Ex Parte Lalgudi et al

Board of Patent Appeals and Interferences

Sep 21, 2010

11239592 (B.P.A.I. Sep. 21, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RAGHUNATH V. LALGUDI,
PHILIP W. MILLER, and KEITH O’CONNELL
__________

Appeal 2010-002589
Application 11/239,592
Technology Center 1600
__________

Before DONALD E. ADAMS, MELANIE L. MCCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
substantially purified nucleic acid molecule and a transformed cell. The

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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Patent Examiner rejected the claims as indefinite, lacking both utility and
enablement, and failing to comply with the written description requirement.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The invention concerns “nucleic acid sequences from the unicellular
green algae, Chlorella vulgaris.” (Spec. 1, l. 10).
Claims 1, 2 and 4-21 are on appeal. Claims 1, 8 and 9 are
representative and read as follows:
1. A substantially purified nucleic acid molecule comprising the nucleic
acid sequence of SEQ ID NO: 9 or the complete complement thereof,
wherein said nucleic acid molecule encodes an algal protein or fragment
thereof.

8. A substantially purified nucleic acid molecule comprising a nucleic
acid sequence wherein said nucleic acid sequence:
(a) hybridizes under high-stringency conditions to a nucleic acid
sequence of SEQ ID NO: 9 or the complete complement thereof, or
(b) shares 90% or greater identity with a nucleic acid sequence of
SEQ ID NO: 9 or the complete complement thereof.

9. The substantially purified nucleic acid molecule of claim 8, wherein
said nucleic acid molecule encodes a[n] algal protein or fragment
thereof.

The Examiner rejected the claims as follows:
• claims 8-10, 16, and 18-21 under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter regarded as the invention (Ans. 5);
• claims 1, 2, 4-7, and 8-21 under 35 U.S.C. §101 “because the
claimed invention lacks patentable utility” (id.);
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• claims 1, 2, 4-7, and 8-21 under 35 U.S.C. § 112, first paragraph as
lacking enablement “because the claimed invention is not supported by
either a specific and substantial asserted utility or a well established utility
… , one skilled in the art clearly would not know how to use the claimed
invention….”2 (id. at 10); and
• claims 9 and 10 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement (id.).
INDEFINITENESS
The Issue
The Examiner’s position is that independent claims 8 and 16 recite the
term “high-stringency” without providing “an explicit definition in the
specification which clearly defines what such conditions are….” (Ans. 5).
According to the Examiner, it is unclear what conditions are deemed “low,”
“moderate,” and “high” because “no such demarcation can be
determined….” (Id.).
Appellants contend that the description of various hybridization
conditions for the claimed nucleic acid molecules in the Specification, along
with the knowledge available to a skilled artisan at the time of the invention
would have “adequately advise[d] those skilled in the art of the metes and
bound of the claimed invention.” (App. Br. 19).
The issue with respect to this rejection is whether the term “high-
stringency” renders claims 8-10, 16, and 18-21 indefinite.

