CORNING INCORPORATED

Patent Trials and Appeals Board

Jun 16, 2021

2020005075 (P.T.A.B. Jun. 16, 2021)

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.
13/660,508 10/25/2012 Steven Edward DeMartino SP12-277 1626
22928 7590 06/16/2021
CORNING INCORPORATED
SP-TI-3-1
CORNING, NY 14831
EXAMINER
YAGER, JAMES C
ART UNIT PAPER NUMBER
1782
NOTIFICATION DATE DELIVERY MODE
06/16/2021 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):
usdocket@corning.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte STEVEN EDWARD DEMARTINO,
JOHN STEPHEN PEANASKY,
ROBERT ANTHONY SCHAUT, and
WENDELL PORTER WEEKS
____________________

Appeal 2020-005075
Application 13/660,508
Technology Center 1700
____________________

Before ADRIENE LEPIANE HANLON, DONNA M. PRAISS, and
N. WHITNEY WILSON, Administrative Patent Judges.

PRAISS, Administrative Patent Judge.

DECISION ON APPEAL1

1 In explaining our Decision, we refer to the Specification filed Oct. 25,
2012 (“Spec.”), the Final Office Action dated Apr. 19, 2019 (“Final Act.”),
the Appeal Brief filed Mar. 2, 2020 (“Appeal Br.”), the Examiner’s Answer
dated Apr. 30, 2020 (“Ans.”), the Reply Brief filed June 29, 2020 (“Reply
Br.”), and the Declaration of Robert A. Schaut filed Mar. 26, 2019 (“Decl.”
or “Schaut Declaration”).
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Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision to reject claims 50, 51, 55–73, and 75–83.3 We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
The subject matter on appeal4 relates to a chemically and
mechanically durable pharmaceutical container that is delamination resistant
and formed, in part, of a glass composition. Spec. ¶ 2. According to the
Specification, delamination is the tendency of the interior surface of a
pharmaceutical package to shed glass particulates following exposure to
pharmaceutical solutions, which often destabilizes the active pharmaceutical
ingredient present in the solution, thereby rendering it ineffective or
unsuitable for therapeutic use. Id. ¶ 9. The Specification states “it is now
believed that the delamination of the silica-rich glass flakes from the interior
surfaces of the glass containers is due to the compositional characteristics of
the glass container in its as-formed condition.” Id. ¶ 51. The Specification
ascribes various properties to the following components: SiO2 (enhances
chemical durability of the glass, resistance to decomposition in acid, and
resistance to decomposition in water), Al2O3 (improves susceptibility to ion
exchange strengthening), alkali oxides such as Na2O and/or K2O (facilitate

