Ex Parte Hunt

Patent Trial and Appeal Board

Jul 7, 2017

14215482 (P.T.A.B. Jul. 7, 2017)

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.
14/215,482 03/17/2014 Terrence J. Hunt 17319 4989
CP3C1DV1DV1CON2
51957 7590
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
EXAMINER
MINNIFIELD, NITA M
ART UNIT
1645
PAPER NUMBER
NOTIFICATION DATE DELIVERY MODE
07/11/2017 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):
patents_ip @ allergan. com
pair_allergan @ firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TERRENCE J. HUNT1
(Applicant: Allergan, Inc.)
Appeal 2017-006993
Application 14/215,482
Technology Center 1600
Before ERIC B. GRIMES, RICHARD J. SMITH, and DAVID COTTA,
Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a multi-
component system for making a botulinum toxin formulation. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellant, the real party in interest is Allergan, Inc. (Br. 3.)
Appeal 2017-006993
Application 14/215,482
STATEMENT OF THE CASE
Claims on Appeal
Claims 6—8 are on appeal. (Claims Appendix, Br. 16.) Claim 6 is
illustrative and reads as follows:
6. A multi-component system for making a botulinum toxin
formulation, comprising: (a) a vacuum-dried or lyophilized
botulinum toxin; and (b) a reconstitution vehicle comprising an
albumin, hydroxyethyl starch, sodium chloride, a buffer, or
combinations thereof; wherein the vacuum-dried or lyophilized
botulinum toxin is reconstituted with the reconstitution vehicle
at the time of use.
Examiner’s Rejections
1. Claims 6—8 stand rejected under 35 U.S.C. § 101 as directed to
non-statutory subject matter (i.e., a product of nature). (Final Act. 2—15.)* 2
2. Claims 6—8 stand provisionally rejected on the ground of
nonstatutory double patenting over claims 6—9 of copending Application No.
13/933,723. (Final Act. 15-16.)
FINDINGS OF FACT
FF 1. The Examiner finds that Johnson et al (US 5,512,547, issued
April 30, 1996) (“Johnson”) “discloses pharmaceutical compositions
comprising botulinum toxin and human serum albumin [], both components
hav[e] their natural structure and therefore are natural products.” (Final Act.
3, citing Johnson cols. 1—2.)
FF 2. The Examiner finds that Goodnough et al. (Stabilization of
Botulinum Toxin Type A during Lyophilization, Applied and Environmental
2 Office Action dated April 14, 2016 (“Final Act.”).
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Application 14/215,482
Microbiology 58 (10), 3426—28 (1992)) (“Goodnough”) teaches that “full
recovery of type A botulinum toxin can be obtained after lyophilization,
therefore indicating that the structure is the same as the natural product as
well as function. . . . [t]he structure and function is not markedly different
from what exists in nature.” (Final Act. 3—4, citing Goodnough Abstract and
3426.)
FF 3. The Examiner finds that “[bjased on the state of the art, the
instant product claim recites something that appears to be a natural product
that is not markedly different in structure and function from naturally
occurring products. There is no structural difference because each of the
components of the claimed invention is not markedly different.” (Final Act.
4.)
FF 4. The Specification states that
a multiple (i.e. two or more) component system for the making
of a final formulation can provide the benefit of allowing
incorporation of ingredients which are not sufficiently
compatible for long-term shelf storage with the first component
of the two component system or which for other reasons it is not
desirable to include with the first component of the
pharmaceutical composition.
(Spec. 69,11. 13-18.)
FF 5. The Specification states that ‘“[bjotulinum toxin’ means a
neurotoxin produced by Clostridium botulinum, as well as a botulinum toxin
(or the light chain or the heavy chain thereof) made recombinantly by a non-
Clostridial species.” {Id. at 30,11. 30—32.)
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DISCUSSION
Rejection No. 1
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection of claims 6—8 under 35 U.S.C. § 101.
