Ex Parte Kurtz et al

Patent Trial and Appeal Board

Apr 26, 2018

11469899 (P.T.A.B. Apr. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111469,899 0910512006 Ronald M. Kurtz
33357 7590 04/30/2018
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 E. ST. ANDREW PLACE
SANTA ANA, CA 92705
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
ATTORNEY DOCKET NO.
JSV6095USNP
(70054-74USO)
CONFIRMATION NO.
7182
EXAMINER
SHAY,DAVIDM
ART UNIT PAPER NUMBER
3769
NOTIFICATION DATE DELIVERY MODE
04/30/2018 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):
JNJUSPatent@corus.jnj.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RONALD M. KURTZ, TIBOR JUHASZ,
MELVIN A. SARA YBA, and ROGER STEINERT
Appeal 2016-002216 1
Application 11/469,8992
Technology Center 3700
Before KENNETH G. SCHOPPER, BRADLEY B. BAY AT, and
AMEE A. SHAH, Administrative Patent Judges.
BAY AT, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Final Rejection
of claims 16, 20, 22, and 30-33 (App. Br. 6; Reply Br. 3). 3 We have
jurisdiction under 35 U.S.C. § 6(b). A hearing was held on March 19, 2018,
a transcript of which has been entered into the record ("Tr.").
1 Our Decision references Appellants' Appeal Brief ("App. Br.," filed May
20, 2015), Reply Brief ("Reply Br.," filed Dec. 18, 2015), the Examiner's
Answer ("Ans.," mailed Oct. 22, 2015), and Final Office Action ("Final
Act.," mailed Jan. 21, 2015).
2 Appellants identify "Abbott Medical Optics Inc." as the real party in
interest. App. Br. 2.
3 We note Appellants' incorrect citation to "US Patent No. 6,110,016" as
referencing Juhasz, which is US 6, 110, 166.
Appeal2016-002216
Application 11/469,899
SUMMARY OF DECISION
We REVERSE and enter a NEW GROUND OF REJECTION
pursuant to our authority under 37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Method claims 16 and 33 are the only independent claims on appeal.
Claim 16, reproduced below, is illustrative of the subject matter on appeal.
16. A method of transplanting donor tissue from a donor
cornea to a recipient cornea, the method comprising:
determining a first incision depth from an anterior
corneal surface;
determining a second incision depth from the anterior
corneal surface, wherein the second incision depth is greater
than the first incision depth;
placing a contact lens against the anterior corneal
surface of each of the recipient cornea and the donor cornea,
wherein the contact lens is adapted to conform the anterior
corneal surface to a shape of the contact lens;
making a resection incision at the first incision depth in
each of the donor cornea and the recipient cornea;
making an annular incision at the second incision depth
in each of the donor cornea and the recipient cornea, the
annular incision having an outer periphery and an inner
periphery, wherein corneal tissue within the inner periphery
and outside of the outer periphery remains intact after the
annular incision is made;
making a first sidecut incision in each of the donor
cornea and the recipient cornea, the first sidecut incision
running from the outer periphery of the annular incision to
one of a posterior corneal surface or the resection incision,
wherein the first sidecut incision forms a first acute angle
with the annular incision;
making a second sidecut incision in each of the donor
cornea and the recipient cornea, the second sidecut incision
running from the inner periphery of the annular incision to the
other of the posterior corneal surface or the resection incision,
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the first sidecut and second sidecut incisions being offset from
each other with the annular incision extending therebetween,
wherein the second sidecut incision forms a second acute
angle with the annular incision, and wherein a combination of
the incisions in each of the recipient cornea and the donor
cornea resects corneal tissue from the recipient cornea and
resects the donor tissue from the donor cornea, respectively;
and
grafting the donor tissue into the recipient cornea,
engagement of incised surfaces of the donor tissue with
incised surfaces of the recipient cornea securing the donor
tissue into the recipient cornea sufficiently that sutures are
not used,
wherein the incisions are made using a surgical laser,
and wherein the annular incision is at a uniform distance from
the posterior corneal surface.
App. Br. 13-14 (Claims Appendix) (emphasis added).
REJECTIONS
I. Claims 16, 20, 22, and 30-32 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Sarayba,4 Juhasz, 5 White, 6 and
Lai. 7
II. Claim 33 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Sarayba, Juhasz, White, Lai, and Stojkovic. 8
4 Sarayba et al., Femtosecond Laser Posterior Lamellar Keratoplasty: A
Laboratory Model Cornea 328-333 (2005) (Sarayba).
