Ex Parte Peyman

Patent Trial and Appeal Board

May 27, 2015

12770011 (P.T.A.B. May. 27, 2015)

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.
12/770,011 04/29/2010 Gholam A. Peyman 2010_0603 8847
13010 7590 05/29/2015
The Law Office of Patrick F. O'Reilly III, LLC
1614 Lafayette Drive
Columbus, OH 43220-3867
EXAMINER
SHAY, DAVID M
ART UNIT PAPER NUMBER
3769
MAIL DATE DELIVERY MODE
05/29/2015 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 GHOLAM A. PEYMAN
____________________

Appeal 2015-002417
Application 12/770,011
Technology Center 3700
____________________

Before CHARLES N. GREENHUT, LYNNE H. BROWNE, and
JILL D. HILL, Administrative Patent Judges.

GREENHUT, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1,
7, 9, 10, 17 and 19–28. Non-Final Act. 1. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm-in-part.

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The claims are directed to a method for laser correction of refractive
errors of an eye with a thin cornea. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A method of altering the refractive properties of the eye, said
method comprising:
forming a flap in a thin cornea that has a thickness of less
than 480 microns, so as to expose one of the stroma and the
Bowman’s Layer of an eye;
after forming the flap in the thin cornea, applying a liquid
suspension having nano particles of riboflavin to the one of the
stroma and the Bowman’s Layer of the eye, the nano particles
facilitating cross linking of the one of the stroma and the
Bowman’s Layer of the thin cornea;
irradiating the thin cornea with at least one of ultraviolet
light and microwaves so as to activate cross linkers in the thin
cornea and thereby stiffen the thin cornea and prevent corneal
ectasia in the thin cornea; and
after the thin cornea has been stiffened by the activation
of the cross-linkers, ablating a portion of the thin cornea
underlying the flap so as to change the refractive properties of
the eye.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
L’Esperance
Warner
Peyman ’748
Karageozian
Peyman ’307
Peyman ’374
Luce
Sand
US 4,665,913
US 4,903,695
US 5,964,748
US 6,537,545 B1
US 6,551,307 B2
US 7,001,374 B2
US 7,004,902 B2
US 7,044,945 B2
May 19, 1987
Feb. 27, 1990
Oct. 12, 1999
Mar. 25, 2003
Apr. 22, 2003
Feb. 21, 2006
Feb. 28, 2006
May 16, 2006
Akiyama US 2007/0135754 A1 June 14, 2007
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Kochevar WO 01/58495 A2 Aug. 16, 2001
Gregor Wollensak, MD, et al., Riboflavin/Ultraviolet -A-induced Collagen
Crosslinking for the Treatment of Keratoconus, Am J Ophthalmol 2003;
135: 620–627 (2003) (hereinafter “Wollensak”).

REJECTIONS
A. Claims 1, 7, 9, 10, 17, 19, 22–25, and 28 under 35 U.S.C. § 103(a) as
being unpatentable over Wollensak, Akiyama, Sand, Karageozian,
Peyman ’748, L’Esperance, and Warner. Non-Final Act. 8.
B. Claims 1, 7, 17, and 19 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, and Peyman ’374. Non-Final
Act. 9.
C. Claims 17 and 19 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, and Luce. Non-Final Act. 10.
D. Claims 1, 7, 17, 19, 22, 23, 25, and 28 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Wollensak, Akiyama, Peyman ’374,
and Kochevar. Non-Final Act. 11–12.
E. Claims 17, 19, 22, 23, 25, and 28 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Wollensak, Akiyama, and Luce.1 Non-Final
Act. 12.