2 The Examiner made a typographical error by not including claims 8-21 in
the enablement rejection (see Ans. 10, fn 3), as acknowledged by Appellants
(see App. Br. 9).
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Findings of Fact
1. The Specification refers to “conventional ‘high-stringency’
conditions.” (Spec. 15-16.)
2. The Specification states that “[c]onventional stringency conditions are
described by Sambrook, et al., In: Molecular Cloning, A Laboratory
Manual, 2nd Edition, Cold Spring Harbor Press … (1989), and by Haymes,
et al. In: Nucleic Acid Hybridization, A Practical Approach, IRL Press …
(1985) . . . .” (Id. at 16, ll. 1-6).
3. The Specification states that “[a]ppropriate stringency conditions
which promote DHA hybridization … are known to those skilled in the art
or can be found in Current Protocols in Molecular Biology, John Wiley &
Sons, N.Y. (1989).” (Id. at 16, ll. 12-15)
4. The Specification describes examples of low and high stringency
conditions. (Id. at 16, ll. 12-20).
Principles of Law
The test for definiteness under 35 U.S.C. § 112, second paragraph, is
whether “those skilled in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics, Inc. v. Safety
Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations
omitted).
Analysis
We agree with Appellants that a person of ordinary skill in the art at
the time the invention was made would have understood “high-stringency”
hybridization conditions, in light of the Specification as well as the
knowledge available in the art. In particular, the Specification refers to
“conventional ‘high-stringency’ conditions” (FF-1) indicating that such
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conditions are not new or unknown conditions, but rather, known in the art.
Additionally, the Specification cites a manual describing conventional
stringency conditions and a reference describing nucleic acid hybridization.
(FF-2). The Specification also states that “[a]ppropriate stringency
conditions which promote DNA hybridization … are known to those skilled
in the art or can be found in Current Protocols in Molecular Biology, John
Wiley & Sons, N.Y. (1989).” (FF-3). Further, the Specification provides
examples of such stringency conditions. (FF-4).
We find this disclosure to be informative such that one of ordinary
skill in the art would understand which nucleic acid sequences hybridize
under “high-stringency” conditions, as recited in the claims. See
Orthokinetics, Inc., 806 F.2d at 1576.
UTILITY
The Issue
The Examiner’s position is the claimed invention is not supported by
a specific asserted utility because the disclosed uses of the nucleic acid
molecules are “generally applicable to any nucleic acid.” (Ans. 7). In
particular, the Examiner found that the Specification discloses that the
nucleic acid molecules “may be useful as probes in an array (pp. 106),
screen for polymorphisms (pp. 101), gene mapping (pp. 101), and to express
a protein (pp. 53), which would be used to make the corresponding
antibodies, and for numerous other generic genetic engineering usages.”
(Id.). According to the Examiner, “[t]hese are non-specific uses that are
applicable to nucleic acids in general and [are] not particular or specific to
the nucleic acids being claimed.” (Id.). Additionally, the Examiner
determined that the claimed molecules are not supported by a substantial
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utility because the invention is only a subject for research to find a “real
world” use. (Id. at 8-9).
Appellants contend that “the utilities asserted in the specification must
be accepted as factually sound unless the Office cites information that
undermines the credibility of the assertion.” (App. Br. 21). Further,
Appellants assert that “the utility of SEQ ID NO: 9, as asserted in the
specification, is further supported by a reasonable correlation to other
sequences.” (Id. at 22). In particular, Appellants assert that BLASTN
results show that the claimed nucleic acid molecules exhibit a high
homology to both the nucleic acid sequence from Chlamydomonas
reinhardtii (green algae) exposed to high levels of light, and also to a major
light-harvesting complex II protein m10 isolated from Scendesmus obliquus.
(Id. 22-24). Appellants assert that the BLASTN analysis confirms that the
nucleotide sequence of SEQ ID NO: 9 “can be used, for example, to isolate
genes, map genes, and determine gene function associated with algae
photosynthesis.” (Id. at 23). According to Appellants, they “are entitled to
provide documentary evidence that the utility set forth in the specification is
a patentable utility.” (Id. at 24).
The issue with respect to this rejection is whether the claimed
compounds have a disclosed or well-established specific and substantial
utility.
Findings of Fact
5. We adopt the Examiner’s findings of fact relating to the
Specification disclosure of uses of the claimed compounds.

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Principles of Law
The basic quid pro quo contemplated by the Constitution and
the Congress for granting a patent monopoly is the benefit
derived by the public from an invention with substantial utility.
Unless and until a process is refined and developed to this
point-where specific benefit exists in currently available form-
there is insufficient justification for permitting an applicant to
engross what may prove to be a broad field.

Brenner v. Manson, 383 U.S. 519, 534-35 (1966).
Courts have used the labels “practical utility” and “real world”
utility interchangeably in determining whether an invention
offers a “substantial” utility. Indeed, the Court of Customs and
Patent Appeals stated that “‘[p]ractical utility’ is a shorthand
way of attributing ‘real-world’ value to claimed subject matter.
In other words, one skilled in the art can use a claimed
discovery in a manner which provides some immediate benefit
to the public.” Nelson [v. Bowler], 626 F.2d [853,] 856 [(CCPA
1980)] (emphasis added). It thus is clear that an application
must show that an invention is useful to the public as disclosed
in its current form, not that it may prove useful at some future
date after further research. Simply put, to satisfy the
“substantial” utility requirement, an asserted use must show that
that claimed invention has a significant and presently available
benefit to the public….
Turning to the “specific” utility requirement, an
application must disclose a use which is not so vague as to be
meaningless. . . . Thus, in addition to providing a “substantial”
utility, an asserted use must also show that that claimed
invention can be used to provide a well-defined and particular
benefit to the public.

