Ex Parte GRUBER

Patent Trial and Appeal Board

Sep 17, 2018

15236355 (P.T.A.B. Sep. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
15/236,355 08/12/2016
84331 7590 09/19/2018
McBee Moore Woodward & Vanik IP, LLC
7900 Westpark Drive, Suite AIOO
McLean, VA 22102
FIRST NAMED INVENTOR
James Vincent GRUBER
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.
2926646-003002 1008
EXAMINER
MARX,IRENE
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
09/19/2018 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):
docketing@mmwvlaw.com
cgmoore@mmwvlaw.com
dwoodward@mmwvlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES VINCENT GRUBER
Appeal 2018-003781
Application 15/236,355
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
personal care composition. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b ). We reverse.
1 Appellant identifies the Real Party in Interest as Arch Personal Care
Products, L .P. (see App. Br. 2).
2 We have considered and herein refer to the Specification of Aug. 12, 2016
("Spec."); Final Office Action of May 30, 2017 ("Final Action"); Appeal
Brief of Oct. 27, 2017 ("App. Br."); Examiner's Answer of Jan. 25, 2018
("Answer"); Reply Brief of Feb. 20, 2018 ("Reply Br.") and Oral Hearing
held Sept. 13, 2018.
Appeal 2018-003781
Application 15/236,355
Statement of the Case
Background
"Ozone is increasingly becoming recognized as a detrimental agent
for skin cells ... ozone will diminish the amounts of vitamins C and E in the
upper layers of the stratum comeum as well as oxidize key lipids in the
bilayer of the stratum comeum. In addition, ozone has been implicated in
protein and nucleic acid damage" (Spec. 1: 16-28). "In a similar fashion to
human skin cells ... High concentration of ozone is typically lethal to yeast.
However, it has been suggested that lower concentrations of ozone may not
only be nonlethal, but may also influence the yeast to increase production of
certain protein" (Spec. 3:58---61).
The Specification teaches that "that Saccharomyces cerevisiae ...
respond well to growth stresses, such as heat shock, ozone, peroxides and
ultraviolet light. Surprisingly, the stress provides enhanced production of
stress response agents, or protective cell components in the yeast. These
stress response agents have therapeutic effects on human skin cells" (Spec.
4:84--88).
The Claims
Claims 19-29, 32 and 33 are on appeal. Claim 19 is representative
and reads as follows:
19. A personal care composition comprising:
an ozone-stressed yeast lysate; and
a preservative,
wherein the preservative is selected from phenoxyethanol,
isopropyl alcohol, benzyl alcohol, propylene glycol, butylene
glycol, pentylene glycol, methylparaben, propylparaben,
butylparaben, benzalkonium chloride, 1-(3-Chloroallyl)-3,5, 7-
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Application 15/236,355
triaza-1-azoniaadamantane chloride (QUATERNIUM 15),
methylisothiazolinone, methylchloroisothiazolinone, 1,3-
Bis(hydroxymethyl)-5 ,5-dimethylimidazolidine-2,4-dione
(DMDM hydantoin), imidazolidinyl urea, diazolidinyl urea,
butylated hydroxytoluene, tocopherol, triclosan, chlorohexidine
digluconate, and combinations thereof,
wherein the ozone-stressed yeast lysate is produced by a
method comprising the steps of:
(a) exposing growing yeast to ozone by aerating the yeast for a
time period of between five minutes and seventy-two hours with
an aeration gas having an ozone concentration of from 0.0001
millimolar (mM) to 1.0 millimolar (mM) based on the total
volume of the fermentation broth to produce ozone-stressed
yeast;
(b) lysing the ozone-stressed yeast to produce an ozone-stressed
yeast lysate comprising water-soluble and water-insoluble
components; and
( c) separating the water-soluble components from the water-
insoluble components to produce an ozone-stressed yeast lysate
comprising the water-soluble components.
The Rejections3
A. The Examiner has rejected claims 19--29 under 35 U.S.C. § I03(a) as
obvious over Scholz, 4 Duffy, 5 Scancarella, 6 Hinze, 7 and Tisdale8 (Final Act.
3 The rejections of claim 30 are moot in view of the cancellation of that
claim (see App. Br. 6, footnote 2). The Examiner withdrew the rejection
under U.S.C. § I02(b)/103(a) (see Ans. 3).
