Alli, Azaam et al.

Patent Trials and Appeals Board

Jan 9, 2020

13915142 - (D) (P.T.A.B. Jan. 9, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/915,142 06/11/2013 Azaam Alli VTN5374USNP1 8263
27777 7590 01/09/2020
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
KHARE, ATUL P
ART UNIT PAPER NUMBER
1742
NOTIFICATION DATE DELIVERY MODE
01/09/2020 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
lhowd@its.jnj.com
pair_jnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AZAAM ALLI and SHIVKUMAR MAHADEVAN
Appeal 2019-003298
Application 13/915,142
Technology Center 1700
Before ROMULO H. DELMENDO, LILAN REN, and JANE E. INGLESE,
Administrative Patent Judges.
REN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 10, 11, 15, 16, and 22. Non-Final Act.
7. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “Applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as Johnson &
Johnson Vision Care, Inc. Appeal Br. 1.
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Application 13/915,142

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CLAIMED SUBJECT MATTER
The claims are directed to a method of manufacturing contact lenses.
Claim 22, reproduced below, is illustrative of the claimed subject matter:
22. A process comprising the steps of:
(i) dispensing to a mold a reactive mixture comprising:
(a) from about 20 to about 70 weight percent of mono-(3-
methacryloxy-2-hydroxypropyloxy)propyl terminated, mono-
butyl terminated polydimethylsiloxane (OH-mPDMS),
(b) from about 1 to about 15 weight percent of PVP K30,
(c) from about 3 to about 15 weight percent of PVP K90,
(d) from about 5 to about 40 weight percent of one or more
hydrophilic monomers,
(e) a crosslinker,
(f) a polymerization initiator, and
(g) less than about 15 wt% diluent;
(ii) curing said reactive mixture within said mold to form a
contact lens;
(iii) removing said contact lens from said mold without
contacting the contact lens with a
liquid; and
(iv) extracting the contact lens using a liquid consisting
essentially of water to produce a hydrated contact lens,
wherein, following extraction step (iv), the hydrated
contact lens retains PVP K30 which is capable of being released
during use of the hydrated contact lens to increase comfort and
wettability.

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REFERENCES
The prior art relied references upon by the Examiner are:
Maiden US 6,367,929 Apr. 9, 2002
McCabe
Molock
Lai
Liu
US 2003/0162862 A1
US 2006/0110427 A1
US 2008/0128930 A1
US 2009/0182067 A1
Aug. 28, 2003
May 25, 2006
June 5, 2008
July 16, 2009

REJECTIONS
The Examiner rejects claims 15 and 16 under 35 U.S.C. § 112(b) or
35 U.S.C. § 112 (pre–AIA), second paragraph. Non-Final Act. 5.
The Examiner rejects claims 22, 10, 11, 15, and 16 under 35 U.S.C.
§ 103 as being unpatentable over Liu in view of McCabe and Maiden. Non-
Final Act. 7.
The Examiner additionally rejects claim 16 under 35 U.S.C. § 103 as
being unpatentable over Liu in view of McCabe, Maiden, and Molock. Non-
Final Act. 11.
The Examiner additionally rejects claims 22, 10, 11, 15, and 16 under
35 U.S.C. § 103 as being unpatentable over Liu in view of McCabe, Maiden,
and Lai. Non-Final Act. 11.
The Examiner additionally rejects claim 16 under 35 U.S.C. § 103 as
being unpatentable over Liu in view of McCabe, Maiden, Lai, and Molock.
Non-Final Act. 13.

