Ex Parte Lisziewicz et al

Board of Patent Appeals and Interferences

Apr 19, 2010

10081922 (B.P.A.I. Apr. 19, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JULIANNA LISZIEWICZ and
FRANCO LORI
__________

Appeal 2010-000027
Application 10/081,922
Technology Center 1600
__________

Decided: April 20, 2010
__________

Before FRANCISCO C. PRATS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

Opinion filed for the Board by Administrative Patent Judge FREDMAN.

Opinion dissenting-in-part filed by Administrative Patent Judge
McCOLLUM.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of transfecting antigen presenting cells by applying the complex to skin or

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mucosal surfaces. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-
in-part.
Statement of the Case
Background
“Expression of foreign genes in antigen presenting cells (APC) may
be used to generate efficient CTL [cytotoxic T lymphocyte] response in
animals. Therefore, gene transfer and genetic modification of APC has
potential to generate effective vaccine and therapeutic approaches against
different diseases, including viral infections and cancer.” (Spec. 4, ll. 7-11.)
The Claims
Claims 23-26, 28, 30-32, 35, 40, 41, 43 and 44 are on appeal1. Claims
23, 26, and 30 are representative and read as follows:
23. A method of transfecting antigen presenting cells, the
steps comprising selecting a gene delivery complex that
transfects antigen presenting cells, comprising DNA and a
sugar, or polyethylenimine, or polyethylenimine derivative,
and administering the complex by applying the complex
without the use of a needle to the skin or mucosa surfaces of
an animal, wherein said DNA comprises a nucleic acid
sequence encoding at least one immunogenic protein
operatively linked to a promoter, and whereby antigen
presenting cells of said skin or mucosa are transfected.

26. The method of Claim 25, wherein the derivative is
mannosylated polyethylenimine.

1 The Examiner has withdrawn the provisional double patenting
rejection and the new matter rejection, so that currently pending
claims 33 and 42 are not subject to any rejection.
2
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30. The method of Claim 26, wherein the complex
comprises a 5:1 ratio of mannosylated polyethylenimine
nitrogen per DNA phosphate.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Holler et al. US 5,908,923 Jun. 1, 1999
Behr et al. US 6,013,240 Jan. 11, 2000

Liu et al., Topical application of HIV DNA vaccine with cytokine-
expression plasmids induces strong antigen-specific immune responses, 20
VACCINE 42-48 (2002).

Mittal et al., Pathology and immunogenicity in the cotton rat
(Sigmodon hispidus) model after infection with a bovine adenovirus type 3
recombinant virus expressing the firefly luciferase gene, 77 J. GEN.
VIROLOGY 1-9 (1996) Abstract Only.

Janis Kuby, Immunology 8-9 (1992).

The issues
A. The Examiner rejected claim 30 under 35 U.S.C. § 112, second
paragraph as being indefinite (Ans. 5).
B. The Examiner rejected claims 23-26, 28, 30-32, 35, 40, 41, 43, and 44
under 35 U.S.C. § 102(e) as anticipated by Behr as evidenced by Liu, Mittal,
and Kuby (Ans. 5-7).
C. The Examiner rejected claims 23-26, 28, 30-32, 35, 40, 41, 43, and 44
under 35 U.S.C. § 103(a) as obvious over Behr, Liu, Mittal, Kuby, and
Holler (Ans. 7-10).
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A. 35 U.S.C. § 112, second paragraph
The Examiner finds that it “is unclear what applicants consider a
mannosylated polyethylenimine nitrogen and how such nitrogens are
distinguished from polyethylenimine nitrogen.” (Ans. 5.) The Examiner
finds that Claim 30 “does not clearly first limit the complex to having
mannosylated polyethylenimine; therefore, limiting the complex to having a
5:1 ratio of mannosylated PEI nitrogen per DNA phosphate without first
limiting the complex to one having mannosylated PEI does not make sense
because the complex can made with sugar” (Ans. 5).
Appellants argue that support for the claim is found in the
Specification at page 22 (see App. Br. 9).
In view of these conflicting positions, we frame the indefiniteness
issue before us as follows:
Does the evidence of record support the Examiner’s conclusion that
claim 30 is indefinite?
Findings of Fact (FF)
1. The Specification teaches that:
We found that, with PEI-man-DNA complexes, less
DNA is required to neutralize PEI-man compared to PEI.
Gel electrophoresis experiments using different N:P ratio of
PEI-DNA complexes demonstrated that 5:1 (N:P) of PEI-
man:DNA complex has neutral charge, in contrast to 3:1
(N:P) PEI-DNA complex. {The neutralization of PEI with
the DNA depends on the N(nitrogen):P(phosphate) ratio;
one microgram DNA = 3 x 109 molar P and 1 mM PEI =
109 molar N/microliter. This means for example that 10:1
ratio is the mixture of 3microliter 10mM PEI and 1
microgram DNA.