4 Scholz et al., US 6,461,857 Bl, issued Oct. 8, 2002.
5 Duffy et al., US 5,676,956, issued Oct. 14, 1997.
6 Scancarella et al., US 5,776,441, issued July 7, 1998.
7 Hinze et al., Effect of ozone on ATP, cytosolic enzymes and permeability of
Saccharomyces cerevisiae, 147 ARCH. MICROBIOLOGY 105-8 (1987).
8 Tisdale et al., US 6,103,246, issued Aug. 15, 2000.
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Application 15/236,355
7-9).
B. The Examiner has rejected claims 32 and 33 under 35 U.S.C. § I03(a)
as obvious over Scholz, Duffy, Scancarella, Hinze, Tisdale, and Shefer9
(Final Act. 13-14 ).
A. 35 US.C. § 103(a) over Scholz, Duffy, Scancarella, Hinze, and
Tisdale
The Examiner finds Scholz, Duffy, and Scancarella "disclose a water
soluble lysate of stressed yeast suitable for personal use" (Final Act. 8). The
Examiner finds Duffy and Scancarella also teach "a water soluble lysate
composition and preservative, such as benzyl alcohol, for personal use ...
wherein at least benzyl alcohol is contained as a preservative" (id.).
The Examiner acknowledges Scholz, Duffy, and Scancarella "differ
from the claimed invention in that the yeast is not stressed with ozone" and
do not teach "the use of liposomes in cosmetics as well as encapsulation
with components providing time release characteristics" (id.).
The Examiner finds Hinze teaches "stressed yeast and the effects of
ozone stress on activation of some enzymes and inhibition of others" (id.).
The Examiner finds Tisdale teaches "that the use of liposomes in cosmetics
as well as encapsulation with components providing time release
characteristics is old and well known" (id.).
The Examiner finds the
effects of stress with U.V. light and with ozone would
reasonably be expected to be to be substantially similar on an
unidentified yeast composition, particularly in the absence of a
9 Shefer et al., US 2003/0232091 Al, published Dec. 18, 2003.
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Application 15/236,355
clear indication of the length of ozone exposure, the nature of
the yeast used, as well as the extent of purification of the yeast
lysate produced.
(Final Act. 8).
The Examiner finds it obvious to modify the compositions of Scholz,
Duffy, and Scancarella "by replacing U.V. or hydrogen peroxide stressed
yeast with ozone stressed yeast in a personal use composition, as suggested
by the teachings of Hinze ... for the expected benefit of providing personal
use compositions containing activated yeast lysates recognized to have
favorable properties" (Final Act. 9).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that Scholz,
Duffy, Scancarella, Hinze, and Tisdale render claim 19 obvious?
Findings of Fact
1. Scholz teaches "a method of preparing a yeast cell extract
which has the properties of cell stimulation and protection from cellular
damage caused by activated oxygen species and/or UV light" (Scholz 2:31-
33).
2. Scholz teaches:
adding a sub-lethal amount of a peroxide to a growing culture
of yeast, observing the change in absorbance of the culture at
256 nm as a measure of the injury occurring to the yeast cells,
and, upon reaching a predetermined absorbance value,
purifying the water-soluble yeast extract from the peroxide
containing yeast culture . . . This product can be combined with
a cosmetically acceptable carrier to provide a composition
suitable for topical application to the skin.
(Scholz 2:35--48).
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3. Scholz teaches yeast "cells respond to the debilitating effects of
the H20 2 by producing various protective substances. The injury process is
continued until the complex biochemical protective mechanisms are
complete" (Scholz 4:32-37).
4. Scholz teaches the "new extract is called Peroxide Treated
Yeast Extract (PTYE)" (Scholz 3 :39-40).
5. Scholz teaches the prior art disclosed that "[ v ]iable yeast
cultures exposed to UV light of a specified wavelength (286 nm) produce
the isolate known as Live Yeast Cell Derivative (L YCD)" (Scholz 1 :52-54).
6. Scholz teaches:
It is clear that insulting yeast cultures with peroxide produces a
product that is equivalent to L YCD in terms of its ability to
stimulate cellular oxygen uptake. This equivalence indicates
that PTYE is capable of producing the same cosmetically
desirable effects as LYCD. Additionally, peroxide induces the
production of some soluble protective factors yet to be
identified which would seem to be stress response factors.
(Scholz 4: 18-25).
