George Mansour et al.

Patent Trials and Appeals Board

Sep 23, 2019

14319617 - (D) (P.T.A.B. Sep. 23, 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.
14/319,617 06/30/2014 George Mansour 122295-6221 4656
80236 7590 09/23/2019
Morgan, Lewis & Bockius LLP (OC)(BD)
600 Anton Boulevard
Suite 1800
Costa Mesa, CA 92626-7653
EXAMINER
STCLAIR, ANDREW D
ART UNIT PAPER NUMBER
3753
NOTIFICATION DATE DELIVERY MODE
09/23/2019 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):
ocipdocketing@morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE MANSOUR, CHRISTOPHER ZOLLINGER,
JONATHAN YEH, and NEIL QUITOVIERA
Appeal 2019-001115
Application 14/319,617
Technology Center 3700
Before DANIEL S. SONG, CHARLES N. GREENHUT, and
JEREMY M. PLENZLER, Administrative Patent Judges.
GREENHUT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant,1 CareFusion 303, Inc.,
appeals from the Examiner’s decision to reject claims 1–4, 6–9, 11, 13, 14,
16–21, 24 and 25. Final Act. 1. 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. Appellant identifies the real party in interest as Carefusion
303, Inc. Appeal Br. 1.
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CLAIMED SUBJECT MATTER
The claims are directed to a system and method for compounding
medication. Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A system comprising:
a removable, circular, rotatable transfer module having
one or more transfer cartridges, each transfer cartridge having an
access device;
a removable, circular, rotatable medication module having
a medication container, wherein the access device of a selected
transfer cartridge is configured to access the medication
container; and
a removable, circular, rotatable filling module, wherein
the transfer module is disposed between the filling module and
the medication module, wherein the filling module comprises a
first pump, and wherein the access device is configured to extend
into the first pump, wherein the transfer module, the medication
module, and the filling module are aligned circumferentially
along a common axis of rotation.
REFERENCES
The prior art relied upon by the Examiner is:
Lasonde
Credle, Jr. et al.
Angus et al.
US 5,697,407
US 6,309,034 B1
US 9,327,958 B2
Dec. 16, 1997
Oct. 30, 2001
May 3, 2016
Uber, III et al. US 2004/0254525 A1 Dec. 16, 2004
REJECTIONS2
Claims 1–4, 6–9, 11, 13, 14, 16–21, 24, and 25 are rejected under 35
U.S.C. § 112(a), as failing to comply with the enablement requirement.
Final Act. 4.

