Ex Parte Frankel

Patent Trial and Appeal Board

Jul 28, 2016

13085416 (P.T.A.B. Jul. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/085,416 04/12/2011
32132 7590 08/01/2016
LAMORTE & ASSOCIATES P.C.
P.O. BOX434
YARDLEY, PA 19067
FIRST NAMED INVENTOR
Mark E. Frankel
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
QuiqMeds-3 2108
EXAMINER
COLLINS, MICHAEL
ART UNIT PAPER NUMBER
3651
NOTIFICATION DATE DELIVERY MODE
08/01/2016 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):
uspatlawl@verizon.net
mail@uspatlaw.com
malamorte@verizon.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK E. FRANKEL
Appeal2014-005344
Application 13/085 ,416
Technology Center 3600
Before JENNIFER D. BAHR, EDWARD A. BROWN, and
FREDERICK C. LANEY, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Mark E. Frankel (Appellant) appeals under 35 U.S.C. § 134(a) from
the Examiner's decision rejecting claims 1-8 and 12-19. 1 We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE and enter NEW GROUNDS OF REJECTION.
1 Appellant states that claims "1-8 and 12-21 are pending in this
application" and "subject to a Final Rejection." Br. 2; see also Final Act. 1
(Office Action Summary). However, we find no record of any claims 20
and 21 ever having been presented in this application.
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Application 13/085,416
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A method of supplying prepackaged pharmaceutical samples
to healthcare providers in the employ of a healthcare
organization, comprising the steps of:
providing a vending machine accessible to said healthcare
providers;
providing an input terminal that [is][2J capable of
presenting a custom selection menu for said vending machine;
having said healthcare organization preauthorize types of
pharmaceutical samples to be stocked within said
vending machine;
stocking said vending machine only with said
pharmaceutical samples preauthorized by said
healthcare organization;
determining which of said pharmaceutical samples each of
said healthcare providers are qualified to prescribe;
providing each of said healthcare providers with a unique
dispensing authorization, wherein said unique dispensing
authorization is indicative of said pharmaceutical samples each
of said healthcare providers are qualified to prescribe;
verifying said dispensing authorization each of said
healthcare providers through said input terminal when each of
said healthcare providers attempts to utilize said vending
machine; and
displaying said custom selection menu to each of said
healthcare providers at said input terminal, wherein said custom
selection menu only contains said pharmaceutical samples for
which the healthcare provider currently using said vending
machine is qualified to prescribe.
2 Appellant submitted an amendment to claim 1 inserting the word "is"
subsequent to the Final Action, but the Examiner did not indicate whether
that amendment was entered. See Amendment filed July 26, 2013; Advisory
Act. issued August 13, 2013.
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Application 13/085,416
REJECTIONS
I. Claims 1, 3-8, 12, 13, and 15-19 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Feeney (US 2002/0032582 Al, pub.
Mar. 14, 2002).
II. Claims 2 and 14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Feeney.
DISCUSSION
Claims 1 and 12 are the independent claims before us in this appeal.
Br. 14--17 (Claims App.). Claim 1 requires, inter alia, "determining which
of said pharmaceutical samples each of said healthcare providers are
qualified to prescribe" and "displaying said custom selection menu to each
of said healthcare providers at said input terminal, wherein said custom
selection menu only contains said pharmaceutical samples for which the
healthcare provider currently using said vending machine is qualified to
prescribe." Id. at 15. Claim 12 requires, inter alia, "assigning custom drug
sample dispensing authorizations to at least some of said healthcare
providers ... wherein said ... authorizations ... correspond to said
prepackaged pharmaceutical samples for which each of said healthcare
providers has been prequalified to prescribe by said healthcare provider" and
"presenting said specific healthcare provider with a selection menu, wherein
said selection menu only displays said prepackaged pharmaceutical samples
for which said specific healthcare provider has said custom drug sample
dispensing authorizations." Id. at 16-17.
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Application 13/085,416
The Examiner cites paragraphs 26, 187,3 189, 273, 278, and 317, and
Figure 19 of Feeney as disclosing these steps. Final Act. 2-3, 6, 8; Ans. 4--
5.
Appellant argues that the portions of Feeney cited by the Examiner
fail to disclose the afore-mentioned limitations of claims 1 and 12 because
Feeney "makes no disclosure concerning the custom display of a selection
menu that depends upon the user" and "makes no disclosure concerning the
custom display of a selection menu that depends upon the authorizations
allotted to a user." Br. 10, 12. For the reasons discussed below, we agree
with Appellant.
Paragraph 26 of Feeney discloses that "[t]he prescription subsystem
can be configured so that access to a medication in inventory ... can be
controlled according to ownership of the medication as tracked in the virtual
inventory." Paragraph 26, however, is silent as to how such access control is
implemented and, in particular, does not mention displaying a custom menu
that only contains or displays samples for which the healthcare provider has
authorization or qualifications to prescribe.
