Ex Parte Stamatas et al

Patent Trial and Appeal Board

May 10, 2013

10735188 (P.T.A.B. May. 10, 2013)

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.
10/735,188 12/12/2003 Georgios Stamatas J&J-5092 2589
27777 7590 05/14/2013
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
CHENG, JACQUELINE
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
05/14/2013 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):
j nju spatent @ corn s .j nj. com
lhowd@its.jnj.com
gsanche@its.jnj.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGIOS STAMATAS and NIKIFOROS KOLLIAS
Appeal 2011-011250
Application 10/735,188
Technology Center 3700
Before LORA M. GREEN, MELANIE L. McCOLLUM, and ULRIKE W.
JENKS, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of determining the effect of a treatment to the skin of a subject. The
Examiner has rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses a “marker that strongly correlates with
skin aging, based on the ratio of the fluorescence intensity due to tryptophan
moieties (centered at 295 nm excitation) to the fluorescence intensity
assigned to collagen and elastin cross-links (centered at 390 nm excitation)”
Appeal 2011-011250
Application 10/735,188
(Spec. 8: 19-24). The Specification refers to this ratio as “normalized
tryptophan fluorescence” {id. at 13: 28-29). The Specification also discloses
that “[normalized tryptophan fluorescence was . . . shown to be able to be
used to monitor the effects of anti-aging treatments” {id. at 8: 26-28).
Claims 11-20 are pending and on appeal (App. Br. 2). Claim 11 is
representative and reads as follows:
11. A method of determining the effect of a treatment to the skin of a
subject, said method comprising the steps of:
(i) exposing a first area of skin to a first exposure radiation to induce
said area of skin to emit a first fluorescent emission, wherein said first
exposure radiation comprises primarily of wavelengths of from about
290 nm to about 300 nm and wherein said first area of skin was exposed to
said treatment;
(ii) measuring the intensity of said first fluorescent emission having a
wavelength of from about 320 nm to about 350 nm;
(iii) exposing said first area of skin to a second exposure radiation to
induce said area of skin to emit a second fluorescent emission, wherein said
second exposure radiation comprises primarily of wavelengths of from about
330 nm to about 420 nm;
(iv) measuring the intensity of said second fluorescent emission
having a wavelength of from about 380 nm to about 470 nm;
(v) calculating a ratio of said intensity measured in step (ii) to said
intensity measured in step (iv);
(vi) repeating steps (i) to (v) for a second area of skin, wherein said
second area of skin was not exposed to said treatment; and
(vii) comparing said ratio for said first area of skin to said ratio for
said second area of skin; and
(viii) determining and reporting the effect of the skin treatment based
on said compared ratios.
Claims 11-20 stand rejected under 35 U.S.C. § 103(a) as obvious over
Trepagnier et al. (US 2002/0016534 Al, Feb. 7, 2002) in view of Leffell et
al. (US 4,894,547, Jan. 16, 1990) (Ans. 4).
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Appeal 2011-011250
Application 10/735,188
The Examiner relies on Trepagnier for teaching
a method of determining the effect of a treatment to the skin of
a subject by measuring factors that assess changes of structural
matrix of the skin, cells of skin, and other cellular components
reflective of metabolic activity (cellular components reflective
of the health of the skin) such as tryptophan and NADH.
(Ans. 4.) In particular, the Examiner finds:
To measure tryptophan and NADH respectively, Trepagnier
teaches directing light in the about 295 nm range causing the
skin to fluoresce at approximately 345 nm, and directing light
in the about 370 nm range causing the skin to fluoresce at
approximately 420-520 nm . . . and calculating relative peak
ratios from the measured fluorescence.
(Id.) In addition, the Examiner finds that the “results can then be compared
to measurements of developed standards or surrounding normal tissue for
use in measuring treatment related changes” (id.).
The Examiner relies on Leffell for disclosing “directing light at
predetermined ultraviolet wavelength ranges at sun-exposed skin such as the
forehead (skin having undergone treatment), measuring fluorescence
emitted, and creating a ratio of the measured fluorescent intensities” (id.).
The Examiner finds that this “ratio is then compared to a ratio of the
fluorescent intensity that is induced from directing light at a predetermined
ultraviolet wavelength at non-sun-exposed skin such as the buttocks (skin
not exposed to the treatment)” and that “[b]y comparing the ratios one can
determine the effect of the sun has on the skin (effect of skin treatment)” (id.
at 4-5). In addition, the Examiner finds that Leffell “discloses that besides
sun exposed skin, his invention can be used to monitor improvement in skin
relating to treatment” (id. at 5).
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Appeal 2011-011250
Application 10/735,188
The Examiner concludes:
It would have been obvious to one skilled in the art at the time
of the invention to create a ratio of measured fluorescent
intensities as taught by Leffell with the measured fluorescent
intensities of tryptophan and NADH as taught by Trepagnier for
the purpose of creating relative peak ratios to analyze changes
of structural matrix of the skin, cells of skin, and other cellular
components reflective of metabolic activity.
(Id.)
FINDINGS OF FACT
1. Trepagnier discloses:
A non-invasive glucose-monitoring instrument according to one
aspect of the invention includes a radiation source capable of
directing radiation to a portion of the surface of the skin (or
other tissue) of a patient. The source emits radiation at least
one wavelength that excites a target or species in the tissue
whose fluorescence can be correlated with blood glucose
content, such that the radiation received at the tissue surface
provides a glucose level indication of the patient. In a preferred
embodiment, the target is a molecule other than glucose, and is
a structural matrix component, such as, collagen cross links.
Alternatively, the target may be tryptophan. Another preferred
target is NADH, FAD, Flavoproteins.
(Trepagnier, | [0057].)
2. Trepagnier also discloses:
When the target being detected is cross linked collagen, the
