Ex Parte Zachwieja

Patent Trial and Appeal Board

Aug 23, 2016

13092199 (P.T.A.B. Aug. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/092,199 04/22/2011
110933 7590 08/24/2016
Carstens & Cahoon, LLP
PO Box 802334
Dallas, TX 75380
FIRST NAMED INVENTOR
Jeffrey J. Zachwieja
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.
CGAT0.3597 6061
EXAMINER
STONE, CHRISTOPHER R
ART UNIT PAPER NUMBER
1628
MAILDATE DELIVERY MODE
08/24/2016 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 PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY J. ZACHWIEJA
Appeal2014-004689
Application 13/092,199
Technology Center 1600
Before DONALD E. ADAMS, DEMETRA J. MILLS, and
RYAN H. FLAX, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation and obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.
STATEMENT OF CASE
The following claims are representative.
1. A method of reducing oxidative modification of one or
more proteins or other cellular constituents involved in muscle
cell contraction comprising administering one or more
antioxidant compounds to an individual engaged in an exercise
regimen in an amount sufficient to reduce oxidative modification
of the one or more proteins or other cellular constituents.
2. The method of claim 1 wherein the protein is myosin
heavy chain protein.
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3. The method of claim 2 wherein the antioxidant
compound is 6-hydroxy-2,5,7,8- tetramethylchroman-2-
carboxylic acid.
4. A method of reducing muscle fatigue in an individual
comprising administering one or more antioxidant compounds
to an individual engaged in an exercise regimen in an amount
sufficient to reduce oxidative modification of one or more
proteins or other cellular constituents involved in muscle cell
contraction.
5. The method of claim 4 wherein the protein is myosin
heavy chain protein.
6. The method of claim 5 wherein the antioxidant
compound is 6-hydroxy-2,5,7,8-tetramethylchroman-2-
carboxylic acid.
7. A method of increasing muscle performance during
exercise comprising administering one or more antioxidant
compounds to an individual engaged in an exercise regimen in
an amount sufficient to reduce oxidative modification of one or
more proteins or other cellular constituents involved in muscle
cell contraction.
8. The method of claim 7 wherein the protein is myosin
heavy chain protein.
9. The method of claim 8 wherein the antioxidant
compound is 6-hydroxy-2,5,7,8- tetramethylchroman-2-
carboxylic acid.
25. The method of claim 1 wherein the antioxidant is
administered to the individual to achieve a blood concentration
of the antioxidant of about l mM.
28. The method of claim 4 wherein the antioxidant is
administered to the individual to achieve a blood concentration
of the antioxidant of about l mM.
31. The method of claim 7 wherein the antioxidant is
administered to the individual to achieve a blood concentration
of the antioxidant of about l mM.
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Cited References
Michael B. Reid, Free radicals and muscle fatigue: Of ROS, canaries,
and the IOC, 44 FREE RADICAL BIOLOGY & MEDICINE 169-179
(2008) (hereinafter "Reid").
Jenna L. Betters et al., Trolox Attenuates Mechanical Ventilation -
induced Diaphragmatic Dysfunction and Proteolysis, 170 AM. J. OF
RESPIRATORY AND CRITICAL CARE MEDICINE 1179-1184 (2004)
(hereinafter "Betters").
Grounds of Rejection
1. Claims 1, 2, 4, 5, 7, 8, and 23-31 remain rejected under 35 U.S.C.
§ 102(b) as being anticipated by Reid.
2. Claims 3, 6, and 9 are rejected under 35 U.S.C. §103(a) as being
unpatentable over Reid in view of Betters.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 2---6.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Where ... the claimed and prior art products are identical
or substantially identical, or are produced by identical or
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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.
Whether the rejection is based on 'inherency' under 35 U.S.C.
