Ex Parte Lai

Patent Trial and Appeal Board

Aug 3, 2017

11829027 (P.T.A.B. Aug. 3, 2017)

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.
DL-06-11 1397
EXAMINER
SHAY, DAVID M
ART UNIT PAPER NUMBER
3769
MAIL DATE DELIVERY MODE
11/829,027 07/26/2007
73719 7590 08/03/2017
SF Bay Area Patents, LLC
Attn: Andrew V. Smith, Ph.D.
805 Watson Canyon Court
#265
SAN RAMON, CA 94582
Shui T. Lai
08/03/2017 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 SHUI T. LAI
Appeal 2016-005579
Application 11/829,0271
Technology Center 3700
Before FRANCISCO C. PRATS, JOHN G. NEW, 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 to ocular
surgery methods in which corneal tissue is ablated by a laser. The Examiner
rejected the claims as being directed to non-statutory subject matter, as
lacking descriptive support, and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm the non-
statutory subject matter rejection, but reverse the written description
rejection. We reverse each of the Examiner’s obviousness rejections, except
as to claims 20 and 21.
1 Appellant states that the “real party in interest is inventor Shui T. Lai.”
Br. 1.
Appeal 2016-005579
Application 11/829,027
STATEMENT OF THE CASE
Claims 1—16, 18—26, and 28 stand rejected and are under appeal. Br.
2;2 see also Non-Final Act. 5—9.3
As a preliminary matter, the Examiner contends that the version of the
claims presented in the Appeal Brief is inaccurate. See Ans. 3^4. We agree.
The Notice of Appeal that generated the present appeal was filed on
June 28, 2012, and appealed “the last decision of the examiner.” Notice of
Appeal 1. The last decision of the Examiner before that Notice of Appeal
was the Non-Final Action entered February 28, 2012.
Review of the prosecution history shows that the last entered
amendment of the claims before the Non-Final Action of February 28, 2012
was on April 17, 2009. See Amendment 3—10 (entered April 17, 2009).
Accordingly, when evaluating the merits of the Examiner’s rejections, we
consider the claims as presented on April 17, 2009, which are the claims the
Examiner rejected in the Non-Final Action of February 28, 2012, the
rejection now on appeal.
We note that a post-appeal Petition to Revive this application, filed on
April 22, 2013, was accompanied by amendments to the claims and
Specification. That Petition was denied, however (see Decision on Petition
(entered June 4, 2013)), and Appellant does not direct us to any indication in
the record showing that the April 22, 2013, amendment was ever entered.
In sum, for the reasons discussed, when evaluating the merits of the
Examiner’s rejections, we consider the claims as they appeared on April 17,
2009, and not as they appear in the claims Appendix in the Appeal Brief.
2 Appeal Brief entered July 14, 2013.
3 Non-Final Action entered February 28, 2012.
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The following rejections are before us for review:
(1) Claims 9, 18, 23, and 28, under 35 U.S.C. § 101, as being directed
to non-statutory subject matter (Non Final Act. 5—6);
(2) Claims 1-16, 18-26, and 28, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement (Id.
at 6);
(3) Claims 1, 2, 4, 7—9, and 19-21, under 35 U.S.C. § 103(a), for
obviousness over Peyman4 (Id.):
(4) Claims 10, 11, 16, and 18, under 35 U.S.C. § 103(a), for
obviousness over Juhasz ’4385 (Id.):
(5) Claims 10, 12, 13, and 18, under 35 U.S.C. § 103(a), for
obviousness over Juhasz ’6536 (Id. at 7);
(6) Claims 24, 26, and 28, under 35 U.S.C. § 103(a), for obviousness
over Juhasz ’1667 (Id.):
(7) Claims 3, 5, 6, 14, 15, 22, and 23, under 35 U.S.C. § 103(a), for
obviousness over Peyman and Juhasz ’438 (Id. at 7—8); and
(8) Claim 25, under 35 U.S.C. § 103(a), for obviousness over Juhasz
’166 and Juhasz ’438 (Id. at 8—9).