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(Spec. 22, ll. 9-16.)

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 are not persuaded by the Examiner’s rejection. Whether the
polyethylenimine is mannosylated or not will not change the location or
presence of the nitrogen atoms present on the polyethylenimine, since
mannose is a sugar which does not contain nitrogen. The Specification
clearly describes how to compare the nitrogen to phosphate ratio (see FF 1).
In light of this description in the Specification (FF 1), we conclude that the
ordinary artisan would have been easily able to calculate the ratio of
nitrogen to oxygen for polyethylenimine, whether mannosylated or not.
We also disagree with the Examiner’s finding that claim 30 “does not
clearly first limit the complex to having mannosylated polyethylenimine”
(Ans. 5). Claim 30 requires that “the complex comprises a 5:1 ratio of
mannosylated polyethylenimine nitrogen per DNA phosphate” (Claim 30).
We conclude that this is a clear and unambiguous requirement for
mannosylated polyethylenimine in the complex.
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Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that claim 30 is indefinite.

B. 35 U.S.C. § 102(e) over Behr
The Examiner finds that “Behr taught a complex comprising i) PEI,
and ii) plasmid DNA comprising a nucleic acid sequence encoding
luciferase operatively linked to a promoter suspended in 5% glucose” (Ans.
6). The Examiner finds that “Behr taught administering any complex of the
invention to the skin or mucosa of an animal” (id.). The Examiner finds that
“applying a gene delivery complex topically as described by Behr inherently
results in transfecting APCs as supported by Liu” (id.). The Examiner finds
that luciferase “is an immunogenic protein” (id.).
Appellants argue that Behr “does not disclose the transfection of
antigen presenting cells, or the targeting of antigen presenting cells, a most
significant subset of cells, and prominent by its omission” (App. Br. 20).
Appellants argue that Behr does not teach “any in vivo method of delivery
except injection” (id.). Appellants also argue that Liu “is not citeable as
prior art against the present claims, which have an admitted priority date of
September 15, 1998” (id. at 21).
Appellants argue that the “inherency argument by the Examiner is
contradicted by the experiments in the Behr reference: Luciferase was used
in those experiments and neither undesired immunogenicity or toxicity was
found” (id. at 33). Appellants argue that “[e]xample 14 of the Behr
reference shows failure of one set of materials used successfully in the
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claimed method. In order for the Behr reference to be predictive to the level
required by an inherency rejection, that transfection with DNA and sugar
injected into neural tissue would have had to have worked” (id.).
In view of these conflicting positions, we frame the anticipation issue
before us as follows:
Does the evidence of record support the Examiner’s conclusion that
Behr, as evidenced by Liu, Mittal, and Kuby, anticipates the claimed
invention?
Findings of Fact
2. Behr teaches that “the pharmaceutical compositions of the
invention contain a vehicle which is pharmaceutically acceptable . . . for a
topical administration (to skin and/or mucosa)” (Behr, col. 6, ll. 5-9).
3. Behr teaches and claims a “composition comprising at least one
nucleic acid and a cationic polymer” (Behr, col. 13, ll. 34-35; claim 1 of
Behr).
4. Behr teaches that the “nucleic acid can also contain one or more
genes coding for an antigenic peptide capable of generating an immune
response in man or animals” (Behr, col. 3, ll. 57-59).
5. Behr teaches that the “peptides include, in particular, antigenic
peptides specific to the Epstein Barr virus, the HIV virus, the hepatitis B . . .
or the pseudorabies virus, or alternatively tumor-specific peptides” (Behr,
col. 3, ll. 63-66).
6. Behr teaches that “30 µg of plasmid pCMV-luc . . . were diluted
in 22.5 µl of sterile 5% glucose . . ., 8.5 µl of 100 mM PEI800K . . . were
then added. The composition thereby obtained hence contains 9 equivalents
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of amines relative to phosphates” (Behr, col. 12, ll. 53-58 (Example 14)).
Examples 1 through 12 also describe using plasmids as the nucleic acid
vector (id. at cols. 7-11).
7. Behr teaches and claims a composition “wherein the polymer is
selected from the group consisting of polyethylenimine (PEI) and
polyproylenimine (PPI)” (Behr, col. 13, ll. 59-61; claim 4 of Behr).
8. Behr teaches and claims a composition “wherein the polymer
amines to nucleic acid phosphates ratio is between 0.5 and 50” (Behr, col.
13, ll. 65-67; claim 6 of Behr).
9. Behr teaches and claims a “composition according to claim 1,
comprising a vehicle which is pharmaceutically acceptable for application to
the skin and/or the mucosae” (Behr, col. 16, ll. 14-17; claim 33 of Behr).
10. Liu teaches a “method of topical application that relies on the
elimination of the keratinocyte layers has made it easier for DNA plasmids
to be taken up by antigen-presenting cells in mice, although a gentle
modification of the method will be necessary for use in human patients” (Liu
43, col. 1).
11. Liu teaches that “Fan et al. have reported that painting DNA
vaccine twice (without stripping) induced an antibody response to HBs
antigen and enhanced the lymphoproliferative response. Although painting
twice without stripping yielded a marked immune response, stronger
immunigenicity, more efficiently achieved, is desirable” (Liu 47, col. 1).
12. Liu teaches that “S-100 immunoreactivity is characteristic of
mature DC cells that are effective in antigen presentation” (Liu 47, col. 1).
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13. Liu teaches that “stripped skin sections showed more S-100
protein staining and neutrophil-like cell infiltration was greater and more
frequently observed (Fig. 3d) than that without stripping (Fig. 3b). These
suggested that the stripping facilitated the passage of DNA vaccine through
the skin and the uptake of plasmids by antigen expressing cells” (Liu 47, col.
1).
14. Mittal teaches that “[a]ntibodies to both BAd3 and luciferase
were detected in sera collected from BAd3-Luc-infected animals until at
least 6 weeks p.i. [post infection]” (Mittal abstract).
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
“It is well settled that a prior art reference may anticipate when the
claim limitations not expressly found in that reference are nonetheless
inherent in it.” In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1349
(Fed. Cir. 2002). See, e.g., MEHL/Biophile Int'l Corp. v. Milgraum, 192
F.3d 1362, 1365 (Fed. Cir. 1999) (“Under the principles of inherency, if the
prior art necessarily functions in accordance with, or includes, the claimed
limitations, it anticipates.”)
Once a prima facie case of anticipation has been established, the
burden shifts to the Appellant to prove that the prior art product does not
necessarily or inherently possess the characteristics of the claimed product.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed
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and prior art products are identical or substantially identical, or are produced
by identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product.”). See also In re Spada,
911 F.2d 705, 708-09 (Fed. Cir. 1990).
A publication dated after an applicant’s filing date is acceptable as