Paragraph 187 of Feeney describes cabinet-type dispensers attached to
and controlled by a kiosk. This paragraph does not disclose any particular
menu to be displayed by the kiosk.
Feeney' s paragraph 189 describes security attributes of the system.
More specifically, paragraph 189 discloses different levels of access for
various user groups, such as "physician, nurse, medical assistant, ... office
3 The Examiner's reference to paragraph "187" (Ans. 4, 5) appears to be
inadvertent. As the language (i.e., "individual user templates") quoted by
the Examiner appears in paragraph 189, and not in paragraph 187, of
Feeney, the Examiner ostensibly intended to refer to paragraph 189. Id.
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manager, pharmaceutical representative, pharmaceutical sales manager, ...
and patients." Paragraph 189 further discloses defining "[ s ]pecific group
and individual user templates [that determine] a user's access rights."
However, paragraph 189 does not specify that the individual user template is
or corresponds to a custom menu, much less a custom menu containing or
displaying only samples for which the user has access rights.
Paragraph 273 discloses a management subsystem that can track the
receipt and dispensing of sample medications and determine if a sample
medication is appropriate and safe for a patient. This management
subsystem requires that the user enter some data elements, "such as, the
access code (password and fingerprint), International Classification of
Disease, ... clinical data elements, and the like." There is no disclosure in
this paragraph of a custom selection menu that contains or displays only
samples for which the user has authorization or qualifications to
prescribe/ dispense.
Paragraph 278 discloses that, after login and collection of doctor and
patient information, the subsystem checks for compatibility of the sample to
be dispensed with other medications that the patient may be receiving, and,
if no adverse interactions are indicated, dispenses the sample. This
paragraph contains no mention of the user selecting the sample to be
dispensed from a custom selection menu containing only samples for which
the user has prescribing/dispensing authorization or qualifications.
Paragraph 317 once again discusses security. In particular, this
paragraph discloses that "only a small set of users are granted access to
perform prescription dispensing."
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Figure 19 depicts a flowchart showing the steps of logging in, entering
doctor and patient information, requesting or prompting sample information,
performing a check for compatibility and drug interactions, and dispensing
the sample. The Examiner states that because Feeney "teaches 'only a small
set of user's rights are granted access to perform prescription dispensing,"'
the login process of Figure 19 "clearly only displays a selection menu based
on a user's authority which may reasonably be interpreted as disclosing [the
afore-mentioned displaying step of claim 1 ]." Final Act. 2-3. The
Examiner explains that Feeney' s disclosure, in paragraph 317, that only a
small set of users are granted access to dispense prescriptions means that
Feeney's input terminal "presents different selection menus for different
authorized users and customizes the selection menu based on user
authorization" and that the "system must determine 'which of said
pharmaceutical samples each of said healthcare providers are qualified to
prescribe."' Id.
The Examiner fails to establish by a preponderance of the evidence
that Feeney discloses the afore-mentioned limitations of claims 1 and 12. As
discussed above, none of the portions of Feeney relied on by the Examiner
discloses a custom selection menu, much less a custom selection menu
containing or displaying only samples for which the user has
prescribing/dispensing authorization. Even accepting the Examiner's
explanation that Feeney's disclosure of limited access rights indicates that a
selection menu is only displayed based on a user's authority (i.e., access
rights), it is not apparent, and the Examiner does not explain sufficiently
why Feeney's teachings regarding limited access rights necessarily require a
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custom selection menu containing or displaying only samples for which the
user has authorization.
Accordingly, we do not sustain the rejection of claims 1 and 12, or
their dependent claims 3-8, 13, and 15-19, as anticipated by Feeney.
In rejecting dependent claims 2 and 14 under 35 U.S.C. § 103(a) as
unpatentable over Feeney, the Examiner does not articulate any additional
findings or reasoning that would cure the deficiency in the anticipation
rejection. See Final Act. 10-11. Thus, we do not sustain the rejection of
claims 2 and 14.
NEW GROUNDS OF REJECTION
Pursuant to our authority under 3 7 C.F .R. § 41. 50(b ), we make the
following new grounds of rejection.
Claims 1, 3---8, 12, 13, and 15-19
Claims 1, 3-8, 12, 13, and 15-19 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Feeney.
