Ex Parte Petrescu et al

Board of Patent Appeals and Interferences

May 20, 2011

10959600 (B.P.A.I. May. 20, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/959,600 10/07/2004 Stefana M. Petrescu 080618-0355 2027
22428 7590 05/23/2011
FOLEY AND LARDNER LLP
SUITE 500
3000 K STREET NW
WASHINGTON, DC 20007
EXAMINER
SAIDHA, TEKCHAND
ART UNIT PAPER NUMBER
1652
MAIL DATE DELIVERY MODE
05/23/2011 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte STEFANA M. PETRESCU, COSTIN I. POPESCU and
RAYMOND A. DWEK
____________

Appeal 2010-002359
Application 10/959,600
Technology Center 1600
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 8, 10, 13, 14, 18,
and 24-30 (App. Br. 5).
1
We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to an isolated polynucleotide (claims 8, 10,
24, and 26-29), an isolated host cell (claim 13, 14, 25, and 30), and a method
for making a tyrosinase mutant (claim 18).

1
Pending “[c]laims 1-7, 11-12, 15-17, and 19-23 are withdrawn from
consideration” (App. Br. 5).
Appeal 2010-002359
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2
Claim 8 is representative and is reproduced below:
8. An isolated polynucleotide encoding a tyrosinase mutant, wherein
the tyrosinase mutant is capable of accumulating in the endoplasmic
reticulum and:
(a) lacks a transmembrane domain; or
(b) lacks the consensus sequence Asn-Arg-Thr by mutating Asn at
position 86 in wild type tyrosinase.

The rejections presented by the Examiner follow:
1. Claims 8, 10, 13, and 14 stand rejected under 35 U.S.C. § 112, second
paragraph, as indefinite.
2. Claims 8, 10, 13, 14, 18, and 24-30 stand rejected under the written
description provision of 35 U.S.C. § 112, first paragraph.
2

We affirm.

Written Description:
The Examiner found that Appellants’ September 26, 2007 and
December 6, 2007 amendments introduced new matter into Appellants’
Specification (see Ans. 3). As a result, the Examiner objected to the
amendments under 35 U.S.C. § 132(a) (id.). Specifically, the Examiner
found that the amendments introduced the following material into
Appellants’ Specification, which is not supported by their original
disclosure: (1) “[t]he reference of Ujvari et al., J. Biol. Chem., 276:5924-

2
We recognize the Examiner’s separate rejection of claims 8, 13, and 18
under the written description provision of 35 U.S.C. § 112, first paragraph
(Ans. 3-5). We find this rejection to be cumulative to the written description
rejection of claims 8, 10, 13, 14, 18, and 24-30 as containing new matter.
Accordingly, we have considered the two written description rejections on
this record together.
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5931 (2001)” (2) the “change of position of the mutant from position 81 to
86”, and (3) “the sequence of SEQ ID NO: 6 and SEQ ID NO: 7” (id.).
Because, inter alia, one or more claims have been amended to change
the position of the amino acid mutation from position 81 to position 86 and
reference is made to SEQ ID NO: 6 and the Examiner has rejected the
claims based on the added material, the Examiner’s objection has raised to
the level of an appealable issue. Manual of Patent Examining Practice
§ 2163.06 (When “both the claims and specification contain new matter
either directly or indirectly, and there has been both a rejection and objection
by the examiner, the issue becomes appealable.”).
ISSUES
Issue 1: Does the preponderance of evidence on this record support a
conclusion that the original Specification
3
failed to provide written
descriptive support for a citation to a particular Ujvari reference by a
specific journal, volume, and page number?
Issue 2: Does the preponderance of evidence on this record support a
conclusion that the original Specification failed to provide a written
description of the specific sequence of human tyrosinase taught by Ujvari et
al., J. Biol. Chem., 276:5924-5931 (2001) that corresponds to Appellants’
SEQ ID NO: 6 and 7?
Issue 3: Does the preponderance of evidence on this record support a
conclusion that the original Specification failed to provide a written
description of a mutated amino acid at position 86 of a wild-type human
tyrosinase?

3
All reference to Appellants’ originally filed Specification refer to the
Specification filed October 7, 2004.
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4
FACTUAL FINDINGS
FF 1. The Examiner finds that Appellants’ disclosure of a single species of
tyrosinase defined by SEQ ID NO. 1 “is insufficient to put one of skill in the
art in possession of the attributes and features of all species within the
claimed genus” (Ans. 5; see also Ans. 4).
FF 2. The Examiner found that Appellants’ September 26, 2007 and
December 6, 2007 amendments introduced the following material into the
Specification, which is not supported by their original disclosure: (1) “[t]he
reference of Ujvari et al., J. Biol. Chem., 276:5924-5931 (2001)” (2) the
“change of position of the mutant from position 81 to 86”, and (3) “the
sequence of SEQ ID NO: 6 and SEQ ID NO: 7” (Ans. 3.)
FF 3. There is one citation to Ujvari et al. in Appellants’ originally filed
Specification, which is reproduced below:
Human tyrosinase is a type I membrane glycoprotein and has
533 amino acids, seven occupied N-glycosylation sites, 17
cysteine residues grouped in two cysteine-rich domains, two
copper binding domains and one C-terminal TM domain
(Ujvari et al. , [sic] 2001).

