Daniel KRAFT

Patent Trials and Appeals Board

Sep 27, 2021

2021001684 (P.T.A.B. Sep. 27, 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.
16/259,785 01/28/2019 Daniel L. KRAFT INT 11.01 CON 2752
27667 7590 09/27/2021
HAYES SOLOWAY P.C.
4640 E. Skyline Drive
TUCSON, AZ 85718
EXAMINER
LULTSCHIK, WILLIAM G
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
09/27/2021 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):
admin@hayes-soloway.com
dlandau@hayes-soloway.com
nsoloway@hayes-soloway.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL L. KRAFT

Appeal 2021-001684
Application 16/259,785
Technology Center 3600

Before HUBERT C. LORIN, MICHAEL C. ASTORINO, and
KENNETH G. SCHOPFER, Administrative Patent Judges.

LORIN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s final decision to reject claims 1, 3–16, 18, 20–29, 31, 33–39, 41,
and 42.1 We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
CLAIMED SUBJECT MATTER
The claimed subject matter relates

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies Daniel Kraft as the real party in interest.
Appeal Br. 2.
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to systems, method, and devices for recommending or
medicating an optimal treatment protocol and/or an optimal
drug selection, combination and dosage for a particular patient,
in particular, by utilizing patient information in combination
with available medical and other relevant information and
datasets to determine, predict or suggest an optimal drug or
therapy.

(Spec. 1:6–10). Claim 1, reproduced below:2
1. A system for producing a personalized drug product for an
individual patient, comprising:
a computer processor configured to control a drug
production device, in communication with the processor, to
produce a personalized drug product for the patient including an
optimal drug selection and dosage of a combination drug product
of at least a first drug and a second drug, wherein the drug
production device comprises:
a plurality of drug containers, each configured to
hold a different quantity of a different drug in the form of
microtablets, each microtablet containing an equal sized
dose of a particular drug, each microtablet being formed
so as to enable different drugs to be in close proximity
without interaction;
a plurality of drug dispensers, each of said drug
dispensers coupled to one of said drug containers;
a supply of first and second empty ingestible open
capsule half shells;
a conveyor for moving the first ingestible capsule
half shells through the drug production device;
a controller, which controls dispensing of selected
quantities of said microtablets of a selected drug or drugs
by count of said microtablets into the first ingestible open
capsule half shells via a commonly shared chute;

