AMGEN INC.

Patent Trials and Appeals Board

Nov 27, 2020

2020005948 (P.T.A.B. Nov. 27, 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.
15/047,815 02/19/2016 Francisca Tan-Malecki 32263/46430ACON4 5415
109438 7590 11/27/2020
Marshall, Gerstein & Borun LLP (Amgen)
233 South Wacker Drive
6300 Willis Tower
Chicago, IL 60606-6357
EXAMINER
SEIF, DARIUSH
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
11/27/2020 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):
EFRHelp@amgen.com
mgbdocket@marshallip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte FRANCISCA TAN-MALECKI, RONALD FORSTER,
SCOTT M. NUNN, SON C. TRAN, SHELDON MOBERG, and
MARK D. HOLT
____________

Appeal 2020-005948
Application 15/047,815
Technology Center 3700
____________

Before EDWARD A. BROWN, MICHELLE R. OSINSKI, and
WILLIAM A. CAPP, Administrative Patent Judges.

Opinion for the Board filed by OSINSKI, Administrative Patent Judge

Opinion Concurring filed by CAPP, Administrative Patent Judge

OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1–10 and 12–22.2 We have jurisdiction over the
appeal under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as AMGEN, INC.
Appeal Br. 3.
2 Claim 11 is cancelled. Appeal Br. A2 (Claims App.).
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Application 15/047,815

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THE CLAIMED SUBJECT MATTER
Claims 1 and 15 are the independent claims. Claim 1 is reproduced
below.
1. A method of assembling an injector, the method comprising:
providing a container having a wall defining an interior
surface and a seal assembly having an interior surface, the wall
and seal assembly defining a reservoir;
providing a fluid delivery system physically separate from
the container, the fluid delivery system comprising a container
needle having a point;
providing an injection member physically separate from
the container needle and configured to be connected in fluid
communication with the container needle during use of the
injector;
sterilizing the container including the reservoir and fluid
delivery system while the container and the fluid delivery system
are separate from each other;
filling the sterile reservoir of the container with a volume
of a drug product under sterile conditions in a first assembly
space, the drug product comprising a granulocyte colony-
stimulating factor (G-CSF);
after sterilizing the container and filling the sterile
reservoir, attaching the fluid delivery system to the container in
a second assembly space such that the point of the container
needle is disposed adjacent to or within the seal assembly to
define a storage state, wherein the first assembly space has a
higher level of freedom from contamination than the second
assembly space;
attaching the container needle to an actuator, the actuator
adapted to move the container needle from the storage state to a
delivery state wherein the container needle is disposed through
the seal assembly, into the sterile reservoir, an d in fluid
communication with the drug product for delivery to a patient via
the injection member.

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Application 15/047,815

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EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Badia US 4,919,658 Apr. 24, 1990
Gross US 6,824,529 B2 Nov. 30, 2004
Py US 2006/0191594 A1 Aug. 31, 2006
Shue US 2007/0276338 A1 Nov. 29, 2007
Smith US 2008/0097306 A1 Apr. 24, 2008
Tachikawa WO 2010/098323 A1 Sept. 2, 2010

REJECTIONS
I. Claims 1–4, 10, 12, and 14–22 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Shue, Smith, Gross, and Badia. Final
Act. 3–11.
II. Claims 5 and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Shue, Smith, Gross, Badia, and Appellant’s
Admitted Prior Art (“AAPA”)3. Id. at 11–12.
III. Claims 6, 7, and 9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Shue, Smith, Gross, Badia, and Py. Id. at 12–14.
IV. Claim 8 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
Shue, Smith, Gross, Badia, Tachikawa, and Py. Id. at 13.

OPINION
Claims 1–4, 10, 12, and 14–20
The Examiner finds that Shue teaches most of the limitations of
independent claim 1, including, among other things, providing a fluid

