SYK TECHNOLOGIES, LLC

Patent Trials and Appeals Board

Jun 1, 2020

15492528 - (D) (P.T.A.B. Jun. 1, 2020)

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.
15/492,528 04/20/2017 Christian S. Minton 3766-2-11-2 1689
11653 7590 06/01/2020
PATE BAIRD, PLLC
36 West Fireclay
Murray, UT 84107
EXAMINER
CHICKOS, SARAH J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
06/01/2020 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):
docket@patebaird.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CHRISTIAN S. MINTON, STEPHEN D. MINTON, and
J. W. RANDOLPH MILLER
____________

Appeal 2019-004603
Application 15/492,528
Technology Center 1600
____________

Before ULRIKE W. JENKS, TAWEN 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 use the word
“Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). We
have considered, and herein refer to, the Specification of April 20, 2017
(“Spec.”); Final Office Action of January 11, 2018 (“Final Act.”); Appeal
Brief of May 17, 2018 (“Appeal Br.”); Examiner’s Answer of September 5,
2018 (“Ans.”); and Reply Brief of September 19, 2018 (“Reply Br.”).

Appeal 2019-004603
Application 15/492,528

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STATEMENT OF THE CASE
Claims 1–19 are on appeal, and can be found in the Claims Appendix
of the 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 a first location of 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 at
a second, untreated location of the mammal as compared to the
initial systemic vasodilation.
Appeal Br. 17 (Claims Appendix) (emphasis added). Claims 10 and 15, the
only other independent claims, similarly recite a method that increases
systemic vasodilation.
REFERENCE(S)
The prior art relied upon by Examiner is:
Name Reference Date
Tucker et al.
(“Tucker”)
US 2004/0013747 A1 Jan. 22, 2004
Kevil et al. (“Kevil”) US 2011/0311653 Al Dec. 22, 2011
Balaban et al.
(“Balaban”)
US 2013/0330244 A1 Dec. 12, 2013
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REJECTIONS
Appellant requests review of following grounds of rejections made by
Examiner:
I. Claims 1–3, 6, 7, 13, 15, and 16 under 35 U.S.C. § 102(b) as
being anticipated by Tucker.
II. Claims 1–3, 5–7, 13, and 15–17 under 35 U.S.C. § 102(b) as
being anticipated by Balaban.
III. Claims 1–3, 5–9, and 15–19 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.

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
FF1. 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
jelly™ 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
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Doppler Fluxmetry (LDF) measured the skin
microcirculatory flux.
Tucker ¶ 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 membrane and reflects a lag phase which is
related to membrane diffusion characteristics.” Id. ¶ 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. ¶ 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. ¶ 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. ¶¶ 26–28.
FF4. The Specification describes using a perfusion index, or blood flow, as
a measure vasodilation.
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One method for measuring 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 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. ¶ 33.
Analysis
Examiner found that Tucker teaches applying a mixture that produced
nitric oxide to the epidermal surface of a mammal. Final Act. 3. Examiner
found that the application increased vasodilation. Id. (citing Tucker Example
7); FF1. 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 1.” Id. (citing Tucker ¶¶ 26–28); FF3. Examiner relies on inherency to
establish “absorbance of at least 500 ppm nitric oxide transdermally.” Id.;
see also Ans. 4 (Tucker “teaches the same composition as that claimed used
in the same way as that claimed but Appellants are arguing that a different
result than that claimed occurs.” (emphasis removed)).
Appellant contends that Tucker does not teach each and every claim
element. Appeal Br. 8. Appellant contends that Tucker does not “support the
assertion in the Office Action that Tucker discloses applying a nitric oxide
producing gel at one location on a mammal and increasing the systemic
vasodilation of that mammal.” Id.
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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. Examiner has not explained how Tucker meets the
claim limitation of applying a composition that contains a nitrite compound
and a second 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.
Moreover, even if we were to agree with Examiner that Tucker
teaches NO producing mixture as claimed, we do not agree that the evidence
supports Examiner’s inherency argument. Specifically, the record does not
support the conclusion that the method disclosed in Tucker necessarily
meets the limitation of “absorbance of at least 500 ppm nitric oxide
transdermally within ten minutes called for in claim 1.” 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
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applying the mixture to the skin and measuring vasodilation in the patient
but does not establish that the effect is systemic.2 Appeal Br. 9.
We agree with Appellant that the results shown in Tucker do not
support Examiner’s position that the application of Tucker’s NO producing
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. See Reply Br. 2 (“If the components and methods described in Tucker
produced a systemic effect, inherent or otherwise, the testing of the placebo
area would have revealed a systemic effect. Instead, the testing of the
placebo shows no effect. The point is that Tucker affirmatively teaches no
systemic effect.”). We agree with Appellant that Examiner’s inherency

2 Systemic: “pertaining to or affecting the body as a whole.” https://medical-
dictionary.thefreedictionary.com/systemic (last accessed May 22, 2020).
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?%20in
stitutionId=743 (last accessed May 22, 2020).
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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.” Final Act. 12–13.
The burden, however, is not on Appellant to establish a relationship between
the microcirculatory system tested in Tucker and systemic vasodilation. See
Appeal Br. 15; 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
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: systemic vasodilation and the limitation
of “absorbing at least 500 ppm of nitric oxide transdermally within 10
minutes after the applying.” See Ans. 6 (“If increased systemic vasodilation
does not result when the exact same method and elements as those taught in
Tucker are used, then Appellants claimed method does not result in
increased systemic vasodilation either. Simply put, if Tucker does not work
than Appellant’s claimed invention does not work either.”). “In relying upon
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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 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 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 insufficient 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
disclosure in Tucker 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.
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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:

Balaban ¶ 82.
The nitric oxide activator gel “A” ingredients are listed in the
table below:
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Id. ¶ 83.
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 blood flux] were reattached to exactly the same
position to continue the measurements.
Id. ¶ 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. ¶ 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. ¶ 85. Balaban concluded the
application of NO producing gel “increased local blood flow.” Id.
¶ 86.

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Analysis
Examiner found that Balaban teaches a method of increasing
vasodilation. Final Act. 4. 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 5.
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 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 that at least 500 ppm nitric
oxide was absorbed. Accordingly, we reverse the anticipation rejection
based on Balaban.

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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 both Tucker and Balaban. We therefore
reverse the obviousness rejection because even with the combination of
Tucker and Balaban the “systemic vasodilation” limitation is still missing.

IV. Obviousness over Tucker, Balaban, and Kevil
This rejection relies upon the underlying obviousness rejection over
Tucker and Balaban. See Final Act. 8. Having reversed the rejection based
on the combination of Tucker and Balaban, we necessarily reverse this
obviousness rejection including Kevil, because Kevil is not relied upon to
teach the “systemic vasodilation” limitation as claimed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–3, 6, 7,
13, 15, 16
102(b) Tucker 1–3, 6, 7,
13, 15, 16
1–3, 5–7,
13, 15–19
102(b) Balaban 1–3, 5–7,
13, 15–19
1–3, 5–9,
15–19
103(a) Tucker, Balaban 1–3, 5–9,
15–19
4, 10–14 103(a) Tucker, Balaban,
Kevil
4, 10–14
Overall
Outcome
1–19

REVERSED