evidence of characteristics of prior art products. In re Wilson, 311 F.2d 266,
268-269 (CCPA 1962) (“The board considered that the publication was
properly cited to show a state of fact. After reading the entire publication, so
do we. It [is] clearly a discussion of the properties of polyurethane foam
products generally, products made by the processes of the prior art of record
in this case.… As evidence of the characteristics of prior art foam products,
however, we know of no reason in law why it is not acceptable.”); In re
Langer, 503 F.2d 1380, 1391 (CCPA 1974) (“the references relied on by the
examiner and the board are not cited as ‘prior art’ references. Indeed, the
effective date, for prior art purposes, of many of these references is
subsequent to appellant's earliest filing date. Rather, these references are
properly cited for the purpose of showing a fact under the principle of In re
Wilson …”).
Analysis
Claims 23 and 44
Behr teaches methods of transfecting cells with DNA and
polyethylenimine (PEI) (FF 2-3, 7). Behr teaches administering the complex
topically (i.e., without a needle) to skin or mucosa surfaces (FF 9). Behr
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teaches that the DNA may comprise a nucleic acid sequence which encodes
an immunogenic protein (FF 4-5).
Appellants argue that Behr “does not disclose the transfection of
antigen presenting cells, or the targeting of antigen presenting cells, a most
significant subset of cells, and prominent by its omission” (App. Br. 20).
While Behr does not expressly teach that topical administration will
result in transfection of antigen presenting cells, Liu evidences that topical
administration will inherently result in transfection of antigen presenting
cells (FF 10-13). In particular Liu demonstrates that a “method of topical
application that relies on the elimination of the keratinocyte layers has made
it easier for DNA plasmids to be taken up by antigen-presenting cells in
mice” (Liu 43, col. 1 FF 10). Liu therefore teaches that even topical
administration without the keratinocyte elimination step results in uptake of
DNA plasmids by antigen-presenting cells and demonstrates this uptake in
S-100 cells without the keratinocyte elimination step in figure 3b (FF 13).
The Examiner has therefore provided significant evidence which
supports the conclusion that topical administration of skin with DNA will
transfect antigen presenting cells. Consequently, under Best, the burden of
proving that the topical administration of Behr does not inherently satisfy the
claims is placed on Appellants. See In re Best, 562 F.2d at 1255 (“Where, as
here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes,
the PTO can require an applicant to prove that the prior art products do not
necessarily or inherently possess the characteristics of his claimed
product.”).
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Appellants respond to the citation of Liu by arguing that Liu “is not
citeable as prior art against the present claims, which have an admitted
priority date of September 15, 1998” (App. Br. 21). This argument is not
persuasive because post-filing evidence can be relied on to show the
properties inherent in a prior art teaching. See In re Wilson, 311 F.2d at 268-
69.
Appellants argue that Behr does not teach “any in vivo method of
delivery except injection” (App. Br. 20). We are not persuaded. Behr
expressly teaches “topical administration (to skin and/or mucosa)” (Behr,
col. 6, ll. 8-9; FF 2). Behr claims a “composition according to claim 1,
comprising a vehicle which is pharmaceutically acceptable for application to
the skin and/or the mucosae” (Behr, col. 16, ll. 14-17; claim 33 of Behr; FF
9). These are in vivo methods of delivery which are topical and do not
require injection (FF 2, 9).
Appellants argue that the “inherency argument by the Examiner is
contradicted by the experiments in the Behr reference: Luciferase was used
in those experiments and neither undesired immunogenicity or toxicity was
found” (App. Br. 33). We find this argument unpersuasive because Example
14 does not disclose administration to skin or mucosa, as described in the
portions of Behr cited by the Examiner, and because the argument is
contradicted by the evidence of Mittal.
When Behr tested a luciferase transfection construct in Example 14,
Behr applied the construct to brains of newborn mice for 48 hours (see Behr,
col. 12, ll. 45-67). Given that Example 14 did not administer the construct
to skin or mucosa, immunogenic response would not necessarily be expected
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to occur. Further, not only does Mittal demonstrate that luciferase is
immunogenic when expressed in lungs after four days (Mittal Abstract, FF
14), but Behr satisfies the requirement in claim 23 for an immunogenic
protein directly, without the necessity of demonstrating that luciferase is
immunogenic (FF 4-5).
Appellants argue that “[e]xample 14 of the Behr reference shows
failure of one set of materials used successfully in the claimed method. In
order for the Behr reference to be predictive to the level required by an
inherency rejection, that transfection with DNA and sugar injected into
neural tissue would have had to have worked” (App. Br. 33).
We are not persuaded because Example 14 of Behr demonstrated that
“the compositions enable the plasmid to be transferred efficiently into the
brain of mice, whereas no significant luciferase activity is observed when
the transfer is carried out by means of the plasmid alone” (Behr, col. 13, ll.
7-10). Thus, Behr demonstrates that when the nucleic acid (plasmid) is
combined with PEI and glucose, as required by the claim, the nucleic acid is
successfully transfected. This does not demonstrate failure, but rather
success.
Claims 24-26 and 30-32
Appellants argue that Behr “does not disclose that glucose and PEI
derivatives could be used in the claimed method” (App. Br. 20). Appellants
also argue that Behr does not teach “that the glucose solution can be
preferred for targeting antigen presenting cells (Claim 31), or that the range
of glucose concentration in a method targeting antigen presenting cells is
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higher than that disclosed for general use for transfecting neurons in the
Behr reference (Claims 32 and 33)” (App. Br. 20).
The Examiner finds that Behr “taught a complex comprising i) PEI,
and ii) plasmid DNA . . . suspended in 5% glucose” (Ans. 6). We note that
the Examiner has withdrawn the rejection regarding Claim 33 (see Ans. 7).
We are not persuaded regarding the use of glucose in Claims 24 and
31-32 because Behr teaches the use of glucose in a composition “used for
intracerebral injections” (Behr, col. 12, ll. 59-60) and not for topical use.
As stated in Arkley, an anticipatory reference under 35 U.S.C. § 102
. . . must clearly and unequivocally disclose the claimed
compound or direct those skilled in the art to the compound
without any need for picking, choosing, and combining
various disclosures not directly related to each other by the
teachings of the cited reference. Such picking and choosing
may be entirely proper in the making of a 103, obviousness
rejection, where the applicant must be afforded an
opportunity to rebut with objective evidence any inference
of obviousness which may arise from the similarity of the
subject matter which he claims to the prior art, but it has no
place in the making of a 102, anticipation rejection.