Independent claims 1 and 10 illustrate the appealed subject matter and
read as follows (Amendment 3, 5, (entered April 17, 2009; strikethroughs
and underlined text omitted)):
Claim 1. A method of correcting wavefront aberrations of an
eye, comprising:
4 US 6,989,008 B2 (issued Jan. 24, 2006).
5 US 5,993,438 (issued Nov. 30, 1999).
6 US 6,676,653 B2 (issued Jan. 13, 2004).
7 US 6,110,166 (issued Aug. 29, 2000).
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(a) determining a corneal ablation tissue volume profile
for an eye in three dimensions for correcting wavefront error
upon removal of corneal tissue in accordance with said
determined profile,
(b) selecting a fill material to be used to fill space within
the tissue volume upon said removal of corneal tissue,
(c) determining an expansion factor: (Nc-l)/(Nm-Nc),
wherein Nc and Nm are indices of refraction of cornea tissue
and the fill material, respectively;
(d) determining an expanded ablation volume in the
cornea, wherein the expanded ablation volume comprises the
determined profile with its thickness multiplied by the
expansion factor in (c),
(e) ablating cornea tissue according to the determined
expanded ablation volume; and
(f) filling a stroma space vacated by ablated cornea tissue
of the expanded ablation volume with the fill material.
Claim 10. A processor-implemented method of reducing
heating of the cornea during an intrastromal laser surgery,
comprising:
(a) determining a corneal tissue volume profile to be
ablated;
(b) determining a cutting pattern for the tissue volume
comprising a series of cutting surfaces, wherein adjacent
surfaces of cut are positioned to be separated by greater than
one (1) times the diameter of an ablation spot created by a
single shot of laser pulses; and
(c) converting the cut pattern into executable steps in a
computerized program for controlling a laser beam to cut the
tissue volume; and
(d) directing the laser beam to cut the tissue volume into
a plurality of pieces according to the cutting pattern, and
(e) wherein the cutting pattern includes intersecting
cutting surfaces and spacings between adjacent surfaces such
that residual pieces of corneal tissue remain within the tissue
volume after directing the laser beam to cut the tissue according
to the cutting pattern, and the method further comprises
removing the multiple residual pieces; and
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(f) wherein a significant reduction in number of laser
pulses used compared with fully ablating the tissue volume
serves to reduce heating of the cornea during a laser surgery.
NON-STATUTORY SUBJECT MATTER
In rejecting claims 9, 18, 23, and 28 under 35 U.S.C. § 101, the
Examiner concluded that the computer readable media recited in those
claims “is not limited to non-transitory embodiments. The claimed
invention is not limited to statutory subject matter and is therefore non-
statutory. However, a claimed ‘non-transitory computer readable medium
...’ would be statutory subject matter.” Non-Final Act. 5—6.
Appellant does not present argument traversing this rejection. See
Br., generally. We therefore summarily affirm it. See MPEP § 1205.02 (“If
a ground of rejection stated by the examiner is not addressed in the
appellant’s brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it, unless the examiner
subsequently withdrew the rejection in the examiner’s answer.”).
We acknowledge the presence of the term “non-transitory” in the
versions of claims 8, 9, 18, 23, and 28 appearing in the Claims Appendix to
the Appeal Brief. Br. 22, 24, 25, 26. As discussed above, however, the
amendment to the claims that would have added this language (filed April
22, 2013) was not entered.
WRITTEN DESCRIPTION
The Examiner’s rejection of claims 1—16, 18—26, and 28, as failing to
comply with the written description requirement, is based on Appellant’s
amendment to the Specification that replaced the refractive index value of
1.443 with the value 1.309, on page 11 of the Specification. See Non-Final
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Act. 6 (asserting lack of support for refractive index of 1.309); see also
Amendment 2 (entered April 17, 2009).
The Examiner reasoned:
The originally filed disclosure is silent on “the exemplary value
of 1.309 for the index of refraction of the implant material”
since all the claims recite providing a specific ratio of implant
material to removed corneal material, based on the refractive
index of the implant material relative to that of the corneal
material, the previously undisclosed implant material refractive
index renders these claims not supported by the originally filed
disclosure.
