Ex Parte Reardan et al

Patent Trial and Appeal Board

Feb 6, 2018

13786956 (P.T.A.B. Feb. 6, 2018)

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.
13/786,956 03/06/2013 Dayton T. Reardan 3482.004US1 2153
21186 7590 02/08/2018
SCHWEGMAN LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
MOSS, NATALIE M
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
02/08/2018 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):
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SLW @blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAYTON T. REARDAN and BRIAN L. MILLER1
Appeal 2016-003120
Application 13/786,956
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge NEW.
Dissenting Opinion filed by Administrative Patent Judge FREDMAN.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state that the real party-in-interest is QOL Medical LLC. App.
Br. 3.
Appeal 2016-003120
Application 13/786,956
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1-5 and 11-22 as unpatentable under
35 U.S.C. § 101 as being directed to non-statutory subject matter.
The claims also stand rejected as unpatentable under 35 U.S.C.
§ 102(b) as anticipated by PRNewswire, Orphan Medical Announces the
Commercial Availability of Suer aid (Sacrosidase) Oral Solution, July 17,
1998 (“PRNewswire”) and CSID Parent Support Group, Sucraid™, 2004
(“Sucraid”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to a solution of sacrosidase in
glycerol/water that is enzymatically stable indefinitely when maintained at
about-18°C to-22°C. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A liquid solution of sacrosidase in an aqueous medium
comprising about 35-55% glycerol and the balance, water,
wherein the sacrosidase enzymatic activity of the solution is
about 7500-19,500 IU/mL, wherein the temperature of the
solution is about -18°C to about -22°C, wherein the enzymatic
activity remains constant for at least about 72 months and
wherein the sacrosidase is a 513 amino acid polypeptide and is
glycosylated.
App. Br. 15.
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Application 13/786,956
ISSUES AND ANALYSES
We adopt the Examiner’s findings of fact and conclusion that the
appealed claims are directed to non-statutory subject matter and are
anticipated by the prior art. We address the arguments raised by Appellants
below.
A. Rejection of claims 1-5 and 11-22 under 35 U.S.C. $ 101
Issue
Appellants argue the Examiner erred because sacrosidase is not a
naturally occurring enzyme and therefore cannot be a product of nature,
which is a judicially-created exception to Section 101.
Analysis
The Examiner finds both sacrosidase and water are naturally
occurring products and that it is well known in the art that glycerol is a
naturally occurring chemical. Final Act. 10. The Examiner concludes that,
because the claim does not include any elements in addition to the natural
product, the claimed invention does not qualify as patent eligible subject
matter. Id. In addition, the prior art of record establishes that it was well-
known, convention, and routine in this art to combine sacrosidase with 50%
glycerol in an aqueous solution and that such a composition was known in
the art as Sucraid®. See PR Newswire 1 and Sucraid 2. In addition, Sucraid
discloses a commercially available form of Sucraid® that has an enzymatic
activity of 8,500 IU/ml, which falls within the scope of Appellant’s claim 1.
Sucriad 6.
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Application 13/786,956
Appellants argue that sacrosidase is not a naturally occurring enzyme,
but is, rather, derived from an external enzyme, invertase, that is firmly
attached to the cell wall of Saccharomyces cerevisiae. App. Br. 10.
According to Appellants, the external glycosylated form of invertase is
secreted by the cell, but remains attached to the cell by a hydrophobic amino
acid tail embedded in the cell wall. Id. Appellants contend that sacrosidase
is formed by cleaving the hydrophobic segment attached to the cell wall with
papain, freeing a 513 amino acid sequence (of the original 532 amino acid
sequence), which retains its enzymatic function. Id. at 11. Because the free
fragment of the external invertase (i.e., sacrosidase) has a different N-
terminal amino acid sequence than the original invertase from which it was
cleaved, Appellants contend that sacrosidase is different in structure from
the naturally-occurring invertase enzyme, and is therefore not a “natural
product.” Id.
We are not persuaded. Claim 1 is directed to a peptide that is made up
of the functioning cleaved majority fragment of the naturally occurring
external invertase protein. The Supreme Court’s opinion in Association for
Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013),
controls in these circumstances. In Myriad, the Court considered claims
directed to isolated DNA encoding the BRCA1 polypeptide and fragments
of at least 15 nucleotides of that DNA. Id. at 2113. The Court held that
“Myriad did not create anything. To be sure, it found an important and
useful gene, but separating that gene from its surrounding genetic material is
not an act of invention.” Id. at 2117. “Myriad found the location of the
BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the
BRCA genes ‘new ... composition^] of matter,’ § 101, that are patent
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Application 13/786,956
eligible.” Id. “Nor are Myriad’s claims saved by the fact that isolating
DNA from the human genome severs chemical bonds and thereby creates a
[non-naturally] occurring molecule.” Id. at 2118.
The same analysis applies here. Claim 1 is directed to a fragment of a
naturally occurring protein, separated from a small portion of the rest of the
protein. Although sacrosidase has somewhat fewer amino acids and a
different TV-terminal sequence (due to cleavage by the enzyme), that does not
render the remaining peptide a new composition of matter that is patent
eligible. Rather, claim 1 is directed to a product of nature, a judicially-
created exception to Section 101.
