Matthias Moehrle

Patent Trials and Appeals Board

Jul 22, 2019

13678998 - (D) (P.T.A.B. Jul. 22, 2019)

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.
13/678,998 11/16/2012 Matthias Moehrle 4965-000527/US/CO 7186
27572 7590 07/22/2019
Harness Dickey (Troy)
P.O. BOX 828
BLOOMFIELD HILLS, MI 48303
EXAMINER
CRAWFORD, ERIK B
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
07/22/2019 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):
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PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MATTHIAS MOEHRLE
____________

Appeal 2018-005342
Application 13/678,9981
Technology Center 1600
____________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims directed to a
method for visual examination of a biological material. The Examiner
rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 Appellant states that “[t]he real party in interest in the present Appeal is the
Eberhard-Karls-Universität Tübingen Universitätsklinikum.” Appeal Br. 3.
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STATEMENT OF THE CASE
Appellant’s Specification discloses that when surgically removing
skin tumors, it is routine to examine the margins of the cut tissue “to make
sure that the tumor material has been completely removed.” Spec. ¶ 3. The
Specification discloses that two known methods of examining excised tissue,
the Mohs’ Surgery and the paraffin section method, both of which use thin
sectioning or “histological cutting,” suffer from certain disadvantages. Id.
¶¶ 5–7, 18.
In particular, while Mohs’ Surgery allows inspection of frozen thin
sections by transmission microscopy in as little as 30 minutes, the method is
“imprecise and can only be used in a reliable manner for solid, nodular basal
cell carcinomas.” Id. ¶ 5.
Although the paraffin section method allows more precise
examination, “because of the complex sample preparation[,] the results of
the examination are only available about 20 hours after the removal of the
biological material,” which can be a problematically long time to wait for
results during surgery. Id. ¶ 6.
The Specification discloses that a third method of examining
surgically removed tissue, confocal laser scanning microscopy, involves the
preparation of “optical sections” (id. ¶ 8) produced by “optical cutting” (id.
¶ 19), but “is technically complex and the diagnostic reliability is
insufficient.” Id. ¶ 8.
The Specification discloses that the above-discussed disadvantages of
previous methods of examining surgically removed tissue are solved by a
process including the steps of
1. Providing biological material, 2. labeling the biological
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material [for example by staining with a dye], 3. switching off
of reflections at the surface of the biological material, and 4.
examining the biological material by direct light microscopy,
wherein the provided biological material is vital biological
material which is neither histologically nor optically cut.
Id. ¶ 10.
In Example 1, the Specification describes the evaluation of skin
cancer samples prepared according to Appellant’s invention, using tumor-
free skin tissue as a control. Id. ¶¶ 52–53. The samples according to
Appellant’s invention were prepared by fixing the tissue in 10% acetic acid
(40 seconds), followed by rinsing with tap water (10 seconds), followed by
staining with toluidine blue (40 seconds), and finally washed again in tap
water (10 seconds). Id. ¶ 54. The preparations according to Appellant’s
invention were examined using digital and stereo microscopes to determine
the presence of tumor tissue in the samples. Id. ¶ 57.
In Example 1, the same tissue samples were also treated according to
the paraffin section method using haematoxylin and eosin staining (HE
staining), and also examined using a stereo microscope and a digital
microscope. Id. ¶ 56.
The Specification discloses that, when the results of the two sample
preparation techniques are compared, “[i]t is shown in an impressive manner
that the results of the examination with the method according to the
invention highly correlate with the classic standard method (HE stained
paraffin sections). Therefore, the method has a high precision and
reliability.” Id. ¶ 60. In particular, “[a] microscopic existing tumor, e.g. a
basal cell carcinoma, can be diagnosed by the method according to the
invention with a very high accuracy. If a tumor cannot be detected by the
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method according to the invention the microscopic existence of a tumor can
be excluded with high accuracy.” Id.
Appellant’s claims 1 and 20, the independent claims on appeal, are
representative and read as follows:
1. A method for visual examination of a biological material
ex vivo, wherein the biological material is vital biological
material which is neither histologically nor optically cut, the
method comprising:
labeling the biological material;
switching off of reflections at the surface of the
biological material; and
visually examining the biological material by reflected
light microscopy.

