--