Principles of Law
On issues of patent eligibility, we “first determine whether the claims
at issue are directed to a patent-ineligible concept,” such as laws of nature,
natural phenomena, and abstract ideas. Alice Corp. Pty Ltd. v. CLS Bank
Int'l, 134 S.Ct. 2347, 2355 (2014) (“Alice”). If this threshold is met, we
move to the second step of the inquiry and “consider the elements of each
claim both individually and ‘as an ordered combination’ to determine
whether the additional elements ‘transform the nature of the claim’ into a
patent-eligible application.” Id. (quoting Mayo Collaborative Services v.
Prometheus Laboratories, Inc., 132 S.Ct. 1289, 1297—98 (2012) (“Mayo”)).
Analysis
We adopt the Examiner’s findings and conclusion that the claims are
directed to patent-ineligible subject matter. (Final Act. 2—16; Ans. 2—9.)
We discern no error in the rejection of the claims under Section 101. We
limit our consideration to claim 6 because the claims were not separately
argued.
Claim Construction
Claims under examination are given their broadest reasonable
interpretation consistent with the specification, as interpreted by one of
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ordinary skill in the art. In re Am. Academy of Sci. Tech Center, 367 F.3d
1359, 1364 (Fed. Cir. 2004). Here, we agree with the Examiner that claim 6
recites two components, a vacuum-dried or lyophilized botulinum toxin and
a reconstitution vehicle (e.g., albumin). (Final Act. 14.) Moreover, claim 6
does not require that the components be mixed or interact in any way. (Id.)
As stated by the Examiner, “[t]he claim is so broad it reads on the two
components sitting in separate vials, in a box.” (Id.)
This construction of separate components is consistent with the
Specification’s description of a multi-component system. (FF 4.) Moreover,
the “wherein” clause at the end of claim 6 indicates that the components are
separate, and that the purpose of the separate components is to be
“reconstituted ... at the time of use.” (Br. 16.) Accordingly, that “wherein”
clause does not change the scope of the claim from two separate components
to a mixture or composition of the components, but merely states the context
in which the two separate components may be used. See Boehringer
Ingelheim Vetmedica v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed.
Cir. 2003) (“An intended use or purpose usually will not limit the scope of
the claim because such statements usually do no more than define a context
in which the invention operates.”).
Alice Inquiry — Step 1
The Examiner finds that claim 6 “is directed to a judicial exception
(i.e., a law of nature, a natural phenomenon, or an abstract idea) without
significantly more.” (Final Act. 2.) In particular, the Examiner finds that
claim 6 is directed to a “product of nature” exception because neither the
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Application 14/215,482
lyophilized (or vacuum-dried) botulinum toxin nor albumin exhibit
markedly different characteristics than found in nature. (Id. at 2—5; FF 1—3.)
Appellant does not dispute that the individual components (i.e.
vacuum-dried or lyophilized botulinum toxin and albumin) of claim 6 are
nature-based products.3 However, Appellant asserts two arguments which
are addressed below.
Argument 1
Appellant argues that “it is not necessary to apply the markedly
different characteristics analysis” because “the claim is focused on the
assembly of components that together form the claimed system and not the
nature-based products.” (Br. 10.) Appellant supports that argument by
referencing the Interim Eligibility Guidance (December 2014) (“Interim
Guidance”) and Nature-Based Product Examples (December 2014)
(“Examples”).4 Appellant specifically points to a hypothetical claim to a
fountain-style firework in which the claim is identified as patent eligible
because “[although the claim recites two nature-based products (calcium
chloride and gunpowder), analysis of the claim as a whole indicates that the
claim is focused on the assembly of components that together form the
firework, and not the nature-based products.” (Br. 10, citing Examples at 1
(claim 2).)
3 We focus our decision on “albumin” as the reconstitution vehicle.
4 Links to both the Interim Guidance and Examples may be found at
https://www.uspto.gov/patent/laws-and-regulations/examination-
policy/subject-matter-eligibility.
