Ex Parte Nunez et al

Patent Trial and Appeal Board

Oct 31, 2018

13480651 (P.T.A.B. Oct. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/480,651 05/25/2012
23702 7590 11/02/2018
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, NY 14609
FIRST NAMED INVENTOR
Ivan Nunez
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. CONFIRMATION NO.
P05310 9015
EXAMINER
LE,NINHV
ART UNIT PAPER NUMBER
1744
NOTIFICATION DATE DELIVERY MODE
11/02/2018 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):
patents@bausch.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IV AN NUNEZ and JENNIFER HUNT
Appeal2018-000837
Application 13/480,651 1
Technology Center 1700
Before JEFFREY T. SMITH, KAREN M. HASTINGS, and
JANEE. INGLESE, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is an appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1-39. 2 We have jurisdiction under 35 U.S.C. § 6(b).
The appealed invention relates to the novel claimed use of Bis 0-
hydroxybenzophenone UV-absorbing agents along with N-vinylpyrrolidone
1 According to Appellants, the real party in interest is Bausch & Lomb
Incorporated. See App. Br. 1.
2 The Examiner has indicated that the subject matter of claims 31 and 32 is
allowable. Final Act. 11.
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Application 13/480,651
(NVP ) monomer ion in a monomer reaction mixture to form fully
polymerized UV blocking hydrogel lenses when polymerized. Independent
claim 1 is representative of the appealed subject matter and is reproduced
below:
1. A method of making a substantially fully polymerized
UV blocking hydrogel lens comprising:
polymerizing a monomer reaction mixture of at least NVP and
one other comonomer and a free-radical polymerizable,
substituted or unsubstituted, Bis 0-hydroxy benzophenone to
provide a substantially fully polymerized hydrogel ophthalmic
device.
Claims Appendix to App. Br.
Appellants (see App. Br., generally) request review of the following
rejections:
I. Claims 1-39 rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Awasthi
(US 2011/0009658 Al) and Brown-Skrobot (US
2005/0079096 Al).
II. Claims 1---6, 9-14, 18-26, and 28-33 rejected 35 U.S.C.
§ I03(a) over the combination of Zhang (WO 2011/037897
A2) and of Brown-Skrobot.
III. Claims 7 and 8 rejected 35 U.S.C. § I03(a) over the
combination of Zhang, Brown-Skrobot and Nueraji
(US 2010/0304163 Al).
IV. Claims 15-17 rejected 35 U.S.C. §I03(a) over the
combination of Zhang, Brown-Skrobot and Kunzler
(US 5,270,418).
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The complete statement of the rejections on appeal appears in
the Final Office Action. (Final Act. 3-30).
OPINION
After consideration of Appellants' arguments and evidence and the
Examiner's position in the Final Office Action and Answer, we AFFIRM the
obviousness determinations for the reasons provided by the Examiner. We
add the following.
Re} ection I3
The Examiner finds A wasthi discloses a method of making a
polymerized UV blocking hydrogel lens comprising polymerizing a
monomer reaction mixture of at least NVP and one other comonomer.
(Final Act. 3). The Examiner finds Awasthi fails to disclose the reaction
mixture includes a photopolymerizable hydroxybenzophenone UV absorber
such as a substituted or unsubstituted, Bis 0-hydroxy benzophenone as
required by the claimed invention. (Final Act. 4). The Examiner finds
Brown-Skrobot discloses in the contact lens art it is known to incorporate
UV blocking agents such as 1,3-Bis(4-benzoyl-3-hydroxyphenoxy)-2-propyl
methacrylate. (Final Act. 5). The Examiner concludes it would have been
obvious to perform the method of Awasthi incorporating known UV
3 Appellants' arguments are principally directed to independent claim 1.
(App. Br. 5-12). Appellants do not present sufficiently separate arguments
addressing the dependent claims. (App. Br. 5-12). We select independent
claim 1 as representative of the rejected claims and limit our discussion to
independent claim 1. Separate arguments for claims 6-8 will be addressed.
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blocking agents such as 1,3-Bis(4-benzoyl-3-hydroxyphenoxy)-2-propyl
methacrylate. (Final Act. 5).
Appellants argue the combination of Awasthi with Brown-Skrobot
does not necessarily teach essentially the same process and materials as
required by the claimed invention. (App. Br. 4). Appellants argue Awasthi
does not teach UV absorbers and thus clearly does not teach making a UV
blocking hydrogel lens which is substantially fully polymerized. (App.