2 We use the word “Appellant” to refer to “applicant(s)” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Corning
Incorporated. Appeal Br. 2.
3 Claims 86–97 are withdrawn from consideration. Final Act. 1.
4 This appeal is related to appeals 2020-005073 and 2020-005074
(Applications 13/660,708 and 13/660,704, respectively). Appellant’s
Petition Under 37 C.F.R. § 41.3, filed February 16, 2021, requesting
suspension of the rules for requesting an oral hearing has been dismissed.
Decision on Petition mailed May 4, 2021.
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chemical strengthening), alkaline earth oxide including MgO and CaO
(improve meltability of the glass batch material and increase chemical
durability of the glass composition), and additional oxides such as ZrO2
(enhance the chemical durability). Id. ¶¶ 61–68.
Independent claims 55 and 66 are representative of the claimed
compositions involved in this Appeal.
55. A delamination resistant pharmaceutical container
comprising a pharmaceutical composition stored in the
container comprising an active pharmaceutical ingredient,
wherein the pharmaceutical container comprises a glass
composition comprising:
SiO2 in a concentration greater than about 74 mol.%;
alkaline earth oxide comprising MgO and CaO, wherein
CaO is present in an amount greater than or equal to about 0.1
mol.% and less than or equal to about 1.0 mol.% relative to the
glass composition, and a ratio (CaO (mol.%)/(CaO
(mol.%)+MgO (mol.%))) is less than or equal to 0.5; and
Y mol.% alkali oxide, wherein the alkali oxide comprises
Na2O in an amount greater than about 8 mol.%, wherein the
glass composition is free of boron and compounds of boron,
wherein the pharmaceutical composition comprises
Adalimumab.
66. A delamination resistant pharmaceutical container
comprising a pharmaceutical composition stored within the
container, wherein the pharmaceutical container comprises a
glass composition comprising:
from about 74 mol.% to about 78 mol.% SiO2;
from about 4 mol.% to about 8 mol.% alkaline earth
oxide, wherein the alkaline earth oxide comprises both MgO
and CaO and a ratio (CaO (mol.%)/(CaO (mol.%)+MgO
(mol.%))) is less than or equal to 0.5;
X mol.% Al2O3, wherein X is greater than or equal to
about 2 mol.% and less than or equal to about 10 mol.%; and
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Y mol. % alkali oxide, wherein the alkali oxide
comprises Na2O in an amount greater than or equal to about 9
mol. % and less than or equal to about 15 mol. %, a ratio of Y:X
is greater than 1, and the glass composition is free of boron and
compounds of boron, wherein the pharmaceutical composition
comprises Adalimumab.
Appeal Br. 20–22 (Claims Appendix). Claim 75 is the other independent
claim in this Appeal which, like claim 66, requires the same ranges for X
mol.% Al2O3 and ratio of Y:X, but specifies that the alkali oxide comprises
about 0.01 mol.% to about 1.0 mol.% K2O. Id. at 23.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Name Reference Date
Baak US 4,065,317 Dec. 27, 1977
Glaesemann US 2009/0202808 A1 Aug. 13, 2009

REJECTIONS
The Examiner maintains the following rejections:
Claim(s) 35 U.S.C. § Reference(s)
50, 51, 55–64, 66–73, 75–83 103(a) Baak
65 103(a) Baak, Glaesemann

ANALYSIS
The Examiner concludes that claims 50, 51, 55–64, 66–73, and 75–83
are unpatentable under 35 U.S.C. § 103(a) over Baak because Baak discloses
containers having high chemical resistance and low thermal coefficient of
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expansion that comprise a glass composition having SiO2, Al2O3, Na2O,
CaO, and MgO in an amount that overlaps the claimed ranges. Final Act. 3–
4. The Examiner determines it would have been obvious to use Baak’s
containers to hold any known pharmaceutical composition including claim
66’s recited pharmaceutical compositions with expected results because
Baak’s containers have high chemical resistance and low thermal coefficient
of expansion. Id. at 4. For dependent claim 65, the Examiner combines Baak
with Glaesemann’s disclosure that SnO2 is known as a fining agent to
eliminate gaseous inclusions in glass articles. Id.
Appellant argues the claims rejected over Baak as a group. Appeal Br.
7–18. In accordance with 37 C.F.R. § 41.37(c)(1)(iv), and in the absence of
separate arguments directed to the subsidiary rejection of dependent claim
65, we select claims 55 and 66 as representative; claims 50, 51, 56, 57, 64,
and 65 will stand or fall together with claim 55 from which they depend;
claims 58–63, 66–73, and 75–83 will stand or fall together with claim 66.
The same claims and the same rejections were before us earlier in
Appeal No. 2017-000881. Decision on Appeal dated July 2, 2018
(“Decision”); Appeal Br. 8. In the Decision, we determined that the
preponderance of the evidence presented supported the Examiner’s
rejections. Decision 15, 17. Among the reasons we determined that
Appellant’s prior arguments and evidence did not establish criticality of the
claimed ranges, we pointed out that arguments of counsel based on
insufficient data cannot take the place of factually supported objective
evidence. Id. at 14, 16. Appellant contends that the submission of the Schaut
Declaration in this Appeal record provides objective evidence showing non-
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obviousness that is sufficient to rebut the Examiner’s prima facie case of
obviousness. Appeal Br. 9.
According to Appellant, the Schaut Declaration shows (1) superior
properties of the glass composition by maintaining the claimed Y:X ratio as
well as criticality of the claimed Y:X ratio, (2) Baak did not appreciate the
CaO/(CaO+MgO) ratio of its glass composition, and (3) a skilled artisan
would have considered Baak’s glasses having significant zirconia content to
be of a different class than the claimed glass. Id. at 11, 12, 14. Appellant
additionally argues that the Examiner did not consider Appellant’s
Declaration evidence. Id. at 15.
We review the appealed rejections for error based upon the issues
identified by Appellant 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) (“it has long been the Board’s practice to require an applicant to
identify the alleged error in the examiner’s rejections”)). Based on our
review of the arguments and evidence of record, we are not persuaded by
Appellant that the Examiner reversibly erred in rejecting claims 55 and 66
over Baak.