1 The Examiner, despite discussing Kochevar in this rejection and not
including Peyman ’374 in the statement of the rejection, states that
“Kochevar et al is not applied in th[is]rejection [and] Peyman (’374)[] is
applied in the rejection.” Ans. 16.
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F. Claim 9 is rejected under 35 U.S.C. § 103(a) as being unpatentable over
Wollensak, Akiyama, Peyman ’374, and L’Esperance. Non-Final Act.
13.
G. Claims 9 and 24 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Peyman ’374, Kochevar, and
L’Esperance. Non-Final Act. 14.
H. Claim 10 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Wollensak, Akiyama, Peyman ’374, L’Esperance, and Warner.
Non-Final Act. 14.
I. Claim 10 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Wollensak, Akiyama, Peyman ’374, Kochevar, L’Esperance, and
Warner. Non-Final Act. 14.
J. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Sand, Karageozian, Peyman
’748, L’Esperance, Warner, and Peyman ’307. Non-Final Act. 15.
K. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Peyman ’374, and Peyman
’307. Non-Final Act. 15.
L. Claims 20 and 2l are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Luce, and Peyman ’307. Non-
Final Act. 16.
M. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Sand, Karageozian, Peyman
’748, L’Esperance, Warner, and Peyman ’307. Non-Final Act. 16.
N. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Peyman ’374, Kochevar, and
Peyman ’307. Non-Final Act. 17.
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O. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Luce, and Peyman ’307. Non-
Final Act. 17.
P. Claims 20, 21, 26, and 27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Wollensak, Akiyama, Sand, Karageozian, Peyman
’748, L’Esperance, Warner, and Peyman ’307. Non-Final Act. 18.

OPINION
Appellant’s Invention
“[T]he normal corneal thickness is about 490-560 microns.” Spec. 27,
para. 148. However, “thin corneas are found often in patients who have high
myopia (i.e., near sightedness). Such thin corneas, i.e., having a thickness of
<480 microns, are not candidates for modern refractive surgery using an
excimer laser or any tissue removal for the correction of refractive errors.”
Id. This is due to the fact that “corneal ablation in these patients generally
will lead to further thinning of the cornea, reduced stability of the cornea,
and possible corneal perforation.” Id.
Appellant sought to develop “a method for correcting refractive error
in patients with thin corneas, e.g., <500 microns thick.” Spec. 27, para 149;
Figs. 41a–f. Appellant recognized that “[c]ross linking of the cornea has
been recently advocated to correct the refractive problems of the eyes having
these types of corneas (e.g., by the present inventor) for advanced corneal
ectasia, such as in Keratoconous to stabilize the condition.” Spec. 27, para
148.
The claimed methods intermingle the steps of performing refractive
eye surgery with the steps of using crosslinking to stabilize ectasia. Spec.
28, para. 151.
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The Prior Art
Wollensak was primarily concerned with using “[c]ollagen
crosslinking [as] a new way for stopping the progression of keratectasia2 in
patients with keratoconus.” Wollensak, p. 620. To do so, Wollensak
cautiously removed “[t]he central 7 mm3 of the corneal epithelium.” Id. at
6214; Non-Final Act. 35. A photosensitizer, riboflavin 0.1 % solution, was
applied and irradiated (id.) followed by reepithelialization (id. at 624). After
discussing the results (id.), Wollensak concluded that “collogen-crosslinking
appears to be effective in stopping the progression of keratoconus” (id. at
625; Adv. Act. mailed Sept. 13, 2012). Wollensak attributed this success to
a known stiffening effect which was shown to increase corneal rigidity in
porcine and rabbit corneas similarly treated. Id. Wollensak goes on to
suggest, albeit briefly, that “[c]ollagen crosslinking could also be useful for
the treatment of iatrogenic keratectasia resulting from laser in situ

