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.
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