Ex Parte O et al

Patent Trial and Appeal Board

Sep 20, 2016

10757708 (P.T.A.B. Sep. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
101757,708 01114/2004
20462 7590 09/22/2016
GlaxoSmithKline
GLOBAL PATENTS -US, UW2220
P. 0. BOX 1539
KING OF PRUSSIA, PA 19406-0939
FIRST NAMED INVENTOR
Derek O' Hagan
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
PAT051724-US-NP 3852
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
09/22/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
US_cipkop@gsk.com
arlene.e.cannon@gsk.com
laura.m.mccullen@gsk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DEREK O'HAGAN and MANMOHAN SINGH1
Appeal2015-001466
Application 10/757,708
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Novartis Vaccines and
Diagnostics, Inc. App. Br. 3.
Appeal2015-001466
Application 10/757,708
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-3, 5, 6, 8-10, 12, 13, 15-18, 23, 26-
28, 33-39, 42--48, 52, 54, 55, 61, 69, 76-83, and 90-101. Specifically, the
claims stand rejected as unpatentable under the non-statutory doctrine of
obviousness-type double patenting over claims 1, 5-19, 24--26, and 35-
40 of O'Hagan et al. (US 6,884,435 Bl, April 26, 2005) ("O'Hagan '435").2
The claims also stand rejected under 35 U.S.C. § 102(e) as being
anticipated by anticipated by O'Hagan '435, as evidenced by Josef
Thalhamer et al., Designing Immune Responses with Genetic Immunization
And Immunostimulatory DNA Sequences, 35 ENDOCRINE REGULATIONS
143-66 (2001) ("Thalhamer").
We have jurisdiction under 35 U.S.C. § 6(b)
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to microparticles with adsorbed
polynucleotide-containing species, compositions containing the same,
methods of making such microparticles, and uses thereof. Abstract.
2 The claims were also rejected by the Examiner as unpatentable under the
non-statutory doctrine of obviousness-type double patenting over claims 1-
5, 11, 30, 31, 36, 37, 40, 43, 45--47, 58, 59, 71, and 79 of US Appl. No.
11/113,861 (the "'861 application"). Final Act. 7. However, the '861
application has been abandoned (Notice of Abandonment mailed Dec. 20,
2013) and the rejection is consequently moot. App. Br. 15.
2
Appeal2015-001466
Application 10/757,708
REPRESENTATIVE CLAIM
Appellants argue all of the claims together. See App. Br. 5, 15.
Claim 1 is argued by Appellants as representative of the claims on appeal
(see, e.g., id. at 7, 14, 17), and recites:
1. Microparticles comprising: (a) a biodegradable polymer;
(b) a cationic surfactant; and ( c) a first polynucleotide-
containing species adsorbed on the surface of the microparticles,
wherein the adsorbed first polynucleotide-containing species
constitutes at least 5 percent of the total weight of the
microparticles, wherein the cationic surfactant is present during
formation of the microparticles, wherein no cationic surfactant
removal step is conducted subsequent to formation of the
microparticles, wherein a first portion of the cationic surfactant
is bound to the polymer, wherein a second portion of the cationic
surfactant forms a complex with the first polynucleotide-
containing species, wherein the complex is adsorbed on the
surface of the microparticles, and wherein the first surfactant
portion and the second surfactant portion comprise the same
surfactant species or different surfactant species.
Br. 20.
ISSUES AND ANALYSIS
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are prima facie obvious over the cited prior art
references. We address the arguments raised by Appellants on appeal
below.
3
Appeal2015-001466
Application 10/757,708
A. Rejection of the claims under the non-statutory doctrine of
obviousness-type double patenting
Issue 1
Appellants argue the Examiner improperly relied upon the
Specification of O'Hagan '435 in finding that O'Hagan '435 teaches the
limitation of claim 1 reciting, "wherein no cationic surfactant removal step is
conducted subsequent to formation of the microparticles." App. Br. 7.