2 We understand Appellant’s use of the term “corneal ectasia” and
Wollensak’s use of the term “keratectasia” to both refer to a condition
wherein the cornea is abnormally thin.
3 Although not specified, we understand this measurement to refer to a
diametrical dimension because, as noted above, typical corneal thickness is
only on the order of 0.49–0.56 mm.
4 “The cornea itself is composed of five layers. The outermost layer is the
epithelium, which is 4–5 cells thick. Beneath the epithelium is the acellular
Bowman’s membrane. The middle layer is the stroma, which is composed of
scattered corneal fibroblasts (keratocytes) among organized lamellae of
collagen, proteoglycans and glycoproteins. Below the stroma is another
acellular layer called Descemet’s membrane. The innermost layer of the
cornea, comprised of a single layer of flattened cells, is the endothelium.”
Karageozian, col. 5, ll. 53–61; Ans. 4.
5 Many of the Examiner’s factual findings are repeated several times in the
Non-Final Action and Answer. For the sake of brevity and clarity we do not
include a citation to every instance.
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keratomileusis6 either as prophylaxis or as postoperative treatment.” Id. at
626; Non-Final Act. 4. Wollensak twice cautions against crosslinking
treatment with a corneal thickness that is not at least 400 µm. Non-Final
Act. Int. Sum., citing Wollensak, p. 626, para. 4; Ans. 4, citing last full
paragraph of the first column of Wollensak, p. 626.
Akiyama is cited by the Examiner to support the undisputed finding
that it was known to deliver riboflavin phosphate via nanoparticles. See
Non-Final Act. 3, (citing Akiyama, para. 46).
Sand was concerned with, inter alia, mitigating degradation of corneal
integrity due to refractive alterations. Sand, col. 1, ll. 56–64. Sand is relied
upon by the Examiner to support the undisputed finding that it was known to
“apply[] an effective amount of a composition [that] creates or restores
cross-links between stromal lamellae, where the cross-links increase the
stability of the scleral stroma . . . A preferred photoactivable composition is
riboflavin, which is activated by heat to form cross-links.” Sand, col. 3, ll.
17–24; Non-Final Act. 8.
Karageozian is relied on by the Examiner for its discussion of the
corneal structure reproduced above and for the undisputed finding that it was
known to employ microwaves as a mechanism by which to heat the cornea,
for example to effectuate the teachings of Sand discussed above. Non-Final
Act. 8; Karageozian, col. 2, ll. 48–53. We note that microwave irradiation is
recited only as an alternative to ultraviolet light irradiation in a Markush-
grouping. As ultraviolet light irradiation is already taught by Wollensk,
which is applied in every rejection, Karageozian is superfluous in this
regard. See In re Skoll, 523 F.2d 1392, 1397 (CCPA 1975) (only one
element of a Markush group need be shown in the prior art for that group as

6 “Lasik”
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a whole to be considered to be known, used or described in the prior art for
purposes of an obviousness analysis).
The Examiner cited L’Esperance as teaching “the use of excimer
lasers to remove corneal tissue.” Non-Final Act. 8. There does not appear
to be any dispute on this point.
The Examiner cited Warner as teaching “the desirability of forming a
flap when performing laser refractive surgery.” Non-Final Act. 8; see, e.g.,
Warner, col. 5, l. 61 et seq. Again, there does not appear to be any dispute
that Warner teaches as much.
Appellant’s prior patent, Peyman ’7487, is also cited by the Examiner
for the undisputed finding that it was known to form a flap in the eye and
irradiating tissues therebeneath for altering the refractive properties of the
cornea by ablating the tissue under the flap using an excimer laser. Non-
Final Act. 8; see, e.g., Peyman ’748, col. 22, ll. 12–18. Insofar as the
rejections that also cite L’Esperance and Warner for such findings, as
discussed above, Peyman’748 is cumulative in this regard. See, e.g., MPEP
§§ 706.02(I)8, 1207.01.
In cumulative rejections (i.e., B, D, possibly E, F–I, K, and N) the
Examiner cites Peyman ’374 as teaching “forming a flap in the eye that is
only epithelial cells in a well known LASEK procedure.” Non-Final Act.
10. The cited portion of Peyman ’374, the exact meaning of which
Appellant and the Examiner appear to dispute, reads:
Additionally, the flap 318 can be formed, so that a
portion of the flap includes epithelial cells and stromal cells, as

