Ex Parte Seul

Board of Patent Appeals and Interferences

Dec 20, 2007

10645426 (B.P.A.I. Dec. 20, 2007)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MICHAEL SEUL
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Appeal 2007-3274
Application 10/645,426
Technology Center 1600
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Decided: December 20, 2007
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Before ERIC GRIMES, LORA M. GREEN, and NANCY J. LINCK,
Administrative Patent Judges.

LINCK, Administrative Patent Judge.

DECISION ON APPEAL
This is a 35 U.S.C. § 134 appeal in the above-referenced case.1
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The application was filed June 21, 2003. The real party in interest is
BioArray Solutions Ltd.
Appeal 2007-3274
Application 10/645,426

STATEMENT OF THE CASE
The field of the invention is materials science and analytical
chemistry. The claimed subject matter is reflected in the following
representative claim:
76. An array of several different particle-attached ligands,
wherein different ligands are attached to different particles
and said particles are encoded with a chemical or physical
characteristic that permits identification of the ligand or
ligands attached thereto and permits distinguishing of
particles having different ligands attached thereto from each
other, and wherein said particles are in a planar defined area
on the surface of a substrate and wherein said particles are
affixed to said substrate.
The Examiner has rejected claims 76-92 under 35 U.S.C. § 103(a) as
follows:
I. Claims 76-84 and 86-90 based on Margel, U.S. Patent 5,652,059
(Jul. 29, 1997)2 and Singer et al, U.S. Patent 5,573,909 (Nov. 12, 1996).
II. Claim 85 based on Margel, Singer, and Nacamulli et al, U.S. Patent
5,527,710 (Jun. 18, 1996); and
III. Claims 91 and 92 based on Margel, Singer, and Gombinski, U.S.
Patent 6,297,062 B1 (Oct. 2, 2001).
The Examiner also has rejected claims 81-83 under 35 U.S.C. § 112,
¶ 2.
These claims read:
81. An array of proteins according to claim 78, wherein
different proteins bind to different cell types.
82. The array of proteins according to claim 78, wherein the
proteins are monoclonal antibodies.