(Spec. 6: ¶[0026].)
FF 4. Petrescu declares that “position 86 of human tyrosinase is a known
glycosylation site (see, for example, Figure 1A in Ujvari et al., J. Biol.
Chem., 276:5924-5931 (2001))” (Petrescu Declaration
4
¶ 5).
FF 5. Unlike the references that Appellants specifically incorporated by
reference into their originally filed Specification (see, e.g., Spec. 9: ¶[0037]
and 10-11: ¶[0042]), there is no specific incorporation of Ujvari by reference
(see Spec. 6: ¶[0026]).

4
Executed September 24, 2007.
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FF 6. Appellants’ originally filed Specification provides a generic
statement that “[a]ll of the publications and patent applications and patents
cited in this specification are herein incorporated in their entirety by
reference” (Spec. 28: ¶[0099]).
FF 7. Example 2 of Appellants’ originally filed Specification discloses that
the “[f]ull-length cDNA encoding human tyrosinase in a pcTyr cloning
vector was a gift from Dr. V.J.Hearing (NCI, National Institute of Health,
Bethesda, MD)” (Spec. 20: ¶ [0075]).
FF 8. The Examiner finds that there are “various allelic, polymorphic and
natural mutant forms of human tyrosinase (See Berson et al., JBC 275(16):
12281-89, 2000 cited in PTO-1449; Oetting et al.[,] Human Mutation 13:
99-115, 1999)” (Ans. 6).
FF 9. With reference to Ujvari et al., J. Biol. Chem., 276:5924-5931
(2001), Petrescu declares that the disclosure in Appellants’ original
Specification that asparagine is found at amino acid position 81 is an
obvious error because “the only asparagine in human tyrosinase in the 80’s
is at position 86” (Petrescu Declaration ¶ 5).
PRINCIPLES OF LAW
When the scope of a claim has been changed by amendment in
such a way as to justify an assertion that it is directed to a
different invention than was the original claim, it is proper to
inquire whether the newly claimed subject matter was described
in the patent application when filed as the invention of the
applicant. That is the essence of the so-called “description
requirement” of § 112, first paragraph.

In re Wright, 866 F.2d 422, 424 (Fed. Cir. 1989).
To incorporate material by reference, the host document must
identify with detailed particularity what specific material it
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incorporates and clearly indicate where that material is found in
the various documents. See In re Seversky, 474 F.2d 671, 674,
177 USPQ 144, 146 (CCPA 1973) (providing that incorporation
by reference requires a statement “clearly identifying the
subject matter which is incorporated and where it is to be
found”).

Advanced Display Systems, Inc. v. Kent State Univ., 212 F.3d 1272, 1282
(Fed. Cir. 2000).
Argument by counsel cannot take the place of evidence. In re Geisler,
116 F.3d 1465, 1471 (Fed. Cir. 1997).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

ANALYSIS
We recognize and find no error in the Examiner’s reasoning as it
applies to the written description rejection addressed below (Ans. 24-25; Cf.
Reply Br. 8; see also FF 1).

Issue 1 - the Ujvari citation:
The citation provided for Appellants’ originally filed Specification
refers to a Ujvari et al. reference one time using the citation “Ujvari et al. ,
2001” (FF 3). Appellants contend that this citation refers to “Ujvari et al., J.
Biol. Chem., 276:5924-5931 (2001)” (Ans. 3; See App. Br. 12; Reply Br. 4;
Cf. FF 2). In support of this contention, Appellants’ counsel asserts that
“only one reference listing Újvári as first author was published in 2001”
(App. Br. 12; Reply Br. 4). We are not persuaded by this unsupported
contention of Appellants’ counsel. Geisler, 116 F.3d at 1471. We also find
that Petrescu’s reference to “Ujvari et al., J. Biol. Chem., 276:5924-5931
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7
(2001)” falls short of suggesting that this specific reference is the only 2001
reference, available to the public, that lists Ujvari as first author (FF 4).
Absent evidence to the contrary, we are constrained to find that the
preponderance of evidence on this record supports a conclusion that the
original Specification failed to provide written descriptive support for a
citation to a particular Ujvari reference by a specific journal, volume, and
page number for the citation.