In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972).
The instant situation is similar to Arkley, where the instant rejection is a §
102, anticipation rejection which would require picking and choosing
glucose from intracerebral injection with a composition for topical
application from unrelated parts of the reference in order to arrive at the
claimed invention. We are therefore constrained to reverse this rejection.
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Claim 43
Appellants argue that Behr does not teach that “use of a sugar-
modified polyethylenimine would be desirable (Claim 43)” (id. at 21).
The Examiner responds that “[c]laims 25, 26 and 43 are included
because they are not limited to a compound that is mannosylated PEI[;] . . .
claims 25, 26 and 43 encompass non-sugar-modified PEI solubilized in
glucose as in parent claim 24” (Ans. 7).
We find that Appellants have the better position. In our opinion,
Claim 43 clearly requires the inclusion of a sugar-modified
polyethylenimine into the DNA complex. The Examiner has not identified,
nor do we find, any teaching of a sugar-modified polyethylenimine in Behr.
Claim 28
Appellants argue that Behr does not teach “manipulation of
electrostatically neutral complexes to target antigen presenting cells (Claim
28)” (App. Br. 20).
We are not persuaded because Behr teaches a composition “wherein
the polymer amines to nucleic acid phosphates ratio is between 0.5 and 50”
(Behr, col. 13, ll. 65-67; claim 6 of Behr; FF 8). Also, the Examiner finds
that “Behr taught that between 5-20 equivalents of PEI amines are used
relative to one DNA phosphate (col 8, lines 15-19). The instant
specification teaches that the ratio of 5:1 cause the complex to be
electrostatically neutral (¶ bridging pg 21-22)” (Ans. 7). See Titanium
Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) (“It is also an
elementary principle of patent law that when, as by a recitation of ranges or
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otherwise, a claim covers several compositions, the claim is ‘anticipated’ if
one of them is in the prior art.”)