5 Juhasz, US 6,110,166, issued Aug. 29, 2000.
6 White, US 4,772,283, issued Sept. 20, 1988.
7 Lai, US 5,549,632, issued Aug. 27, 1996.
8 Stojkovic et al., Corneal Shrinkage Induced by Nonmechanical Q-switched
Erbium: YAG Laser Trephinationfor Penetrating Keratoplasty in Porcine
Eyes Graefes Arch Clin Exp Ophthalmol. 667----672 (2003) (Stojkovic ).
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Application 11/469,899
ANALYSIS
As set forth below, pursuant to our authority under 37 C.F.R.
§ 41.50(b), we enter a new ground of rejection of claims 16, 20, 22, and 30-
33 under 35 U.S.C. § 112, second paragraph, as being indefinite. In light of
this new rejection, it would be premature to reach the merits of the rejections
under 35 U.S.C. § 103(a) at this time.
Before a proper review of the rejections under§ 103(a) can be made,
the subject matter encompassed by the claims on appeal must be reasonably
understood without resort to speculation. Because the claims fail to satisfy
the requirements under 35 U.S.C. § 112, second paragraph, we are
constrained to reverse, proforma, the Examiner's rejections under 35 U.S.C.
§ 103(a). See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art
rejection cannot be sustained if the hypothetical person of ordinary skill in
the art would have to make speculative assumptions concerning the meaning
of claim language).
It should be understood that our decision to reverse the rejections of
claims 16, 20, 22, and 30-33 under 35 U.S.C. § 103(a) is based solely on the
indefiniteness of the claims, and does not reflect on the merits of the
underlying rejections.
New Ground of Re} ection-Jndefiniteness
In determining whether a claim is definite under 35 U.S.C. § 112,
second paragraph, "[t]he USPTO, in examining an application, is obliged to
test the claims for reasonable precision." In re Packard, 751F.3d1307,
1313 (Fed. Cir. 2014 ). "[A] claim is indefinite when it contains words or
phrases whose meaning is unclear." Id. at 1322; Ex Parte McAward, No.
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2015-006416, 11 (PTAB Aug. 25, 2017) (precedential) (quoting In re
Packard, 751 F.3d at 1314). The Office "determines the scope of claims ...
not solely on the basis of the claim language, but upon giving claims their
broadest reasonable construction 'in light of the specification as it would be
interpreted by one of ordinary skill in the art."' Phillips v. A WH Corp., 415
F.3d 1303, 1316 (Fed. Cir. 2005) (en bane) (quoting Jn re Am. Acad. Of Sci.
Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). During examination, an
applicant must "clearly and precisely set out the metes and bounds of the
claimed [subject matter]." See Ex parte Miyazaki, 89 USPQ2d 1207, 1211-
13 (BP AI 2008) (precedential) (holding that "if a claim is amenable to two
or more plausible claim constructions, the USPTO is justified in requiring
the applicant to more precisely define the metes and bounds of the claimed
invention by holding the claim unpatentable under 35 U.S.C. § 112, second
paragraph, as indefinite.").
"The present invention is directed toward [] a method for resecting
corneal tissue as part of a transplant procedure." Spec. i-f 4. The final
"grafting" step performed in each of independent claims 16 and 33, which
appears central to the Appellants' argument against the art rejections (see,
e.g., App. Br. 8-11; Reply Br. 7-10; Tr. 3-12, 15-18), recites the step of
"grafting the donor tissue into the recipient cornea, engagement of incised
surfaces of the donor tissue with incised surfaces of the recipient cornea
securing the donor tissue into the recipient cornea sufficiently that sutures
are not used." App. Br. 14, 16 (Claims Appendix).
The Appellants interpret the non-use of sutures as recited in the
"grafting" step of the claims as encompassing the whole transplant
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procedure because "one of ordinary skill in the art, having read Applicants'
Specification, would have reasonably and properly concluded that the
claimed methods include entirely sutureless procedures, such as sutureless
PLK methods." Reply Br. 8; see also App. Br. 8. In support of this
interpretation, the Appellants assert that "[ t ]he preambles of independent
claims 16 and 33 are directed to a 'method of transplanting donor tissue
from a donor cornea to a recipient cornea' and a 'method for performing
partial thickness transplant,' respectively ... [which] refer to the entire
complete 'transplant' procedure, and not merely a selected portion thereof."