Prima Facie Obviousness Over Baak
Appellant couches its argument in this Appeal as a rebuttal of a prima
facie case of obviousness. Appeal Br. 8. To the extent that Appellant
challenges the Examiner’s finding that Baak discloses a glass container
composition comprising SiO2, Al2O3, CaO, Na2O, and MgO in ranges that
overlap the claimed ranges that is suitable for holding pharmaceutical
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compositions, we provide the following comparison chart that shows the
record supports the Examiner’s finding of overlapping ranges. Final Act. 3–
4; Dec. 5; Baak 1:14–30; 12:60–13:8.
Component Claim 55 Claim 66 Baak
SiO2 >74 mol.% 74–78 mol.% 70–83 mol.%
CaO 0.1–1.0 mol.% 0–15 mol.%
MgO 0–15 mol.%
CaO+MgO 4–8 mol.% 0–30 mol.%
N2O (Y) >8 mol.% 9–15 mol.% 0–10 mol.%
Al2O3 (X) 2–10 mol.% 0–5 mol.%
CaO/(CaO+MgO) <0.5 <0.5 0–1
Y:X >1 0–2

Therefore, having identified the pertinent disclosures of Baak and
determining that it would have been obvious to use the containers of Baak to
hold a known pharmaceutical composition is nothing more than using a
known article for its intended use in a known environment to accomplish an
entirely expected result, the Examiner has established a prima facie case of
obviousness of claims 55 and 66 over Baak. In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists
when the ranges of a claimed composition overlap the ranges disclosed in
the prior art.”); In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (“[T]he
examiner bears the initial burden, on review of the prior art or on any other
ground, of presenting a prima facie case of unpatentability.”). Once a prima
facie case of unpatentability has been established, Appellant may introduce
evidence and arguments to counter the prima facie case. Obviousness is then
determined on the basis of the evidence as a whole and the relative
persuasiveness of the arguments. Oetiker, 977 F.2d at 1445.
We address each of Appellant’s arguments below.
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Ratio of Alkali Oxides to Alumina
Appellant contends Baak does not recognize the importance of the
Y:X ratio being greater than 1. Appeal Br. 10. This argument is not
applicable to independent claim 55 and dependent claims 50, 51, 56, 57, 64,
and 65 which do not recite a Y:X ratio. Ans. 8. Limitations not appearing in
the claims cannot be relied upon for patentability. In re Self, 671 F.2d 1344,
1348 (CCPA 1982).
Regarding independent claim 66, which recites “a ratio of Y:X is
greater than 1,” Appellant directs us to paragraphs 8–11 of the Schaut
Declaration and the Specification’s Example 2 and Figure 2 as evidence of
“unexpected performances of glass compositions with claimed Y:X ratio as
well as the criticality of the claimed Y:X ratio.” Appeal Br. 10–11.
Appellant’s argument that Baak discloses examples that do not include any
alumina (X) indicating the Y:X ratio is unimportant or essentially infinite is
not well taken because Appellant’s claim 55 also does not include any
alumina (X). Id. at 10. Moreover, in a determination of obviousness, a
reference may be relied upon for all that it would have reasonably suggested
to one having ordinary skill in the art. Merck & Co. v. Biocraft Labs., 874
F.2d 804, 807 (Fed. Cir. 1989) (“That the [prior art] patent discloses a
multitude of effective combinations does not render any particular
formulation less obvious.”).
Appellant concedes that samples G, H, and I in Example 2 are
narrower than the recited glass compositions, but asserts that they are
“exemplary of the full scope of the claimed glass compositions” because the
inventor’s declaration states this. Appeal Br. 11; Schaut Decl. ¶ 10. We do
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not accord significant weight to the conclusion in the Schaut Declaration that