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We are not persuaded. The firework claim argued by Appellant also
recites a cardboard body having different compartments for the calcium
chloride and gunpowder, as well as other elements, such as a plastic ignition
fuse extending out of the cardboard body. (Br. 10, Examples at 1.) Here,
unlike the firework claim, claim 6 merely recites two natural components
that may be contained in separate vials or other containers that are not
“assembled” or otherwise connected in any manner. (See Ans. 5—6.)
Argument 2
Appellant also argues that “the claimed pharmaceutical composition is
markedly different from its naturally occurring components” because, for
example, “whether the albumin is natural or recombinant, the albumin
stabilizes the botulinum toxin.” (Br. 10-13.) Thus, according to Appellant,
“the changed property [e.g., enhanced stability] between botulin toxin as a
part of the claimed composition and botulinum toxin in nature is a marked
difference.” (Id. at 13.)
Appellant supports that argument by reference to certain Examples
regarding composition claims. (Br. 10—13.) One of those claims is “[a]
beverage composition comprising pomelo juice and an effective amount of
an added preservative” in which “the preservative affects the juice so that it
spoils much more slowly.” (Br. 10—11, citing Examples at 2 (claim 2).) The
analysis of that claim indicates that the property of slower spoiling of the
combination “is markedly different from properties of the juice by itself in
nature.” (Br. 11, Examples at 2, emphasis by Appellant.) The other claim
referred to by Appellant is to “[a] stable aqueous composition comprising:
amazonic acid; and a solubilizing agent,” in which the solubility property
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“between amazonic acid as a part of the claimed stable aqueous composition
and amazonic acid in nature is a marked difference.” (Br. 10-11, citing
Examples at 3—5 (claim 6), emphasis by Appellant.)
We are not persuaded. Claim 6 on appeal is not directed to a
composition, and the components (as claimed) are not required to be
combined or mixed. (See discussion above.) As such, the structural and
functional characteristics of the components are the same (i.e., not markedly
different than found in nature). (See Ans. 6—7.) Accordingly, we find that
claim 6 is directed to a patent-ineligible product of nature.
Alice Inquiry — Step 2
Appellant does not specifically argue the second step of the Alice
framework.5 Moreover, we agree with the Examiner’s analysis that the
claim as a whole does not amount to “significantly more than the judicial
exception.” (Ans. 7—9.) Thus, for example, even if the Appellant’s separate
components are part of a kit, that would be insufficient to provide the
inventive concept necessary to render the claims patent eligible, or otherwise
transform the nature of the claim into a patent-eligible application. See
Mayo, 132 S.Ct. at 1297; see also Genetic Technologies Ltd. v. Merial
L.L.C., 818 F.3d 1369, 1375—77 (Fed. Cir. 2016). Accordingly, the rejection
of claim 6 under 35U.S.C. § 101 is affirmed.
5 All of the Examples argued by Appellant state that the hypothetical claims
are not directed to a “product of nature” exception (Alice Step 1). (See
Examples at 1—5.) Furthermore, Appellant concludes the arguments by
stating that claim 6 “is not directed to an exception [], and qualifies as
eligible subject matter.” (Br. 13.)
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Conclusion
A preponderance of evidence of record supports the Examiner’s
rejection of claim 6 under 35 U.S.C. § 101. Claims 7 and 8 were not argued
separately and fall with claim 6.
Rejection No. 2
Appellant does not contest the provisional double patenting rejection.
Accordingly, the rejection of claims 6—8 on the ground of nonstatutory
double patenting over claims 6—9 of copending Application No. 13/933,723,
is summarily affirmed. See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir.
2008).
SUMMARY
We affirm the rejection of claims 6—8 under 35 U.S.C. § 101.
We affirm the rejection of claims 6—8 on the ground of provisional
nonstatutory double patenting.
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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