3 The Examiner refers to paragraph 55 of the Specification as AAPA. Final
Act. 12.
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delivery system (seat member 22/needle cannula 23) that is physically
separate from a container (sealed chamber 31). Final Act. 3; see also Ans. 4
(“The embodiment of FIG. 22 also shows how the fluid delivery system
(22/23) and container (31) may be made separately ([0058, last sentence),
and threadedly attached (123a/123b) by removing end caps 6 and 7.”). The
Examiner also finds that Shue teaches “attaching the fluid delivery system to
the filled container.” Final Act. 3 (citing Shue Fig. 5).
The Examiner acknowledges that “Shue does not expressly disclose
. . . a step of sterilizing the container including the reservoir and fluid
delivery system while the container and fluid delivery system are separate
from each other.” Final Act. 3. With respect thereto, the Examiner takes the
position that “the separate sterilizing of components of medical instruments
in clean room conditions prior to their assembly is old and well known in the
art as a way to make the instruments safe to use in medical procedures.” Id.
at 4. The Examiner also points to Smith’s teaching that “syringe
components may be sterilized in a clean room environment as well as
assembled in the clean room environment.” Id. (quoting Smith ¶ 23)
(emphasis omitted). The Examiner concludes that it would have been
obvious to “separately sterilize the reservoir and fluid delivery systems of
Shue . . . as taught by Smith.” Id.
The Examiner also acknowledges that Shue fails to expressly disclose
filling the sterile reservoir of the container with a drug product under sterile
conditions in a first assembly space that has a higher level of freedom from
contamination than a second assembly space in which the fluid delivery
system is attached to the filled container. Final Act. 3. As to filling the
reservoir, the Examiner takes the position that “syringes containing
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granulocyte colony-stimulating factors (G-CSF) are old and well known in
the art . . . and it would have been obvious to a person having ordinary skill
in the art . . . to fill the syringe of Shue with a drug product comprising a . . .
G-CSF . . . in the event that G-CSF was desired to be administered.” Id.
at 4. As to filling the container prior to the container’s attachment to the
delivery device, the Examiner takes the position that “[a]s envisaged in the
FIG. 22/23 embodiment of Shue, the container (31) is filled prior to being
attached to the delivery device (22/23)” and “[a] person having ordinary skill
in the art would recognize that this order of operations would obviously
apply to the Fig. 5 embodiment as well.” Id. at 15. The Examiner also
states that it would be “highly counter-intuitive” to attach the fluid delivery
system to the container before filling the container with a drug product in
Shue because this “would dramatically increase the complexity of the filling
process.” Id.
As to filling the reservoir under sterile conditions in an assembly
space with a high level of freedom from contamination, the Examiner turns
to Gross, noting its teaching that “[t]he term ‘sterile area’ denotes a higher
standard of cleanliness (i.e. sterility) such as is required for areas in which
syringes are pre-filled. While medical devices must be assembled in clean
areas according to well defined standards, the level of cleanliness is not as
stringent as for a filling suite in which parenteral drug containers are filled.”
Final Act. 4 (quoting Gross 5:49–59) (emphasis omitted).
As to a second assembly space (in which the fluid delivery system is
attached to the container) having a lower level of freedom from
contamination than the first assembly area in which the container is filled
with a drug product, the Examiner takes the position that “Gross teaches that
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a filling area is required to have the highest level of cleanliness compared to
any other portion of the manufacturing process (such as the assembling
process).” Final Act. 4. The Examiner concludes that it would have been
obvious “to modify the combination of Shue and Smith by having the sterile
reservoir of the container filled in one location having the highest level of
freedom from contamination (cleanliness), as compared to a separate
location where the components are attached to one another.” Id. at 5. The
Examiner explains that “[i]n in a world where operating costs were non-
existent, all further assembling steps (e.g.[,] attaching the needle, packaging,
etc.) would also happen in the sterile environment, however[,] this is not
practical in the real world, because sterile areas are very expensive to
maintain.” Ans. 5. The Examiner states that, with the teachings of Gross
“in mind, it would have been obvious and clear to a person having ordinary
skill in the art, that the Shue container (3[1]) would need to be filled in a
‘sterile environment’, however, the fluid delivery portion (22/23) would not
necessarily need to be attached to the container in that same sterile
environment, but rather a clean environment with a less stringent standard of
cleanliness.” Id.; see also id. at 7 (“The motivation for filling and
assembling the Shue injector in sterile and clean environments are for the
purposes of avoiding contamination . . . . Of course[,] there are additional
cost benefits of filling in a highly sterile environment and then sterilizing
and assembling the components in a less sterile, clean environment.”).4

4 The Examiner also finds that Shue does not expressly disclose “an
injection member physically separate from the container needle and
configured to be connected in fluid communication with the container needle
during use of the injector.” Final Act. 3–4. The Examiner finds that Badia
“teaches providing an injection member . . . physically separate from an
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Appellant argues that the cited references fail to disclose or render
obvious attaching a fluid delivery system to a drug-filled sterile container in
an assembly space having a lower level of freedom from contamination than
an assembly space in which the container is previously filled with a drug.
Appeal Br. 11. More particularly, Appellant argues that the Examiner’s
characterization of Gross as teaching a filling area being required to have the
highest level of cleanliness “is an oversimplification and mischaracterization
of what is taught by Gross.” Id. at 12–13. Appellant argues that instead
Gross more precisely teaches that only if a container were filled and “all
parts of the fluid path” were sealed under sterile conditions can
contamination in subsequent assembly steps be avoided when later steps of
assembly are performed at lower levels of cleanliness. Id. at 13.
Appellant argues that Gross does not teach or suggest attaching a fluid
delivery system to a container after the container has been filled with a drug,
nor that such an attachment can be conducted “post-filling or in an assembly
space which has a lower level of freedom from contamination than where
the syringe was previously filled with the drug.” Appeal Br. 13. Appellant
also argues that “Smith does not disclose attaching a fluid delivery system to
a container of an injector after that container has been filled and sterilized.”