Analysis
Appellants argue that the Examiner improperly relies on the
disclosures of the O'Hagan '435 Specification, rather than on the claims of
the patent, in concluding that the claims are obvious over O'Hagan '435.
App. Br. 8 (citing MPEP § 804 (B)(l)). Specifically, Appellants allege the
Examiner improperly relied on the teachings of the specification of 0 'Hagan
'435 beyond the portion that supports the patent claims to make the
obviousness double patenting rejection of the pending claims. Id. at 9.
According to Appellants, the Examiner characterizes the claims of
0' Hagan '4 3 5 as being directed to a process comprising forming
microparticles comprising the polymer and cationic detergent. App. Br. 9.
Appellants contend the Examiner does not point to any teaching in the
0' Hagan '4 3 5 claims related to washing of the microparticles or the removal
of detergent. Id. Rather, Appellants argue, the Examiner asserts that the
"specification also discloses that the cationic surfactant is not removed after
the formation of the microparticles." Id. (quoting Final Act. 5 (citing
O'Hagan '435 col. 13, 11. 10-39)). Appellants point out that the claims of
0' Hagan '4 3 5 do not include the terms "wash" or "remove" and that the
4
Appeal2015-001466
Application 10/757,708
Examiner cannot therefore be relying upon the Specification only "as a
dictionary to learn the meaning of a term in the patent claim" to make the
rejection. Id. at 10 (quoting MPEP § 804 (B)(2)(a)). Nor, Appellants assert,
does the Examiner rely upon portions of the O'Hagan '435 Specification that
provide support for the O'Hagan '435 claims. Id. Therefore, Appellants
allege, the Examiner must improperly rely on the O'Hagan '435
Specification as prior art to the claims on appeal. Id.
Appellants argue that, because the O'Hagan '435 claims provide no
teaching or suggestion related to a method in which the cationic surfactant is
not removed after the formation of the microparticles, and the portions of the
O'Hagan '435 Specification relied upon by the Examiner to support the
rejection cannot properly be relied upon, the rejection is improper and
should be reversed. App. Br. 10-11.
The Examiner replies that claim 1 is a product-by-process claim and
the test of patentability for a product-by-process claim is based on the
product itself, and not the means by which the product is made. Ans. 9
(citing MPEP § 2113). The Examiner therefore finds Appellants' claim 1 is
limited only by the structure of the recited microparticles, viz., ( 1) a
biodegradable polymer; (2) a cationic surfactant; and (3) at least 5% of
surface-adsorbed polynucleotide, wherein a first portion of the cationic
surfactant is associated with the biodegradable polymer and wherein a
second portion of the cationic surfactant forms a complex with the
polynucleotide on the microparticle surface. Id. The Examiner finds that
claim 1 of O'Hagan '435 similarly recites: (1) microparticles comprising a
biodegradable polymer; (2) a cationic surfactant; and (3) and a
polynucleotide adsorbed on the surface of the microparticles, wherein the
5
Appeal2015-001466
Application 10/757,708
microparticles are formed in the presence of a cationic surfactant. Id. at 9-
10.
We cannot entirely agree with the Examiner that claim 1 is a product-
by-process claim as strictly defined, i.e., a claim that relies upon process
recitations to describe the ultimate article. See In re Johnson, 394 F.2d 591,
594 (C.C.P.A. 1968). Rather, claim 1 is a product claim that recites a hybrid
of structural and process elements. The inclusion of process elements in a
composition claim that is otherwise described with sufficient structural
clarity to satisfy the requirements of 35 U.S.C. § 112 is not necessarily fatal
to a claim.3 Id. Nevertheless, it is well-settled that "the presence of process
limitations in product claims, which product [claim] does not otherwise
patentably distinguish over the prior art, cannot impart patentability to that
product." In re Stephens, 345 F.2d 1020, 1023 (C.C.P.A. 1965) (citing In re
Dilnot, 300 F.2d 945, 950 (C.C.P.A. 1962); see also In re Thorpe, 777 F.2d
695, 697 (Fed. Cir. 1985) ("[E]ven though product-by-process claims are
limited by and defined by the process, determination of patentability is based
on the product itself').