a person having ordinary skill in the art would recognize the results of
Example 2 would be “essentially the same” for the broader claimed
compositions because it is not supported by evidence. See In re Am. Acad. of
Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is
entitled to weigh the declarations and conclude that the lack of factual
corroboration warrants discounting the opinions expressed in the
declarations.”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776
F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion
going to factual determinations . . . may render the testimony of little
probative value in a validity determination.”); In re Brandstadter, 484 F.2d
1395, 1406 (CCPA 1973) (affidavits reciting conclusions and few facts to
buttress said conclusions fail in their purpose). Moreover, Appellant has not
shown that samples G, H, and I meet all of the limitations of independent
claims 55 and 66. Nor has Appellant explained how comparative examples
1, 2, and 3 are representative of the closest prior art compositions.
In addition, the claimed range for the Y:X ratio in claim 66 is “greater
than 1.” Appeal Br. 22 (Claims Appendix). The Schaut Declaration, on the
other hand, indicates samples G, H, and I in Example 2 show a Y:X ratio
from 1.200 to 1.940 and asserts that “a person of ordinary skill in the art
would recognize that the results of Example 2 . . . would be essentially the
same, even in the slightly broader claimed composition.” Schaut Decl. ¶ 10.
Because “greater than 1” is not “slightly broader” than 1.940, we agree with
the Examiner that the evidence does not support the conclusory assertions
that Example 2 is commensurate in scope with the claims for this reason as
well. Ans. 7, 8. See In re Peterson, 315 F.3d at 1330 (“In general, an
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applicant may overcome a prima facie case of obviousness by establishing
‘that the [claimed] range is critical, generally by showing that the claimed
range achieves unexpected results relative to the prior art range.’ That same
standard applies when, as here, the applicant seeks to optimize certain
variables by selecting narrow ranges from broader ranges disclosed in the
prior art. Moreover, the applicant’s showing of unexpected results must be
commensurate in scope with the claimed range.” (citations omitted)).
Appellant has not established that the outer limits of its claimed range
for Y:X are critical or that the claimed narrower ranges provide unexpected
results compared to the prior art range because Appellant has not compared
the claimed compositions to the closest prior art, which is Baak. The burden
of establishing that unexpected results support a conclusion of
nonobviousness rests with Appellant. In re Huang, 100 F.3d 135, 139 (Fed.
Cir. 1996). “[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991). “[I]t is not enough to show that results are obtained which differ
from those obtained in the prior art: that difference must be shown to be an
unexpected difference.” In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972).
Additionally, the relied-upon results must be commensurate in scope with
the claims. See In re Peterson, 315 F.3d at 1329–31. “Establishing that one
(or a small number of) species gives unexpected results is inadequate proof,
for ‘it is the view of [the CCPA] that objective evidence of non-obviousness
must be commensurate in scope with the claims which the evidence is
offered to support.’” In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978)
(quoting In re Tiffin, 448 F.2d 791, 792 (CCPA 1971)). Accordingly, we do
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not find Appellant’s objective evidence of non-obviousness of the claimed
Y:X ratio to be adequate, in light of all of the evidence of record, to support
a reversal of the obviousness rejection.