analogous container needle . . . and configured to be connected in fluid
communication, via a flexible tubing duct . . . , with the container needle
during use of the injector.” Id. at 5 (citing Badia Figs. 1A–1C, 4–5). The
Examiner concludes that it would have been obvious “to modify the method
of the combination of Shue, Smith, and Gross . . . as taught by Badia, since
this would make the device more versatile and capable of accessing injection
sites with the injection member alone that may otherwise have been difficult
to reach with the entire syringe assembly.” Id. Appellant does not challenge
these particular findings or conclusions.
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Id.; see also id. at 19 (“Smith’s syringe is sterilized and assembled in the
same ‘clean room environment.’”). Appellant further argues that “Badia . . .
does not disclose the conditions under which a container is filled with a drug
or describe how, in terms of cleanliness, those conditions compare to an
assembly space where a fluid delivery system is attached to said container.”
Id. at 13–14.
As to Appellant’s arguments regarding Gross, Smith, and Badia each
failing to teach attaching a fluid delivery system after a container has been
filled and sterilized (Appeal Br. 13–14), we do not find such argument
persuasive where the Examiner’s rejection is first based on Shue rendering
obvious filling the container prior to the container’s attachment to the fluid
delivery system and is then further based on Smith rendering obvious the
sterilization of the container and fluid delivery systems of Shue when they
are separated before they are then attached in accordance with the further
teachings of Shue. See Final Act. 4, 15. We also do not find Appellant’s
argument regarding Smith teaching that its syringe is sterilized and
assembled in the same environment to be persuasive of error where the
Examiner is relying on Smith only for teaching that the reservoir and fluid
delivery systems of Shue may be separately sterilized and is relying on the
teachings of Gross for conducting filling and assembling in different rooms.
See id. at 3–4. In sum, Appellant’s arguments are unpersuasive because they
attack Gross, Smith, and Badia individually, rather than the combination of
references relied on by the Examiner in the rejection so as to apprise us of
error in the Examiner’s rejection. See In re Keller, 642 F.2d 413, 425
(CCPA 1981) (one cannot show nonobviousness by attacking references
individually when the rejection is based on a combination of the references).
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As to Appellant’s argument that Gross does not teach or suggest that
attachment of a container to a fluid delivery system can be conducted in an
assembly space that has a lower level of freedom from contamination than
where the container was filled, because Gross only teaches that later
assembly steps can be performed at lower levels of cleanliness if the
container were filled and “all parts of the fluid path” were sealed under
sterile conditions (Appeal Br. 13), we are not persuaded of error by the
Examiner. We are not persuaded by such an argument because, in our view,
Gross’s teaching of the ability to complete further assembly steps (e.g.,
Shue’s attachment of a fluid delivery system to a filled container) in a space
having a lower level of cleanliness is applicable to Shue. The Examiner
explains that Smith renders obvious the sterilization of Shue’s container and
fluid delivery systems while they are separated. Final Act. 4. Shue itself
then teaches end caps 6, 7 for “shielding the communicating end 231 of the
[fluid delivery system] 23” and “the [container] 3” (Shue ¶ 58), such that the
parts of the fluid path in Shue are shielded so as to be kept under sterile
conditions for later attachment of the fluid delivery system to the filled
container in a clean room.
We have considered Appellant’s argument that “a person of ordinary
skill in the art would have thought it was not appropriate to attach Shue’s
needle cannula 23 (i.e., part of the alleged fluid delivery system) to Shue’s
carpule 3 (i.e., the alleged container) in a less-than-sterile environment”
because “the end 231 of Shue’s needle cannula 23 (and perhaps also the
end 232 of Shue’s needle cannula 23) would be exposed to contaminants if
the needle cannula 23 was attached to Shue’s carpule 3 in an assembly space
that was less-than-sterile” which “would compromise the fluid path defined
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by Shue’s needle cannula 23.” Appeal Br. 16; see also id. at 21 (making
similar argument). As explained above, the sterilization and shielding of
needle cannula 23 and Shue’s carpule 3 via end caps 6, 7 would help ensure
that the fluid path, as previously separately sterilized in accordance with the
teachings of Smith, would not be compromised before assembly in a clean
room.
Appellant argues that the Examiner “does not address why it would
have been obvious to fill Shue’s carpule 3 (i.e., the alleged container of
claim 1) with G-CSF under sterile conditions in a first assembly space, and,
subsequently, attach Shue’s needle cannula 23 and the seat member 22 (the
combination of which is alleged to correspond to the claimed fluid delivery
system) to Shue’s filled carpule 3 in a second assembly space that has a
lower level of freedom from contamination than the first assembly space.”
Appeal Br. 14; see also id. at 20 (making similar argument). More
particularly, Appellant argues that the teachings of Gross do “not explain
why a person of ordinary skill in the art would have sought to assemble
Shue’s injector in the manner that is allegedly taught by Gross.” Id. at 15;
see also id. at 20 (“[T]he Examiner’s assertion [of avoiding contamination as
the reason why it would have been obvious to sterilize components before
attaching a fluid delivery system to a container] fails to address why it would
have been obvious to perform these steps in different assembly spaces