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OPINION
Indefiniteness
Appellant does not contest the Examiner’s rejection of claims 15 and
16 for indefiniteness. Appeal Br. 3–9. We summarily affirm the
indefiniteness rejection of claims 15 and 16.
Obviousness
We review the appealed rejections for error based upon the issues
Appellant identifies, and in light of the arguments and evidence produced
thereon. Cf. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010)
(precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed.
Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to
identify the alleged error in the examiner’s rejections.”)). After having
considered the evidence presented in this Appeal and each of Appellant’s
contentions, we are not persuaded that Appellant has identified reversible
error, and we affirm the Examiner’s § 103 rejections for the reasons
expressed in the Non-Final Office Action and the Answer. We add the
following primarily for emphasis.
Rejections based on Liu, McCabe, and Maiden
The Examiner finds that Liu describes a contact lens manufacturing
method having the recited dispensing, curing, and removing steps whereas
Maiden describes such a method having the extracting step. Non-Final Act.
7, 9. The Examiner finds that Liu describes the recited reactive mixture for
manufacturing contact lenses but without the OH-mPDMS and cites
McCabe for the teaching. Id. at 7–8. Appellant does not dispute these
findings. See Appeal Br. 3–9. The Examiner finds that a skilled artisan
would have combined the references for reasons such as “McCabe
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recognizes a known difficulty in including silicone ingredients, which offer
various improvements to contact lenses” and the similarities in the prior art
reactive mixture formulations. Non-Final Act. 8, 9–10 (citing various
portions of the prior art as support). Appellant does not address these fact
findings in support of the Examiner’s rationale. See Appeal Br. 3–9.
Appellant instead argues the hydroxyl-functionalized silicone-
containing monomer in McCabe is insufficient as a solubilizing agent for the
reactive mixture recited in claim 22. Id. at 5. Appellant states that “[t]his is
apparent from the data submitted in Appellant’s response to the 5/25/18
Office Action.” Id.
As the Examiner points out, “no data was submitted in response to the
25 May 2018 Office Action[.]” Ans. 6. Appellant does not state otherwise.
Reply Br. 2–3. Appellant’s argument is not supported by evidence or an
explanation as to why the Examiner reversibly erred here. In any event,
Appellant does not address the Examiner’s fact finding with regard to
McCabe ¶¶ 60, 61, Tables 1, 3, 7–9, and 13–15 for the teaching of a contact
lens reactive mixture formulation having the recited weight percentage of
OH-mPDMS. Compare Appeal Br. 5, with Non-Final Act. 8–9. Appellant
does not address the Examiner’s reasoning that a skilled artisan would have
optimized the amount of OH-mPDMS based on McCabe’s teaching of using
an “effective amount” of the silicon-containing monomer. Compare Appeal
Br. 5, with Non-Final Act. 9 (citing McCabe ¶ 60). No reversible error has
been identified in this aspect of the obviousness analysis.
Appellant next argues that “McCabe would not lead a person of
ordinary skill in the art to use less than 15 weight percent diluent[.]” Appeal
Br. 5. Appellant’s argument is not persuasive of reversible error because it
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does not address the Examiner’s finding that Liu describes a contact lens
formulation having the recited amount of diluent. Compare id., with
Non-Final Act. 7 (citing Examples 6 and 7 in Liu for the teaching).
In support of this argument, Appellant cites a Declaration (dated April
3, 2018) (which is not submitted with the Appeal Brief) arguing that the data
in the Declaration shows that “the amount of diluent present in the monomer
mixture impacts the ease with which contact lenses . . . can be removed from
the mold.” Appeal Br. 5. As the Examiner points out, the data in the
Declaration is not commensurate in scope with claim 22. Ans. 7 (listing at
least four reasons as to why the data is not commensurate in scope with the
claim). Moreover, the data in the Declaration is not based on the closest
prior art, nor does it show that the results are unexpected. See Bristol-Myers
Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014)
(“To be particularly probative, evidence of unexpected results must establish
that there is a difference between the results obtained and those of the closest
prior art, and that the difference would not have been expected by one of
ordinary skill in the art at the time of the invention.”); see also Reply Br. 3
(arguing merely that the data shows “the amount of diluent used has a
noticeable impact on lens demolding” without specifying or quantifying the
purported impact).
Appellant’s argument that Maiden “contain[s] amounts of diluents
that are outside those presently claimed” similarly fails to address the
Examiner’s finding that Liu describes a contact lens formulation having the
recited amount of diluent. Compare Appeal Br. 5, with Non-Final Act. 7
(citing Examples 6 and 7 in Liu for the teaching). We are unpersuaded that
reversible error has been identified.
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We are also unpersuaded by Appellant’s argument that the Examiner
engaged in impermissible hindsight. See Appeal Br. 6.
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.