Claims 35 and 41
Appellants argue that Behr does not teach that the “further step of
receptor stimulation, tissue injury or cell injury might activate antigen
presenting cells and therefore enhance a (disclosed in the Behr reference to
be an undesired) immune response (Claim 35)” (App. Br. 20-21).
Appellants argue that Behr does not teach that “Langerhans cells can be
targeted using the claimed method and materials (Claim 41)” (id. at 21).
The Examiner responds that “[c]laims 35 and 41 are included because
administering the complex to the skin/mucosa as taught by Behr inherently
would activate APCs by toxin activation” (Ans. 7).
We find that the Examiner has made a reasonable argument based
upon the evidence of Liu that administration of an antigen would activate
antigen presenting cells, including Langerhans cells found in the epidermis
(FF 10-13). Appellants have provided no evidence to rebut this position.
See In re Best, 562 F.2d at 1255.
Claim 40
Appellants argue that Behr does not teach “that a plasmid DNA can be
successfully used in the claimed method” (App. Br. 21).
We are not persuaded because Behr teaches the use of plasmid DNA
throughout its Examples, for example, in the transfection in Example 14 (FF
6), where Behr states that “the compositions enable the plasmid to be
transferred efficiently into the brain of mice” (Behr, col. 13, ll. 7-8).
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Conclusions of Law
The evidence of record supports the Examiner’s conclusion that Behr,
as evidenced by Liu, Mittal, and Kuby, anticipates claims 23, 28, 35, 40, 41,
and 44.
The evidence of record does not support the Examiner’s conclusion
that Behr, as evidenced by Liu, Mittal, and Kuby, anticipates claims 24-26,
30-32, and 43.
C. 35 U.S.C. § 103(a) over Behr, Liu, Mittal, Kuby, and Holler
We have already found that Behr anticipates the method of claims 23,
28, 35, 40, 41, and 44. Anticipation is the epitome of obviousness. In re
McDaniel, 293 F.3d 1379, 1385-1386 (Fed. Cir. 2002). Therefore, we affirm
the § 103 rejection of claims 23, 28, 35, 40, 41, and 44.
The Examiner provides no reason why claims 24-26, 30-32, and 43
would have been obvious. Therefore, we reverse the § 103 rejection of
claims 24-26, 30-32, and 43. See KSR Int'l Co. v. Teleflex Inc., 550 U.S.
398, 418 (2007) (“[R]ejections on obviousness grounds cannot be sustained
by mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.”)
SUMMARY
In summary2, we reverse the rejection of claim 30 under 35 U.S.C. §
112, second paragraph as being indefinite,

