Ex Parte Minton et al

Patent Trials and Appeals Board

May 28, 2019

14274419 - (D) (P.T.A.B. May. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/274,419
11653 7590
PATE BAIRD, PLLC
36 West Fireclay
Murray, UT 84107
05/09/2014
05/29/2019
FIRST NAMED INVENTOR
Christian S. Minton
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.
3766-2-11 1093
EXAMINER
CHICKOS, SARAH J
ART UNIT PAPER NUMBER
1619
MAIL DATE DELIVERY MODE
05/29/2019 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 CHRISTIANS. MINTON, STEPHEN D. MINTON, and
J. W. RANDOLPH MILLER
Appeal 2018-003717
Application 14,274,419
Technology Center 1600
Before ULRIKE W. JENKS, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of increasing vasodilation. Examiner rejected
the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We REVERSE.
1 Appellant is the Applicant, SyK Technologies, LLC, which, according to
the Brief, is the real party in interest. Appeal Br. 2. We have considered,
and herein refer to, the Specification of May 9, 2014 ("Spec."); Final Office
Action of March 23, 2016 ("Final Act."); Appeal Brief of Aug. 16, 2016
("Appeal Br."); Supplemental Appeal Brief of Oct. 17, 2016 ("Suppl.
Appeal Br."); Examiner's Answer of Feb. 10, 2017 ("Ans."); and Reply
Brief of March 30, 2017 ("Reply Br.").
Appeal 2018-003717
Application 14/274,419
STATEMENT OF THE CASE
Claims 1-14 and 19-23 are on appeal, and can be found in the Claims
Appendix of the supplemental Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. A method for increasing vasodilation comprising:
providing a mammal with an epidermal surface and a
bloodstream having an initial systemic vasodilation of the
bloodstream;
providing a first medium comprising a nitrite compound;
providing a second medium comprising at least two
reducing agents;
creating a mixture of the first medium and the second
medium thereby initiating production of nitric oxide;
applying the mixture onto the epidermal surface of the
mammal;
absorbing at least 500 ppm of nitric oxide transdermally
within 10 minutes after the applying; and
increasing the systemic vasodilation of the bloodstream of
the mammal as compared to the initial vasodilation.
Suppl. Appeal Br. 8 (Claims Appendix) (emphasis added). Claims 10 and
19, the only other independent claims, similarly recite a method that
increases systemic vasodilation.
Appellant requests review2 of following rejections made by Examiner:
I. Claims 1-3, 6, 7, and 19-21 under 35 U.S.C. § 102(b) as being
anticipated by Tucker. 3
2 Appellant contends that the June 1, 2016 After-Final Amendment should
have been entered. See Appeal Br. 4. We are not in a position to grant relief
on this matter. Refusal by Examiner to enter an amendment is a petitionable
matter under 3 7 C.F .R. § 1.181 and not within the jurisdiction of the Board.
37 C.F.R. § 1.127; In re Berger, 279 F.3d 975, 984 (Fed. Cir. 2002); see
MPEP 1201.
3 Tucker et al., US 2004/0013747 Al, published Jan. 22, 2004 ("Tucker").
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Appeal 2018-003717
Application 14/274,419
II. Claims 1-3, 5-7, and 19-21 under 35 U.S.C. § 102(b) as being
anticipated by Balaban. 4
III. Claims 1-3, 5-9, and 19-23 under 35 U.S.C. § 103(a) as
unpatentable over Tucker in view of Balaban.
IV. Claims 4 and 10-14 under 35 U.S.C. § 103(a) as unpatentable
over Tucker in view of Balaban and further in view of Kevil. 5
I. Anticipation by Tucker
The issue presented is whether the preponderance of the evidence of
record supports Examiner's finding that Tucker teaches systemic
vasodilation after applying a nitric oxide (NO) generating composition to the
skin of a patient.
Findings of Fact
FF 1. Example 7 of Tucker teaches testing of a microcirculatory response of
a NO-generating gel.
The nitric oxide generating gel consisting of 330 mM of
both sodium nitrite and ascorbic acid in KY jellyâ„¢ was applied
directly to the forearm skin and simultaneously to SympatexTM
10 µm membrane (Akzo Nobel), which was then applied to the
forearm skin of the contralateral limb if nine healthy subjects ...
. Laser Doppler Fluxmetry (LDF) measured the skin
microcirculatory flux.
Tucker ,-J 74. "[T]he vasodilator response to the direct treatment reached a
plateau phase in all patients within 10 minutes of gel application .... [While
it took] 16 minutes when the NO-generation gel was applied to the
4 Balaban et al., US 2013/0330244 Al, published Dec. 12, 2013
("Balaban").