2 We reproduce the claim as it appears in the Amendment of April 16, 2020
filed prior to the Final Action, which was apparently entered and the subject
of the pending rejections being appealed. See Final Act. 2. The Claims
Appendix to the Appeal Brief presents claim 1 in a previous form.
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a capsule closer for closing the first ingestible open
capsule half shells following dispensing of a determined
quantity of the selected drugs onto the first ingestible open
capsule half shells by application of the second ingestible
half shells;
a verification stage including an imaging device to
visually inspect and count the microtablets as the microtablets are
being loaded into the capsule half shells to verify the contents of each,
some or randomly selected capsules; and
wherein the combination drug product comprises at least a
first microtablet of a first drug and a second microtablet of a
second drug, wherein the second drug is distinct from the first
drug, in a closed unitary ingestible capsule package customized
for the patient produced from the selected dispensed drugs,
wherein the patient information includes information
selected from (1) at least one of the group consisting of: weight;
age; sex; BSA (body surface area); body mass index; lean body
mass, percentage body fat, metabolism; renal function; liver
enzymes; proteomics/biomarkers, blood chemistries,
pharmacokinetics; risk factors for disease; partial or full genome
SNP screening data; whole or partial genome analysis; vitamin
deficiencies; vitamin and micronutrient levels; diet;
environmental, toxin or other allergy history; the patient's
medical history; diagnostic information; exercise activity; sleep
activities; tissue expression profiling; hormonal cycles,
biomarker information; radiologic/imaging information,
demographic information; monthly reproductive cycle;
geolocation, social network, consumer information, habits,
physiologic data, electroencephalogram (EEG) recordings,
behavioral history, geographic history, exposures or potential
exposures to toxins and other environmental factors including
exposure to radiation, compliance history and personality testing
from body measurement devices, and (2) at least one of the
group consisting of current medications; other
medications/supplements; history of prior side effects to one or
more medications; analysis of pharmacogenomic and/or
pharmacogenetic profile; drug-drug interaction information;
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drugdiet interaction information; and drug allergies and/or
sensitivities, and
wherein the biomarker information comprises information
obtained from the at least one of the group consisting of the
patient's blood, urine, sweat, saliva, body tissue, biopsy or bodily
fluid.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Mayaud US 2002/0042725 A1 Apr. 11, 2002
Wright, IV (“Wright”) US 2004/0172169 A1 Sept. 2, 2004
Kamineni US 2005/0210834 A1 Sept. 29, 2005
Begleiter US 2006/0068006 A1 Mar. 30, 2006
Kadhiresan US 2006/0089856 A1 Apr. 27, 2006
Abrams US 2007/0087048 A1 Apr. 19, 2007
Trebbi US 2008/0209858 A1 Sept. 4, 2008
Dick US 2012/0189693 A1 July 26, 2012
REJECTIONS
Claims 1, 3, 5–10, 12, 13, 16, 18, 22–26, 29, 31, and 34–39 are
rejected under 35 U.S.C. § 103(a) as being unpatentable over Kaminei,
Wright, Dick, Trebbi, and Mayaud.
Claims 4, 11, 20, 21, and 33 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and
Kadhiresan.
Claims 14, 27, and 41 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and Abrams.
Claims 15, 28, and 42 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and Begleiter.
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OPINION
The rejection of claims 1, 3, 5–10, 12, 13, 16, 18, 22–26, 29, 31, and 34–39
under 35 U.S.C. § 103(a) as being unpatentable over Kamineni, Wright,
Dick, Trebbi, and Mayaud.
The Examiner finds that Kamineni discloses all that is claimed in the
independent claims (claims 1, 18, and 31) but for
o the drug being in the form of microtablets containing equal
sized doses of a particular drug, each microtablet being
formed so as to enable different drugs to be in close proximity
without interaction;
o a conveyor for moving the first ingestible capsule half shells
through the drug production device;
o the controller controlling dispensing by count of said
microtablets;
o a verification stage including an imaging device to visually
inspect and count the microtablets as the microtablets are
being loaded into the capsule half shells to verify the contents
of each, some, or randomly selected capsules;
o the combination drug product comprising at least a first
microtablet of the first drug and a second microtablet of the
second drug, wherein the second drug is distinct from the first
drug;
o wherein the biomarker information comprises information
obtained from the at least one of the group consisting of the
patient's blood, urine, sweat, saliva, body tissue, biopsy or
bodily fluid
(Final Act. 7; Answer 6–7), for which Wright, Dick, and Trebbi are relied
upon.
Trebbi is relied upon for showing “a verification stage including an
imaging device to visually inspect and count the microtablets as the
microtablets are being loaded into the capsule half shells to verify the
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contents of each, some or randomly selected capsules” (claims 1, 18, 31).
Final Act. 9–10 (emphasis omitted):
Trebbi next teaches that it was old and well known in the
art of pharmaceutical dispensing at the time of the invention to
control dispensing of microtablets by count of said microtablets
([12], [19]-[22], [25], and [26] describe counting microtablets
prior to deposition into a capsule, and controlling the dose based
on the number of microtablets), to verify the contents of capsules
using an imaging device to inspect and count microtablets as the
microtablets are being loaded into capsule half shells (Figure 2,
[22], and [23] describe using a camera to count the number of
microtablets as they are fed from a storage hopper to a funnel for
deposition into a capsule), . . . .
Therefore it would have been obvious to one of ordinary
skill in the art of pharmaceutical dispensing at the time of the
invention to control dispensing of microtablets by count of said
microtablets, to verify the contents of capsules using an imaging
device to inspect and count microtablets as the microtablets are
being loaded into capsule half shells, . . . as taught by Trebbi in
the combination of Kamineni and Wright since the claimed
invention is only a combination of these old and well known
elements which would have performed the same function in
combination as each did separately. In the present case, the
combination of Kamineni and Wright already teaches measuring
quantities of drugs, using microtablets, and filling capsules, and
measuring the amount of drug by counting the microtablets,
optically counting the microtablets, . . . as taught by Trebbi
would perform that same function as part of the combination of
Kamineni and Wright, making the results predictable to one of
ordinary skill in the art (MPEP 2143).
Appellant disagrees that Trebbi discloses “a verification stage” as
claimed. Appeal Br. 14 (emphasis omitted):
Trebbi doesn't count microtablets. Trebbi teaches a capsule
filling machine in which a roller having a predetermined plurality
of surface suction recesses is rotated through a mass of particles
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in a hopper to pick up particles. Trebbi employs an imaging
detector to determine if all of the recesses are filled with the exact
predetermined number of particles [00221], and activates a unit
to reject capsules that are determined as not being properly filled
[0023]. Trebbi's imaging detector does not count microtablets or
particles. Rather, Trebbi's imaging detector inspects the roller 14
surface to determine if one or more suction recesses 15 are
empty, and if one or more recesses are determined to be unfilled,
the capsule is rejected [0023]. In other words, Trebbi teaches a
binary decision-go or no-go decision.
We have reviewed Trebbi and find that Appellant has the better
argument.
Examiner cites paras. 12, 19–23, 25, 26 and Fig. 2 of Trebbi. Final
Act. 9–10.
Fig. 2 and paras. 12 and 19–22 disclose various aspects of a capsule
filling machine.
Para. 23 discloses a sensor means comprising a camera that can be
connected to means for activating units for rejecting capsules that are not
correctly filled with the microtablets.
Para. 25 discloses a capsule filling machine with a feed nozzle
structure for dosing an exact number of microtablets into capsules.
Para. 26 discloses that the dose of microtablets filling each capsule
can be varied by varying the number of recesses on a roller.
We do not see in any of these cited passages disclosure of an imaging
device to visually inspect and count the microtablets as the microtablets are
being loaded into the capsule half shells, as claimed. The camera that is
disclosed (para. 23) facilitates “rejecting capsules C that are not correctly
filled with the microtablets.” Using the camera to visually inspect and count
the microtablets is not disclosed.
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The Examiner argues that:
Paragraphs 20-25 of Trebbi expressly describe counting the
number of microtablets that are dispensed into each of a series of
capsules using an imaging device. Paragraph 20 states that the
apparatus has a series of recesses to accommodate an retain a
predetermined number of microtablets, while paragraphs 22 and
23 state that “[t]he unit 11 also comprises display and detection
sensor means 20 designed to check that the arrays G of recesses
15 are filled with the exact, predetermined number of
microtablets 12 to be filled into the capsule bodies” and that
“[p]referably, the sensor means 20 comprise a camera ... ”. The
camera of Trebbi is expressly described as determining whether
a predetermined number of microtablets are being delivered to
each capsule. Examiner notes that the claims only recite the
imaging device as visually inspecting and counting the
microtablets as the microtablets are being loaded into the capsule
half shells, do not recite a specific manner by which the imaging
device performs the inspecting and counting function.
Answer 44 (emphasis original).
We agree that Trebbi suggests employing a camera in ensuring
capsule bodies are filled with an exact, predetermined number of
microtablets. But the claim calls for using the camera to count the
microtablets. We agree with Appellant that “all that Trebbi’s imaging device
20 is capable of is determining whether each and every hollow recess 15 in
pick-up roller 14 is filled. That is to say, all that Trebbi is capable of doing is
to determine if one (or more) of the hollow recesses 15 is/are unfilled.
However, Trebbi doesn't count anything.” Reply Br. 4.
Accordingly, the rejection is not sustained on the ground that a prima
facie case of obviousness has not been made out in the first instance.