Issue 2 – SEQ ID NOs: 6 and 7, the human tyrosinase taught by Ujvari:
The sole citation to Ujvari et al. as it appears in Appellants’ originally
filed Specification is reproduced below:
Human tyrosinase is a type I membrane glycoprotein and has
533 amino acids, seven occupied N-glycosylation sites, 17
cysteine residues grouped in two cysteine-rich domains, two
copper binding domains and one C-terminal TM domain
(Ujvari et al. , 2001) .

(FF 3.)
Initially, we note that unlike the references Appellants specifically
incorporated by reference into their originally filed Specification there is no
specific incorporation of Ujvari by reference (see FF 5; Cf. FF 3). Instead,
Appellants direct attention to the end of their originally filed Specification
for a generic statement that “[a]ll of the publications and patent applications
and patents cited in this specification are herein incorporated in their entirety
by reference” (App. Br. 12; Cf. FF 6).
Nevertheless, Appellants contend that the foregoing reference to
Ujvari is an incorporation of a specific sequence for wild-type human
tyrosinase (App. Br. 14; see also Appeal Br. 15-16 and Reply Br. 4).
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Specifically, Appellants contend that “the Újvári reference, incorporated by
reference into the original specification, discloses the wild-type human
tyrosinase gene having GenBank
TM
accession number Y00819 at page 5925,
left column, under the subtitle Construction of Plasmids Encoding Wild
Type and Mutant Tyrosinase Proteins” (App. Br. 14; see also App. Br. 15-
16 and Reply Br. 4). We are not persuaded.
Appellants fail to identify with any particularity that a specific
sequence for wild-type human tyrosinase is intended to be incorporated into
Appellants’ Specification by reference to the Ujvari reference. Advanced
Display Systems, Inc. v. Kent State Univ., 212 F.3d at 1282 (“To incorporate
material by reference, the host document must identify with detailed
particularity what specific material it incorporates”). Further, unlike
Appellants’ Brief, which specifically identifies the precise page, column,
and subtitle where the sequence information is found, Appellants’ originally
filed Specification provides no such detail. Id. (“To incorporate material by
reference, the host document must . . . clearly indicate where that material is
found in the various documents.”).
Appellants contend that “SEQ ID NO: 6 is the cDNA sequence of the
human tyrosinase gene disclosed in the incorporated Újvári reference under
GenBank
TM
accession number Y00819. SEQ ID NO: 7 is the amino acid
sequence encoded by SEQ ID NO: 6” (App. Br. 14; see also App. Br. 15-
16). For the reasons set forth above, we disagree with Appellants’
contention that this “is material that was previously incorporated by
reference into the original application” (id.).
Lastly, we recognize Appellants’ contention that their Specification
“describes the soluble tyrosinase mutants of the invention as truncated forms
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of the wild-type (WT) tyrosinase (see Examples 2-4)” (Reply Br. 5).
Example 2 of Appellants’ originally filed Specification discloses that the
“[f]ull-length cDNA encoding human tyrosinase in a pcTyr cloning vector
was a gift from Dr. V.J.Hearing (NCI, National Institute of Health,
Bethesda, MD)” (FF 7 (emphasis added)). The Examiner has provided
evidence on this record to establish that “various allelic, polymorphic and
natural mutant forms of human tyrosinase” were known in the art at the time
the instant invention was made (FF 8).
While Appellants obtained their human tyrosinase from Dr. Hearing
and it was known in the art that human tyrosinase exists in various forms,
Appellants contend that “SEQ ID NO: 6 corresponds to the wild-type human
tyrosinase gene having GenBank
TM
accession number Y00819 in the Újvári
reference incorporated into the original specification . . . [because] [t]he
Újvári reference discloses the plasmid pcTYR carrying the human tyrosinase
gene, which is the same cloning vector disclosed in the present application”
(Reply Br. 5). We are not persuaded. For the reasons set forth above, we
are not persuaded by the unsupported arguments of Appellants’ counsel that
Dr. Hearing’s human tyrosinase and Ujvari’s human tyrosinase have the
same sequence simply because they were both cloned into a pcTYR plasmid.
For the foregoing reasons we find that the preponderance of evidence
on this record supports a conclusion that the original Specification failed to
provide a written description of the specific sequence of human tyrosinase
taught by Ujvari et al., J. Biol. Chem., 276:5924-5931 (2001) that
corresponds to SEQ ID NO: 6 and 7.