Non-Final Act. 6
The amendment in question relates to Equation (1), which appears on
page 9 of the Specification, and also in claims 1 and 14. See Spec. 9; see
also Amendment 3, 6 (entered April 17, 2009). Equation (1) provides for
determining an “expansion factor” which equals (Nc-l)/(Nm-Nc), wherein
Nc and Nm are indices of refraction of cornea tissue and fill material to be
placed into a volume vacated by ablated corneal tissue, respectively. See id.
The Specification explains that, when removing a volume of corneal tissue
by ablation to correct a vision defect, and replacing the removed tissue with
a vision-correcting filler material such as silicon hydrogel, the volume of the
removed corneal tissue must be expanded by the expansion factor. Spec. 9—
10.
The amendment at issue concerns the following change to an
illustrative example in the Specification at page 11: “For example, if the
implant material has an index of 1.309 [[1.443]], the expansion factor is 5.6
using Equation (1). The height of the tissue volume along the light ray’s
traversing direction is multiplied by the expansion factor of 5.6.”
Amendment 2 (entered April 17, 2009; inserted material underlined, deleted
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material bracketed).
As is evident, the amendment to the Specification that forms the basis
of this rejection does not change the scope of the claims in any way. That
the amendment either corrects or inserts a mathematical error in an example
in the Specification (see Ans. 5—6) does not demonstrate that any portion of
the rejected claims lacks descriptive support in the Specification. While the
Examiner urges that Equation (1) encompasses a negative denominator (see
id. at 7), that is true whether or not the amendment at issue is entered.
In sum, we have carefully considered the Examiner’s position in light
of Appellant’s arguments. We are not persuaded, however, that the
Examiner has explained adequately why the amendment at issue, which
simply changes a value in an illustrative example in the Specification, results
in a situation in which a skilled artisan reading the claims in view of
Appellant’s Specification would have failed to recognized that Appellant
possessed the full scope of the claimed subject matter. See Ralston Purina
Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (The test for
determining whether a specification is sufficient to support a particular claim
“is whether the disclosure of the application relied upon ‘reasonably conveys
to the artisan that the inventor had possession at that time of the later
claimed subject matter.’”) (quoting In re Kaslow, 707 F.2d 1366, 1375 (Fed.
Cir. 1983)). We, therefore, reverse the Examiner’s written description
rejection.
OB VIOUSNES S—PE YMAN
The Examiner’s Prima Facie Case
In rejecting claims 1, 2, 4, 7—9, and 19-21 over Peyman, the Examiner
stated as follows:
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Peyman teaches a method as claimed except for the explicit
discussion of the determination of the “expansion factor”.
However, as set forth above, the proper volume of the implant
must be produced, in order to correct the patient’s vision, and
thus the particular equation employed to arrive at this volume
would have been obvious to one having ordinary skill in the art.
Non-Final Act. 6.
The Examiner noted in particular that correction of refractive error in
the eye using wavefront technology to determine the size and shape of
corneal tissue to be removed was known in the art. Id. at 2 (citing Peyman,
4:19—27). Based on this knowledge in the art, the Examiner reasoned:
This process will require the determination of the relative
volume of the implant with respect to the volume of the tissue
removed. Therefore, regardless of the manner in which
Peyman arrives at the relative volume of the implant with
respect to the tissue removed, the employment of applicants!”]
“expansion factor” in order to provide the refractive correction
disclosed by Peyman, would have been obvious, since, in the
end, the size and shape of the implant must be the same to
provide corrected vision, regardless of the precise mathematical
manipulations employed to arrive at the size and shape thereof,
as would be appreciated by one of ordinary skill in the art.
Id. at 2—3.