In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005).
“It is well established that the enablement requirement of § 112
incorporates the utility requirement of § 101.” Id. at 1378.

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Analysis
We agree with the Examiner that the disclosed uses of the compounds
as probes in an array, to identify polymorphism, in genetic mapping, etc.
(FF-5) are generic genetic engineering uses and not uses specific to the
claimed invention. See Fisher, 421 F.3d at 1371. To the extent that
Appellants attempt to revise this disclosure to include a specific use “to
isolate genes, map genes, and determine gene function associated with algae
photosynthesis, we are not persuaded. (See App. Br. 23, emphasis added).
As the Examiner explained, while the Specification disclosed using the
claimed invention to isolate genes, map genes, and determine gene function,
there is no disclosure “what actual gene they are isolating, or what function
they are assaying for.” (Ans. 19; FF-6). Appellants’ assertion of utility
relating specifically to algae photosynthesis is supported only by correlating
the results of the BLASTN analysis to SEQ ID NO: 9, submitted long after
the filing date of the application (see App. Br. 12-13). The Specification did
not disclose any such correlation. (FF-7). Thus, the BLASTN analysis does
not provide documentary evidence supporting a specific and substantial use
that was set forth in the Specification, contrary to Appellants’ contention
(App. Br. 24). Further, the BLASTN analysis is not evidence that
Appellants disclosed such a use in the Specification.
For the reasons the Examiner set out, we find that the Examiner has
established that the claimed invention lacks specific and substantial utility
and we affirm the rejection. Because the enablement rejection relied upon
the utility rejection, we affirm it also. See Fisher, 421 F.3d at 1378.