Appellants argue that:
The invertase coded by the SUC2 gene sequences is known to
contain 532 amino acid residues (GenBank). The enzyme
solubilized with papain to produce sacrosidase is 513 amino acid
residues, which begins with a different N-terminal amino acid
sequence (SMTNET) than does the “natural” cell wall bound
enzyme (MLLQA...). This evidences that sacrosidase is
markedly different in structure from the naturally-occurring
invertase enzyme, and is not a “natural product.”
Ans. 11.
This argument is not persuasive because the Court in Myriad
expressly held that the isolated BRCA genes were not patent eligible even
though isolating the DNA required severing chemical bonds. Myriad, 133
S.Ct. at 2118; see also In re BRCA1- and BRCA2-Based Hereditary Cancer
Test Patent Litigation, 11A F.3d 755, 760 (Fed. Cir. 2014) (“The Supreme
Court held ineligible claims directed to segments as short as 15 nucleotides,
the same length as the primer claims at issue here, suggesting that even short
strands identical to those found in nature are not patent eligible”). The logic
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Application 13/786,956
of the Myriad Court similarly applies when the naturally occurring product
is a fragment of a protein rather than a gene. See also Ex parte Cannon,
Appeal No. 2015-007470, 2017 WL 1020322, at *4 (PTAB March 14,
2017).
Having determined that the claimed sacrosidase enzyme is a product
of nature and, therefore, a judicially-created exception to Section 101, we
then determine whether the remaining limitations, both individually and “as
an ordered combination,” “transform the nature of the claim” into a patent-
eligible application that is that is “sufficient to ensure that the patent in
practice amounts to significantly more than a patent upon the [ineligible
concept] itself.” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,
1375 (Fed. Cir. 2015) (quoting Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66, 72-73, 78 (2012)).
We conclude that they do not. In the appeal before us, the claim 1
requires that the claimed sacrosidase be “in an aqueous medium comprising
about 35-55% glycerol and the balance, water.” Claim 1. The enzyme from
which sacrosidase is derived is naturally found in an aqueous solution in
vivo and glycerol is a routine additive to aqueous solutions being stored at
low temperatures. See, e.g., Spec. 1 (“CSID [Congenital sucrose-isomaltase
deficiency] is currently treated by the oral administration, with meals, of a
glycerol-water (1:1 w/w) solution of sacrosidase, which provides an enzyme
replacement therapy for CSID”). We conclude that these remaining
constituents of the claimed composition do no more than involve “well-
understood, routine, conventional activity previously engaged in by
researchers in the field” that do not contain an “inventive concept,”
sufficient to ensure that the patent in practice amounts to significantly more
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Application 13/786,956
than a patent upon the natural law itself. See Mayo, 566 U.S. at 72-73. We
consequently affirm the rejection of the claims under 35 U.S.C. § 101.
The remaining limitations of Appellants’ claimed invention do no
more than identify the properties of the well-known, convention, routine,
and commercially available Sucraid® formulation. Cf. In re Spada, 911
F.2d 705, 709 (Fed. Cir. 1990) (“discovery of an unobvious property and use
does not overcome the statutory restraint of section 102 when the claimed
composition is known”); see also In re Wiggins, 397 F.2d 356, n. 4 (CCPA
1968) (“Counsel for appellants produced a bottle containing a composition
at oral argument. It seems to us that the composition in the bottle would be
exactly the same whether the user were told to cure pneumonia in animals
with it... or to promote plant growth with it... . The directions on the
label will not change the composition of the contents”). See Animal Legal
Defense Fund v. Quigg, 932 F.2d 920, 923 (Fed. Cir. 1991) (“An article of
manufacture or composition of matter occurring in nature will not be
considered patentable unless given a new form, quality, properties or
combination not present in the original article existing in nature in
accordance with existing law”).
B. Rejection of claims 1-5 and 11-22 under 35 U.S.C. $ 102(b)
Issue
Appellants contend the Examiner erred because the cited prior art
references fail to disclose that the claimed solutions would be stable for at
least about 72 months when held at the recited temperature range. App. Br.
12.
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Analysis
Appellants argue that their Specification expressly discloses that the
combined shelf life, under FDA specifications, of the bulk drug substance
and the drug product (Sucraid®)2 is only 36 months. App. Br. 12 (citing
Spec. 2). Furthermore, Appellants argue Example 2 of their Specification
discloses that the shelf life of Sucraid® was “highly variable” when stored at
2-8°C. Id. Appellants point out that the recommended refrigerator storage
temperature is defined six times on the Sucraid® package insert and label as
being 2°-8°C. Id. (citing Sucraid 3-4). Appellants therefore contend that,
coupled with Sucraid’s direction to not freeze a sacrosidase solution, a
person of ordinary skill in the art would not consider cooling Sucraid®
below refrigerator temperature. Id.