5 Kevil et al., US 2011/0311653 Al published Dec. 22, 2011 ("Kevil").
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Application 14/274,419
membrane and reflects a lag phase which is related to membrane diffusion
characteristics." Id. ,i 75.
FF2. Example 1 of Tucker teaches application of NO-generating gel on one
forearm and "placebo treatment was measured simultaneously on the
contra-lateral limb." Id. ,i 57.
Placebo treatment did not have any effect upon
microcirculatory blood flow in either the forearm or the
finger of the normal subjects. The vasodilator response to
the active treatment reached a plateau phase in all patients
within the ten minutes of active gel application. Forearm
skin and finger pulp blood flow increased markedly
following topical application of a NO-generating gel in the
healthy volunteers. When the active gel was applied to the
forearm skin all subjects showed a large vasodilator
response to active gel treatment in both volume and flux.
This increase in blood flow was sustained after removal of
the active gel. The active gel had no significant effect on
finger microcirculatory volume (PPG) ....
Id. iJ 58.
FF3. Tucker teaches multiple acidifying agents including: ascorbic acid
(vitamin C), salicylic acid, acetyl salicylic acid, a (C1 -C6) alkyl
carboxylic acid, for example ethanoic acid ( acetic acid), and citric
acid to name a few. Id. ,i,i 26-28.
FF4. The Specification describes using a perfusion index, or blood flow, as
a measure vasodilation.
One method for measurmg vasodilation is to
monitor the perfusion index, or blood flow. Perfusion
index is a relative assessment of the blood pulse strength
at the monitoring site in pulse oximetry. If the perfusion
index trends up, it indicates vasodilation and improved
peripheral perfusion, or tissue blood flow. If the perfusion
index trends down, it indicates a decrease in peripheral
perfusion. The perfusion index (Pl) may be expressed as
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Application 14/274,419
a rate of inflow pulsatile arterial light absorbed (AC)
divided by the non-pulsatile absorbed light, venous and
non-pulsatile blood or tissue (DC). PI = AC/DC.
Spec. ,i 33.
Analysis
Examiner found that Tucker teaches applying a mixture that produced
nitric oxide to the epidermal surface of a mammal. Final Act. 3-4.
Examiner found that the application increased vasodilation. Id. at 4 ( citing
Tucker Example 7); FF 1. Examiner found that "Tucker teaches using citric
acid and ascorbic acid which the requirements for the at least two reducing
agents called for in claim l." Id. (citing Tucker,i,i 26-28); FF3. Examiner
relies on inherency to establish "absorbance of at least 500 ppm nitric oxide
transdermally." Id.
Appellant contends that "Tucker does not teach each and every claim
element." Appeal Br. 5. Appellant contends "that Tucker, taken as whole,
does not support the assertion that Tucker discloses increasing the 'systemic'
vasodilation of a mammal." Id. at 7.
On this record, we agree with Appellant that the evidence does not
support Examiner's anticipation rejection. We recognize that Tucker
provides a list of reducing agents that include citric acid and ascorbic acid.
FF3. Tucker's example 7, relied on by Examiner in formulating the
rejection, uses only one acid in the mixture and not two as currently claimed.
FF1-FF2. We further note that Tucker's list does not suggest using these
acids in combination. Thus, the problem is that Tucker does not expressly
suggest putting two different acids into the reducing agent mixture.
Examiner has not explained how Tucker meets the claim limitation of
applying a composition that contains a nitrite compound and a second
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Application 14/274,419
medium containing at least two reducing agents. "A rejection for
anticipation under section 102 requires that each and every limitation of the
claimed invention be disclosed in a single prior art reference." In re
Paulsen, 30 F.3d 1475, 1478-79 (Fed. Cir. 1994). Because Tucker does not
disclose the use of two acids in the mixture, the reference thereby does not
meet each and every limitation as recited in the claim. Although the
combination of acids may be obvious, this is not the rejection before us.
Even ifwe were to agree with Examiner that Tucker teaches NO
producing mixture as claimed, we do not agree, however, that the evidence
supports Examiner's inherency argument. Specifically, the record does not
support the conclusion that the method disclosed and Tucker necessarily
meets the limitation of "absorbance of at least 500 ppm nitric oxide
transdermally within ten minutes called for in claim l." See Final Act. 4.