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WRITTEN DESCRIPTION
The Issue
The Examiner contends that while SEQ ID NO:9 meets the written
description requirement, “it is not apparent the specification discloses the
full open reading frame of the elected SEQ ID Numbers, rendering the
claims encompass [sic] gene sequences, corresponding sequences from other
species, and full-length cDNA.” (Final Rej. 13.) According to the
Examiner, “[t]he specification provides insufficient written description to
support the genus encompassed by the claim.” (Id.) “With the exception of
SEQ ID NO: 1 [sic, 9], the skilled artisan cannot envision the detailed
chemical structure of the encompassed polynucleotides . . . .” (Id.)
Appellants contend that the Specification satisfies the written
description requirement by “providing a structural feature, namely the
nucleic acid sequence of SEQ ID NO: 9, that distinguishes members of the
claimed genus from non-members.” (App. Br. 42). According to
Appellants, “[t]he presence of other nucleic acids at either end of the recited
sequence, or variations of the recited sequence, will not interfere with the
recognition of a claimed nucleic acid molecule… it either contains the
nucleic acid sequence of SEQ ID No.: 9, or its complement, or it does not.”
(Id. at 43). Appellants contend that “one of ordinary skill in the art would
recognize the function of the protein encoded by the claimed nucleic acid
molecules and would possess the ability to modify the claimed nucleic acid
molecules in such a way as to achieve a functional algal protein or fragment
thereof, as recited in claims 9 and 10.” (Id. at 45.)
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The issue with respect to this rejection is whether the Examiner
established that a person of ordinary skill in the art would not credit
Appellants with possession of the claimed invention.
Findings of Fact
8. The Specification discloses a nucleic acid comprising the sequence of
SEQ ID NO: 9. (Spec. 13).
9. Claims 9 and 10 depend from claim 8 which specifically recites that
the nucleic acid sequence of the claimed substantially purified nucleic acid
molecule “hybridizes under high-stringency conditions to a nucleic acid
sequence of SEQ ID NO: 9 or the complete complement thereof….” (App.
Br. 56-57, Claims App’x).
10. Claim 9 recites that the “nucleic acid molecule encodes a[n] algal
protein or fragment thereof,” and claim 10 further recites that the “algal
protein or fragment thereof is a Chlorella vulgaris protein or fragment
thereof.” (Id.).
Principles of Law
When an Applicant claims a class, the Applicant “must describe that
class in order to meet the description requirement of the statute.” In re
Lukach, 442 F.2d 967, 968 (CCPA 1971). “The adequate written description
requirement . . . serves ‘to ensure that the inventor had possession, as of the
filing date of the application relied on, of the specific subject matter later
claimed by him; how the specification accomplishes this is not material.’”
In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996) (citation omitted). The
amount of description needed to meet the requirement can vary with the
scientific and technologic knowledge already in existence. Capon v. Eshhar,
418 F.3d 1349, 1357 (Fed. Cir. 2005). “It is not necessary that every
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permutation within a generally operable invention be effective in order for
an inventor to obtain a generic claim, provided that the effect is sufficiently
demonstrated to characterize a generic invention.” Id. at 1359.
Analysis
Claims 9 and 10 are directed to nucleic acid molecules that either
hybridize to SEQ ID NO: 9 or share at least 90% identity with SEQ ID NO:
9, “wherein said nucleic acid encodes an algal protein or fragment thereof.”
The Examiner pointed out there is no indication, for example, about where a
full open reading frame coding for a protein might be recognized, and
Appellants do not dispute the omission or argue that reading frame
information would not be needed. Like the Examiner, we see no clues in the
Specification providing guidance for recognizing a protein coding reading
frame, or any other way of distinguishing members of the claimed algal
protein or protein fragment genus from non-algal proteins or protein
fragments. The Examiner aptly referred to a Regents of Univ. of Cal. v. Eli
Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997). (Ans. 10-11.) In that case,
the name human insulin cDNA lacked a description. Id. at 1568-69. Here, a
description of the claimed genus “nucleic acid [that] encodes an algal protein
or fragment thereof” is missing. As the Specification does not provide
sufficient information to allow a person of ordinary skill in the art to
distinguish members of the genus from non-members, the claimed nucleic
acids are not sufficiently described.
Appellants’ argument that SEQ ID NO: 9 distinguishes members of
the claimed genus from non-members is unpersuasive because claims 9 and
10 are not limited to molecules comprising SEQ ID NO: 9 or its
complement. (See App. Br. 42-43). Appellants contention that “one of
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ordinary skill in the art would recognize the function of the protein encoded
by the claimed nucleic acid molecules and would possess the ability to
modify the claimed nucleic acid molecules in such a way as to achieve a
functional algal protein or fragment thereof, as recited in claims 9 and 10”
(id. at 45) is not supported by evidence.
We recognize that “every permutation within a generally operable
invention” does not have to be described. Capon, 418 F.3d at 1359.
However, the claims on appeal are not supported by evidence that
Appellants described a “generally operable invention.” We find that the
Examiner established that a person of ordinary skill in the art would not
credit Appellants with possession of the invention of claims 9 and 10.
Although we affirm the rejection of claims 9 and 10 for lack of
written description, our reasoning differs from the Examiner’s.
Accordingly, we designate the affirmance a new ground of rejection under
37 C.F.R. § 41.50(b).
CONCLUSIONS OF LAW
The term “high-stringency” does not render claims 8-10, 16, and 18-
21 indefinite.
The claimed compounds do not have a disclosed or well-established
specific and substantial utility, and are therefore also not enabled.
A person of ordinary skill in the art would not credit Appellants with
possession of the invention of claims 9 and 10.
SUMMARY
We reverse the rejection of claims 8-10, 16, and 18-21 under
35 U.S.C. § 112, second paragraph, as being indefinite;
we affirm the rejection of claims 1, 2, 4-7, and 8-21 under 35 U.S.C.
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§101;
we affirm the rejection of claims 1, 2, 4-7, and 8-21 under 35 U.S.C.
§ 112, first paragraph as lacking enablement; and
we affirm the rejection of claims 9 and 10 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.

37 C.F.R. § 41.50(b)
Regarding the affirmed rejection(s), 37 C.F.R. § 41.52(a)(1) provides
"[a]ppellant may file a single request for rehearing within two months from
the date of the original decision of the Board."
In addition to affirming the examiner's rejection(s) of one or more
claims, this opinion contains a new ground of rejection pursuant to 37 C.F.R.
§ 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12,
2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR
§ 41.50(b) provides "[a] new ground of rejection pursuant to this paragraph
shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the examiner, in which event the
proceeding will be remanded to the examiner. . . .

(2) Request rehearing. Request that the proceeding be reheard under §
41.52 by the Board upon the same record. . . .

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Should the appellant elect to prosecute further before the examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If the appellant elects prosecution before the examiner and this does
not result in allowance of the application, abandonment or a second appeal,
this case should be returned to the Board of Patent Appeals and Interferences
for final action on the affirmed rejection, including any timely request for
rehearing thereof.
AFFIRMED

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