7. Scholz teaches "tissue treated with LYCD (0.7% w/w active)
and irradiated produced an average of79,139 pg/ml PGE2. PTYE (0. 7%
w/w active) reduces PGE2 to an average of 54,490 pg/ml" (Scholz 4: 10-13).
8. Scholz teaches "[ o ]ther oxidative materials, which can generate
the superoxide anion, the hydroxyl radical and nitric oxide can also be used
to oxidatively stress yeast cultures and produce PTYE" (Scholz 4:49-52).
9. Duffy teaches "a topical formulation for treating under-eye
bagginess and associated discolorations which comprises about 0.5 to about
10.0% live yeast cell derivative" (Duffy 2:29-32).
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10. Duffy teaches the "living yeast cells are then stressed with UV
light (286 nm). The cells respond by producing various protective
substances" (Duffy 3:59---61).
11. Duffy teaches "[i]n addition ... preservatives such as
methylparaben, imidazolidinyl urea and benzyl alcohol ... can all be
employed in diverse combinations to enhance the efficacy of and impart
general skin benefits to the present invention" (Duffy 3:1-10).
12. Scancarella teaches LYCD is produced when after fermentation
"living yeast cells are then subjected to an 'injury' process such as
irradiating them with UV light of a specified wavelength (286 nm). The
cells respond to the debilitating effects of the UV light by producing various
protective substances" (Scancarella 2:43--47).
13. Hinze teaches "[i]t is evident from the data presented here that
in the case of yeast, during ozone treatment a break of the permeability
barrier preceeds the damage of the energy metabolism as characterized by
the ATP content of the cells" (Hinze 107, col. 2).
14. Hinze teaches that various enzyme activities change after
treatment of yeast with ozone (see Hinze 106, col. 2, table 1 ).
15. The Specification teaches that an "ozone-stressed yeast lysate
showed increased protection against the oxidizing power of ozone and less
degradation to indigo potassium indigo trisulfonate compared to water and
nontreated yeast lysate. This study suggests that ozone-stressed yeast lysate
contains protective agents to retard the degradation of indigo dye" (Spec.
34:722725).
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16. The Specification teaches:
Of the entire yeast genome present on the microarray,
570 genes were up-regulated in ozone-stressed yeast with 148
(26%) of them being different than those up-regulated by
hydrogen peroxide. Likewise, of the 502 genes up-regulated by
hydrogen peroxide, 80 (15.0%) were different than those up-
regulated for ozone stressed yeast.
Of the 342 genes down-regulated by ozone stressing
yeast, 321 (93.8%) were not downregulated by hydrogen
peroxide stress. Likewise, of the 57 genes down-regulated by
hydrogen peroxide stress, 36 (63%) were not down-regulated
by ozone stress.
Of the genes observed in the microarray analysis, it was
noted that GAPDH was up-regulated in the presence of ozone,
while it was not affected by hydrogen peroxide consistent with
the earlier published scientific studies discussed above.
(Spec. 33:696-706).
Principles of Law
A prima facie case for obviousness requires "a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
"Inherency ... may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient." MEHL/Biophile Int'!. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999).
Analysis
Appellant contends "Duffy and Scancarella disclose ultraviolet (UV)
radiation-stressed yeast lysates" (App. Br. 7) and Scholz "discloses using a
peroxide (H20 2)-stressed yeast lysate" (App. Br. 24--25). Appellant
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Application 15/236,355
contends "the Office has disregarded the data in the specification that
demonstrates that a clear difference exists between yeast responses to
different stressors" (App. Br. 7). In particular, Appellant notes the "results
presented in ,r,r [0070-0071] indisputably show that ozone results in different
gene expression from H202" (App. Br. 11 ). Appellant also notes that in
Scholz, "[t]here are additional proteins induced by peroxide that are not
present in the lysates induced by UV" (App. Br. 25; citing Scholz 3:60 to
4:5).
The Examiner responds
It is submitted that the argued differences between the
responses of yeast to different stressors has not been
substantiated with appropriate evidence commensurate in scope
with the claims. As was indicated previously, the data in the
specification are directed exclusively to a lysate obtained [ from
a] particular strain of Saccharomyces cerevisiae, Red Star brand
baker's yeast and not to yeasts in general. There is nothing on
the present record to show or even to suggest the effects of
different stressors on any yeast.
(Ans. 4).
We find that Appellant has the better position. The Examiner may
initially rely upon an In re Best rationale for products produced by
"substantially identical processes" to establish prima facie obviousness and
the burden of proof then shifts to Appellant "to prove that the subject matter
shown to be in the prior art does not possess the characteristic relied on." In
re Best, 562 F.2d 1252, 1255 (CCPA 1977).