CaO/(CaO+MgO) Ratio
Claims 55 and 66 each require a CaO/(CaO+MgO) mol.% ratio that is
less than or equal to 0.5. Appeal Br. 20, 21 (Claims Appendix). Appellant
asserts that Baak’s broad ranges for CaO and MgO allow for compositions
having a ratio greater than 0.5 and as high as 1. Id. at 12 (citing Decl. ¶ 13).
Appellant contends this shows Baak does not teach a ratio over 0.5 is a
concern. Id. According to Appellant, the criticality and “unexpected
performance” of the claimed glass compositions due to the
CaO/(CaO+MgO) ratio is shown by the Specification’s Example 3,
Appellant’s Figures 4 and 5, and the Schaut Declaration’s paragraph 12. Id.
at 13. Appellant acknowledges that samples J, K, and L in Example 3 are
narrower than the recited glass compositions, but asserts they are exemplary
of the full scope of the claimed glass compositions because the inventor
declaration attests to that conclusion. Id. (citing Decl. ¶ 14). We do not
accord the conclusion in the Schaut Declaration that a person having
ordinary skill in the art would recognize the results of Example 3 would be
“essentially the same” for the broader claimed compositions significant
weight because it is not adequately supported by evidence. See In re Am.
Acad. Of Sci. Tech Ctr., 367 F.3d at 1368; Ashland Oil, Inc. v. Delta Resins
& Refractories, Inc., 776 F.2d at 294; In re Brandstadter, 484 F.2d at 1406.
Similar to Appellant’s arguments and evidence regarding the Y:X
ratio limitation, Appellant has not shown that samples J, K, and L meet all of
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the limitations of independent claims 55 and 66. Nor has Appellant
explained how comparative examples 4, 5, and 6 are representative of the
closest prior art compositions.
Paragraph 12 of the Schaut Declaration states that Table 10 and
Figures 4 and 5 show that higher diffusivities are produced by minimizing
the ratio CaO/(CaO+MgO), that decreasing the ratio by increasing the MgO
concentration generally improves the resistance of the glass to hydrolytic
degradation, and that Example 3’s data in Table 10 shows the criticality of
the claimed ratio range of less than or equal to 0.5. Decl. ¶ 12. Table 10 is
shown below.

Table 10 above shows the composition and properties of samples J–L
relative to comparative compositions 4–6 in Example 3. Spec. ¶ 184. Figures
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4 and 5 below depict the diffusivity D and compressive stress decreases for
the compositions of Table 10. Id. ¶ 185.

According to the Specification, Figure 4 shows that as the ratio
increases, the diffusivity of alkali ions in the glass decreases thereby
diminishing the ion exchange performance of the glass and this trend is
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supported by Figure 5 which shows stress change rate increases (i.e.,
becomes more negative and less desirable) as the ratio increases. Id. ¶ 185.
Thus, the Specification’s Example 3 and the Schaut Declaration each
indicate a trend that can be plotted relative to the ratio of CaO/(MgO+CaO)
for improvements in the glass produced. Such a trend, however, merely
establishes a relative improvement in certain properties of the glass
composition rather than criticality or an unexpected result as a glass
composition that falls within the ranges taught by Baak would have been
expected to produce a useful glass composition. “[I]t is not enough to show
that results are obtained which differ from those obtained in the prior art:
that difference must be shown to be an unexpected difference.” In re Klosak,
455 F.2d at 1080; see also In re Sebek, 465 F.2d 904, 907 (CCPA 1972)
(“Where, as here, the prior art disclosure suggests the outer limits of the
range of suitable values, and that the optimum resides within that range, and
where there are indications elsewhere that in fact the optimum should be
sought within that range, the determination of optimum values outside that
range may not be obvious.”).
In addition, as the Examiner finds, the Specification’s Example 3 does
not establish that it is the ratio itself that is critical to the relative
performance of the glass as the compositions between samples J–L and
comparative samples 4–6 vary in multiple components. Ans. 10. In the
Reply Brief, Appellant asserts that the Examiner’s finding that the content of
SiO2 varies in the samples “make[s] no technical sense” because “modifying
the amount of a component,” in the glass composition means “other
components in the glass composition must also be modified as a function of
mathematics.” Reply Br. 10. While modifying one component may also
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modify other components in the glass composition, the Specification itself
notes that the CaO/(MgO+CaO) ratio may be modified by changing the
relative content of MgO and CaO in the glass compositions. Spec. ¶ 184.
Appellant does not adequately explain why more components in addition to
the MgO and CaO components should be modified among comparative
samples that ostensibly establish criticality of the ratio CaO/(MgO+CaO).
See In re Dunn, 349 F.2d 433, 439 (CCPA 1965) (cause and effect sought to
be proven is lost in the welter of unfixed variables).
A party asserting unexpected results as evidence of nonobviousness
has the burden of proving that the results are unexpected. In re Geisler, 116
F.3d 1465, 1469–70 (Fed. Cir. 1997). Absent supporting evidence, the
conclusory statement that the inventors “unexpectedly determined that
glasses that can timely achieve a good compressive stress and depth of layer
as well as improved resistance to hydrolytic degradation can be achieved by
maintaining the CaO/(CaO+MgO) ratio to less than or equal to 0.5”
(Decl. ¶ 13) is insufficient to overcome the Examiner’s prima facie
obviousness rejection over Baak’s glass compositions that overlap the
claimed ranges. Accordingly, we do not find Appellant’s objective evidence
of non-obviousness of the claimed CaO/(MgO+CaO) ratio sufficient to
warrant reversal of the obviousness rejection.