§ 102, on 'prima facie obviousness' under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO' s inability to manufacture
products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (footnote omitted) (citation
omitted). The principles set forth in In re Best are also applicable to process
or method claims as discussed in In re King, 801 F.2d 1324, 1327 (Fed. Cir.
1986).
Inherent anticipation does not require intent or recognition that a prior
art process achieve a result which is claimed. "Inherency is not necessarily
coterminous with the knowledge of those of ordinary skill in the art.
Artisans of ordinary skill may not recognize the inherent characteristics or
functioning of the prior art." MEHL/Biophile Int'! Corp. v. Milgraum, 192
F.3d 1362, 1365 (Fed. Cir. 1999). "Newly discovered results of known
processes directed to the same purpose are not patentable because such
results are inherent." Bristol-Myers Squibb v. Ben Venue Labs., 246 F.3d
1368, 1376 (Fed. Cir. 2001).
Rejection I -Anticipation Reid
We agree with the Examiner's fact finding, statement of the rejection
and responses to Appellant's arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
anticipation. We provide the following additional comment to the
Examiner's argument set forth in the Final Action and Answer. For claims
which are not separately argued, we select claim 1 as representative. Claims
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4, 7, and 23-31 fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). Separately
argued claims are addressed separately below.
The Examiner finds that Reid teaches each element claimed. In
particular, Reid teaches:
a method of reducing oxidative modification of muscle cell
proteins (e.g. myosin heavy chain) comprising administering an
antioxidant (e.g. NAC [N-acetylcysteine]) in an amount
sufficient to oxidative modification of proteins in a frequency
of administration prior to an exercise regimen (p. 172, left
column, p. 176, left column, first paragraph). The treatment is
taught to reduce muscle fatigue and improve endurance, i.e.
muscle performance during exercise (p. 176, left column, first
paragraph).
Final Act. 2-3.
Appellant contends that, "Reid fails to disclose administering one or
more antioxidant compounds to achieve a reduction in modification of one
or more proteins or other cellular constituents involved in muscle cell
contraction; as required by the appealed claims." App. Br. 9.
We are not persuaded and agree with the Examiner that
Reid teaches the administration of the instantly claimed
compound (i.e. an antioxidant) to the instantly claimed patient
population (an individual engaged in an exercise regimen) at
the instantly claimed dosage, i.e. in an amount sufficient to
reduce fatigue/oxidative modification of proteins and products
of identical chemical composition cannot exert mutually
exclusive properties when administered under the same
circumstances.
Ans. 4. The claims are not limited to any specific antioxidant or group of
antioxidants, therefore, the claims encompass any antioxidant. Furthermore,
Reid (citing Moopanar and Allen) discloses:
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ROS [reactive oxygen species] oxidize critical sulthydryls on
myofibrillar proteins to disulfides, thereby reducing calcium
sensitivity ... Alternatively, Andrade and associates ... have suggested
that oxidants may act indirectly via redox-sensitive regulatory
enzymes, e.g., kinases or phosphatases, which then modify
myofibrillar proteins to depress function.
Reid 174, col. 1 (citations omitted). Reid suggests:
The controlling reaction seems to be ROS-induced oxidation of
thiols on one or more regulatory proteins .... Protein thiol
groups with high thiol/disulfide oxidation potentials are the
most likely target for such reaction .... In cellular systems,
oxidized protein thiols can be reduced via constitutive reaction
pathways ... , providing a general mechanism by which ROS
effects on calcium sensitivity could be reversed. This reasoning
is consistent with the rapid reversibility of physiological fatigue
by rest under some conditions ....
Reid went on to show that NAC pretreatment "slowed fatigue of human limb
muscle" and "protects human respiratory muscle, i.e., diaphragm." Reid
175, cols. 1 and 2.