Reply Br. 8. According to the Appellants, "the Specification teaches that the
use of sutures is optional: 'Following the graft, the donor tissue may be
secured using a plurality of sutures, each preferably passing through the
sidecut incision which is nearest the posterior surface of the recipient
cornea,' ... [thus,] the use of the permissive 'may' indicates that sutures
may or may not be used." Id. (quoting Spec. i-f 5). The Appellants assert
that the statement: "[i]n a PLK procedure, sutures are not necessary to
secure the donor tissue to the recipient cornea" (Spec. i-f 17), "clearly refers
to the entirety of the PLK procedure and not merely a subset of incision
directed to forming a graft." Id. at 9. Finally, in support of their
interpretation, the Appellants refer to the originally filed independent claims,
which are "silent as to the requirement of sutures," but are further limited by
the dependent claims, which require "securing the donor tissue to the
recipient cornea with a plurality of sutures." Id. at 8.
The Examiner states that none of the incisions discussed in the
Specification relate to the opening up of the cornea to provide access to
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remove and replace the recipient and donor tissue as part of the PLK
procedure. Ans. 9. According to the Examiner, "it is clear that the
originally filed disclosure does not provide support for the scope of the
claims which appellant is relying on for patentability" (id.), and, therefore,
the Examiner has interpreted the non-use of sutures as recited in the claims
to be limited to grafting the donor tissue into the recipient cornea, rather than
an entirely suture-less procedure.
The majority of the discussion during oral hearing involved the
Appellants' and the Examiner's differing interpretations as to the "grafting"
step of claims 16 and 33. See Tr. 3-12, 15-18. Appellants' counsel
acknowledged the "two competing interpretations" (Tr. 4:7; see also id. at
6: 15-19 ("Does it encompass both the grafting step and the closing step or
the opening step or maybe other pre or post steps ... I admit there are two
different interpretations.")), and framed the issue as one of claim breadth.
According to Appellants, "the narrower interpretation would require non-use
of sutures for the grafting as well as the non-use of sutures in the entire
procedure which include the axis opening, or closing of the axis opening,"
and "[t]he [E]xaminer's interpretation is a broader one, and that says that the
claim element required non-use of sutures for the grafting part but places no
restriction on whether sutures could be used elsewhere." Id. at 4: 10-17.
We do not agree that the issue before us is one of claim breadth,
because that would require the scope of the claimed subject matter to be
clearly defined. Instead, we determine that claims 16 and 33 are indefinite
because the boundaries of the protected subject matter are not clearly
delineated and the scope is unclear. It is unclear how one of ordinary skill in
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the art would understand the scope of "grafting the donor tissue into the
recipient cornea, engagement of incised surfaces of the donor tissue with
incised surfaces of the recipient cornea securing the donor tissue into the
recipient cornea sufficiently that sutures are not used" (App. Br. 14, 16
(Claims Appendix with added emphasis)), when interpreted in light of the
Specification. We acknowledge that relative terms do not automatically
render a patent claim indefinite; however, the use of relative terms in a claim
must be evaluated on a case-by-case basis, the acceptability of which is
determined based on whether an artisan would understand the scope of the
claim when read in light of the specification.
\Vhen a term of degree such as sufficiently9 is used as recited in claims
16 and 33, the Specification must provide some objective standard for
measuring that degree. See Datamize, LLC v. Plumtree Software, Inc., 417
F.3d 1342, 1350-55 (Fed. Cir. 2005). The term sufficiently neither appears
in the Specification, nor is any standard provided for measuring the requisite
degree of engagement of the incised surfaces of the donor tissue with the
incised surfaces of the recipient cornea to secure the donor tissue into the
recipient cornea without sutures. In other words, the determination of what
is considered sufficient engagement of the incised surfaces so that sutures
need not be used is subjective, and completely dependent on a person's
subjective opinion. "The scope of claim language cannot depend solely on
the unrestrained, subjective opinion of a particular individual purportedly
9 Defined as: "to the degree that is needed for a particular purpose."
https://www.macmillandictionary.com/us/ dictionary/ american/ sufficiently
(last visited April 23, 2018).
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Application 11/469,899
practicing the invention." See id. at 1350 (citations omitted). One of
ordinary skill in the art would not understand the requisite degree of
engagement needed between the incised surfaces of the donor tissue and
recipient con1ea so that sutures are not needed to either graft the donor tissue
into the recipient cornea, or, to perfonn the entire corneal transplant
procedure without sutures.