Analysis
In KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, but also reaffirmed the importance of determining
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” Id. at 418 (emphasis added).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
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Application 11/829,027
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
In the present case, Appellant persuades us8 that the Examiner has not
adequately explained why Peyman would have suggested using the
refractive index of corneal filler material to determine the volume of corneal
tissue to be removed when performing corrective surgery, as required by
independent claim 1.
As seen above, claim 1 requires using an expansion factor, based on
the refractive index of the filler material to be inserted into the cornea, to
determine the amount of tissue to be ablated from the cornea before the
vision-correcting filler material is inserted. See Amendment 3 (entered April
17, 2009; claim 1 steps (c) through (f)).
We acknowledge that, like Appellant’s claim 1, Peyman discloses
ablating corneal tissue to produce an internal “pocket” in the corneal tissue,
into which “an ocular implant is introduced through [an] incision and into
the internal pocket of the cornea.” Peyman, Abstract; see also id. at 4:61—
5:65 (ocular implant can be gel, polymer, or lens).
The Examiner does not, however, identify any specific teaching or
disclosure in Peyman suggesting any relationship between the refractive
index of the implanted material and the amount of corneal tissue that must
be removed. Although the Examiner contends that it was well known in the
8 We acknowledge, as the Examiner points out (see, e.g. Ans. 8, 12, 18), that
Appellant erroneously characterizes a number of the Examiner’s
obviousness rejections as rejections under § 102(b). See Br. 15, 17, 19. We,
nonetheless, review each of the rejections in light of the arguments
presented.
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art that the shape of any corrective vision device depends on its refractive
index (Ans. 8—9), none of the portions of Peyman cited by the Examiner
suggests that, in the particular process described in Peyman, the volume of
corneal tissue to be ablated is determined on the basis of the refractive index
of the material to be inserted in the cornea, as required by Appellant’s claim
1.
Accordingly, because a preponderance of the evidence does not
support the Examiner’s position that Peyman would have taught or
suggested a process having all of the features of Appellant’s claim 1, we
reverse the Examiner’s rejection of claim 1, and its dependent claims 2, 4,
7—9, and 19, over Peyman.
However, our analysis differs as to claims 20 and 21.
Appellant contends that claim 20 is “allowable for the same reasons as
claim 1.” Br. 16. We are not persuaded.
Claim 20 reads as follows:
Claim 20. A method of relaxing a rigid mechanical structure of
a Bowman layer comprising making an excision pattern in the
Bowman layer including at least one excision, wherein the
excision pattern comprises a line or ring cut, or both.
Amendment 7 (entered April 17, 2009; strikethroughs and underlined text
omitted). Claim 20, thus, encompasses processes in which an excision in the
form of a line or a ring is made in the Bowman layer.
As explained in Juhasz ’166, Bowman’s membrane is the layer of
tissue immediately below the outermost layer of the cornea (the epithelium),
and immediately above the stroma. Juhasz ’166, 5:16—23; see also id. at Fig.
3.
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As taught in Peyman, the laser-ablated pocket into which the ocular
implant is inserted can extend to the outermost layer of the cornea, and can
include the Bowman’s layer:
As seen specifically in FIGS. 1—5, a laser 12 is aimed at
an internal portion of the cornea, adjacent the external surface
of the cornea of the eye and fired. Preferably, the laser is
focused to create the pocket 18 in the first one-third of the
cornea, and not in the back of the cornea. In other words, the
pocket is preferably formed adjacent [outermost corneal]
surface 28 or closer to surface 28 then to the interior or anterior
chamber 11 of eye 10. By forming the pocket in the first one-
third of the cornea, the pocket or pockets may extend beyond the
Bowman[]s layer and the cornea, to create a large pocket,
which would allow raising of the entire front portion 10 of the
cornea, as described above.
Peyman, 5:66—6:10 (emphasis added).
Earlier in its disclosure, Peyman explains the configuration of
the pocket further, in relation to insertion of a vision-correcting gel:
The gel can be inserted into a pocket that encompasses the
entire front of the cornea, or extend past the cornea and
Bowman layer to the sclera. By extending the pocket past the
Bowman layer, the portion of the cornea above the pocket
would become loose. The injection of the gel would allow
lifting of the Bowman layer, lifting up the entire front surface
of the cornea, allowing the eye to be reshaped as desired.