Appellants dispute the Examiner’s conclusion that “the temperature
limitation does not change the claimed composition” and argue that, to the
contrary, the properties of the claimed composition have been changed.
App. Br. 13. According to Appellants, within the recited temperature range,
the glycerol/water solution interacts with the sacrosidase enzyme so as to
effectively halt its degradation, while still remaining in a liquid phase. Id.
Appellants argue that because, to constitute anticipation, all material
elements of a claim must be found in one prior art source, the art cited by the
Examiner does not anticipate the claimed composition. Id. (citing In re
Marshall, 54 F.2d 421, 423 (C.C.P.A. 1932).
2 Sucraid® is the trade name of Appellants’ claimed composition, a glycerol-
water (1:1 w/w) solution of sacrosidase. Spec. 1.
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We are not persuaded by Appellants’ arguments. Claim 1 is directed
to a composition and recites, in relevant part: “wherein the temperature of
the solution is about -18°C to about -22°C, wherein the enzymatic activity
remains constant for at least about 72 months.” In other words, claim 1
recites what Appellants contend is a hitherto unknown property of a
composition that is expressly disclosed by the prior art, viz., that it retained
its activity for at least about 72 months when stored between -18°C to about
-22°C.
However, a newly discovered or unusual property of a composition is
insufficient to render the composition patentably distinct from a disclosure
of that composition in the prior art:
[D]i sco very of an unobvious property and use does not overcome
the statutory restraint of section 102 when the claimed
composition is known.... When the claimed compositions are not
novel they are not rendered patentable by recitation of properties,
whether or not these properties are shown or suggested in the
prior art.”
In re Spada, 911 F.2d at 709 (Fed. Cir. 1990); see also In re Papesch, 315
315 F.2d 381, 391 (C.C.P.A. 1963) (“From the standpoint of patent law, a
compound and all of its properties are inseparable; they are one and the same
thing”); In re Wiggins, 397 F.2d at n.4. Although Appellants have
discovered that the claimed enzyme has the property of retaining its activity
for long intervals when kept within the recited temperature range, this
hitherto unknown property is not enough to render the composition
patentably distinct over the disclosures of the prior art. Stated differently,
the properties of a known composition do not change because Appellants
place a label on a bottle containing the composition which instructs those of
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ordinary skill in this art to store the composition in the freezer. See In re
Wiggins, 397 F.2d at n. 4. We consequently affirm the Examiner’s rejection
of the claims on this ground.
DECISION
The Examiner’s rejection of claims claims 1-5 and 11-22 as
unpatentable under 35 U.S.C. § 101 is affirmed.
The Examiner’s rejection of claims claims 1-5 and 11-22 as
unpatentable under 35 U.S.C. § 102(b) is affirmed.
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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAYTON T. REARDAN and BRIAN L. MILLER
Appeal 2016-003120
Application 13/786,956
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge, dissenting.
I respectfully dissent from the Majority’s opinion. While I concur
with the Majority’s decision affirming the rejection under 35 U.S.C. § 101,1
would have reversed the rejection under 35 U.S.C. § 102(b).
Claim 1 requires a particular range of amounts of the enzyme
sacrosidase in a aqueous solution with 35-55% glycerol and a particular
temperature for the solution of about -18°C to -22°C (Claim 1). I disagree
with the Majority’s finding that temperature in this context represents a
“newly discovered or unusual property of a composition.” (Dec. supra).
Appeal 2016-003120
Application 13/786,956
Instead, I would treat the temperature limitation as a structural
limitation that is not taught by the prior art reference.3 My reasoning is
consistent with King, where the CCPA found “the patentability of a product
is to be determined independently of the patentability of the process for
making it” and that different temperature processes produced “products
having entirely different physical properties, albeit the same chemical
structure.” In re Klug, 3333 F.2d 905, 907 (C.C.P.A. 1964). Here, the
different temperature in combination with the enzyme amounts, glycerol,
and water, result in different stability properties that are not taught by the
cited prior art.4
Just as reducing temperatures changes the phase of H2O from steam to
water to ice, with different properties for each of these phases, the reduced
temperature of the sacrosidase, glycerol, and water solution is reasonably
interpreted as a structural limitation that results in a product that is not
anticipated by a solution at a different temperature.
I disagree with the Majority’s comparison of the temperature to a
“label on a bottle” because the claim does not recite an instruction
requesting that the solution is held at the specified temperature, the claim
31 do not address obviousness because an obviousness rejection would have
afforded Appellants the opportunity to present secondary consideration evidence,
an opportunity not available in an anticipation rejection. See Cohesive Techs., Inc.
v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008) (distinguishing anticipation
from obviousness because “obviousness requires analysis of secondary
considerations of nonobviousness, while secondary considerations are not an
element of a claim of anticipation”)
41 do not address the inherency issue because before a property such as stability
can be inherent in a product, there must be either a teaching or suggestion of all the
structural limitations, including temperature.
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Application 13/786,956
requires the solution to be held at the specified temperature. This is a
structural difference, not a printed matter distinction.
For these reasons, I respectfully dissent from the Majority’s
anticipation analysis.
3