20. A method for visual examination of a biological material
ex vivo, wherein the biological material is vital biological
material which is neither histologically nor optically cut, the
method comprising:
labeling the biological material;
switching off of reflections at the surface of the
biological material; and
visually examining the biological material by reflected
light microscope, without performing a spectrographic analysis
of light reflected from the biological material.
Appeal Br. 13, 15.
The following rejections are before us for review:
(1) Claims 1, 2, 4–6, 19, and 20, rejected under 35 U.S.C. § 103(a) as
being unpatentable over Yaroslavsky2 and Mullani3 (Ans. 3–6); and

2 US 2012/0029348 A1 (published Feb. 2, 2012).
3 US 2004/0174525 A1 (published Sept. 9, 2004).
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(2) Claim 3, rejected under 35 U.S.C. § 103(a) as being unpatentable
over Yaroslavsky, Mullani, and Alfano4 (id. at 6–7).
DISCUSSION
The Examiner’s Rejections
In rejecting claims 1, 2, 4–6, 19, and 20, the Examiner cited
Yaroslavsky as disclosing a process of examining biological material, and
found that Yaroslavsky’s process included all of the claimed steps, except
for the step of switching off reflections at the surface of the biological
material. Ans. 4–6. The Examiner cited Mullani as evidence that a skilled
artisan would have considered it obvious to include a step of switching off
surface reflections when performing Yaroslavsky’s process. Id. at 5–6.
In rejecting claim 3, the Examiner cited Alfano as evidence that it
further would have been obvious to fix the tissue examined in Yaroslavsky’s
process. Id. at 7.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
(citations omitted):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
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 the present case, Appellant does not persuade us that the
preponderance of the evidence does not support the Examiner’s conclusion

4 US 2004/0111031 A1 (published June 10, 2004).
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of obviousness as to claim 1. As to claim 20, however, we find Appellant’s
arguments persuasive, for the reasons discussed below.
Appellant does not assert error in the Examiner’s finding that a skilled
artisan had sufficient motivation for, and a reasonable expectation of success
in, combining the teachings in the cited references in the manner advanced
in the rejections. See Appeal Br. generally; Reply Br. generally.
Rather, Appellant contends that Yaroslavsky is not prior art with
respect to the present application, because the claims of Yaroslavsky do not
find sufficient descriptive support in the provisional application to which
Yaroslavsky claims priority. Appeal Br. 5–6; see also Yaroslavsky ¶ 1
(claiming priority to provisional application 61/169,258 filed April 14, 2009
(“the Yaroslavsky provisional application”)).
In particular, Appellant contends that the Yaroslavsky provisional
application does not provide adequate descriptive support for generating an
image of a tissue structure based on first, second, third, and fourth lights, as
recited in claim 23 of Yaroslavsky. Appeal Br. 6. Appellant also contends
that the term “contrast agent” in claim 23 of Yaroslavsky does not find
adequate descriptive support in the Yaroslavsky provisional application. Id.;
see also Reply Br. 1–3.5 We are not persuaded.
Claim 23 of Yaroslavsky reads as follows:
23. A method for imaging a tissue region comprising the
steps of:
treating said tissue region with a contrast agent;
directing a first light having a first wavelength onto the
tissue region;