2 We note that claims 33 and 42 were not subject to any rejection
on appeal.
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We affirm the rejections of claims 23, 28, 35, 40, 41, and 44 under 35
U.S.C. § 102(e) and 35 U.S.C. § 103(a).
We reverse the rejections of claims 24-26, 30-32, and 43 under 35
U.S.C. § 102(e) and 35 U.S.C. § 103(a).
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-IN-PART

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McCOLLUM, Administrative Patent Judge, dissenting-in-part.

I concur with the decision to reverse the rejection of claim 30 under 35
U.S.C. § 112, second paragraph, affirm the rejections of claims 23, 28, 35, 40,
41, and 44 under 35 U.S.C. §§ 102(e) and 103(a), and reverse the rejections of
claims 24-26 and 30-32 under 35 U.S.C. §§ 102(e) and 103(a). However, I
disagree with the decision to reverse the rejections of claim 43 under 35 U.S.C.
§§ 102(e) and 103(a).
Claim 23 is directed to a method comprising “selecting a gene delivery
complex . . . comprising DNA and a sugar, or polyethylenimine, or
polyethylenimine derivative.” Claim 43 depends from claim 23 and recites that
“the derivative is a sugar-modified polyethylenimine.”
The majority interprets claim 43 to require that the complex contain a
sugar-modified polyethylenimine. I do not agree.
Claim 23 requires that the complex contain a sugar, polyethylenimine, or
a polyethylenimine derivative. Claim 43 requires that the polyethylenimine
derivative is a sugar-modified polyethylenimine. Claim 43 does not explicitly
state that the complex comprises the polyethylenimine derivative. Therefore, I
do not agree that the language in claim 43 cannot reasonably be interpreted to
require that the complex comprise a sugar, polyethylenimine, or a sugar-
modified polyethylenimine. Thus, giving claim 43 its broadest reasonable
interpretation, I agree with the Examiner that claim 43 “encompass[es] non-
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sugar-modified PEI . . . as in parent claim [23]” (Ans. 7).3 The majority finds,
and I agree, that Behr discloses a complex containing PEI (FF 7). Thus, I
would affirm the rejections of claim 43 for the reasons we are affirming the
rejections of claim 23.

DISSENTING-IN-PART

cdc

LOOPER,VALERIE E.
11726 LIGHTFALL COURT
COLUMBIA MD 21044

3 The Examiner rejects claims 25 and 26 on the same basis (Ans. 7). However,
unlike claim 43, claims 25 and 26 depend from claim 24, which recites that the
“complex comprises DNA and glucose or a polyethylenimine derivative.”
Thus, unlike claim 43, claims 25 and 26 require that the complex contains
glucose or a polyethylenimine derivative. Thus, I agree with the majority’s
decision to reverse the rejections of claims 25 and 26.
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