hav[ing] different levels of freedom from contamination.”). We are not
persuaded by this argument because the Examiner has explained at least that
there are cost benefits in filling in a highly sterile environment and then
assembling the components in a less sterile, but clean environment. Final
Act. 7.
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We have also considered Appellant’s argument that “it is
inappropriate to assume that cost savings alone would have motivated a
person of ordinary skill in the art to assemble Shue’s device according [to]
the method disclosed in Gross” and “a person of ordinary skill in the art
would have balanced any cost savings against the increased risk of
contamination.” Reply Br. 5. Our reviewing court has recognized that a
given course of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate any or all reasons to combine
teachings. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed.
Cir. 2006) (explaining that if there are tradeoffs involved regarding features,
such things do not necessarily prevent the proposed combination); Winner
Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The
fact that the motivating benefit comes at the expense of another benefit,
however, should not nullify its use as a basis to modify the disclosure of one
reference with the teachings of another. Instead, the benefits, both lost and
gained, should be weighed against one another.”). Here, that a cost-savings
benefit gained from completing assembly in a different space may come at
the expense of an increased risk of contamination should not nullify its use
as the basis to further modify Shue. It would have been obvious to a person
of ordinary skill in the art to choose which advantages to pursue given the
known tradeoffs stemming from the available choices. Therefore, the
Examiner has provided a reason with rational underpinning for further
combining of prior art teachings, resulting in known tradeoffs.
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s determination that the combination of Shue, Smith, Gross,
and Badia renders obvious the subject matter of independent claim 1.
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Accordingly, we sustain the rejection of claim 1, and claims 2–4, 10, 12,
and 14–20, for which Appellant relies on the same arguments and reasoning
(Appeal Br. 21), under 35 U.S.C. § 103(a) as unpatentable over Shue, Smith,
Gross, and Badia.
Claims 21 and 22
Dependent claims 21 and 22 recite “sterilizing, while in the second
assembly space, a surface of the seal assembly to be penetrated by the point
of the container needle prior to attaching the fluid delivery system to the
container.” Appeal Br. A4 (Claims App.). The Examiner concludes that “it
would have been obvious . . . to sterilize the entirety of . . . Shue’s container,
including the surface of the seal assembly (35) to be penetrated by the point
of the container needle prior to attaching the fluid delivery system to the
container, in order to ensure the seal is sterile prior to removal of the
contents of the container.” Final Act. 11.
Appellant argues that the Examiner’s “assertion is improper because it
is [not] supported by the prior art.” Appeal Br. 22. More particularly,
Appellant argues that “[t]here is no indication in . . . Shue that contaminants
exist on a surface of the ‘seal’ of Shue’s alleged container or that such
contaminants would be transferred to Shue’s needle cannula 23 upon the
needle cannula 23 penetrating the ‘seal.’” Id. More particularly, Appellant
also argues that “if the components of Shue’s syringe were assembled in a
sterile manufacturing environment, there would be no concern that the ‘seal’
of Shue’s container was prone to contamination and thus in need of the
sterilization step proposed by the Examiner.” Id.
The Examiner maintains that it would have been obvious “to fill the
container of Shue, with any desired medicament to be injected, in a highly
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sterile environment, to avoid contaminating the fluid, and then, to
subsequently sterilize and attach the fluid delivery system to the container,
in a clean environment having less stringent cleanliness requirements.”
Ans. 6; see also id. (quoting Smith ¶ 23) (“After the syringe components are
fabricated, the syringe components may be sterilized in a clean room
environment as well as assembled in the clean room environment.”). We
agree with the Examiner that it would have been obvious to one of ordinary
skill in the art to sterilize the seal assembly in the second assembly space
having a lower level of freedom from contamination (e.g., upon removal of
Shue’s end caps 6, 7 in a clean environment with a less stringent standard of
cleanliness) in order to ensure the seal is sterile.
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s determination that the combination of Shue, Smith, Gross,
and Badia renders obvious the subject matter of dependent claims 21 and 22.
Accordingly, we sustain the rejection of claims 21 and 22 under 35 U.S.C.
§ 103(a) as unpatentable over Shue, Smith, Gross, and Badia.
Rejections II–IV
In contesting the rejection of dependent claims 5–9 and 13, Appellant
relies on the same arguments and reasoning we found unpersuasive in
connection with independent claim 1 as the basis for seeking reversal of the
rejection of claims 5–9 and 13. Appeal Br. 21–22. Accordingly, for the
same reasons discussed above in connection with the rejection of claim 1,
we also sustain the rejections, under 35 U.S.C. § 103, of: claims 5 and 13 as
unpatentable over Shue, Smith, Gross, Badia, and AAPA; claims 6, 7, and 9
as unpatentable over Shue, Smith, Gross, Badia, and Py; and claim 8 as
unpatentable over Shue, Smith, Gross, Badia, Tachikawa, and Py.
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CONCLUSION
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–4, 10, 12,
14–22
103(a) Shue, Smith, Gross,
Badia
1–4, 10, 12,
14–22