5 The Reply Brief does not include page numbers. In citing to the Reply
Brief we cite to the first page as page 1, and the remaining pages as if
numbered consecutively.
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directing a second light having a second wavelength onto
the tissue region;
detecting a third light remitted from the tissue region
based on the first light and a fourth light remitted from the
tissue region based on the second light; and
generating an image of at least one tissue structure within
said tissue region based on said first, second, third, and fourth
lights.
Yaroslavsky 8.
As is evident, Yaroslavsky’s claim 23 requires the first and second
lights directed onto the tissue to have different wavelengths. See id.
(reciting “directing a first light having a first wavelength” and “a second
light having a second wavelength” onto the tissue).
As the Examiner found, the Yaroslavsky provisional application
discloses directing multiple wavelengths of light, i.e. at least two
wavelengths of light, onto tissue. See the Yaroslavsky provisional
application 5 (“The monochromator 2 can further be configured to provide
light from the Xe-Arc lamp l at particular wavelengths onto a tissue
specimen 11.” (Emphasis added)); see also id. at 1 (“The present disclosure
is directed to a method and apparatus that facilitates accurate cancer
delineation in tissue samples by applying spectral analysis of reflectance
images at two or more particular wavelengths.”).
Yaroslavsky’s claim 23 does not require the third and fourth lights
remitted from the tissue region to have any particular wavelength, or have
different wavelengths than the first and second lights. Rather, Yaroslavsky’s
claim 23 only specifies that the third and fourth lights are “remitted from the
tissue region based on” the first and second lights, respectively.
Yaroslavsky 8 (emphasis added).
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As the Examiner found, the Yaroslavsky provisional application
discloses that “[r]eflected light” based on the light directed onto the tissue by
the light source (monochromator) “at these wavelengths can be detected by
the CCD camera 9.” The Yaroslavsky provisional application 5.
Because Yaroslavsky thus describes generating an image based on at
least two lights of different wavelengths directed onto tissue, with that image
also being based on the reflected light generated by the lights directed onto
the tissue, Appellant does not persuade us that the Examiner erred in
determining that the Yaroslavsky provisional application supports generating
an image using first, second, third, and fourth lights in the manner recited in
claim 23 of Yaroslavsky.
Appellant also does not persuade us that the Yaroslavsky provisional
application fails to provide adequate descriptive support for claim 23’s
recitation of “treating said tissue region with a contrast agent.” Yaroslavsky
8.
Contrary to Appellant’s contention that the specification of
Yaroslavsky’s published application does not specify a structure that
performs the function of the contrast agent recited in claim 23 (see Appeal
Br. 6), Yaroslavsky describes treating tissue “with a contrast agent, e.g. a
dye such as methylene blue (MB).” Yaroslavsky ¶ 9; see also id. ¶ 10
(disclosing “imaging a tissue region or sample treated with a contrast agent
such as a dye at two or more particular wavelengths” (emphasis added)).
Yaroslavsky thus explains that a dye is a structure sufficient to
perform the function of a contrast agent, and provides a specific example of
a dye that is a contrast agent (methylene blue). Consistent with that
disclosure in the published application, and contrary to Appellant’s
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contention that the provisional application “never discloses a structure that
corresponds to the claimed ‘contrast agent’” (Reply Br. 2), the Yaroslavsky
provisional application describes treating tissue samples with methylene
blue, precisely the contrast agent exemplified in the Yaroslavsky
publication. See the Yaroslavsky provisional application 5–6. Appellant
does not persuade us, therefore, that the Yaroslavsky provisional application
fails to provide adequate descriptive support for the recitation of a “contrast
agent” in claim 23 of Yaroslavsky.
In sum, for the reasons discussed, Appellant does not persuade us that
claim 23 of Yaroslavsky lacks adequate descriptive support in the
Yaroslavsky provisional application. Accordingly, Appellant also does not
persuade us that Yaroslavsky does not constitute prior art to the present
application.
We are also unpersuaded that Yaroslavsky fails to teach or suggest the
step in Appellant’s claim 1 of “visually examining the biological material by
reflected light microscopy.” See Appeal Br. 7–9; id. at 13 (claim 1); Reply
Br. 3–4.
In particular, Appellant contends that the CCD CoolSnap HQ camera
used in Yaroslavsky to acquire images of dyed tissue specimens is not a
microscope, and that Yaroslavsky therefore does not describe the claimed
step of visually examining the biological material by reflected light