Turning first to claim 1, Feeney discloses a method of supplying
prepackaged (see i-f 254, referring to "individual packages") pharmaceutical
samples to healthcare providers in a healthcare organization, the method
comprising providing a vending machine (dispenser 24, see i-f 181) and
providing an input terminal capable of presenting a custom selection menu
for the vending machine (see i-fi-1169, 175, 214, 228; Fig. 8B). Feeney
discloses having the healthcare organization preauthorize types of
pharmaceutical samples to be stocked within the vending machine. See
i-f 248 (addressing approval of restocking requests by the party, i.e., the
medical office), i-f 256 (describing the subsystem seeking approval of the
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user prior to proceeding with an order). Feeney also discloses stocking the
vending machine only with the pharmaceutical samples preauthorized by the
healthcare organization. See i-fi-1248, 256. Further, Feeney discloses
determining which of the samples each of the healthcare providers is
qualified to prescribe. In particular, Feeney discloses granting access to only
a small set of users to perform prescription dispensing (i-f 317) and
controlling access to medications in inventory according to ownership of the
medication as tracked in the virtual inventory (i-fi-126, 40, 4 7). In order to
control access to only those medications over which the user has ownership
(i.e., authority or qualifications to dispense) and to limit access to only a
small set of users to dispense prescriptions, the system must first determine
which of the samples the user is authorized (i.e., qualified) to dispense or
prescribe. Feeney also discloses defining "[s]pecific group and individual
use templates" that determine "a user's access rights." i-f 189. In view of
Feeney's teachings, a person having ordinary skill in the art would have
recognized that such individual templates, which determine a user's access
rights, would also provide an individually tailored identification of the
samples in the dispenser inventory that are available to the particular
authorized (i.e., qualified) user to dispense or prescribe. Feeney describes
having the authorized user (i.e., healthcare provider) login in order to use the
dispensing system. i-fi-1278, 314. One of ordinary skill in the art would have
immediately envisaged having the system verify the user's access rights
after or as part of the login process in order to limit the user's access to only
those samples the user owns or has authorization (i.e., qualifications) to
dispense. See i1 210 (disclosing limiting access to authorized users after
proper login).
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As discussed above, Feeney does not explicitly disclose displaying a
custom selection menu containing only the pharmaceutical samples for
which the healthcare provider currently using the vending machine is
qualified to prescribe. However, Feeney discloses that, "[a]fter the user
selects the appropriate patient the subsystem displays a list of pending
subscriptions for the patient and the user can select the desired prescription
for dispensing." i-f 228; see Fig. 8B. In other words, Feeney teaches
displaying a custom selection menu containing only a list of pharmaceuticals
appropriate for selection for the selected patient. Feeney is silent as to how,
in terms of user interface, the system limits user access to only those
samples over which the user has ownership or authorization (i.e.,
qualifications) to dispense. Given Feeney's teaching to display a custom
selection menu of only those inventory items suitable for selection, it would
have been obvious to limit the items displayed on that custom selection
menu to only those items that the user is authorized to dispense, in order to
limit user access to only those items in inventory over which the user has
authorization as disclosed by Feeney.
Regarding claim 12, Feeney's method includes placing a vending
machine (dispenser 24) in a medical office (see i-f 181), wherein the vending
machine has a computer control. See i-f 192 (describing a server with a user
interface kiosk for controlling medication dispensers). Feeney also discloses
stocking the vending machine with prepackaged (see i-f 254, referring to
"individual packages") pharmaceutical samples. See, e.g., i-fi-1248, 256.
Feeney discloses assigning custom drug sample dispensing authorizations to
at least some healthcare providers, wherein said authorizations correspond to
the samples for which each healthcare provider has been prequalified to
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prescribe. In particular, Feeney discloses granting access to only a small set
of users to perform prescription dispensing (i-f 317) and controlling access to
medications in inventory according to ownership of the medication as
tracked in the virtual inventory (i1i126, 40, 47). Feeney also discloses
defining "[ s ]pecific group and individual use templates" that determine "a
user's access rights." i-f 189. In view ofFeeney's teachings, a person having
ordinary skill in the art would have recognized that such individual
templates, which determine a user's access rights, would also provide an
individually tailored identification of the samples in the dispenser inventory
that are available to the particular authorized (i.e., qualified) user to dispense
or prescribe. Feeney also discloses identifying a specific healthcare provider
attempting to operate the vending machine. See i1i1278, 314 (discussing
login).
As discussed above, Feeney does not disclose presenting the specific
healthcare provider with a selection menu displaying only the samples for
which the specific provider has custom sample dispensing authorizations.
However, for the reasons discussed above in regard to claim 1, given
Feeney's teaching to display a custom selection menu of only those
inventory items suitable for selection (i-f 228, Fig. 8B), it would have been
obvious to limit the items displayed on that custom selection menu to only
those items that the user is authorized to dispense, in order to limit user
access to only those items in inventory over which the user has authorization
as disclosed by Feeney.
