Manuel, Michele Viola. et al.

Patent Trials and Appeals Board

Nov 1, 2019

15366263 - (D) (P.T.A.B. Nov. 1, 2019)

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.
15/366,263 12/01/2016 Michele Viola Manuel UF#-16582 (222109-1232) 9367
154717 7590 11/01/2019
THOMAS|HORSTEMEYER, LLP - UF
University of Florida (UF)
3200 WINDY HILL ROAD, SE
SUITE 1600E
ATLANTA, GA 30339
EXAMINER
BROWN, COURTNEY A
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
11/01/2019 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):
docketing@thomashorstemeyer.com
ozzie.liggins@thomashorstemeyer.com
uspatents@thomashorstemeyer.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHELE VIOLA MANUEL, HARPREET SINGH BRAR,
IDA E. SVENSSON BERGLUND, MALISA SARNTINORANONT,
and BENJAMIN G. KESELOWSKY1
____________

Appeal 2019-003912
Application 15/366,263
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
JOHN G. NEW, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies University of Florida Research
Foundation, Inc. as the real party-in-interest. App. Br. 3.

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Application 15/366,263

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1–19 as unpatentable under 35 U.S.C.
§ 103(a) over the combination of Yang et al. (US 2010/0075162 A1, March
25, 2010) (“Yang”), Rathenow et al. (US 2005/0079200 A1, April 14, 2005)
(“Rathenow”), and Boyden et al. (US 2010/0262239 A1, October 14, 2010)
(“Boyden”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to a non-toxic, bioresorbable alloy
for use in implants that incorporates magnesium, calcium, and strontium.
Abstr.

REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A bioresorbable, non-toxic, osteogenic magnesium alloy,
said alloy comprising, by weight percentage:

0.3 to 10 percent calcium;

0.3 to 10 percent strontium; and

80 to 99.4 percent magnesium.

App. Br. 14.

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ISSUES AND ANALYSIS
We agree with, and expressly adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are obvious over the prior art. We
address below the arguments raised by Appellant.

Issue 1
Appellant argues that the claimed alloy would not have been “obvious
to try” in view of the “broad genus” of alloys taught by the prior art. App.
Br. 5–6.

Analysis
The Examiner finds Yang teaches “an implant consisting of a
biodegradable magnesium-based alloy” with “excellent strength and
interfacial strength to an osseous tissue.” Final Act. 5 (citing Yang Abstr.).
The Examiner finds the biodegradable magnesium alloy is represented by
the formula MgaCabXc, wherein X is selected from a group of thirteen
elements including strontium (Sr). Id. (citing Yang ¶ 10, claims 1–3). The
Examiner finds Yang teaches the following molar ratios a, b, and c for each
component: 50–100% Mg, 0–40% Ca, and 0–40% Sr. Id. The Examiner
determines “it would have been obvious to one of ordinary skill in the art at
the time of the invention to select any point within the ranges taught by
Yang” to form the claimed biodegradable magnesium-based alloy with a
reasonable expectation of success. Id. at 6.
Appellant argues the “fact that the claimed subgenus is encompassed
by the broad genus of Yang is not sufficient by itself to establish a prima
facie case of obviousness.” App. Br. 5 (citing In re Baird, 16 F.3d 380, 382
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(Fed. Cir. 1994)). Appellant contends that “the Examiner is alleging that it
would be obvious to try every combination of metal and molar ratio until
one arrived at the claimed alloy.” Id.
Appellant argues further that “a claimed invention is not obvious to
try when the prior art discloses ‘a broad selection of choices for further
investigation.’” App. Br. 7 (citing Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d
1346, 1356 (Fed. Cir. 2013). Appellant argues that “Yang’s formula covers
over a billion combinations of alloys and their respective molar ratios” and
Yang provides no guidance on how to narrow the broad genus to achieve the
claimed combination. Id. Appellant argues that Yang teaches that
component X is an impurity, and is included as a substitute for lower purity
magnesium to decrease manufacturing costs, but not to create an alloy with
improved properties. See id. at 7–8 (citing Yang ¶¶ 11, 49). Appellant
argues, therefore, that Yang does not provide guidance “for selecting any of
the various Xs having various values of ‘c,’ much less providing guidance
for selecting Sr in particular for use in the alloy, or use of Sr at the
percentage recited in claim 1.” Id. at 8.
We are not persuaded. The facts of the present appeal are
distinguishable from those presented before our reviewing court in Leo. In
Leo, our reviewing court determined that “[b]ecause the problem was not
known, the possible approaches to solving the problem were not known or
finite, and the solution was not predictable, it would not have been obvious
for a person of ordinary skill to make the claimed invention.” 726 F.3d at
1356–1357. Particularly, the court found that:
While the record shows that … the prior art indicated that both
vitamin D analogs and corticosteroids were effective treatments
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for psoriasis … that same prior art gave no direction as to which
of the many possible combination choices were likely to be
successful. Instead, the prior art consistently taught away from
combining vitamin D analogs and corticosteroids.