ultraviolet radiation source is preferably operative to irradiate at
approximately 330-345 nm, and the ultraviolet detector is
sensitive to emitted wavelengths in the range of 370-410 nm,
more preferably, 380-400 nm and, most preferably, 390 nm. . . .
When the target being detected is tryptophan, the ultraviolet
radiation source is preferably operative to irradiate at
approximately 285-305 nm, more preferably at approximately
295 nm, and the ultraviolet detector is preferably sensitive to
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Appeal 2011-011250
Application 10/735,188
emitted wavelengths in the range of 315-420 nm, more
preferably 340-360 nm, and most preferably, 345 nm. When
the target being detected is NADH, the ultraviolet radiation
source is preferably operative to irradiate at approximately 320-
370 nm, more preferably at approximately 340 nm, and the
ultraviolet detector is preferably sensitive to emitted
wavelengths in the range of 400-550 nm, more preferably 450-
470 nm, and most preferably, 460 nm.
(Id.)
3. In addition, Trepagnier discloses:
Useful targets include structural matrix, cellular, or
mitochondrial components, or other cellular components
reflective of metabolic activity. For example, the target may be
selected from the group consisting of a pepsin-digestible
collagen cross link, a collagenase-digestible collagen cross link,
a non-pepsin digestible collagen cross link, free tryptophan,
tryptophan-containing proteins, elastin cross links, FAD,
flavoproteins, NADH, other matrix, cellular or mitochondrial
components, or combinations thereof.
(Id. at 1 [0061].)
4. Trepagnier also discloses:
The above described instrument may also be used as non-
invasive device for assessing changes in structural matrix, cells
or mitochondria, or the environment of said components, or
other cellular components reflective of metabolic activity, due
to a variety of conditions including, for example, disease
conditions (e.g. infections, cancer), the presence of topical
chemicals such as steriods [sic], age, photodamage, and
combinations thereof which may provide the general state of
health of the patient. This embodiment allows the assessment
of changes in the structural matrix non-invasively by measuring
the combination of fluorescence and scattering, and comparing
these results to measurements of developed standards, temporal
correlates or surrounding normal tissue. . . . Treatment related
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Appeal 2011-011250
Application 10/735,188
changes and drug concentration monitoring are additional
clinical and research applications.
{Id. at 1 [0116].)
5. Leffell discloses:
[A] method for quantifying and evaluating induced
fluorescence comprises the steps of inducing a subject area to
fluorescence, sensing the induced fluorescent radiation,
obtaining a measure of intensity of said induced fluorescent
radiation over a predetermined frequency band and using the
measure of intensity as a basis to make comparisons between
different test subject areas. A preferred form of the method
includes forming a ratio of the measured fluorescent intensity of
skin at two preselected wavelengths and, further, employing the
ratio to determine the degree of long term exposure of the skin
to solar ultraviolet radiation.
(Leffell, col. 2,11. 53-64.)
6. Leffell also discloses that the “method, in one form of the
invention, encompasses evaluating changes in skin pigmentation over a
period of time by the measure of intensity of fluorescent radiation” {id. at
col. 2,11. 64-68).
7. In addition, Leffell discloses: “By employing a ratio of a
subject’s sun-exposed skin to his (or her) own non-sun-exposed skin, the
subject acts as his (or her) own control.” {Id. at col. 4,11. 56-59.)
8. Leffell also discloses that the “ratio (R 390/429) was chosen
because relative fluorescence peaks were noted at these wavelengths in
solar-protected skin but other methods of analysis and comparison are
possible” {id. at col. 6,11. 7-12).
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Appeal 2011-011250
Application 10/735,188
9. In addition, Leffell discloses that “[ijmprovement in skin,
relating to treatment, could be documented and recorded for the patient’s
benefit using the inventive method and system” {id. at col. 9,11. 21-25).
ANALYSIS
Appellants argue that “Leffell teaches away from the present
invention as Leffell is directed to measuring skin pigmentation, while
Appellants’ method cancels the effects of skin pigmentation” (App. Br. 6).
We are not persuaded. Leffell does disclose that its “method, in one form of
the invention, encompasses evaluating changes in skin pigmentation”
(Finding of Fact (FF) 6 (emphasis added)). However, Leffell does not teach
away from other ratios. In fact, Leffell teaches its “ratio (R 390/429) was
chosen because relative fluorescence peaks were noted at these wavelengths
in solar protected skin but other methods of analysis and comparison are
possible” (FF 8).
Appellants also argue that neither Trepagnier nor Leffell “teach or
suggest the specific multiple wavelength measurements, generation of ratios,
or comparison of ratios for treated versus untreated skin of the present
invention” (App. Br. 5-6). However, Trepagnier does suggest the specific
wavelength measurements and combinations thereof (FF 1-3). Trepagnier
also discloses “assessing changes . . . due to . . . the presence of topical
chemicals,” monitoring treatment related changes, and “comparing the[]
results to measurements of. . . surrounding normal tissue” (FF 4). In
addition, Leffell specifically teaches “forming a ratio of the measured
fluorescent intensity of skin at two preselected wavelengths,” using the
method and system to document improvement in skin, relating to a
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Application 10/735,188
treatment, and using the subject’s own unexposed skin as a control (FF 5, 9,
& 7). Appellants have not adequately explained why the combination of
Trepagnier and Leffell fails to suggest the claimed method.
CONCLUSION
The evidence supports the Examiner’s conclusion that claim 11 would
have been obvious. We therefore affirm the obviousness rejection of
claim 11. Claims 12-20 are not separately argued and therefore fall with
claim 11. 37 C.F.R. § 41.37(c)(l)(vii).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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