Br. 4). Appellants argue the majority of UV absorbers disclosed in Brown-
Skrobot are not Bis 0-hydroybenzophenones and the selection of the Bis 0-
hydroybenzophenone UV blocker from the disclosure Brown-Skrobot for
use in the reaction mixture including NVP as described by Awasthi would
have been premised upon hindsight. (App. Br. 4). Appellants argue the
Examiner has not identified any actual prior art product or method that is
identical or substantially identical to the present claimed invention, so as to
support the assertion that the required properties of a lens prepared in
accordance with the present claimed invention would necessarily or
inherently be obtained in such actual prior art product or method. (App. Br.
4).
Appellants' arguments lack persuasive merit. A person of ordinary
skill in the art would have reasonably expected that the monomer mix
utilized in a method of making a polymerized hydro gel lens may include
UV-absorbing agents such as those known in the contact lens art. Brown-
Skrobot discloses in the contact lens art it is known to incorporate a UV
blocking agents such as 1,3-Bis(4-benzoyl-3-hydroxyphenoxy)-2-propyl
methacrylate. (Brown-Skrobot ,r 50). While Brown-Skrobot also describes
other suitable UV blocking agents, this disclosure does not detract from the
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disclosure that Bis 0-hydroxy benzophenone is known for use as a UV
blocking agent for formation ofhydrogel lens. A reference is available for
all that it teaches to a person of ordinary skill in the art. See In re Inland
Steel Co., 265 F.3d 1354 (CA FC 2001); Merck & Co. v. Biocraft Labs.,
Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Consequently, the evidence of
record establishes that a person of ordinary skill in the art would have
recognized the suitability of utilizing Bis 0-hydroxy benzophenone UV-
absorbing agents in the monomer mix utilized in a method of making a
polymerized hydrogel lens such as described by Awasthi. A person of
ordinary skill in the art preforming the process of Awasthi and employing
Bis 0-hydroxy benzophenone UV-absorbing agent for formation of
hydrogel lens would have been practicing the claimed invention.
Mehl/Biophile Int'! Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir.
1999) ("Where, as here, the result is a necessary consequence of what was
deliberately intended, it is of no import that the article's authors did not
appreciate the results."); In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir.
1990) ("It is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable.");
accord In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
Claim 6-8
Appellants argue Awasthi does not "necessarily anticipating the
features for UV absorbing lenses obtained in accordance with the present
claimed invention with regard to the water content as set forth in claim 6."
(App. Br. 9--10, emphasis omitted). Appellants argue the present record
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demonstrates the type of UV absorbing agent employed impacts the
properties required by the claimed invention. (App. Br. 9).
Appellant's argument is not persuasive of reversible error. The
Examiner has not rejected claims 6-8 as anticipated by Awasthi. The
Examiner relies on Brown-Skrobot as providing the suggestion for utilizing
the UV absorbers required by the claimed invention. As set forth above, the
cited prior art establishes the obviousness of utilizing the reaction mixture
required by the claimed invention. The claimed properties would be a
necessary result of utilizing the same components.
Rejection 114
The Examiner finds Zhang discloses a method of making a
polymerized UV blocking hydrogel lens comprising polymerizing a
monomer reaction mixture of at least NVP and one other comonomer, and a
free-radical polymerizable, hydroxyl benzophenone (photopolymerizable
hydroxybenzophenone) to provide a substantially fully polymerized
hydrogel ophthalmic device. (Final Act. 17). The Examiner finds the
photopolymerizable hydroxybenzophenone UV absorber of Zhang is not
specified as a substituted or unsubstituted, Bis 0-hydroxy benzophenone as
4 Appellants present substantially the same arguments for independent claim
1. (App. Br. 5-12). Addressing Rejection II, Appellants rely on the same
evidence of unexpected results to overcome both Rejections I and II. (App.
Br. 12). Appellants do not present sufficiently separate arguments
addressing dependent claims 12-14 and 25-29. (App. Br. 5-12). We select
independent claim 1 as representative of the rejected claims and limit our
discussion to independent claim 1. Separate arguments for claims 9 and 10
will be addressed.