However, the gel can be injected or positioned into any size
pocket desired and the pocket does not have to encompass the
entire front of the cornea.
Id. at 5:3—12 (emphasis added).
Peyman further discloses that, as seen in Figures 2—5, an incision 38
“is made in the surface 28 of the cornea to access pocket 18 or pockets 18',
18" and 18"'. Preferably, the incision 38 is made at the periphery of the
pocket; however, it may be made anywhere desired that would allow access
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to the pocket 18.” Id. at 6:49-53. Because this access-providing incision 38
passes from the exterior of the eye to the laser-ablated pocket, the incision
38 must pass through the Bowman’s layer, as required by Appellant’s claim
20. Moreover, as seen in Peyman’s Figure 2, incision 38 is in the form of a
line, as claim 20 also requires.
In addition, laser-ablated pocket 18, which can include the Bowman’s
layer as discussed above, is in the form of a ring, the other excision pattern
recited in Appellant’s claim 20. See Peyman Fig. 2.
Therefore, given the discussed teachings, Appellant does not persuade
us that Peyman fails to teach or suggest the process recited in claim 20. We
therefore affirm the Examiner’s rejection of claim 20 over Peyman.
Turning to Appellant’s claim 21, Appellant contends that claim 21 is
allowable over Peyman “because Peyman does not teach the advantageous
invention set forth there by Applicant. Peyman does not disclose any
method of reducing a mechanical rigidity of a Bowman layer of an eye, and
as such, clearly does not set forth the advantageous method recited at
Applicant’s claim 21.” Br. 16—17. We are not persuaded.
Appellant’s claim 21 reads as follows:
Claim 21. A method of reducing a mechanical rigidity of a
Bowman layer of an eye, comprising:
(a) determining a tissue volume profile in a Bowman
layer to be removed; and
(b) directing laser pulses to ablate Bowman layer tissue
within the tissue volume profile, and
(c) wherein Bowman layer tissue anterior to the ablated
tissue volume is less rigid and more conforming to the shape of
a stromal bed posterior to the Bowman layer.
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Amendment 7—8 (entered April 17, 2009; strikethroughs and underlined text
omitted). Claim 21, thus, encompasses processes in which Bowman’s layer
tissue in a predetermined profile volume is ablated by laser. We interpret
the “wherein” clause of step (c) as a functional result of that ablation step.
As discussed above, Peyman discloses using a laser to ablate a pocket
of corneal tissue in the anterior-most portion of the cornea, the pocket
extending beyond the Bowman’s layer to more interior portions of the
cornea. See Peyman, 5:66—6:10; see also id. at 5:3—12. In addition to thus
teaching and/or suggesting the positive process steps of Appellant’s claim
21, Peyman suggests that its pocket would reduce the rigidity of the
Bowman’s layer, as claim 21 also recites. See id. at 5:5—7 (“By extending
the pocket past the Bowman layer, the portion of the cornea above the
pocket would become loose.”).
Thus, given the discussed teachings, Appellant does not persuade us
that Peyman fails to teach or suggest the process recited in Appellant’s claim
21. We therefore affirm the Examiner’s rejection of claim 21 over Peyman.
OBVIOUSNESS—JUHASZ ’438
The Examiner’s Prima Facie Case
The Examiner’s rationale for rejecting claims 10, 11, 16, and 18 over
Juhasz ’438 reads as follows:
Juhasz et al (’438) teaches a method as claimed except
for the explicit discussion of the determination of the
“expansion factor”. However, as set forth above, the proper
volume of the implant must be produced, in order to correct the
patient’s vision, and thus the particular equation employed to
arrive at this volume would have been obvious to one having
ordinary skill in the art.
Non-Final Act. 7.
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Analysis
Appellant persuades us that a preponderance of the evidence does not
support the Examiner’s conclusion that Juhasz ’438 teaches or suggests a
process having all of the process steps of claim 10, the only independent
claim subject to this rejection.