microscopy. Appeal Br. 7–9.
The Examiner responds that the dictionary definition of a microscope
is “‘an optical instrument consisting of a lens or combination of lenses for
making enlarged images of minute objects.’” Ans. 12 (citing Merriam-
Webster.com). Therefore, the Examiner reasons, when claim 1 is given its
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broadest reasonable interpretation consistent with the Specification, claim 1
encompasses the camera used in Yaroslavsky. Id.
Appellant replies that the Examiner’s interpretation of claim 1 as
encompassing the dictionary definition of microscope is not consistent with
the Specification’s use of the term. Reply Br. 3. Appellant contends,
moreover, that because Appellant has argued that claim 1 does not
encompass the use of Yaroslavsky’s camera, “under the doctrine of
prosecution disclaimer the claim scope cannot now reach to a digital camera
such as the CCD COOLSNAP.” Id.
We find that the Examiner has the better position. Although we
acknowledge the use of two specific types and brands of microscopes in the
Specification (see Spec. ¶ 56), claim 1 does not specify any particular type
of equipment. We are not persuaded, therefore, that it is proper in this
instance to limit claim 1 based on the disclosures in the Specification, or
Appellant’s arguments in that regard. See In re Trans Texas Holdings Corp.,
498 F.3d 1290, 1299 (Fed. Cir. 2007) (“[W]hile ‘the specification [should be
used] to interpret the meaning of a claim,’ courts must not ‘import[ ]
limitations from the specification into the claim.’ . . . [I]t is improper to
‘confin[e] the claims to th[e] embodiments’ found in the specification . . . .”)
(quoting Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005)
(citations omitted, bracketed text in internal quotes in original)).
Appellant, moreover, does not identify any disclosures or definitions
in the Specification contrary to the dictionary definition of microscope
advanced by the Examiner. We are not persuaded, therefore, that it was
unreasonable for the Examiner to interpret claim 1 as encompassing the use
of an instrument encompassed by the dictionary definition of a
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microscope—i.e., an optical instrument consisting of a lens or combination
of lenses for making enlarged images of minute objects.
Turning to the disclosures at issue, Yaroslavsky discloses using a
“CCD CoolSnap HQ camera . . . equipped with an achromatic CCD lens . . .
to acquire co- and cross-polarized reflectance images of the specimens.”
Yaroslavsky ¶ 41 (emphasis added); see also the Yaroslavsky provisional
application 4 (same disclosure). Yaroslavsky thus uses reflected light when
examining its tissue specimens, as required by Appellant’s claim 1.
Moreover, consistent with the definition of a microscope,
Yaroslavsky’s camera also uses a lens to make enlarged images of a small
object. See Yaroslavsky ¶ 21 (“FIG. 2a is an exemplary grayscale
superficial reflectance image at 665 nm image of a 16×7 mm scalp tissue
specimen containing a basal cell carcinoma.”); see also the Yaroslavsky
provisional application 3 (“Fig. 2a is an exemplary color-coded superficial
reflectance image at 665 nm image of a 16×7mm scalp tissue specimen
containing a basal cell carcinoma.”).
Because Yaroslavsky’s camera uses a lens to enlarge a relatively
small 16×7 mm scalp tissue specimen to the significantly larger size seen in
Figure 2a, we agree with the Examiner that Yaroslavsky’s examination of its
tissue specimens is consistent with the definition of a microscope, and
therefore is encompassed by claim 1. We also agree with the Examiner that
Yaroslavsky discloses visual examination of the specimen.
In particular, contrary to Appellant’s assertion that Yaroslavsky does
not describe visual examination of the specimen by reflected light
microscopy (see Appeal Br. 9; Reply Br. 3–4), Yaroslavsky expressly
discloses that the significantly magnified reflectance image shown in Figure
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2a was visually examined. See, e.g., Yaroslavsky ¶ 53 (“The BCC [basal
cell carcinoma] shown in the optical images of FIGS. 2a and 2b exhibits a
higher contrast as compared with the histopathology generated at the same
magnification in FIG. 2c.”); see also the Yaroslavsky provisional application
7 (same disclosure).
In sum, for the reasons discussed, Appellant does not persuade us that
the Examiner erred in determining that Yaroslavsky describes visually
examining biological material by reflected light microscopy, as required by
Appellant’s claim 1. Accordingly, Appellant does not persuade us that the
Examiner erred in determining that the combination of Yaroslavsky and
Mullani teaches or suggests a process having all of the steps and features
required by Appellant’s claim 1.
We are not persuaded, moreover, that Appellant has advanced
objective evidence of nonobviousness sufficient to outweigh the prior art
evidence of obviousness advanced by the Examiner. In particular, while