2 The dates in the citations to patents are issue dates.
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83. An array of oligonucleotides according to claim 79
wherein the nucleic acids are DNA or RNA.
Claims 78 and 79 upon which these claims depend read:
78. The array of claim 76 wherein the ligands are proteins.
79. The array of claim 76 wherein the ligands are nucleic
acids.
OBVIOUSNESS UNDER § 103(a)
The § 103(a) Issues
I. Claims 76-84 and 86-90 based on Margel and Singer:
Appellant contends Margel does not disclose “different particles . . .
are encoded with a chemical or physical characteristic that permits
identification of the ligand or ligands attached thereto and permits
distinguishing of particles having different ligands attached thereto from
each other” (claim 76). He further contends Margel does not disclose
particles “in a planar defined area of the surface of a substrate” (id.). With
respect to Singer, Appellant contends this reference does not disclose or
suggest encoded microparticles “having different ligands attached thereto
from each other” (id.). (Brief on Appeal (rec’d Sep 15, 2006) (hereafter
“App. Br.”) 4-5.)
The Examiner responds Margel teaches particles coated with different
ligands and discloses “at least two different micropheres each having
different ligands coated thereon” (Supplemental Examiner’s Answer (mailed
April 12, 2007) (hereafter “Ans.”) 8 (citing Margel, col. 2, l. 35 to col. 3, l.
5).) With respect to the “planar” issue, the Examiner points out that
Margel’s substrate can be a glass disc or a polypropylene film (id. (citing
examples 1, 6, and 20)). Responding to Appellant’s argument based on
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Singer, the Examiner finds “Singer teaches that encoded microparticles can
be distinguished individually; and that encoded microparticles having
different ligand/target complement attached thereto are distinguishable from
each other;” more specifically, Singer teaches microparticles “encoded or
coated with a mixture of dyes that emits a detectably distinct spectral
characteristic” (id. at 10 (citing Singer, col. 16, l. 54 to col. 17, l. 11)).
II. Claim 85 additionally requires the substrate to be a semiconductor
electrode. The Examiner additionally cites Nacamulli for this limitation.
Appellant contends Nacamulli does not “disclose or suggest encoded,
distinguishable particles” (App. Br. 6). The Examiner points out that
Nacamulli is relied upon for the "teaching of a semiconductor substrate such
as an electrode, not encoded, distinguishable particles" (Ans. 10). Thus,
resolution of Issue I (supra pp. 3-4) will also resolve this issue.
III. Claims 91 and 92 further require “two or more of any of the
arrays defined in claim 76 to 90" and "the location of each array on said
substrate in combination with the chemical or physical characteristic
indicates the types of ligands therein,” respectively. The Examiner
additionally cites Gombinski to address this limitation.
Appellant contends Gombinski does not address the deficiencies of
Margel and Singer with respect to claim 76, upon which these two claims
depend (App. Br. 8). Appellant further argues the three references’
combination “would not make sense” because of “the vast differences in
subject matter and encoding methods in each” (id.). Again, the resolution of
Issue I will substantially resolve this issue as well.
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Based on the contentions of Appellant and the Examiner, we frame
the issue for decision as follows: Would there have been reason to combine
the cited references, as done by the Examiner? And, if so, would the
teachings of Margel and Singer have suggested to the skilled artisan an array
of “different particles … encoded with a chemical or physical characteristic
that permits identification of the ligand or ligands attached thereto and
permits distinguishing of particles having different ligands attached thereto
from each other” arranged in a “planar defined area . . . of a substrate”?
We discuss these issues with reference to representative claim 76.
Findings of Fact Relating to Obviousness
1. Claim 76 is to an “array of several different particle-attached
ligands” (claim 76).
2. Giving claim 76 its broadest reasonable interpretation, the various
references to “particles” and “ligands” refer to these entities as part of the
claimed “particle-attached ligands” (see claim 76).
3. Thus, claim 76 requires the claimed particle-attached ligands to be
composed of “different particles” and “different ligands,” to be
distinguishable from each other, and to be “affixed” to a planar defined area
on the “surface of a substrate” (claim 76).
4. Margel discloses “a solid substrate having covalent bonds to . . . at
least one species of microspheres containing residual reactive functions” on
the “outermost layer” of the microspheres (col. 2, ll. 36-48).
5. Margel’s “covalent bonds . . . may be provided by a ligand denoted
‘(A)’, and the adjoining layers of the multiplicity of layers may be
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covalently linked together by a connecting ligand denoted ‘(B)’, the ligands
(A) and (B) being the same or different from each other” (col. 2, ll. 48-53).
6. Margel discloses the microspheres “may consist of substantially a
single species, or alternatively may consist of more than one species” (col. 2,
l. 61 to col. 3, l. 4).
7. Margel discloses affixing microparticles to a glass disc,
polyethylene or polypropylene film, or “Eliza [sic, ELISA] titer plates” (e.g.,
Examples 1-6, 8-9, 20, and 31) or to semiconductive materials such as
silicon (col. 3, ll. 44-49 & Example 7).
8. Margel teaches that the use of microsphere particles in ELISA
improves the detection limits (col. 12, ll. 9-12) and therefore would have
suggested the advantages of combining his teachings with other prior art.
9. Thus, Margel discloses or would have suggested an “array of
several different particle-attached ligands” (FF 4-6) and further discloses or
would have suggested affixing the particles in a “planar defined area on the
surface of a substrate” (FF 7).
10. Margel is not relied upon for teaching or suggesting the claim 76
recitation “particles encoded with a chemical or physical characteristic that
permits identification of the ligand or ligands attached thereto and permits
distinguishing of particles having different ligands attached thereto from
each other” (see Ans. 4).
11. Singer discloses an improvement upon the prior art methods of
“detecting multiple analytes in a single sample using . . . two or more
different fluorescent labels . . . detected at different wavelengths, where each
emission spectrum is characteristic of a single analyte” (col. 2, ll. 13-21).
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12. According to Singer, the challenge of these prior art methods was
to obtain good separation of the fluorescent emission peaks when materials
excited at the same wavelength and the Stokes shifts were small (col. 2, ll.
20-29).
13. Singer addresses this challenge by “labeling one or more target
materials using surface coated fluorescent microparticles,” each having “an
external substance or coating (target complement) that is selective for each
target material and an internal mixture of multiple fluorescent dyes to allow
for controlled enhancement of the effective Stokes shift of the microparticle”
(col. 4, ll. 37-57).
14. Singer’s “microparticles, when used with a surface material that
is selective for target molecules, provide labels having excitation and
emission characteristics . . . useful for the detection of specified target
molecules or combinations of target molecules” (col. 3, ll. 48-53).
15. “When more than one material is targeted simultaneously,
multiple target complements (one for each target material) are optionally
included on one microparticle or on multiple microparticles. . . .
[M]icroparticles having detectably distinct spectral characteristics are used
for each target material, with each individual microparticle being labeled
with a different target complement” (col. 16, ll. 54-61; see also col. 16, l. 62-
col. 17, l. 11 & Ans. 10).
16. Thus, Singer discloses or suggests “particles encoded with a
chemical or physical characteristic that permits identification of the ligand or
ligands attached thereto and permits distinguishing of particles having
different ligands attached thereto from each other,” i.e., different target
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materials affixed to substrate and labeled with multiple fluorophore ligands
that permit the ligands and therefore the different target materials, or
particles, to be distinguished from each other (FF 11-15).
17. Both Margel and Singer disclose their microspheres as useful in
detecting and analyzing target materials (see FF 4-9, 11-16) and thus would
have suggested their combination, with a reasonable likelihood of success.
Discussion of the § 103(a) Issue
Based on our findings and those of the Examiner, we find the skilled
artisan at the relevant time would have had reason to combine the cited
references (FF 4-9, 11-16). Both Margel and Singer disclose the use of
microparticles to detect target materials in assays, and both describe the
advantages of their techniques. Thus, one skilled in the art, wanting to adapt
the teachings of Singer to a planar surface, would have recognized merit in
their combination. Alternatively, the skilled artisan, wanting to utilize the
teachings of Margel to distinguish different particles from each other, would
have reason to look to Singer. “When there is a design need or market
pressure to solve a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads to the
anticipated success, it is likely the product not of innovation but of ordinary
skill and common sense. In that instance the fact that a combination was
obvious to try might show that is was obvious under § 103.” KSR Int’l Co.
v. Teleflex Inc., 127 S. Ct. 1727, 1742 (2007).
We further find the combined teachings of Margel and Singer would
have suggested to the skilled artisan an array of “different particles . . .
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encoded with a chemical or physical characteristic that permits identification
of the ligand or ligands attached thereto and permits distinguishing of
particles having different ligands attached thereto from each other” arranged
in a “planar defined area . . . of a substrate” (FF 7, 16).
Appellant’s arguments to the contrary have been considered but fail to
convince us the Examiner erred in concluding claim 76 would have been
obvious to the skilled artisan. In this regard, we adopt and rely on the
Examiner’s responses to Appellant’s arguments (see Ans. 7-12, particularly
Ans. 10; see also FF 1-9, 11-16).
All Appellant’s arguments are based upon the limitation of claim 76,
i.e.,“different ligands are attached to different particles and said particles are
encoded with a chemical or physical characteristic that permits identification
of the ligand or ligands attached thereto and permits distinguishing of
particles having different ligands attached thereto from each other” (App.
Br. 6-8; Reply to Supplemental Examiner's Answer 1-4). Accordingly, we
affirm the § 103(a) rejections of all the claims for the reason given above.