2 The written description rejection has been withdrawn. Ans. 2.
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Claims 1, 2, 6–9, 11, 13, 14, 16–18, 20, 21, 24, and 25 are rejected
under 35 U.S.C. § 103 as being unpatentable over Lasonde, Angus and/or
Credle. Final Act. 8.
Claims 3, 4, and 19 are rejected under 35 U.S.C. § 103 as being
unpatentable over Lasonde, Angus, and/or Credle, and Uber. Final Act. 12.
OPINION
Enablement
The claims subject to this rejection are argued as a group for which
claim 1 is representative under 37 C.F.R. § 41.37(c)(1)(iv).
The aspects of the claimed subject matter for which the Examiner
concludes there is insufficient detail in the Specification to comply with the
enablement requirement are: the pump, the means for rotating the
medication module, and the fluidic circuit formed by the components. Final
Act. 4–7. While the drawings are probably more than purely “artistic
representations” as the Examiner submits (Final Act. 8; Reply Br. 3), for
essentially the reasons articulated by the Examiner, we do agree with the
Examiner that the figures coupled with the Specification lack the detail
necessary to satisfy the enablement requirement of 35 U.S.C. § 112(a).
Neither the Examiner nor Appellant discusses in detail, or indicates
there is any disagreement as to, the legal standards for analyzing compliance
with the enablement requirements of 35 U.S.C. § 112(a). Accordingly, we
need not reproduce those standards here and refer instead to MPEP
§ 2164.01 (discussing inter alia In re Wands, 858 F.2d 731, 737 (Fed. Cir.
1988)).
In response to the Examiner’s determination with regard to the
features identified above, Appellant essentially dismisses the Examiner’s
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position as related to unclaimed subject matter. App. Br. 13. The Examiner’s
mention of the so-called unclaimed subject matter was done to demonstrate
the amount of speculation necessary for the skilled artisan to determine how
to make the invention. It is true that meticulous details of certain common
structures, which in appropriate circumstances may include pumps, for
example, may not be necessary to enable or demonstrate possession of an
invention. Reply Br. 3. Indeed, it is preferable to omit that which is already
generally known to a skilled artisan. Here, however, the Examiner raised a
reasonable “doubt [] about enablement because information is missing about
one or more essential parts or relationships between parts which one skilled
in the art could not develop without undue experimentation.” MPEP
§ 2164.04 Appellant produces no rebuttal evidence, or argument to inform
the Examiner or the Board how, based on the original disclosure, one skilled
in the art would understand how to make and use a device including the
parts and relationships for which the Examiner determines there is
insufficient direction. Appellant points out the reference numerals where
various claim elements can be found in the figures (App. Br. 12–13). This,
without more, does little to explain their operation. Considering the pumps
that are very poorly illustrated in Figures 3A-D, which Appellant relies on
for support (App. Br. 11–12, 15), we, like the Examiner, are unable to
discern the structure of any pump, either specifically taught by Appellant’s
disclosure, or generally known to a skilled artisan, such that a skilled artisan
would be able to determine, and incorporate, the necessary pump, without
resorting to undue experimentation. Likewise, it is unclear to us, and
Appellant produces neither evidence nor explanation, as to how, and with
respect to what, rotation of the medication module is effectuated. Perhaps
most importantly the Examiner indicated that the fluidic pathway that allows
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the device to actually operate is not clear and Appellant’s have not directed
our attention to any aspects of the disclosure, supplied any external
evidence, or even provided arguments, that explain the nature and operation
of this pathway. We therefore disagree with Appellant’s essentially
unsupported assertion that “the amount of direction provided by the inventor
is high.” See App. Br. 14; Ans. 4. The fact that the amount of direction
provided by the inventor is low, weighs in favor of undue experimentation
and nonenablement.
Appellant’s only other argument concerning the enablement
requirement is that “any enabled use” suffices to satisfy this requirement and
it suffices that even if one does not know how to operate the claimed
invention for the purpose of compounding medication, the claimed invention
is enabled for a use as retention device for medication, cartridges and
pumps. App. Br. 14–15. However, the claim recites numerous elements that
are associated with various functions beyond acting merely as a retention
device. Similarly, the Specification associates these generically described
elements with functions other than acting only as a retention mechanism. In
some instances a description of a result to be achieved may be enough to
allow the skilled artisan to work out the precise details of construction.
However, there is no evidence or technical reasoning of record to
demonstrate that that is the case here. Thus, as to Appellant’s attempt to
divorce the claim elements from the functions and results recited in the
claims and disclosed in the Specification, we agree with the Examiner’s
assessment that, even under the standards for enablement quoted by
Appellant (App. Br. 14), enabling what essentially amounts to a storage
cabinet does not constitute enabling a use that “reasonably correlate[s] with
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the entire scope of the claim,” particularly when that claim is read, as all
claims must be, in light of the Specification. Id.; Ans. 3;
Accordingly, for the foregoing reasons, we sustain the Examiner’s
rejection under 35 U.S.C. § 112(a).