Tucker's example 1 applies the NO producing composition to the forearm of
a patient and measures vasodilation at the application site as well as blood
flow through the finger. FF2. Appellant points out that Tucker teaches
applying the mixture to the skin and measuring vasodilation in the patient
but does not establish that the effect is systemic. 6 Appeal Br. 7.
We agree with Appellant that the results shown in Tucker do not
support Examiner's position that the application of Tucker's NO producing
6 Systemic: "pertaining to or affecting the body as a whole."
https://medical-dictionary. thefreedictionary.com/systemic, last accessed
May 15, 2019. Systemic: "A description of something-for example, a
drug or an illness - that affects the whole body and not just part of it."
BLACK'S MEDICAL DICTIONARY, 43rd Edition, edited by Harvey Marcovitch,
A&C Black, 43rd edition, 2018. Credo Reference,
https://search.credoreference.com/content/entry/blackmed/systemic/0?
institutionld=743. Last accessed May 15, 2019.
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Application 14/274,419
mixture to the skin results in systemic vasodilation as claimed. The results
show that vasodilation response to the active treatment reached a plateau
within 10 minutes and forearm skin and finger pulp flow increased markedly
following this topical application. FF2. In Tucker the effect of the placebo
treatment was measured simultaneously on the contra-lateral limb, in other
words, one forearm was used for the application of the active agent while the
other forearm received the placebo. When measuring the microcirculatory
blood flow in either the forearm or finger of the placebo treated arm no
increase in vasodilation was observed. FF2. Thus, as Appellant points out,
the treatment supplied in Tucker does not have a systemic effect, because if
it did the measurements in the placebo treatment area would have increased
as well. We agree with Appellant that Examiner's inherency argument fails
because in this case Tucker shows that the application of NO producing
material onto the skin does not produce systemic increase in the
microcirculatory response.
Examiner found that Appellant has "made no showing and have
provided no evidence regarding the relationship if any between the
microcirculatory system tested and systemic vasodilation." Ans. 9. The
burden, however, is not on Appellant to establish a relationship between the
microcirculatory system tested in Tucker and systemic vasodilation. See
Appeal Br. 12; see Reply Br. 5.
[T]he examiner bears the initial burden, on review of the prior art
or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
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Application 14/274,419
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Tucker applies a NO generating compositions to the skin of patients
and measures microcirculatory flow in the contralateral limbs of the subject.
See FF1-FF3. Examiner in making the prima facie rejection relied on
inherency to establish two elements: (1) systemic vasodilation and (2) the
limitation of "absorbing at least 500 ppm of nitric oxide transdermally
within 10 minutes after the applying." See Ans. 9 ("Increased systemic
circulation is an inherent property that will necessarily be possessed by
following the method and composition taught in Tucker because the exact
same composition is used and the exact same method steps are followed.").
"In relying upon the theory of inherency, the examiner must provide a basis
in fact and/or technical reasoning to reasonably support the determination
that the allegedly inherent characteristic necessarily flows from the teachings
of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (BPAI
1990) (emphasis omitted). Examiner is relying on Tucker's disclosure of
applying a NO generating composition onto the skin of a patient for at least
the recited time as set out in the claims to establish that the NO composition
results in the absorption of the 500 ppm nitric oxide and thereby results
systemic vasodilation.
Here, we find that Appellant adequately traversed Examiner's
inherency rejection by pointing to evidence in Tucker that Tucker's
treatment method does not establish an increase in the microcirculatory flow
in the placebo treated area of the patient. Appeal Br. 6; FF2. The meaning
of systemic is "pertaining to or affecting the body as a whole." See above
fn. 6. Given this definition, the results disclosed in Tucker would lead one
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Application 14/274,419
of ordinary skill in the art to conclude that the treatment described is not
sufficient to produce a systemic effect. In other words, there is no evidence
that Tucker's method inherently meets the limitation of "absorbing at least
500 ppm of nitric oxide transdermally within 10 minutes after the applying"
step, because Tucker does not show its method as having an increased effect
on the whole body - the microcirculatory measurements on the contra lateral
limb resulted in no measured increase as compared to a treated limb. This
reasonably shifted the burden back to Examiner to establish that an increase
in systemic circulation would not necessarily result in an increase in
microcirculatory measurements as disclosed in Tucker.
We find that the preponderance of evidence of record does not support
Examiner's conclusion that Tucker anticipates the claimed method.
Accordingly, we reverse the anticipation rejection based on Tucker.
II. Anticipation by Balaban
The issue presented is whether the preponderance of the evidence of
record supports Examiner's finding that Balaban teaches systemic
vasodilation after applying a nitric oxide (NO) generating composition onto
the skin of a patient.