Zirconia Content
Appellant contends that a person having ordinary skill in the art would
not have looked to Baak’s glass compositions because they contain high
amounts of zirconia which allegedly “increase the base (high pH) durability
of the glass” but “will not provide the balanced durability of the glasses” of
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Appellant’s invention. Appeal Br. 14 (citing Decl. ¶ 16). According to the
Schaut Declaration, Baak’s composition contains a significant amount of
zirconia “that is greater than the amount of zirconia in the glasses of the
present applications” and a skilled artisan would recognize them as “a
different class.” Decl. ¶ 16.
Even assuming that the statements in the Appeal Brief and the Schaut
Declaration concerning glass compositions containing zirconia are supported
and true, claims 55 and 66 do not exclude or even limit the content of
zirconia. Therefore, neither Appellant’s arguments nor the Schaut
Declaration statements establish reversible error in the Examiner’s rejection
over Baak.

Consideration of Appellant’s Evidence
Appellant contends the Examiner did not adequately consider the
Schaut Declaration because the Examiner considered the declaration “mere
opinion evidence and no data is presented to support this assertion.” Appeal
Br. 15 (citing Final Act. 6). Appellant directs us to paragraphs 10 and 14 of
the Schaut Declaration that find Examples 2 and 3 are commensurate in
scope with the claimed glass compositions and argues they are not merely
opinion evidence. Id. at 16. Appellant also argues that paragraphs 10 and 14
of the Schaut Declaration include “technical explanation” why the
differences would not affect the results and outcome of the examples. Id. at
17. Appellant cites In re Alton, 76 F.3d 1168, 1174–75 (Fed. Cir. 1996), in
which the Federal Circuit stated that the examiner and Board failed to
consider the totality of the record where there was a failure to articulate
adequate reasons to rebut a submitted declaration. Appeal Br. 16.
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We agree with Appellant that the Examiner’s Answer is not a tailored
response to the Appeal Brief in that it largely repeats the Examiner’s
position in Appellant’s previous appeal that included arguments not present
in this Appeal. Ans. 6 (“[a]s set forth in the Examiner’s Answer dated 11
August 2016”); Reply Br. 8 (“Appellant did [not] present genus-species
arguments in their Appeal Brief. This is rote copying without consideration
of Appellant’s arguments and the objective, factually supported evidence in
the Declaration.”), 11 (“Again Appellant did not present these arguments in
their Appeal Brief.”). Nevertheless, the Examiner accurately finds that the
Schaut Declaration does not provide any new data that was not already made
of record in the prior appeal, the Schaut Declaration summarizes that same
data, and no data supports the conclusory assertions that Examples 2 and 3
apply to the full scope of the claims. Ans. 6.
As pointed out above, the data submitted in this Appeal is the limited
data in Appellant’s Examples 2 and 3, Tables 9 and 10, and Figures 1–5.
This data was all previously submitted in the prior Appeal. Regarding
Example 2, the data is not commensurate in scope with claim 66 which
recites “Y:X is greater than 1.” Regarding Example 3, this data does not
adequately establish the criticality of the CaO/(MgO+CaO) ratio because the
data is not limited to different ratios. The Schaut Declaration does not
include any additional data or testing to show criticality or unexpected
results due to the claimed ratios across the scope of the claimed ratios or the
narrower component ranges compared to the closest prior art which is Baak.
Nor does the Schaut Declaration provide a direct comparison to show that,