In the instant case, Appellant has addressed this burden of proof and
provided evidence that ozone-stressed yeast lysates differ from either UV or
H20 2 stressed yeast lysates. In particular, Appellant shows that ozone
stressed lysate differs from H202 stressed yeast lysate based on differential
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gene expression (FF 16). In addition, Scholz evidences that UV and H20 2
stressed yeast lysates differ from each other (FF 6-8). Thus, the evidence of
record supports Appellant's position that an ozone-stressed yeast lysate
differs structurally from either a UV or H20 2 stressed yeast lysate. 10
The Examiner also contends that the ordinary artisan would have
modified the stressor in Scholz, Duffy, or Scancarella from UV or H20 2 to
ozone based on Hinze because Hinze teaches "stressed yeast and the effects
of ozone stress on activation of some enzymes and inhibition of others."
(Final Act 8). The Examiner finds:
One of ordinary skill in the art would have reasonably expected
yeast lysates produced from stressed yeast to have substantially
the same components and properties. The effects of stress with
U.V. light and with ozone would reasonably be expected to be
to be substantially similar on an unidentified yeast composition,
particularly in the absence of a clear indication of the length of
ozone exposure, the nature of the yeast used, as well as the
extent of purification of the yeast lysate produced.
(Final Act. 8).
Appellant responds "because Hinze teaches that ozone permeabilized
the yeast after 3 minutes, the yeast would not have time to produce any
protective biological response required by Duffy, Scancarella and
[Scholz], which takes several days" (App. Br. 27). Appellant further
contends "there is no motivation to combine Hinze with the other cited
10 To the extent that the Examiner addresses the scope of different yeasts
(see Ans. 4, 6), this argument is drawn to either scope of enablement or to
written description but is not relevant to the obviousness rejection. Indeed,
to the extent that the claim encompasses different yeast species in the yeast
lysate, the expectation would be that such different yeast species would also
react differently to other stressors such as UV and H20 2 than the tested
baker's yeast.
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references" because Hinze "discloses no personal care composition" (Reply
Br. 9).
We again agree with Appellant because the Examiner has provided no
explicit reason to select ozone as the oxidative stressor in the place of either
UV or H202 (see Final Act. 8). In addition, the Examiner has not provided
evidence to establish that ozone is an obvious substitution as an equivalent
"other oxidative material" consistent with the teaching of Scholz that
"[ o ]ther oxidative materials, which can generate the superoxide anion, the
hydroxyl radical ... can also be used to oxidatively stress yeast cultures and
produce PTYE" (FF 8). Nor has the Examiner provided any other reason
from Hinze or the other cited art that would suggest that an implicit
motivation to combine exists because "the 'improvement' is technology-
independent and the combination of references results in a product or
process that is more desirable, for example because it is stronger, cheaper,
cleaner, faster, lighter, smaller, more durable, or more efficient." DyStar
Textilfarben GmbH & Co. Deutsch/and KG v. CH Patrick Co., 464 F.3d
1356, 1367 (Fed. Cir. 2006). In contrast, Appellant has provided reasons
why ozone would not have been selected based on Hinze, including the
argument that "Hinze teaches that ozone results in cell membrane
permeabilization and breakdown of energy metabolism (leading to certain
death) after only 3 minutes" (App.Br. 27-28).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner's conclusion that Scholz, Duffy, Scancarella, Hinze, and Tisdale
render claim 19 obvious.
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B. 35 US.C. § 103(a) over Scholz, Duffy, Scancarella, Hinze, Tisdale,
and Shefer
The Examiner relies upon the rejection over Scholz, Duffy,
Scancarella, Hinze, and Tisdale to address the ozone limitation.
Having reversed the obviousness rejection of claim 19 over this
rejection for the reasons given above, we also find that the further
combination with Shefer does not render the rejected claims obvious
for the same reasons.
SUMMARY
In summary, we reverse the rejection of claims 19--29 under 35 U.S.C.
§ 103(a) as obvious over Scholz, Duffy, Scancarella, Hinze, and Tisdale.
We reverse the rejection of claims 32 and 33 under 35 U.S.C. § 103(a)
as obvious over Scholz, Duffy, Scancarella, Hinze, Tisdale, and Shefer.
REVERSED
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