Findings of Fact
FF5. Balaban teaches mixing two gels to produce a mixture that generates
NO and applying the mixture to the skin a patient and measuring
blood flux. Nitric Oxide donor gel "N" contains the following
ingredients listed in the table below:
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Appeal 2018-003717
Application 14/274,419
E.u.~::yt )1> }lE.9f~lfi 3 .. 0 111g
HydNJXy?thyk~?Hulz\;,.~~ (EEC; 28.8 mg
Balaban ,i 82.
\.\\ight
l:\:::n::i:lllt.:l:gt (\:sm:::0nh'at inn
The nitric oxide activator gel "A" ingredients are listed in the table
below:
Sndinrn citm.b:.~
}<)~<:-:thy i Ml(;gbk: Arkt
Id. iJ 83.
J 4.,J) t\)}~
4 .. 7 tng
.l:5.Qmg
}.Q mg
2:S.8 mg
18 ~1~.rvt
73 rii\,1
Each set of two gels were individually mixed in a one-to-
one ratio (about 0.5 ml gel "N"+0.5 ml gel "A" for the
active composition; and 0.5 ml placebo gel+0.5 ml gel "A"
for the placebo composition) and applied to the marked
area of each forearm. The placebo mixture was applied to
the right arm, while the active ingredient mixture was
applied to the left arm. After 1-2 min for air drying, the
residual gel was removed and the probes [to measure
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Application 14/274,419
blood flux] were reattached to exactly the same position to
continue the measurements.
Id. iJ 84.
FF6. Balaban teaches that blood flux was measured using a dual channel
Laser Doppler Perfusion Monitor (Moor DRT4) with probes applied
to each forearm. Id. ,i 84. "The blood perfusion increased
immediately after applying the active ingredient gel. The perfusion
initially decreased with a time constant of about 10 minutes, but
remained elevated throughout the test. The placebo mixture appeared
to have no effect on blood perfusion." Id. ,i 85. Balaban concluded
the application of NO producing gel "increased local blood flow." Id.
iJ 86.
Analysis
Examiner found that Balaban teaches a method of increasing
vasodilation. Final Act. 5. Examiner found that Balaban teaches a medium
containing sodium nitrite and the second medium containing citric acid. Id.
Examiner relies on inherency to establish "absorbance of at least 500 ppm
nitric oxide transdermally." Id. at 6.
Appellant contends that Balaban does not disclose each and every
element of the claim. Appeal Br. 8. Specifically, "Appellant asserts that
Balaban does not support the assertion that Balaban discloses increasing the
systemic vasodilation of a mammal." Id.
We agree with Appellant that Balaban does not teach a method of
applying a NO generating composition in sufficient amount to show
increased systemic vasodilation. The meaning of systemic is "pertaining to
or affecting the body as a whole." See above fn. 6. Here, Balaban shows
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Application 14/274,419
that the application of the composition onto one forearm has no effect on the
blood flow or perfusion on the contra-lateral arm. See FF5-FF6. The
Specification relies on perfusion measurements to establish vasodilation.
FF4. Here, Balaban teaches the application of a NO generating composition
that contains at least two reducing agents but still does not show any
increase in systemic vasodilation as determined by blood perfusion
measurements. FF6. Therefore, we agree with Appellant that the evidence
does not support Examiner's inherency argument. Accordingly, we reverse
the anticipation rejection based on Balaban.
III. Obviousness over Tucker and Balaban.
This obviousness rejection relies upon the underlying anticipation
rejection based on Tucker, where Tucker is relied upon to address the
claimed systemic vasodilation. See Final Act. 6-8. For the obviousness
rejection, Examiner acknowledges that "Tucker does not expressly teach
sodium bicarbonate" and looks to Balaban for this teaching. Id. at 7. Thus,
Examiner does not rely on the teaching of Balaban to teach systemic
vasodilation, a limitation missing in Tucker. We therefore reverse the
obviousness rejection because even in the combination of Tucker and
Balaban this limitation is still missing.
IV. Obviousness over Tucker, Balaban, and Kevil
This rejection relies upon the underlying obviousness rejection over
Tucker and Balaban. Having reversed the rejection based on the
combination of Tucker and Balaban, we necessarily reverse the obviousness
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Application 14/274,419
rejection that further includes Kevil, since Kevil is not relied upon to teach
the "systemic vasodilation" limitation as claimed.
SUMMARY
We reverse the rejection of all claims.
REVERSED
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