We consequently agree with the Examiner that the process elements
of claim 1, including "wherein no cationic surfactant removal step is
conducted subsequent to formation of the microparticles" are not limiting
upon the composition claimed in claim 1. As such, whether or not the
Examiner properly relied on the O'Hagan '435 Specification for support of
3 In this instance of a rejection based on obviousness-type double patenting,
the determination is whether the Appellants' claims are obvious over
0' Hagan '4 3 5' s claims, when read in light of Appellants' Specification. See
In re Braat, 937 F.2d 589, 592-93 (Fed. Cir. 1991).
6
Appeal2015-001466
Application 10/757,708
this element is immaterial to the Examiner's finding that the claims on
appeal are obvious over the cited claims of O'Hagan '435. Moreover,
because Appellants advance no argument that the claims on appeal are not
structurally nonobvious over the cited claims of O'Hagan '435, we are not
persuaded that the Examiner erred.
Issue 2
Appellants next argue that, if the Examiner's reliance on O'Hagan
'435's Specification is indeed proper, the Examiner has mischaracterized the
relied-upon disclosures of the Specification. However, as we have explained
supra, the process elements of the claims argued by Appellants are
immaterial when analyzing the O'Hagan '435 claims. Therefore, whether
the Examiner correctly characterized the disclosures of O'Hagan '435 with
respect to the element of claim 1 reciting "wherein no cationic surfactant
removal step is conducted subsequent to formation of the microparticles" is
immaterial as to whether Appellants' claims on appeal are obvious over the
claims of O'Hagan '435. We consequently affirm the Examiner's rejection
of the claims on this ground. 4
4 We are compelled to point out that claims 52, 92, 93, 99, and 101 are
directed to methods rather than compositions. See App. Br. 25, 29, 30.
However, Appellants do not argue these claims separately, but rather
explicitly include these claims in the arguments made with respect to claim
1. Id. at 14, 15. Nor did Appellants file a Reply Brief in response to the
Examiner's Answer. Consequently, any potential separate argument with
respect to these claims is deemed waived. See 37 C.F.R. § 41.37(c)(iv)
("[T]he failure of appellant to separately argue claims which appellant has
grouped together shall constitute a waiver of any argument that the Board
must consider the patentability of any grouped claim separately").
7
Appeal2015-001466
Application 10/757,708
B. Rejection of the claims under 35 U.S.C. § 102(e)
Appellants next argue the Examiner erred because O'Hagan '435 fails
to disclose the element of claim 1 reciting, "wherein the cationic surfactant
is present during formation of the microparticles, wherein no cationic
surfactant removal step is conducted subsequent to formation of the
microparticles." App. Br. 17. Appellants' arguments founder upon the same
principle of law we explained supra, viz., that "the presence of process
limitations in product claims, which product [claim] does not otherwise
patentably distinguish over the prior art, cannot impart patentability to that
product." Stephens, 345 F.2d at 1023. Appellants make no argument that
the composition recited in the claims on appeal is structurally
distinguishable from the composition defined by the cited O'Hagan '435's
claims. Therefore, Appellants arguments are insufficient to overcome the
Examiner's prima facie conclusion that Appellants' claims on appeal are
anticipated by O'Hagan '435. We consequently affirm the Examiner's
rejection of the claims on this ground.
DECISION
The Examiner's rejection of claims 1-3, 5, 6, 8-10, 12, 13, 15-18, 23,
26-28, 33-39, 42--48, 52, 54, 55, 61, 69, 76-83, and 90-101 as unpatentable
under the nonstatutory doctrine of obviousness-type double patenting is
affirmed.
The Examiner's rejection of claims 1-3, 5, 6, 8-10, 12, 13, 15-18, 23,
26-28, 33-39, 42--48, 52, 54, 55, 61, 69, 76-83, and 90-101 as unpatentable
under 35 U.S.C. § 102(e) is affirmed.
8
Appeal2015-001466
Application 10/757,708
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
9