7 Appellant does not dispute the availability of any of Appellant’s prior
patents as statutory prior art. Cf. MPEP 2129(I).
8 Although it is noted that MPEP § 706.02(I) does suggest rejections should
be “backed up” when reference availability may become an issue.
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is generally done in a Lasik procedure, or the flap can be
formed in only epithelial cells, as is generally done in the Lasek
procedure.
Peyman ’374, col. 17, ll. 36–40; Ans. 11–12.
In additional cumulative rejections (C, E, L, and O) the Examiner
cites Luce as teaching that “candidates for LASIK s[h]ould be chosen taking
into account the biomechanical characteristics of the cornea, and not simply
its thickness.” Non-Final Act. 11; Ans. 14, citing Luce Figs. 10 and 12.9
This finding is used to buttress the Examiner’s conclusion that it would have
been obvious to one having ordinary skill in the art “to evaluate the propriety
of performing LASIK on a thin cornea.” Id.
In further cumulative rejections (D, possibly E, G, I, and N), the
Examiner initially cites Kochevar as teaching that “corneal strength is
increased with the use of riboflavin placed under the flap and irradiation
with UV.” Non-Final Act. 12. However, the Examiner appears to retract the
portion of this statement concerning riboflavin application specifically under
a flap, pointing out that Kochevar more generally instructs,
elements, e.g., cut or otherwise separated edges or surfaces, of
the subject’s corneal tissue can be joined together, or to graft
tissue . . . [when a] cornea, has been subjected to trauma, a
surgical incision, LASIK flap reattachment . . .[by] contacting a
corneal tissue with at least one photosensitizer agent, e.g. [inter
alia, riboflavin-5-phosphate] . . . and applying electromagnetic
energy, e.g., light, the corneal tissue-photosensitizer mixture.
Kochevar, Abstract, p. 2, l. 31, p. 3, ll. 26–29, p. 4, ll. 5–6; Ans. 15.
Finally, Peyman ’307 is cited by the Examiner in each of the various
rejections (J–P) of claims 20, 21, 26 and 27 as teaching “that the patient can
undergo a second ablation at a much later time.” Non-Final Act. 15(citing

9 The labels of Figure 12 are discussed without specific reference to Figure
12.
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Peyman ’307, col. 10, ll. 24–29). On this point Appellant contends “that
waiting a period of time between two ablations is totally unrelated to that
which is recited in claims 20, 21, 26, and 27” which require waiting a
predetermined period of time after irradiating to activate cross linkers and
stiffen the cornea prior to ablating the cornea. App. Br. 29.

Analysis
Rejections A-D and F-I are affirmed.
Appellant’s initial contention that no reference teaches forming a flap
in a thin cornea (App. Br. 510) is essentially just pointing out that the
Examiner did not identify an anticipatory reference. As discussed above, it
is Wollensak that is cited for performing a stiffening procedure on a thin
cornea and for suggesting such a procedure may be performed in
conjunction with Lasik. The Examiner relies on L’Esperance, Warner, and
Peyman ’748 regarding the details of the laser refractive surgery including
flap formation. It is when these teachings are combined that this aspect of
the claimed method results. A determination of obviousness does not
require the claimed invention, or a particular subcombination thereof, to be
expressly suggested by any one or all of the references. See, e.g., In
re Keller, 642 F.2d 413, 425 (CCPA 1981). “Non-obviousness cannot be
shown by attacking references individually when the rejection is predicated
upon the teachings of a combination of references.” In re Merck & Co.,
Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986)(citation omitted).