Thus, Reid suggests the claimed method step and therefore inherently
teaches the reduction of the one or more proteins or other cellular
constituents involved in muscle cell contraction. Inherent anticipation does
not require intent or recognition that a prior art process achieve a result
which is claimed. MEHL/Biophile Int'! Corp., 192 F.3d at 1365. The
Appellant has not shown that the dosage of Reid does not inherently result in
the reduction of the one or more proteins or other cellular constituents
involved in muscle cell contraction. "It is a general rule that merely
discovering and claiming a new benefit of an old process cannot render the
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process again patentable." Jn re Woodruff; 919 F.2d 1575, 1578 (Fed. Cir.
1990).
Appellant additionally argues that Appellant's Specification discloses
that it was known in the art that NAC was unsuitable for treating muscle
fatigue associated with intense, near-maximal muscle activity. Reply Br. 4--
5. We are not persuaded. The pending claims are not limited to treating
muscle fatigue associated with intense, near-maximal muscle activity. Reid
discloses that NAC treats muscle fatigue and also inherently reduces
oxidative modification of one or more proteins or other cellular constituents
involved in muscle cell contraction.
Claims 2
Appellant contends, "Reid does not disclose detecting oxidative
modification of myosin heavy chain protein, let alone disclose administering
an antioxidant compound to decrease oxidative modification of myosin
heavy chain protein, as required by dependent claims 2, 5 and 8." App. Br.
14. We are not persuaded. Claims 5 and 8 are not separately argued and fall
with claim 2. 37 C.F.R. § 41.37(c)(l)(iv).
In addition to Reids' disclosure discussed above with respect to
modification of myosin, myofibrillar proteins by reactive oxygen species,
the pending claims do not require a step of "detecting oxidative modification
of myosin heavy chain protein," as argued by Appellant. The only active
method step required by the claims is "administering one or more
antioxidants" in a sufficient dosage amount. Reid teaches this method step.
Reid teaches the administration of the instantly claimed compound
(i.e. an antioxidant), such as NAC to the instantly claimed patient population
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(an individual engaged in an exercise regimen) at the instantly claimed
dosage, i.e. in an amount sufficient to reduce fatigue/oxidative modification
of proteins, including myosin heavy chain protein, and products of identical
chemical composition cannot exert mutually exclusive properties when
administered under the same circumstances. Ans. 4; Reid 171-172. The
Specification (at 13) discloses, "certain amounts of [an antioxidant] ...
compound within the scope of the present invention include about 1 mg
compound per kg of body weight (l mg/kg) to about 100 mg/kg, about 5
mg/kg to about 50 mg/kg, about 10 mg/kg to about 25 mg/kg, about 15
mg/kg to about 20 mg/kg." Reid's dosages overlap the claimed dose range
amount sufficient to reduce oxidative modification of the one or more
proteins or other cellular constituents disclosed in the Specification.
Appellant has not shown that the dosages of Reid (e.g., 176, col. 1) do not
overlap with the claimed dosage or that Reid's dosage does not inherently
result in the reduction of the one or more proteins or other cellular
constituents involved in muscle cell contraction.
Claims 25
Claims 28 and 31 are not separately argued and, therefore, fall with
claim 25. 37 C.F.R. § 41.37(c)(l)(iv). Dependent claim 25 further requires
the antioxidant administered to the individual to achieve a blood
concentration of about 1 mM. Appellant argues that he "has discovered that
the pre-treatment of myotubes with 1 mM antioxidant resulted in a 42%
decrease in oxidative modification of myosin heavy chain protein. (See
Example 3, pages 43-44 of the subject specification.)." Br. 15. Appellant
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further argues that "Reid does not disclose administering an antioxidant to
achieve a blood concentration of the antioxidant of about 1 mM." id.
The Examiner responds, determining that the claim language "merely
describes that intended result of a positively recited method step, i.e. the
administration of an antioxidant compound at a particular dosage to a
particular patient population and is thus not given patentable weight." Ans.