Finally, Feeney discloses enabling the vending machine (dispenser
24) to vend samples from the selection menu. See i1228 (disclosing
selection), i1i1229--230 (allowing manual removal), i1235 (disclosing
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Application 13/085,416
automated dispenser door opening upon receipt of a control signal), il 236
(disclosing automated dispensing upon receipt of a control signal).
Appellant argues that "Feeney does not disclose providing different
authorizations to different healthcare providers, wherein the authorization is
indicative of the pharmaceutical samples the healthcare provider is qualified
to prescribe." Br. 7. For the reasons set forth above, in light ofFeeney's
teaching of limiting user access rights to those medications over which the
user has authorization or ownership (i1i1 317, 26, 40, 4 7), a person having
ordinary skill in the art would have recognized that the "[ s ]pecific group and
individual user templates," which determine "a user's access rights," as
disclosed by Feeney (i-f 189), would also provide an individually tailored
identification of the samples in the dispenser inventory that are available to
the particular authorized (i.e., qualified) user to dispense or prescribe.
Appellant submits that Feeney "only states that physicians have one
level of access, office workers have a lesser level of access." Br. 10, 11.
Thus, Appellant argues that the authorizations disclosed in Feeney do not
distinguish between doctors, but, rather, "are by job title and are not
customized to the individual." Id. This contention focuses primarily on
Feeney's reference to "user groups" requiring "different levels of access:
physician, nurse, medical assistant, clerk, office manager, [etc.]" and
"[s]pecific group" templates, but appears to overlook Feeney's disclosure of
"individual user templates" as distinct from "group" user templates. See
Feeney i-f 189 (emphasis added). Nevertheless, even assuming Feeney' s
"individual user templates" are individualized only down to the job title and
do not distinguish between doctors, this distinction is not recited in claims 1
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and 12. Those claims do not require the "healthcare providers" to be doctors
or to include more than one provider having the same job title.
With respect to dependent claims 3-8, 13, and 15-19, we adopt the
findings of the Examiner on pages 6-7 and 9-10 of the Final Action, which
have not been specifically contested by Appellant. See Br. 5-12.
Claims 2 and 14
Claims 2 and 14 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Feeney, Appellant's Admitted Prior Art (AAPA) on pages 2 and 4--5 of
the Specification, and Petite (US 6,430,268B1, iss. Aug. 6, 2002).
Claim 2 depends from claim 1 and further recites a "step of charging
vending machine stocking fees to manufacture[ r ]s of said pharmaceutical
samples." Br. 15 (Claims App.). Claim 14 recites a "step of charging a fee
to drug manufacturers who manufacture said prepackaged pharmaceutical
samples for having said prepackaged pharmaceutical samples stocked in said
vending machine." Id. at 18.
As acknowledged by the Examiner, Feeney does not explicitly
disclose charging vending machine stocking fees to manufacturers of the
pharmaceutical samples. See Final Act. 10. Feeney does broadly disclose a
subsystem to "handle the logistics of physical and virtual inventory
management, reordering, billing, shipping, and other related supply issues."
i-f 304. Further, as admitted by Appellant and evidenced by Feeney, it was a
well-established practice, at the time of Appellant's invention, to have
pharmaceutical representatives bring the samples to medical offices, often at
substantial cost. See Spec. 4--5; Feeney i-f 12. Further, as evidenced by
Petite, it was common practice in the vending machine field to employ
individuals to periodically stock vending machines. Petite 1 :38--46. Thus, it
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would have been obvious for an individual, such as a pharmaceutical
representative, employed by the drug manufacturer, to stock the vending
machines to charge a stocking fee to the drug manufacturer. Charging fees
for services rendered, whether by turning in a time card, in the case of an
employee, or by sending an invoice, in the case of a third-party contractor, is
a fundamental tenet of business.
Appellant argues that the claimed step of charging stocking fees to the
drug manufacturer "is not well known," but, rather, "is opposite of what is
currently used in the art." Br. 13. Appellant asserts: "In the prior art,
products are typically purchased by a vending machine operator before those
objects are placed in the vending machine. As such, the product
manufacturer is paid money for supplying the product." Id. The evidentiary
record before us does not support Appellant's assertion, at least insofar as it
applies to stocking of dispensers of pharmaceutical samples. In fact, quite to
the contrary, Appellant's Specification explicitly states: "Physicians do not
buy pharmaceutical samples. Rather, pharmaceutical samples are provided
to physicians by drug company sales representatives." Spec. 2.
DECISION
The Examiner's decision rejecting claims 1-8 and 12-19 is reversed.
We enter new grounds of rejection of claims 1-8 and 12-19 under
35 U.S.C. § 103(a).
FINALITY OF DECISION
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides "[a] new ground of rejection
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pursuant to this paragraph shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the Examiner, in which event the prosecution will be
remanded to the Examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
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)(l )(iv).
REVERSED; 37 C.F.R. § 41.50(b)
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