10 Appellant, like the Examiner, repeats many points several times. As was
done above, for the sake of clarity and brevity, we do not include a citation
to every instance. Our analysis pertaining to each reference is relevant to
each of the enumerated rejections in which that reference is applied.
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Appellant contends that the known dangers associated with flap
formation in a thin cornea and the regulations against doing so, would teach
away rather than motivate one to perform such a procedure. App. Br. 5–6
(citations omitted); Reply Br. 3. The inquiry under § 103(a) however, is not
limited to only that which is safe, desirable or even legal. What regulators
permit is not necessarily coextensive with that which would have been
obvious to skilled artisans. The prohibition itself makes it clear that flap
formation on thin corneas had at least been contemplated. What was lacking
was a safe and successful way to carry out such a procedure. Wollensak
suggested that the procedure described therein could also be useful in
conjunction with Lasik for corneas above 400 µm, which are within the
recited range. Thus, we agree with the Examiner’s conclusion that it would
have been would have been obvious to one having ordinary skill in the art to
perform Lasik-type procedures on a thin cornea when done in conjunction
with Wollensak’s stiffening process, even if changes or exceptions to the
regulatory framework would be required to actually do so.
Appellant argues that there is no evidence concerning the specific
location of the photosensitizer, or riboflavin, as under the flap or the specific
timing when it is applied, before ablating in claims 1 and 17, or after
ablating in claims 22 and 28. App. Br. 6–7. The Examiner, despite initially
making a comment indicating Kochevar discloses application of the
photosensitizer under the flap (above), ultimately does not appear to dispute
this. Rather, insofar as the precise location of the photosensitizer is
concerned, the Examiner reasoned that under the flap would be an optimal
location because, in summary, “this would strengthen the tissue in the area
where tissue has been removed.” Non-Final Act. 3–7. Appellant’s only
remark on this point attacks a straw man instead of the Examiner’ position:
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“The mere application of riboflavin to tissue underneath a flap would not
strengthen the tissue to which it is being applied. After all, riboflavin . . .
does not possess any inherent properties that strengthen tissue.” App. Br. 7.
Appellant clearly mischaracterizes the Examiner’s position as each of the
cited portions of Wollensak, Sand and Kochevar make it very clear how to
use riboflavin for strengthening corneal tissue. As noted above, in those
rejections relying on Kochevar, the Examiner cites Kochevar as suggesting
application proximate the surgical wound. We agree with the Examiner that
the articulated reasoning that it would have been obvious to apply riboflavin
specifically under the surgical wound is “an assertion that remains as yet
unrebutted by applicant.” Non-Final Act. 3. Akiyama was cited only to
demonstrate a point not disputed—that nanoparticles were a known delivery
method of riboflavin. See App. Br. 7–8. Akiyama need not also teach that
which is already taught by Wollensak, Sand and Kochevar in order to
support a conclusion of obviousness under § 103(a). Simply pointing out
the absence of a specific teaching in Kochevar relating to application under a
corneal flap (Reply Br.6) does not demonstrate error in the Examiner’s
conclusion.
We agree that the express language of claims 1 and 17 requires
application of riboflavin prior to ablation and that of claims 22 and 28
requires the application of a photosensitizer after ablation. See, e.g.,
Mantech Envtl. Corp. v. Hudson Envtl. Servs., Inc., 152 F.3d 1368, 1375–76,
(Fed. Cir. 1998) (holding that the steps of a method claim had to be
performed in their written order because each subsequent step referenced
something logically indicating the prior step had been performed).
Appellant asserts that “[a]t best, one of ordinary skill in the art would
consider Wollensak et al. as merely teaching cross linking before a LASIK
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procedure is even started, and not during a LASIK-type procedure as
required by claims 1[,] 17 [,22, and 28] of the present application.” Reply
Br. 3; App. Br. 11. The Examiner states that although,
Wollensak et al do not explicitly state that the crosslinking
occurs during the LASIK procedure, the teaching of Wollensak
et al to perform the crosslinking as either prophylaxis or
postoperative treatment clearly places the knowledge of
performing the crosslinking during the LASIK procedure within
the grasp of one having ordinary skill in the art, particularly in
view of the fact that nowhere in the originally filed disclosure is
the crosslinking being performed during the LASIK procedure
discussed as being critical, nor has appellant provided any
evidence of criticality of such.
Ans. 12–13. We agree with the Examiner. Although each order may have
certain advantages and disadvantages, either would seem to serve the
purpose of decreasing the risk of post-operative ectasia with neither being
disclosed as critical. See Spec. p. 28, para. 151.
While it is quite true that such limitations are to be found in