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The rejection of claims 4, 11, 20, 21, and 33 under 35 U.S.C. § 103(a) as
being unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and
Kadhiresan.
The rejection of claims 14, 27, and 41 under 35 U.S.C. § 103(a) as being
unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and Abrams.
The rejection of claims 15, 28, and 42 under 35 U.S.C. § 103(a) as being
unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and Begleiter.
These rejections of dependent claims are not sustained for the reason
given above in not sustaining the rejection of the independent claims from
which they depend.
CONCLUSION
The decision of the Examiner to reject claims 1, 3–16, 18, 20–29, 31,
33–39, 41, and 42 is affirmed.
More specifically:
The rejection of claims 1, 3, 5–10, 12, 13, 16, 18, 22–26, 29, 31, and
34–39 under 35 U.S.C. § 103(a) as being unpatentable over Kamineni,
Wright, Dick, Trebbi, and Mayaud is reversed.
The rejection of claims 4, 11, 20, 21, and 33 under 35 U.S.C. § 103(a)
as being unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and
Kadhiresan is reversed.
The rejection of claims 14, 27, and 41 under 35 U.S.C. § 103(a) as
being unpatentable Kamineni, Wright, Dick, Trebbi, Mayaud, and Abrams is
reversed.
The rejection of claims 15, 28, and 42 under 35 U.S.C. § 103(a) as
being unpatentable over Kamineni, Wright, Dick, Trebbi, Mayaud, and
Begleiter is reversed.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 5–10,
12, 13, 16,
18, 22–26,
29, 31, 34–
39
103 Kamineni, Wright,
Dick, Trebbi,
Mayaud
1, 3, 5–10,
12, 13, 16,
18, 22–26,
29, 31, 34–
39
4, 11, 20,
21, 33
103 Kamineni, Wright,
Dick, Trebbi,
Mayaud,
Kadhiresan
4, 11, 20,
21, 33
14, 27, 41 103 Kamineni, Wright,
Dick, Trebbi,
Mayaud, Abrams
14, 27, 41
15, 28, 42 103 Kamineni, Wright,
Dick, Trebbi,
Mayaud, Begleiter
15, 28, 42
Overall
Outcome
1, 3–16, 18,
20–29, 31,
33–39, 41,
42

REVERSED