Contrary to the Examiner’s assertion, claim 10 does not recite an
expansion factor. Rather, claim 10 recites a method in which corneal tissue
is ablated by a laser beam, the ablation being performed in a cutting pattern
that results in “spacings between adjacent [cutting] surfaces such that
residual pieces of corneal tissue remain within the tissue volume after
directing the laser beam to cut the tissue according to the cutting pattern.”
Amendment 5 (entered April 17, 2009; underlining omitted). Thus, as
Appellant contends, claim 10 requires the laser cutting to produce “residual
pieces” of non-laser-ablated tissue within the overall volume of tissue to be
removed from the cornea. Id.
In contrast, Juhasz ’438 describes serially ablating entire layers of
stromal tissue of the cornea, by sequentially focusing a laser beam at
adjacent portions of tissue. See, e.g., Juhasz ’438, Abstract (“With this
progressive pattern of photodisruption, each spot is placed substantially
contiguous with adjacent a volume of previously disrupted tissue. The
resultant photodisrupted tissue creates a layer which is substantially centro-
symmetrical around the optical axis. A plurality of layers can be removed to
create a cavity in the stroma.”).
The Examiner identifies the following disclosure in Juhasz ’438 as
evidence that Juhasz contemplates non-overlapping tissue disruptions which
would result in the residual pieces required by claim 10 (Ans. 13—14):
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“Importantly, the distance along path 50 between first focal spot central
point 42a and second focal spot central point 426 is selected so that the
adjacent volumes of disrupted tissue in cavitation bubbles 36a, 36b will
preferably overlap.” Juhasz ’438, 6:31—35 (emphasis added).
Although we acknowledge this teaching of a preference for
overlapping tissue disruptions, the Examiner does not identity, nor do we
discern, any teaching or suggestion in Juhasz ’438 of producing non-photo-
ablated residual pieces of corneal tissue, as required by Appellant’s claim
10, even as an unpreferred result. Rather, as aptly summarized in the
abstract, quoted above, Juhasz ’438 consistently teaches ablating adjacent
portions of tissue, without leaving residual non-photo-ablated pieces of
tissue, as required by claim 10.
Thus, because a preponderance of the evidence does not support the
Examiner’s conclusion that Juhasz ’438 teaches or suggests a process having
all of the process steps of claim 10, we reverse the Examiner’s rejection of
that claim, and its dependent claims 11, 16, and 18, over that reference.
OBVIOUSNESS—JUHASZ ’653
The Examiner’s Prima Facie Case
The Examiner’s rationale for rejecting claims 10, 12, 13, and 18 over
Juhasz ’653 reads as follows:
Juhasz et al (’653) teaches a method as claimed except
for the explicit discussion of the determination of the
“expansion factor”. However, as set forth above, the proper
volume of the implant must be produced, in order to correct the
patient’s vision, and thus the particular equation employed to
arrive at this volume would have been obvious to one having
ordinary skill in the art.
Non-Final Act. 7.
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Analysis
Appellant persuades us that a preponderance of the evidence does not
support the Examiner’s conclusion that Juhasz ’653 teaches or suggests a
process having all of the process steps of claim 10, the only independent
claim subject to this rejection.
As noted above, claim 10 recites a method in which corneal tissue is
ablated by a laser beam, the ablation being performed in a cutting pattern
that produces “residual pieces” of non-laser-ablated tissue within the overall
volume of tissue to be removed from the cornea. Amendment 5 (entered
April 17, 2009; underlining omitted).
Juhasz ’653 is directed to a device that is placed on top of the outer
surface of the eye during laser surgery, the device including a suction pump
that removes gas and debris generated by the laser’s photodisruption of the
corneal tissue. See Juhasz ’653, Abstract.
The Examiner contends that the residual tissue debris generated
during laser ablation of corneal tissue corresponds to the residual pieces of
non-laser-ablated tissue required by Appellant’s claim 10. Ans. 16—17
(citing Juhasz ’653, 1:20-33).