5, 13 103(a) Shue, Smith, Gross,
Badia, AAPA
5, 13
6, 7, 9 103(a) Shue, Smith, Gross,
Badia, Py
6, 7, 9
8 103(a) Shue, Smith, Gross,
Badia, Tachikawa, Py
8
Overall
Outcome
1–10, 12–22

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

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte FRANCISCA TAN-MALECKI, RONALD FORSTER,
SCOTT M. NUNN, SON C. TRAN, SHELDON MOBERG, and
MARK D. HOLT
____________

Appeal 2020-005948
Application 15/047,815
Technology Center 3700

OPINION CONCURRING
CAPP, Administrative Patent Judge
I concur in the result reached by the panel in all respects. I write
separately to add my own personal observations regarding Appellant’s
contentions that it is somehow nonobvious to perform different steps of
assembling an item in places that have differing controlled environments.
Persons skilled in the art of manufacturing delivery systems for
medications, such as syringes, know how to assemble the various
components to create a finished article. Persons skilled in the art similarly
know how to fill containers, such as syringe fluid reservoirs. Persons skilled
in industrial design know how to perform various stages of manufacturing an
item or assembly in a variety of locations and environments. Manufacturing
and assembling items in a “clean room” is not unique to the medical supply
industry. “Clean rooms” have, for example, been routinely used in the
manufacture of semiconductor chips for decades.
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An industrial designer tasked with designing an assembly operation
for, say, syringes filled with medication, approaches the task with certain
criteria in mind in terms of quality control and the safety and efficacy of the
desired finished product. Depending on the criteria required of the finished
product, the industrial designer may choose to perform one or more (or
perhaps sometimes none) of the steps of the manufacturing process in a
controlled environment. The choice as to which manufacturing process
steps are performed in environments that are controlled to various degrees in
terms of temperature and the number of contaminant particles per unit of
atmospheric volume in order to arrive at a desired finished product is a
matter of routine optimization that is well within the capabilities of someone
with only ordinary skill.
Anyone skilled in the art would immediately recognize that the level
of sterilization/cleanliness in a finished article of manufacture is affected by
and is a function of the cleanliness of the surrounding environment in which
the manufacturing, assembly, and filling takes place. See In re Applied
Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) (A recognition in the
prior art that a property is affected by a variable is sufficient to find the
variable result-effective). Where the general conditions of a claim are
known in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation. Id. at 1295, quoting In re
Aller, 220 F.2d 454, 456 (CCPA 1955). It is well settled that a claim to a
product does not become non-obvious simply because the patent
specification provides a more comprehensive explication of the known
relationships between variables and the properties affected by such
variables. Id. at 1297. I see no reason to reach a different result here
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because the claim at issue is directed to a method of manufacture instead of
a manufactured article.
Here, Appellant merely manufactures and assembles an article in
various steps and in various controlled environments. Appellant presents
neither evidence nor persuasive technical reasoning that ordering of the
various steps and selection of the various controlled environments for
performing those steps requires more than ordinary skill or produces
unexpected results.
With the foregoing in mind, I fully concur in the result reach by the
majority.