This lack of clarity is underscored in that the difference between the
use and non-use of sutures appears essential to how substantially engaged
the incised surfaces of the donor tissue is to the recipient cornea. For
example, in comparing the lamellar keratoplasty 10 procedures of the anterior
surface of the cornea (ALK procedure) to the posterior surface of the cornea
(PLK procedure), the Specification discloses that in an ALK procedure
"donor tissue may be secured to the recipient cornea by either of the
[suturing] techniques described" (Spec. i-f 16), and that "[i]n a PLK
procedure, sutures are not necessary to secure the donor tissue to the
recipient cornea." Spec. i-f 17. In distinguishing the prior art's disclosure of
a PLK procedure from the above statement, the Appellants' counsel
asserted: "one important feature of our innovation is to use the Z-shaped
side-cut, and because of that we are able to avoid the use of sutures - in the
grafting step. That's actually why the claim language reads the way it does.
It's the fitting." Tr. 7:21-24; id. at 8: 16-17 ("there's the interlocking aspect
10 "Transplantation of donated corneal tissue into the middle layers of the
cornea, leaving the corneal endothelium and inner layers of the cornea
intact." https://medical-
di cti onary. thefreedi cti onary. com/lamellar+ keratop lasty (last visited April
23, 2018).
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of the [Z-shaped] side cut that make it more secure."). When asked where
the Specification describes the lack of sutures as being the result of the Z-
shaped cut, the Appellants could only direct us to Figure 4. See Tr. 8: 1-11.
But Figure 4 does not demonstrate such a nexus, especially in comparison to
Figure 3, in which a similar Z-shaped cut is shown as part of an ALK
procedure, wherein sutures are placed to secure the donor tissue to the
recipient cornea. cf Spec., Figs. 3 and 4. Therefore, the distinction between
the use and non-use of sutures is in part dependent on the degree to which
the incised surfaces of the donor tissue is engaged with the recipient cornea
to create the requisite "fitting" so that sutures are not used. On the one hand,
Appellants argue that the claims are directed to an entirely suture-less
corneal transplant procedure "includ[ing] the axis opening, [and] closing of
the axis opening" (Tr. 4: 11-12), and on the other hand, Appellants admit
that "[ t ]he [axis] opening is actually not mentioned in our disclosure ...
[because w ]e focused on the shape of the side cut and the grafting part" (id.
at 5:18-20). As such, one skilled in the art reading Appellants'
Specification is left to consult the subjective opinion of ophthalmologists to
determine what degree of engagement of the incised surfaces of the donor
tissue with the recipient cornea is sufficient, so that sutures are not required
to secure the graft, or not required for any other part of the corneal transplant
procedure (i.e., axis opening).
Having considered this claim language in the context of the
circumstances, we determine the term "sufficiently that sutures are not
used" renders the claims indefinite because they are susceptible to at least
two equally reasonable interpretations, in the absence of any objective
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standard or description. The Miyazaki standard for evaluating
indefiniteness is justified, at least in part, because applicants have the
opportunity and the obligation to define the invention precisely during
prosecution before the US Patent & Trademark Office. See Miyazaki, 89
USPQ2d at 1215. Section 112 places the burden of precise claim drafting on
applicants. See Packard, 751 F.3d at 1313 ("Given the role of the applicant
in the process, it is a reasonable implementation of the examination
responsibility, as applied to § 112[, second paragraph], for the [Office], upon
providing the applicant a well-grounded identification of clarity problems, to
demand persuasive responses on pain of rejection.").
Accordingly, we enter a New Ground of Rejection of independent
claim 16 and 33 as indefinite under 35 U.S.C. § 112, second paragraph,
including claims 20, 22, and 30-32 dependent thereon.
DECISION
The Examiner's prior art rejections of claims 16, 20, 22, and 30-33
are reversed proforma.
A NEW GROUND OF REJECTION is entered for claims 16, 20, 22,
and 30-33 as indefinite under 35 U.S.C. § 112, second paragraph.
Section 41.50(b) provides that "[a] new ground of rejection pursuant
to this paragraph shall not be considered final for judicial review." Thus,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION,
Appellants must exercise one of the following two options with respect to
the new ground of rejection to avoid termination of the appeal as to the
newly rejected claims:
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( 1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the proceeding will be remanded to the
Examiner; or
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
REVERSED; 37 C.F.R. § 41.50(b)
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