PATENTABILITY UNDER § 112, ¶ 2
The Indefiniteness Issues
The Examiner finds claims 81-83 indefinite under § 112, ¶ 2 due to
lack of antecedent basis for the terms “proteins” (claims 81 and 82) and
“oligonucleotides” (claim 83) (Ans. 3). According to the Examiner, these
terms are “inconsistent with what is recited in the preamble of claims 76, 78
or 79, ‘an array of several different particle-attached ligands’” (Ans. 7). The
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Examiner also takes issue with the introductory phrase “An array” rather
than “The array” (claims 81 and 83) (Ans. 3).
Appellant argues claims 81 and 82 depend on claim 78, “which recites
that the ligands of claim 76 are proteins” (App. Br. 3). He further argues
that claim 83 depends on claim 79, “which recites that the ligands of claim
76 are nucleic acids” (id.). Finally, he argues “An array” does not need to be
changed to “The array” (id. at 4).
In view of these conflicting positions, we frame the § 112, ¶ 2 issue
as follows: Do these claim terms provide sufficient antecedent basis such
that claims 81-83 particularly point out and distinctly claim that which
Appellant regards as his claimed invention?
Discussion of the Indefiniteness Issues
During prosecution, claims can be amended to more clearly point out
and distinctly claim the subject matter an applicant regards as his or her
invention. Thus, if claim language introduces uncertainty into the claim’s
interpretation, it must be clarified during prosecution to avoid issues during
potential litigation down the road. Our reviewing court has made this clear:
During patent examination the pending claims must be
interpreted as broadly as their terms reasonably allow. When
the applicant states the meaning that the claim terms are
intended to have, the claims are examined with that meaning,
in order to achieve a complete exploration of the applicant's
invention and its relation to the prior art. . . . The reason is
simply that during patent prosecution when claims can be
amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.
In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir. 1989).
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In this case, while “protein” clearly has antecedent basis in the claim
from which it depends, the same cannot be said of “oligonucleotide,”
appearing for the first time in claim 83. A ligand could be a single nucleic
acid without being an oligonucleotide. Thus, with respect to these claim
terms, we disagree with the Examiner regarding the term “protein” but agree
with the Examiner regarding the term “oligonucleotide.”
With respect to the introductory phrase “An array” appearing in
claims 81 and 83, we agree with the Examiner this phrase renders these
claims unpatentable under § 112, ¶ 2. Appellant cannot have it both ways—
if there is antecedent basis for the claimed arrays, then “The” is the
appropriate term for referring back to them, not “An.”
Thus, we affirm the § 112, ¶ 2 rejection of claims 81 and 83 and
reverse the § 112, ¶ 2 rejection of claim 82.
CONCLUSION
We affirm the § 103(a) rejections of claims 76-92. We also affirm the
§ 112, ¶ 2 rejection of claims 81 and 83. We reverse the § 112, ¶ 2 rejection
of claim 82.

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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED

Ssc:

ERIC P. MIRABEZ
BIOARRY SOLUTIONS LLC
35 TECHNOLOGY DRIVE
WARREN, NJ 07059
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