some of the claims, it seems to us a sufficient answer to refer to
the statements in appellant's specification, above [cited], which
make it clear that these details are no more than details, culled
from the specific example in the specification and lacking in
patentable significance because well within the skill of the art.
None is critical according to appellant’s own disclosure of the
invention.
In re Citron, 326 F.2d 418, 421 (CCPA 1964). As the Examiner correctly
points out, the lack of an express disclosure of a particular claim element, in
this case the order of the photosensitizer application and ablation steps, does
not necessarily defeat a rejection under 35 U.S.C. § 103(a). Such a
requirement would essentially defeat the purpose of § 103(a). An artisan
must be presumed to know something about the art apart from what the
references expressly disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA
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1962). We must attribute skill to the hypothetical person described in
§ 103(a). In re Sovish, 769 F. 2d 738, 743 (Fed. Cir. 1985). The fact that
some judgment and surgical skill may be required to select the appropriate
order of photosensitizer application with respect to ablation in order to arrive
at the claimed method does not necessarily mean that the method constitutes
a nonobvious invention. Graham v. John Deere Co., 383 US 1, 10–12
(1966)(discussing Hotchkiss v. Greenwood, 11 How. 248 (1851)). “[A]
person of ordinary skill is also a person of ordinary creativity, not an
automaton.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
Claim 1 requires the exposure of either Bowman’s Layer or the
stroma, whereas claims 17, 22 and 28 each require exposure of the stroma.
In arguing the rejections (B, D, F–I) where the portion of Peyman ’374
quoted above is cited as meeting this limitation (which is alternatively met
by any of Wollensak, Peyman ’748, and Warner), Appellant argues that “a
flap consisting of only epithelial cells would not expose the stroma of a thin
cornea.” App. Br. 11. The Examiner agrees stating “removing only the
epithelium will expose Bowman’s Layer - one of the structures to which
claim 1 recites the riboflavin being applied.” Ans. 11. Even if a sufficient
amount of the epithelium remained during this process so as not to expose
Bowman’s Layer as the Examiner suggests, the Examiner goes on to point
out that claim 1 (and claims 17, 22, and 28) allows for the stroma to
alternatively be exposed, and Peyman’374 describes such an alternative (“ . .
.includes epithelial cells and stromal cells”). Ans. 12. We understand the
procedures described by Peyman to occur no deeper than the stroma. As
previously noted, only one element of a Markush group need be shown in
the prior art. See In re Skoll, supra.
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Regarding the Examiner’s application of Luce, Appellant contends
that
even assuming arguendo that other biomechanical
characteristics of the cornea should be taken into account before
performing LASIK, this does not preclude the thickness of the
cornea as being one of the most important biomechanical
characteristics that must be taken into account prior to
performing the LASIK procedure. As such, the teachings of
Luce fail to render it obvious to perform a LASIK procedure on
an excessively thin cornea (i.e., less than 480 microns), when
there is a substantial amount of evidence in the industry that
indicates such a procedure is unsafe.
App. Br. 15. Appellant points out that in Figure 12 of Luce “there is no
cornea having a thickness less than 540 microns which lies within the
acceptable range for a LASIK procedure” concluding that this “demonstrates
that it is not obvious to create a flap in a thin cornea of an eye with a
thickness of less than 480 microns.” Reply Br. 5–6. In regards to the
suggestion to perform Lasik on a cornea having a thickness under 480 µm,
we note that Luce is cumulative to Wollensak in this regard. Nevertheless,
we agree that it lends further support to the Examiner’s position. Luce’s
suggestion to use a factor other than thickness as determinative of whether
Lasik is safe is twofold. First, Luce seeks to exclude patients that may have
a cornea typically regarded as sufficiently thick enough to successfully
undergo the procedure, but nevertheless do not exhibit sufficient corneal
hysteresis so as to make them good candidates. Luce, col. 8, ll. 17–22. It is
the exclusion of this group that is depicted in Figure 12. Immediately after
this discussion Luce suggests that “certain corneas may be too thin to qualify
for surgery under present practice, but are formed of corneal tissue that
exhibits excellent resistance to 25 deformation. Conceivably, such corneas
might pose an acceptable risk for surgery.” Luce, col. 8, ll. 22–26.
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Although no actual data points for such individuals are depicted on Figure
12, we agree that this suggests additionally considering hysteresis for those
having corneas typically regarded as too thin as a factor for determining
whether a patient is a good candidate for Lasik. We agree with the
Examiner that, when Luce’s suggestion in this regard is considered in light
of Wollensak’s corneal stiffening procedure, it would have suggested to one
skilled in the art that a thin, yet stiffened cornea may be a suitable candidate
for Lasik.
For the foregoing reasons we sustain rejections A–D and F–I.