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required by the claimed invention. (Final Act. 18-19). The Examiner finds
Brown-Skrobot discloses in the contact lens art it is known to incorporate a
UV blocking agent such as 1,3-Bis(4-benzoyl-3-hydroxyphenoxy)-2-propyl
methacrylate. (Final Act. 19). The Examiner concludes it would have been
obvious to perform the method of Zhang incorporating a known UV
blocking agent such as 1,3-Bis(4-benzoyl-3-hydroxyphenoxy)-2-propyl
methacrylate. (Final Act. 19).
Appellants argue the combination of Zhang with Brown-Skrobot does
not necessarily teach essentially the same process and materials as required
by the claimed invention. (App. Br. 12). Appellants argue Zhang does not
teach utilizing the claimed UV absorbers and thus clearly does not teach
making a UV blocking hydrogel lens which is substantially fully
polymerized. (App. Br. 11). Appellants argue the majority of UV absorbers
disclosed in Brown-Skrobot are not Bis 0-hydroybenzophenones and the
selection of the Bis 0-hydroybenzophenone UV blocker from the disclosure
Brown-Skrobot for use in the reaction mixture including NVP as described
by Zhang would have been premised upon hindsight. (App. Br. 13).
Appellants argue while each reference may disclose separate elements which
may be employed in the present claimed invention, the combination of
Zhang and Brown-Skrobot does not reasonably teach specifically selecting a
Bis 0-hydroxy benzophenone for use in the materials and method of Zhang,
as Brown-Skrobot rather teaches that benzotriazole UV blocking agents are
most preferred for the materials thereof. (App. Br. 13).
Appellants' argument lacks persuasive merit for the reasons presented
above. The evidence of record establishes that a person of ordinary skill in
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the art would have recognized the suitability of utilizing Bis 0-hydroxy
benzophenone UV-absorbing agents in the monomer mix utilized in a
method of making a polymerized hydro gel lens such as described by Zhang.
A person of ordinary skill in the art preforming the process of Zhang and
employing a Bis 0-hydroxy benzophenone UV-absorbing agent for
formation of hydro gel lens would have been practicing the claimed
invention.
Claim 6
Appellants argue Zhang does not utilize the reaction mixture required
by the claimed invention and therefore does not produce a hydrogel lens that
exhibits a water content of from 42.3% to 59.1 % as required by the claimed
invention. (App. Br. 14). Appellants argue the present record demonstrates
fully polymerized UV blocking hydrogel lens prepared by polymerizing a
monomer reaction mixture specifically in accordance with the present
invention necessarily results in a water content of from 42.3% to 59.1 %.
(App. Br. 13-14).
We have previously addressed the obviousness of utilizing reaction
mixture required by the claimed invention above. As to the water content,
Zhang teaches the water content can preferably range from 40-60%. (Zhang
,r 135).
Re} ections III and IV
The Appellants traversed rejections III and IV because Nueraji and
Kunzler, the additionally cited references in Rejections III and IV
respectively, further fail to teach or suggest the criticality of use of a Bis 0-
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hydroxy benzophenone UV absorbing agent in forming a UV blocking
hydrogel lens in accordance with the claimed invention. (App. Br. 15 and
16).
Appellant's arguments are not persuasive of reversible error because
they do not address the reasons the Examiner cited Nueraji and Kunzler. As
explained above, the prior art previously discussed above establishes the
obviousness of utilizing a Bis 0-hydroxy benzophenone UV-absorbing
agent in the monomer mix utilized in a method of making a polymerized
hydrogel lens. Thus, for the same factual findings and conclusions set forth
above, we determine that the preponderance of evidence relied upon in this
appeal weighs most heavily in favor of obviousness of the subject matter
recited in claims 7, 8, and 15-17 within the meaning of 35 U.S.C. § 103(a).
Secondary Considerations5
When evidence of secondary considerations is submitted, we begin
anew and evaluate the rebuttal evidence along with the evidence upon which
the conclusion of prima facie obviousness was based. In re Rinehart, 531
F.2d 1048, 1052 (CCPA 1976).
Appellants argue they have presented evidence of nonobviousness
which demonstrates the differences in results obtained when forming UV
absorbing lens material when including conventional benzotriazole and
mono 0-hydroxybenzophenone UV absorbing agents in such reaction
mixtures relative to including a Bis 0-hydroxybenzophenone. (App. Br. 5-
7).
5 Appellants rely on the same evidence of unexpected results to overcome
both Rejections I and II. (App. Br. 5-9 and 13).