We acknowledge Juhasz ’653’s disclosure that laser ablation results in
vaporization of tissue, as well as “mechanical effects” such as “tearing,
separation, and division of the affected tissue,” and also “thermal effects
which include charring and scorching of the affected tissue.” Juhasz ’653,
1:22—26. As noted above, however, we interpret Appellant’s claim 10 as
requiring laser ablation in a cutting pattern that produces residual pieces of
non-laser-ablated tissue within the overall volume of tissue to be removed
from the cornea.
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We are not persuaded that Juhasz ’653 ’s disclosure, that laser ablation
results in a variety of types of damaged corneal tissue, sufficiently teaches or
suggests performing laser ablation in a cutting pattern that produces residual
pieces of non-laser-ablated tissue within the overall volume of tissue to be
removed from the cornea, as Appellant’s claim 10 requires. We, therefore,
reverse the Examiner’s rejection of claim 10, and its dependent claims 12,
13, and 18, over Juhasz ’653.
OBVIOUSNESS—JUHASZ ’166
The Examiner’s Prima Facie Case
The Examiner’s rationale for rejecting claims 24, 26, and 28 over
Juhasz ’166 reads as follows:
Juhasz et al (’166) teaches a method as claimed, see
Figures 3-8, and attendant text, except for the explicit
discussion of the determination of the “expansion factor”.
However, as set forth above, the proper volume of the implant
must be produced, in order to correct the patient’s vision, and
thus the particular equation employed to arrive at this volume
would have been obvious to one having ordinary skill in the art.
Non-Final Act. 7.
Analysis
Appellant persuades us that a preponderance of the evidence does not
support the Examiner’s conclusion that Juhasz ’166 teaches or suggests a
process having all of the process steps of claim 24, the only independent
claim subject to this rejection.
Contrary to the Examiner’s assertion, claim 24 does not recite an
expansion factor. Rather, claim 24, similar to claim 10 discussed above,
recites a method in which corneal tissue is ablated by a laser beam in a
cutting pattern that produces residual pieces of non-laser-ablated tissue in
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the cornea. Amendment 8—9 (entered April 17, 2009). Claim 24 also
requires the laser ablation pattern to include “at least one grid pattern of
contiguous laser spots.” Id.
Juhasz ’ 166 discloses a method in which laser ablation is performed
around a non-laser-ablated volume of tissue, termed a “lentoid volume,”
allowing removal of the lentoid volume, thereby correcting a vision defect
such as myopia. Juhasz ’166, 5:24-41.
Juhasz ’ 166 discloses that the excised lentoid volume can have
different shapes, depending on the needs of the physician. See id. at 5:42—
46; see also id. at Fig. 3A (showing convex lens-shaped lentoid volume);
Fig. 3C (showing lentoid volume having rectangular cross-section).
The Examiner contends that excising the lentoid volume shown in
Figure 3C of Juhasz ’166 corresponds to excising the grid pattern required
by Appellant’s claim 24:
[TJaking the lenticel of Figure 3C of Juhasz et al (’166) as
exemplary, the upper surface (anterior surface 38") is produced
by a layer of contiguous laser spots, and the remaining ablation
(posterior surface 40" and contiguous flat annular surface 41)
constitute the grid pattern, as defined by the last full sentence
on page 13, the sentence bridging pages 13 and 14, and the first
full sentence on page 14 of the originally filed disclosure (the
third to fifth sentences in paragraph [0056] of the Pre-Grant
Publication).
Ans. 19.
We are not persuaded that the Examiner has adequately explained
why simply excising the flat posterior surface of the lentoid volume shown
in Figure 3C of Juhasz ’166 equates to excising a grid pattern, as required by
Appellant’s claim 24. The portion of Appellant’s Specification cited by the
Examiner states, in relevant part, that “[a] next layer 820 is illustrated in
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Figure 8B. Here the laser only ablates the ‘wall’ surrounding the ‘dissected’
tissue like a grid.” Spec. 14. As seen in Appellant’s Figure 8B, the ablated
tissue pattern includes a plurality of ablated portions of tissue that intersect
at right angles, “like a grid.” Id.', see also Fig. 8B.