5. The Examiner finds that Reid teaches each element claimed. In
particular, Reid teaches a method of reducing oxidative modification of
muscle cell proteins (e.g. myosin heavy chain) comprising administering an
antioxidant (e.g. NAC [N-acetylcysteine]) in an amount sufficient to
oxidative modification of proteins in a frequency of administration prior to
an exercise regimen (at 172, left col., and 176, left col., first para.). The
treatment is taught to reduce muscle fatigue and improve endurance, i.e.
muscle performance during exercise (at 176, left col., first para.). Final Act.
2-3.
Under the principles set forth in In re Best, the burden of proof shifts
to Appellant to show that the dosages of Reid (e.g., 176, col. 1) do not
overlap with the claimed dosage or that Reid's dosage does not inherently
result in a blood concentration of the antioxidant of about l mM. Compare,
In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986).
Appellant has not shown that the dosages of Reid (e.g., 176, col. 1) do
not overlap with the claimed dosage or that Reid's dosage does not
inherently result in a blood concentration of the antioxidant of about l mM.
The anticipation rejection is affirmed for the reasons of record.
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Rejection 2 - Obviousness Reid and Betters
The Examiner acknowledges that
Reid et al[.] teaches the aforementioned method, but does
not teach the administration of Trolox as the particular
antioxidant.
Betters et al[.] teaches that Trolox is an antioxidant
compound that can reduce oxidative stress/muscle fatigue in
humans (p. 1170, right column, 2nd full paragraph, and p. 1180,
right column, Effects of Trolox on Contractile Properties
heading).
Final Act. 4.
Appellant contends that, "[n]either Reid nor Betters, alone or in
combination, provide any disclosure or discussion that it would be desirable
or possible to administer 6-hydroxy-2,5, 7 ,8-tetramethylchroman-2-
carboxylic acid to an individual engaged in an exercise regimen in an
amount sufficient to reduce oxidative modification of one or more proteins
or other cellular constituents involved in muscle cell contraction. Br. 6-7.
Appellants further contend that the Examiner has engaged in hindsight
reconstruction of Appellant's invention. Br. 7.
We are not convinced by Appellant's argument. Reid discloses that it
is known in the art that, "[ s ]keletal muscle fibers continually generate
reactive oxygen species (ROS) at a slow rate that increases during muscle
contraction. This activity dependent increase in ROS production contributes
to fatigue of skeletal muscle during strenuous exercise." Reid (Abstract).
Reid shows that the antioxidant, NAC, mediates muscle fatigue caused by
antioxidants. Id. Reid further discloses:
Other antioxidants have not been evaluated systematically and
could prove beneficial. For example, recent reports suggest
endurance is augmented in rodents that receive green tea extract ... ,
capsaicin ... , or Anoectochilus formaosanus .... Melatonin is reported
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to alleviate perceptions of fatigue in chronic fatigue syndrome ... and
the herb Rhodiola rosea may have ergogenic properties ....
Reid, 17 6, col 2. Betters confirms the findings of Reid, concluding:
our novel results clearly demonstrate that an antioxidant, Trolox,
effectively prevents MV [mechanical ventilation]-induced contractile
impairments and proteolysis in the diaphragm during MV. Oxidative
damage and atrophy are implicated in MY-induced contractile
deficits. Oxidative damage to proteins during MV likely increases
proteolytic degradation, which would contribute to diaphragmatic
weakness. Trolox effectively spares the unloaded diaphragm from
contractile dysfunction and protein degradation during 12 hours of
controlled MV.
Betters, 1183, col. 2. Betters also discloses, "Trolox attenuated the increase
in total [muscle] protein degradation induced by MV (Figure 3)." Betters,
1183, col. 2.
We agree with the Examiner's response to Appellant's arguments and
adopt them as our own. Arguments not made are deemed waived. The
obviousness rejection is affirmed for the reasons of record.
CONCLUSION OF LAW
The cited references support the Examiner's anticipation and
obviousness rejections, which are affirmed. All pending, rejected claims
fall.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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