Rejections E and J–P are reversed.
“[T]he precise language of 35 U.S.C. § 102 that ‘(a) person shall be
entitled to a patent unless,’ concerning novelty and unobviousness, clearly
places a burden of proof on the Patent Office which requires it to produce
the factual basis for its rejection of an application under sections 102 and
103.” In re Warner 379 F.2d 1011, 1016 (CCPA 1967). The Patent Trial
and Appeal Board is primarily a tribunal of review. See Ex Parte Frye, 94
USPQ2d 1072, 1075–1077 (BPAI 2010)(precedential). For that review to
be meaningful it must be based on some concrete evidence in the record to
support the Examiner’s factual findings and legal conclusions. In re Zurko,
258 F.3d 1379, 1386 (Fed. Cir. 2001). A rejection must be set forth in
sufficiently articulate and informative manner as to meet the notice
requirement of § 132, such as by identifying where or how each limitation of
the rejected claims is met by the prior art references. In re Jung, 637 F. 3d
1356, 1363 (Fed. Cir. 2011); see also 37 C.F.R. § 1.104(c)(2) (“When a
reference is complex or shows or describes inventions other than that
claimed by the applicant, the particular part relied on must be designated as
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Application 12/770,011
17
nearly as practicable. The pertinence of each reference, if not apparent, must
be clearly explained and each rejected claim specified.”); Gechter v.
Davidson, 116 F.3d 1454, 1460 (Fed. Cir. 1997) (PTO must create a record
that includes “specific fact findings for each contested limitation and
satisfactory explanations for such findings.”). It is neither our place, nor
Appellant’s burden, to speculate as to the basis for rejecting claims. In re
Stepan, 660 F. 3d 1341, 1345 (Fed. Cir. 2011)(It is the PTO’s obligation to
provide prior notice to the applicant of all matters of fact and law asserted
prior to an appeal hearing before the Board.)
Concerning rejection E (and therefore O), the lack of any definitive
statement as to the grounds of rejection, as noted above, demonstrates that
this rejection does not satisfy the requirements of 35 U.S.C. § 132. Even if
a prior art reference is cited to support the rejection in a minor capacity, it
should be positively included in the statement of rejection. In re Hoch,
428 F.2d 1341, 1342 n.3 (CCPA 1970). “It is well-established that the
Board is free to affirm an examiner’s rejection so long as appellants have
had a fair opportunity to react to the thrust of the rejection.” In re Jung, 637
F. 3d 1356, 1365 (Fed. Cir. 2011)(citations omitted). As Appellant has not
had a fair opportunity to do so we cannot sustain rejection E (and therefore
O).
Concerning rejections J–P, the Examiner does not apprise us, nor is it
apparent why “waiting a period of time between two ablations is [not] totally
unrelated to that which is recited in claims 20, 21, 26, and 27” (App. Br. 29,
supra), which require waiting a predetermined period of time after
irradiating to activate cross linkers and stiffen the cornea prior to ablating
the cornea. As we are unable to ascertain the facts and reasoning supporting
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Application 12/770,011
18
these rejections premised in part on Peyman ’307, these rejections also
cannot be sustained.

DECISION
Rejections A–D and F–I are affirmed. Rejections E and J–P are
reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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