Appellant contends that the claimed invention solves a long-felt but unmet
need, Appellant does not advance any specific evidence establishing that the
particular asserted need (quick and accurate evaluation of surgically
removed tissue samples) was actually felt for a long time, or was unsolved.
See Appeal Br. 10–11; see also In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir.
1997) (attorney argument lacking evidentiary support is insufficient to
demonstrate nonobviousness).
As the Examiner contends, moreover, Yaroslavsky discloses that its
process is performed in a short time, comparable to the amount of time
disclosed in Appellant’s Specification. See Yaroslavsky ¶¶ 44–48
(disclosing dyeing skin specimens with methylene blue for at most 2
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minutes, washing the specimens, and then imaging the specimens at various
wavelengths); see also the Yaroslavsky provisional application 5–6 (same
disclosure). Indeed, similar to Appellant’s own Specification, Yaroslavsky
discloses that Mohs’ surgery has certain shortcomings including excessive
time consumption and staffing requirement (see Yaroslavsky ¶ 5; the
Yaroslavsky provisional application 1), and then expressly discloses that its
methods address those issues:
[I]n view of the above-described deficiencies, a simpler, more
accurate, and/or time-efficient method would be desirable for
mapping tumor borders and for improved distinguishing
between tumor tissue and healthy tissue. . . .
The present invention is directed to meeting the
aforementioned needs and addressing the deficiencies
particularly discussed above and generally in the prior art.
Yaroslavsky ¶¶ 8–9; see also the Yaroslavsky provisional application 2
(substantially identical disclosure).
In sum, for the reasons discussed, Appellant does not persuade us that
the Examiner erred in determining that the combination of Yaroslavsky and
Mullani teaches or suggests a process having all of the steps and features
required by Appellant’s claim 1. For the reasons discussed, moreover, we
are not persuaded that Appellant has advanced objective evidence of
nonobviousness sufficient to outweigh the prior art evidence of obviousness
advanced by the Examiner. We therefore affirm the Examiner’s rejection of
claim 1 over Yaroslavsky and Mullani.
Because they were not argued separately, claims 2, 4–6, and 19 fall
with claim 1. Because Appellant relies on the arguments addressed above in
traversing the Examiner’s rejection of claim 3 over Yaroslavsky, Mullani,
and Alfano (see Appeal Br. 11), we affirm that rejection as well.
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Our analysis differs as to claim 20, however. As Appellant contends,
claim 20 recites “visually examining the biological material by reflected
light microscope, without performing a spectrographic analysis of light
reflected from the biological material.” Appeal Br. 15 (emphasis added).
The Examiner states that “merely viewing the image of Figure 2a is
believed to read on the limitation ‘visually examining the biological material
by reflected light microscope, without performing spectrographic analysis of
light reflected from the biological material.’” Ans. 13. We are not
persuaded.
As noted above, we agree with the Examiner that Yaroslavsky
describes visually examining its specimens by reflected light microscopy.
As Appellant contends, however, throughout its disclosure Yaroslavsky
consistently discloses performing spectrographic analysis of its acquired
images. See e.g., Yaroslavsky ¶ 2 (describing its invention as facilitating
“accurate delineation of cancerous tissue or other particular types of
biological tissue in tissue samples by comparing absorbance properties
and/or other optical interactions of dyes by different tissue types at two or
more particular wavelengths”) (emphasis added); see also the Yaroslavsky
provisional application 1 (“The present disclosure is directed to a method
and apparatus that facilitates accurate cancer delineation in tissue samples by
applying spectral analysis of reflectance images at two or more particular
wavelengths.”) (Emphasis added).
Thus, although for the reasons discussed above we agree with the
Examiner that Yaroslavsky describes visually examining its specimens by
reflected light microscopy, we are not persuaded that Yaroslavsky teaches or
suggests performing that visual examination without performing
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spectrographic analysis of light reflected from the biological material, as
recited in Appellant’s claim 20. Accordingly, we reverse the Examiner’s
rejection of claim 20 over Yaroslavsky and Mullani.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1, 2, 4–6, and 19 for obviousness over Yaroslavsky and Mullani.
For the reasons discussed, we reverse the Examiner’s rejection of
claim 20 for obviousness over Yaroslavsky and Mullani.
For the reasons discussed, we affirm the Examiner’s rejection of claim
3 for obviousness over Yaroslavsky, Mullani, and Alfano.

TIME PERIOD
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-IN-PART