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Appellants specifically states
As shown in Tables 1 and 5, e.g., increasing the concentration
of the benzotriazole UV absorbing agent SA Monomer
(identified as benzotriazole UV blocker in paragraph [0048]) in
Comparative Examples 1-5 results in decreasing water content
in the hydrated formed lens, evidencing a decrease in the
hydrophilic polymer content after extraction due to incomplete
cure of the NVP monomer. Comparative Examples 12 and 13
(see Table 3) demonstrate a similar decrease in water content
with increase in concentration of BP A-1 (UV blocking agent of
Formula VII on page 7, a mono 0-hydroxybenzophenone ). In
inventive Examples 4, 7 and 9 (see Table 3), on the other hand,
increasing the concentration of corresponding Bis 0-
hydroxybenzophenone compound BP A-2 (Formula Von page
6) surprisingly did not result in a decrease in water content in
the resulting hydrated formed lens. Further surprisingly, the
wettability ( as evidenced by lower advancing contact angle
reported in Table 3) of inventive Example 7 was significantly
better than that of Comparative Example 12, and the wettability
of inventive Examples 4 and 9 was significantly better than that
of Comparative Example 13, where essentially the only
difference between these noted examples was the use of a Bis
0-hydroxybenzophenone in place of a corresponding mono 0-
hydroxybenzophenone at an equivalent weight percent. Thus,
such evidence is clearly commensurate in scope with
establishing criticality of the claimed invention directed
towards use of a Bis 0-hydroxybenzophenone compound.
(App. Br. 6).
Appellants have not demonstrated the data presented in the
Specification exhibits unexpected results. According to Appellants,
Comparative Examples 1-5 result in decreasing water content in the
hydrated formed lens, evidencing a decrease in the hydrophilic polymer
content after extraction due to incomplete cure of the NVP monomer. Table
5 reveals the percent water content ranges from 3 7. 0-51. 5. This evidence
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purportedly showing incomplete cure of the NVP monomer overlaps the
percent water content exhibited by the inventive examples 7-10 disclosed in
Table 3. Appellants further state that the contact angle exhibited by
examples 4, 7, and 9 was better than the contact angle of comparative
examples 12 and 13. However, this evidence is inconclusive because the
contact angle and percent water content of comparative example 10 appears
to be comparable to the range of the exemplary examples.
To the extent that Appellants are relying on increasing the
concentration of the UV absorbing agent as providing the alleged
improvement, this alleged improvement is not commensurate in scope with
the claimed invention that does not limit the content of the UV absorbing
agent. Consequently, Appellants have failed to direct us to evidence that
establishes a patentable distinction is achieved utilizing a UV absorbing
agent that is reasonably commensurate with the scope of protection sought
by the claims on appeal. Cf In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir.
1997); In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) ("the burden of
showing unexpected results rests on he who asserts them"); see also In re
Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) ("Even assuming that the
results were unexpected, Harris needed to show results covering the scope of
the claimed range. Alternatively Harris needed to narrow the claims."); In
re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978) ("Establishing that one (or
a small number of) species gives unexpected results is inadequate proof, for
'it is the view of this court that objective evidence of non-obviousness must
be commensurate in scope with the claims which the evidence is offered to
support."') (quoting In re Tiffin, 448 F.2d 791,792 (CCPA 1971)); In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (indicating that in cases in
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which the difference between the claimed invention and the prior art is some
range or other variable within the claims, the applicant must show that the
particular range is critical, generally by showing that the claimed range
achieves unexpected results relative to the prior art range.). Appellants have
not adequately explained how the evidence presented in the Specification is
representative of the scope of the claimed invention.
Finally, we again emphasize that, although secondary considerations
of nonobviousness must be taken into account, they do not necessarily
control the obviousness conclusion. Pfizer, Inc. v. Apotex, 480 F.3d 1348,
1372 (Fed. Cir. 2007). Here, the record establishes a strong case of
obviousness whereas the Specification Examples in support of
nonobviousness (1) fail to characterize the results as being unexpected, (2)
are inconclusive as to whether the argued parameter was responsible for
generating these results, and (3) are not commensurate in scope with the
representative claim on appeal. The case of obviousness established by the
Examiner is so strong that Appellants' alleged superior results are ultimately
insufficient.
DECISION
The Examiner's rejections of claims 1-39 under 35 U.S.C. § 103(a)
are affirmed.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED
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