Id. at 1357.
In contrast to the unknown combination at issue in in Leo, Yang
teaches a: “biodegradable magnesium-based alloy” with “excellent
strength,” “represented by Formula MgCaX” wherein X is an element “that
is added on manufacturing an implant in the related art.” Yang ¶¶ 8, 10.
Yang teaches X is one of thirteen specific elements, including strontium. Id.
Contrary to Appellant’s argument, Yang provides specific guidance that the
choice of alloy is one that is suitable for a biodegradable implant having a
controlled biodegradation rate and excellent strength. Accordingly, the
Examiner has identified detailed methodology for practicing the invention as
well as evidence suggesting that the proposed modification would be
successful. See In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (“[T]he
record shows that a skilled artisan would have had a resoundingly
‘reasonable expectation of success’ in deriving the claimed invention in light
of the teachings of the prior art”).
With respect to Appellant’s argument regarding the molar ratios of
each component of the alloy, our reviewing court has stated that “[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 Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003). Moreover, if “the claimed ranges are
completely encompassed by the prior art, the conclusion is even more
compelling than in cases of mere overlap.” Id. at 1330. Yang teaches a
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biodegradable alloy for use in a surgical implant with molar ratios of 50–
100% Mg, 0–40% Ca, and 0–40% Sr that encompass the ranges recited in
the claims. Therefore, we agree with the Examiner that claim 1 is prima
facie obvious over the prior art and we turn to Appellant’s evidence of
unexpected properties. “[T]he existence of overlapping or encompassing
ranges shifts the burden to the applicant to show that his invention would not
have been obvious.” Id.

Issue 2
Appellant argues the claimed alloys have superior and unexpected
properties. Reply Br. 3.

Analysis
Appellant contends that the claimed ternary alloys of magnesium,
calcium, and strontium “have improved degradation and compressive
strength as compared to other magnesium alloys.” App. Br. 9. Appellant
argues that Examples 1–9 of the Specification demonstrate improved
degradation rate and improved compressive strength of ternary alloys
compared to binary Mg-Ca alloys with similar calcium content. Id. (citing
Spec. ¶¶ 47–56). Appellant argues that the “findings were not predictable
and are in fact unexpected” in view of Yang’s conclusion that “strontium
was just another impurity like iron and nickel, which increase corrosion and
decrease strength.” Reply Br. 4.
The Examiner responds that Yang teaches ternary alloys as claimed,
and not the binary alloys distinguished by Appellant’s examples. See Ans.
6. The Examiner finds Yang teaches an implant with an easily controlled
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biodegradation rate and excellent strength. Id. The Examiner determines
that “the instant claims would have been obvious with the expected benefit
of providing an implant in wherein the biodegradation rate can be easily
controlled as well as have excellent strength and interfacial strength to an
osseous tissue.” Id. at 7.
We are not persuaded by Appellant’s evidence of allegedly
unexpected results. “When 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). Appellant has not provided any evidence directly comparing the
claimed alloys to the prior art, and particularly to the ternary alloys taught by
Yang, to demonstrate that the superior properties argued by Appellant are,
indeed, unexpected.
Just as importantly, Appellant has not shown that the allegedly
unexpected properties that Appellant claims are not inherently present in the
alloys of Yang. Appellant argues that certain alloys within the claimed
range have different properties compared to others outside of that range.
However:
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
… Whether the rejection is based on “inherency” under 35
U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C.
§ 103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO’s inability to
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manufacture products or to obtain and compare prior art
products.

In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977). Appellant has not
demonstrated that the alloys of Yang do not possess these allegedly
unexpected properties, and does not, therefore, overcome the Examiner’s
prima facie conclusion of obviousness.
Finally, Appellant argues that the claimed alloys possess “a
significantly improved degradation rate” and an “improved compressive
strength,” compared to related alloys outside the claimed range. In addition
to our reasons explained supra, i.e., that Appellant has not compared the
results to the closest priot art or shown that the alleged superior results are
not inherent to the alloys of Yang, unexpected results that are probative of
nonobviousness are those that are: “different in kind and not merely in
degree from the results of the prior art.” Iron Grip Barbell Co. v. USA
Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (citation omitted).
Appellant does not adduce any evidence of record to persuade us that the
differences between the properties of the claimed alloys and those of the
alloys taught by Yang are differences in kind, rather than merely of degree.
We are consequently not persuaded that the Examiner erred in
concluding the claims are obvious over combined cited prior art and we
affirm the Examiner’s rejection of the claims.

CONCLUSION

The rejection of claims 1–19 as unpatentable under 35 U.S.C. § 103(a)
is affirmed.
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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

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1–19 103(a) Yang, Rathenow, Boyden 1–19