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10
Issue 3 - the mutated amino acid position:
The Examiner contends that the “change of position of the mutant
from position 81 to 86” is not supported by Appellants’ originally filed
Specification (FF 2). With reference to Ujvari et al., J. Biol. Chem.,
276:5924-5931 (2001), Petrescu declares that Appellants’ original disclosure
that the asparagine found at amino acid position 81 is an obvious error
because “the only asparagine in human tyrosinase in the 80’s is at position
86” (FF 9; see also Reply Br. 5 and 6-7).
In sum, Appellants rely on the sequence identified in the Ujvari et al.,
J. Biol. Chem., 276:5924-5931 (2001) reference to support an amendment to
their Specification and claims that changes the amino acid position mutated
from position 81 to 86. However, for the reasons discussed above,
Appellants have failed to establish:
(1) that Ujvari’s J. Biol. Chem. article is the only 2001 article
available to the public that lists Ujvari as the first author,
(2) that Appellants’ original Specification intended to incorporate the
sequence from this specific Ujvari reference into the original Specification,
(3) that the specific human tyrosinase disclosed in this specific Ujvari
reference is the same as that provided to Appellants by Dr. Hearing, and
(4) that the human tyrosinase disclosed in Appellants’ original
Specification is not an allelic, polymorphic or natural mutant form of human
tyrosinase.
Given that variant forms of human tyrosinase were known in the art
the time the invention was made and that Appellants failed to establish an
evidentiary basis supporting a conclusion that the specific sequence
identified in Ujvari et al., J. Biol. Chem., 276:5924-5931 (2001) was
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11
specifically incorporated into their originally filed Specification by
reference, we are compelled to agree with the Examiner that the original
Specification failed to provide written descriptive support for a mutation at
amino acid position 86 of a wild-type human tyrosinase.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
that Appellants’ Specification fails to provide written descriptive support for
the claimed invention. Specifically, the preponderance of evidence on this
record supports a conclusion that the original Specification failed to provide
written descriptive support for a citation to a particular Ujvari reference by a
specific journal, volume, and page number. The preponderance of evidence
on this record supports a conclusion that the original Specification failed to
provide a written description of the specific sequence of human tyrosinase
taught by Ujvari et al., J. Biol. Chem., 276:5924-5931 (2001) that
corresponds to Appellants’ SEQ ID NO: 6 and 7. The preponderance of
evidence on this record supports a conclusion that the original Specification
failed to provide a written description of a mutated amino acid at position 86
of a wild-type human tyrosinase.
The rejection of claim 8 under the written description provision of 35
U.S.C. § 112, first paragraph is affirmed. Because they are not separately
argued claims 10, 13, 14, 18, and 24-30 fall together with claim 8. 37 C.F.R.
§ 41.37(c)(1)(vii).

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12
Definiteness:
ISSUE
Does the preponderance of evidence support a conclusion that a
person of ordinary skill in the art could not determine the metes and bounds
of Appellants’ claimed invention?
FACTUAL FINDINGS
FF 10. The Examiner finds that because the art at the time the invention was
made establishes that human tyrosinase was known to exist in various forms
it is important that claim 8 identify the specific tyrosinase sequence that is to
be mutated at a particular amino acid position (see Ans. 6).
PRINCIPLES OF LAW
“The test for definiteness is whether one skilled in the art would
understand the bounds of the claim when read in light of the specification.”
Miles Laboratories, Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir.
1993).
ANALYSIS
Appellants contend that “the Examiner’s position [is] that the
reference WT human tyrosinase sequence in the claims is not defined by the
proper sequence identifier and therefore the requirements for definiteness are
not met” (App. Br. 17 (emphasis added)). In this regard, Appellants contend
that their Specification provides written descriptive support for wild type
human tyrosinase having SEQ ID NO: 6 and SEQ ID NO: 7 as defined by
the Újvári et al., J. Biol. Chem., 276:5924-5931 (2001), which Appellants
contend is “clearly identified and defined and properly incorporated by
reference into the application” (Reply Br. 8; see also App. Br. 17-18). We
are not persuaded because (1) claim 8 is not limited to mutants derived from
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13
a specific sequence (i.e., human tyrosinase) and (2) for the reasons set forth
above, the sequence set forth in Újvári et al., J. Biol. Chem., 276:5924-5931
(2001) is not properly incorporated by reference into Appellants’
Specification.
In addition, for the reasons set forth above, we are not persuaded by
Appellants’ contentions regarding particular amino acid positions in human
tyrosinase, which are based on the Újvári et al., J. Biol. Chem., 276:5924-
5931 (2001) sequence (App. Br. 17; Reply Br. 8).
CONCLUSION OF LAW
The preponderance of evidence supports a conclusion that a person of
ordinary skill in the art could not determine the metes and bounds of
Appellants’ claimed invention. The rejection of claim 8 under 35 U.S.C.
§ 112, second paragraph is affirmed. Because they are not separately argued
claims 10, 13, and 14 fall together with claim 8. 37 C.F.R. § 41.37(c)(1)(vii).

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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