Obviousness
Regarding the first obviousness rejection listed above, the claims are
argued as a group with the exception of claims 13, 16, 18 and 24. App. Br.
16–19. Arguments are not presented for the second obviousness rejection
and we presume Appellant advocates those claims based only on
dependency. The arguments for claims 13, 16, 18 and 24 do no more than
point out what the claim recites coupled with the naked assertion that the
claim is in a condition for allowance. App. Br. 18–19. We do not regard this
form of argument to comply with the requirements to “explain why the
examiner erred” under 37 C.F.R. § 41.37(c)(1)(iv). See In re Lovin 652 F.3d
1349, 1357 (Fed. Cir. 2011) “[37 C.F.R. § 41.37(c)(1)(iv)] requires more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
found in the prior art.” We also note this Board does not “allow” claims of
an application and cannot direct an examiner to pass an application to
issuance. Rather, this Board’s primary role is to review adverse decisions of
examiners including the findings and conclusions made by the examiner. See
Ex Parte Frye, 94 USPQ2d 1072, 1077 (BPAI 2010) citing 37 C.F.R.
§ 41.50(a)(1) (“The Board, in its decision, may affirm or reverse the decision
of the examiner in whole or in part on the grounds and on the claims
specified by the examiner”). Accordingly, the obviousness rejections of the
claims before us hinge on claim 1.
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Appellant initially contends that by comparing Figure 1 of Lasonde
with Figures 3A–D of the present application it can be seen that the device
of Lasonde “is not at all similar to the system as claimed in claim 1.” App.
Br. 16. A comparison of Figure 1 of Lasonde with Figures 3A–D of the
present application may potentially reveal, that the device depicted in
Lasonde is not at all similar to the device depicted in Figures 3A–D of the
present application. However, without pointing to express or implicit
limitations in claim 1 embodying the distinguishing features between
Appellant’s disclosed invention and Appellant’s claimed invention, these
alleged differences based on the figures are of little significance. “[T]he
name of the game is the claim.” In re Hiniker Co., 150 F. 3d 1362, 1369
(Fed. Cir. 1998).
Appellant next argues, misinterpreting the Examiner’s rejection, that
the Examiner improperly relies on Lasonde’s piercing spikes as three
different claim elements, the transfer module, the transfer cartridge, and the
access device. App. Br. 17. The Examiner’s statement on the top of page 9
of the Final Action regarding the limitations in question is sufficiently clear.
However, the Examiner provides additional explanation in the Answer
demonstrating the error in Appellant’s argument:
The Final Action includes the finding that the structures (64, 65,
66, 58, 59, 60) of Lasonde collectively constitute a transfer
module. The module (64, 65, 66, 58, 59, 60) of Lasonde has one
or more individual cartridges (64, 65, 66). The cartridge (64) of
Lasonde has an access device (spike portion; see Annotated
Figure A below). This configuration falls within the scope of the
claim language. Notably, in a manner exactly akin to the claim
language and the disclosure of the pending application, the
access device (spike portion) of Lasonde is a component of the
cartridge (64) and the cartridge (64) is a component of the
module (64, 65, 66, 58, 59, 60).
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Ans. 5–6 (Annotation omitted). As to the final argument presented in the
Appeal brief, that elements 64–69 of Lasonde are a spike as opposed to
elements including one, the Examiner correctly responds:
Figure 1 of Lasonde shows that the connector/administration
spike (64) has a base portion and a spike portion, as indicated in
Annotated Figure A above. The base portion is the portion that
can be gripped and manipulated by a user, and the spike portion
is the portion that actually penetrates into the container (20).
Ans. 6 (Annotation omitted). A “spike” sufficient to satisfy the claim
language is, as the Examiner correctly points out, the penetrating portion of
the connector elements. This is in no way negated by the fact that Lasonde
attributes a descriptive name to the entire element, a “spike,” based on only
an important sub-component of the element. In re Neugebauer, 330 F. 2d
353, 356 n.4 (CCPA 1964) (“In the construction of words, not the mere
words, but the thing and the meaning, are to be inquired after.”)
Appellant does not articulate any further arguments regarding the
issues discussed above in the Reply Brief. Rather, Appellant characterizes
the clarification provided by the Examiner in the Answer as new
contentions. Reply Br. 4–5. Although the Examiner explained in eight lines
in the Answer what seemed apparent from the two lines in the Final
Rejection, we cannot agree with Appellant that the Examiner’s clarification
altered the thrust of the rejection or in any way deprived Appellant of
adequate notice as to the basis for the Examiner’s rejection. As such,
Appellant has not demonstrated “good cause” for introducing new
arguments in the Reply Brief. See 37 C.F.R. § 41.41(b)(2). The additional
arguments in the Reply Brief are mere unsupported assertions that the
Examiner’s proposed combination would not have been successful or
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obvious. Reply Br. 5–6. As they are untimely, they need not be further
addressed for purposes of this appeal. 37 C.F.R. § 41.41(b)(2).
For the foregoing reasons we sustain the Examiner’s obviousness
rejections.
DECISION
The Examiner’s rejections are affirmed.
FINALITY 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