In re McLaughlin, 443 F.2d 1392, 1395, (CCPA 1971). In this case, the
Examiner finds that the recited reactive mixture as well as the method steps
are known in the prior art. Non-Final Act. 7–10. The Examiner also provides
a rationale, supported by fact findings, to combine the references. Id.
Appellant has not sufficiently explained why the obviousness analysis is
based on “knowledge gleaned only from applicant’s disclosure,”
McLaughlin, 443 F.2d at 1395, and we are not persuaded that reversible
error has been identified.
Accordingly, we affirm the rejection of claim 22 based on Liu in view
of McCabe and Maiden. Appellant does not argue the rejection of claims 10,
11, 15, and 16 based on Liu in view of McCabe and Maiden separately.
Appeal Br. 3–9. Thus, we also affirm the rejection of claims 10, 11, 15, and
16 based on Liu in view of McCabe and Maiden. See 37 C.F.R.
§ 41.37(c)(1)(iv).
We also affirm the rejection of claim 16 based on Liu in view of
McCabe, Maiden, and Molock, which is also not argued separately. See
Appeal Br. 3–9; see also 37 C.F.R. § 41.37(c)(1)(iv).
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Rejections based on Liu, McCabe, Maiden, and Lai
The Examiner rejects claim 22 additionally based on Liu in view of
McCabe, Maiden, and Lai finding that Lai describes a lens removal step
using “a closely encompassing diluent amount[.]” Non-Final Act. 12 (citing
various portions of Lai). Appellant does not address this finding. Appeal Br.
6. Appellant instead argues that Lai describes a N-vinyl pyrrolidone (PVP)
which – according to Appellant – is different from that of Liu because Liu’s
PVP is “designed to be capable of releasing from Liu.” Appeal Br. 7.
According to Appellant, the PVP in Lai is “a comonomer that is combined
with a silicone-containing monomer in the monomer mixture and then
polymerized while in a lens-shaped mold.” Id. Appellant’s argument does
not address, and does not identify error in, the Examiner’s rationale to
combine the references, which is supported by the record. Compare id., with
Non-Final Act. 12 (citing various portions of Lai and providing a rationale to
combine the references). More specifically, the Examiner reasons that a
skilled artisan “would have been motivated to experiment with diluent
amount to determine what would provide the most optimal lens
softness/stiffness and in turn the most optimal lens release from a mold
without damage.” Non-Final Act. 12. Appellant does not address this
reasoning. See Appeal Br. 7. The Examiner further provides rationale (a) and
rationale (b) as reason to combine the references (See Appeal Br. 7), which
Appellant does not address. See Appeal Br. 7.
Accordingly, we affirm the rejection of claim 22 based on Liu in view
of McCabe, Maiden, and Lai. Appellant does not argue the rejection of
claims 10, 11, 15, and 16 based on Liu in view of McCabe, Maiden, and Lai
separately. Appeal Br. 3–9. Thus, we also affirm the rejection of claims 10,
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11, 15, and 16 based on Liu in view of McCabe, Maiden, and Lai. See 37
C.F.R. § 41.37(c)(1)(iv).
We also affirm the rejection of claim 16 based on Liu in view of
McCabe, Maiden, Lai, and Molock which is also not argued separately. See
37 C.F.R. § 41.37(c)(1)(iv).

DECISION
The Examiner’s rejections are affirmed.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
15, 16 112, second
paragraph
Indefiniteness 15, 16
10, 11, 15, 16,
22
103 Liu, McCabe,
Maiden
10, 11, 15,
16, 22

16 103 Liu, McCabe,
Maiden,
Molock
16
10, 11, 15, 16,
22
103 Liu, McCabe,
Maiden, Lai
10, 11, 15,
16, 22

16 103 Liu, McCabe,
Maiden, Lai,
Molock
16
Overall
Outcome
10, 11, 15,
16, 22

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TIME AND RESPONSE
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