We are not persuaded that the Examiner has explained adequately
why excising the entire flat posterior surface of the lentoid volume shown in
Figure 3C of Juhasz ’166 equates to excising a pattern of tissue having
ablated portions that intersect at right angles, like a grid. Because we are not
persuaded, therefore, that the Examiner has adequately explained why
Juhasz ’166 teaches or suggests a process having all of the steps and features
of Appellant’s claim 24, we reverse the Examiner’s rejection of claim 24,
and its dependent claims 26 and 28, over that reference.
OBVIOUSNESS—
PEYMAN AND JUHASZ ’438
In rejecting claims 3, 5, 6, 14, 15, 22, and 23 over Peyman and Juhasz
’438, the Examiner concluded that it would have been obvious to employ the
laser pulses and placement taught in Juhasz ’438 in Peyman’s methods.
Non-Final Act. 7—8.
Each of claims 3, 5, 6, 22, and 23 depends directly or ultimately from
claim 1, discussed above. As discussed above, we are not persuaded that
Peyman teaches or suggests a process having all of the steps and features
recited in claim 1. Because the Examiner does not identify, nor do we
discern, any teaching in Juhasz ’438 that remedies the deficiencies discussed
above of Peyman with respect to claim 1, we reverse the Examiner’s
rejection of claims 3, 5, 6, 22, and 23 over the combination of Peyman and
Juhasz ’438.
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Each of claims 14 and 15 depends directly or ultimately from claim
10, also discussed above. As discussed above, we are not persuaded that
Juhasz ’438 teaches or suggests a process having all of the steps and features
recited in claim 10. Because the Examiner does not identify, nor do we
discern, any teaching in Peyman that remedies the deficiencies discussed
above of Juhasz ’438 with respect to claim 10, we reverse the Examiner’s
rejection of claims 14 and 15 over the combination of Peyman and Juhasz
’438.
OBVIOUSNESS—
JUHASZ ’166 AND JUHASZ ’438
In rejecting claim 25 over Juhasz ’166 and Juhasz ’438, the Examiner
concluded that it would have been obvious to employ the laser pulse
placement taught in Juhasz ’438 in the methods of Juhasz ’166. Non-Final
Act. 8—9.
Claim 25 depends from claim 24, discussed above. As discussed
above, we are not persuaded that Juhasz ’ 166 teaches or suggests a process
having all of the steps and features recited in claim 24. Because the
Examiner does not identify, nor do we discern, any teaching in Juhasz ’438
that remedies the deficiencies discussed above of Juhasz ’ 166 with respect to
claim 24, we reverse the Examiner’s rejection of claim 25 over the
combination of Juhasz ’166 and Juhasz ’438.
SUMMARY
For the reasons discussed:
(1) We affirm the Examiner’s rejection of claims 9, 18, 23, and 28,
under 35 U.S.C. § 101, as being directed to non-statutory subject matter;
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(2) We reverse the Examiner’s rejection of claims 1—16, 18—26, and
28, under 35U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement;
(3) We reverse the Examiner’s rejection of claims 1, 2, 4, 7—9, and 19
for obviousness over Peyman;
(4) We affirm the Examiner’s rejection of claims 20 and 21 for
obviousness over Peyman;
(5) We reverse the Examiner’s rejection of claims 10, 11, 16, and 18
for obviousness over Juhasz ’438;
(6) We reverse the Examiner’s rejection of claims 10, 12, 13, and 18
for obviousness over Juhasz ’653;
(7) We reverse the Examiner’s rejection of claims 24, 26, and 28 for
obviousness over Juhasz ’166;
(8) We reverse the Examiner’s rejection of claims 3, 5, 6, 14, 15, 22,
and 23 for obviousness over Peyman and Juhasz ’438; and
(9) We reverse the Examiner’s rejection of claim 25 for obviousness
over Juhasz ’166 and Juhasz ’438.
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
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