for example, the CaO/(MgO+CaO) ratio is directly responsible for improved
properties in the glass composition and not due to the compositional
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difference in the composition apart from the amounts of CaO and MgO
relative to each other.
At most, the Schaut Declaration in combination with Appellant’s
Examples, Tables, and Figures, show a trend between the claimed ratios and
an improvement in certain properties of the glass composition rather than
criticality of the ratios or an unexpected result because a glass composition
that falls within the broader ranges taught by Baak would have been
expected to produce a useful glass composition. It is insufficient to merely
show a difference or improvement. In re Klosak, 455 F.2d at 1080.
“Establishing that one (or a small number of) species gives unexpected
results is inadequate proof, for ‘it is the view of [the CCPA] that objective
evidence of non-obviousness must be commensurate in scope with the
claims which the evidence is offered to support.’” In re Greenfield, 571 F.2d
at 1189 (quoting In re Tiffin, 448 F.2d at 792). The scope of the claims
includes the claimed ratios themselves. The statements in the Schaut
Declaration regarding the data being commensurate in scope with the claims
refers to the compositional ranges, i.e., the individual components being
commensurate in scope with the claimed ranges of the individual
components in the container composition rather than the data being
commensurate in scope across the claimed ranges for the ratios in a single
composition. Decl. ¶¶ 10, 14.
Finally, “it is well settled that unexpected results must be established
by factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d at 1470 (quoting In
re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1994)). The Schaut Declaration
refers to achieving good properties in glass compositions by maintaining the
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CaO/(CaO+MgO) ratio as an “unexpect[ed] determin[ation].” Decl. ¶ 13.
The reason provided for it being unexpected is “Baak does not mention the
importance of this ratio or any of its effects.” Id. The Declaration further
notes that Baak’s compositions are both within the claimed ratio and outside
the claimed ratio. The Declaration does not provide any basis for what
would have been expected from glass compositions that fall within Baak’s
compositional ranges and whether the claimed compositions unexpectedly
outperform Baak’s examples that fall outside of the claimed ratio. Without
an explanation or basis for what would have been expected from Baak’s
compositions, the conclusion that the properties of the claimed composition
are unexpected lacks underlying support for the statement. Accordingly, we
agree with the Examiner that the Schaut Declaration is conclusory as to the
objective evidence it purports to add to this Appeal record.

Summary
Having considered Appellant’s arguments and declaration evidence
together with the Examiner’s findings, the evidence of record weighs in
favor of the Examiner’s conclusion that the glass container compositions
recited in claims 55 and 66 would have been obvious to one of ordinary skill
in the art to use to hold a known pharmaceutical composition in view of the
teachings of Baak.

CONCLUSION
We affirm the Examiner’s rejection of claims 50, 51, 55–73, and 75–
83 as obvious under 35 U.S.C. § 103(a).
Appeal 2020-005075
Application 13/660,508

20
DECISION SUMMARY
For the above reasons, we AFFIRM the Examiner’s rejection of
claims 50, 51, 55–73, and 75–83.
In summary:
Claim(s)
Rejected
35 U.S.C.
§  Reference(s)/Basis Affirmed Reversed
50, 51, 55–
64, 66–73,
75–83
103(a) Baak
50, 51, 55–
64, 66–73,
75–83

65 103(a) Baak, Glaesemann 65
Overall
Outcome
50, 51, 55–
73, 75–83

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).

AFFIRMED