Siemens Medical Solutions USA, Inc.

Patent Trials and Appeals Board

Jul 19, 2021

2020002957 (P.T.A.B. Jul. 19, 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.
14/602,304 01/22/2015 Danny Bingham 2014P21865US 7480
28524 7590 07/19/2021
SIEMENS CORPORATION
IP Dept - Mail Code INT-244
3850 Quadrangle Blvd
Orlando, FL 32817
EXAMINER
HANDY, DWAYNE K
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
07/19/2021 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):
ipdadmin.us@siemens.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DANNY BINGHAM, MICHAEL NAZERIAS,
ERIC WEBSTER, and STEVEN ZIGLER

Appeal 2020-002957
Application 14/602,304
Technology Center 1700
____________

Before DONNA. M. PRAISS, SHELDON M. McGEE, and
JANE E. INGLESE, Administrative Patent Judges.

PRAISS, Administrative Patent Judge.

DECISION ON APPEAL1

Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–4, 6–13, and 18–20, which constitute
all the claims pending in this application. We have jurisdiction under
35 U.S.C. § 6(b). We AFFIRM.

1 In this Decision, we refer to the Specification filed Jan. 22, 2015
(“Spec.”), the Non-Final Office Action dated May 16, 2019 (“Non-Final
Act.”), the Appeal Brief filed Oct. 9, 2019 (“Appeal Br.”), the Examiner’s
Answer dated Feb. 10, 2020 (“Ans.”), and the Reply Brief filed Mar. 11,
2020 (“Reply Br.”).
2 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Siemens Medical Solutions USA, Inc.
as the real party in interest. Appeal Br. 1.
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STATEMENT OF THE CASE
The invention relates to a method for producing radiopharmaceuticals
for functional imaging. Spec. ¶ 4. According to the Specification,
radiopharmaceuticals have a short half-life and are produced near healthcare
facilities which use them for positron emission tomography (PET) or single
photon emission computed tomography (SPECT). Id. ¶ 1. The Specification
describes the production of radiopharmaceuticals as batches on demand that
are dispensed and packaged for specific patient subscriptions. Id.
Appellant’s invention is described in the Specification as dispensing and
packaging a standard amount in unit dosages rather than in patient specific
dosages to allow pharmacists to be replaced by chemists at the manufacturer
using good manufacturing practice (GMP). Id. ¶ 4. Independent claims 1 and
18, reproduced below, are illustrative of the subject matter on appeal
(emphasis added).
1. A method for producing radiopharmaceutical for
functional imaging, the method comprising:
generating, in a vial of a shielded area, the
radiopharmaceutical with a half-life of less than one day;
packaging the radiopharmaceutical from the vial into a
plurality of unit dose containers each of a labeled unit dosage,
the packaging including labeling the unit dose containers with
the unit dosage not specific to any of the patients; and
distributing the unit dose containers to different
healthcare facilities having patients with orders for the
functional imaging.
18. A method for producing radiopharmaceutical for
functional imaging, the method comprising:
manufacturing, with a cyclotron or a generator, a drug for
positron emission tomography or single photon emission
computed tomography;
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dispensing the drug in unit dosage into containers
without an amount dictated by a patient prescription; and
packaging the containers with the unit dosage for
transport to positron emission tomography scanners or single
photon emission computed tomography scanners;
wherein the dispensing and packaging into the
containers with unit dosage are performed by a chemist and
not a pharmacist.
Appeal Br. 11, 12–13 (Claims Appendix).
ANALYSIS
We review the appealed rejections for error based upon the issues
Appellant identifies, and in light of the arguments and evidence produced
thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential)
(cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011)
(“[I]t has long been the Board’s practice to require an applicant to identify
the alleged error in the examiner’s rejections.”)). After considering the
argued claims in light of each of Appellant’s arguments, we are not
persuaded Appellant has identified reversible error in the appealed
rejections.
The Examiner rejects claims 1–4, 6–13, and 18–20 under 35 U.S.C.
§ 103 as unpatentable over Hirschman (US 2011/0178359 A1, published
July 21, 2011) for the reasons provided in the Non-Final Office Action.
Non-Final Act. 4–6.
Appellant separately argues the obviousness rejection of claims 1, 8,
12, and 18. Appeal Br. 4–9. Therefore, claims 2–4, 6, 7, 9–11, and 13 stand
or fall with claim 1 from which they depend and claims 19 and 20 stand or
fall with claim 18 from which they depend. See 37 C.F.R. § 41.37(c)(1)(iv).
We address Appellant’s arguments below.
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Independent Claim 1
The Examiner finds Hirschman discloses generating a
radiopharmaceutical in a generator, dispensing into a container in a shielded
area, the container is a syringe and it is delivered to a hospital or other
facility. Non-Final Act. 4. The Examiner acknowledges that Hirschman does
not recite multiple bulk containers, however, the Examiner considers the
bulk container disclosed in Hirschman’s paragraph 86 meets the limitation
of a unit dose that is not specific to a patient. Id. at 5. The Examiner
determines it would have been obvious to a person having ordinary skill in
the art to provide a plurality of bulk containers that may be distributed to
individual patients. Id.
According to Appellant, the Examiner erred in determining that
Hirschman’s paragraph 86 discloses a unit dose not specific to patients.
Appeal Br. 5. Appellant directs us to Hirschman’s paragraph 15 which
recites “prepare unit doses for individual patients” and argues these are
prepared from Hirschman’s bulk containers. Id. Appellant also directs us to
Hirschman’s paragraph 82 which recites “only within 10% of the correct or
desired dosage” and argues verification and adjustment is specific to the
patient of paragraph 15.
Appellant also argues that Hirschman’s paragraph 86 does not
disclose multiple unit dose containers are each labeled as required by claim
1. Id. at 5–6. Appellant argues Hirschman does not teach manufacturing a
specific amount of bulk to allow a labeled unit dose for each or packaging
into a plurality of unit dose containers each of a labeled unit dosage. Id. at 6.
Appellant’s arguments do not persuade us that the Examiner
reversibly erred in rejecting claim 1 as obvious over Hirschman.
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The preponderance of the evidence in this Appeal record supports the
Examiner’s determination that Hirschman discloses transportation of both
bulk and individual doses to a patient treatment site. Hirschman ¶ 86. In the
Reply Brief, Appellant argues that Hirschman’s bulk container is a vial and
therefore does not disclose or suggest packaging from a vial into a plurality
of unit dose containers as required by claim 1. Reply Br. 3. Appellant’s
argument does not further patentably distinguish the claim over the cited
prior art because Hirschman teaches dispensing the radiopharmaceutical into
a container that “is a syringe . . . but may also be a vial, bottle, or similar
container.” Hirschman 184; Non-Final Act. 4. To the extent that Appellant’s
argument that Hirschman does not disclose or suggest a unit dose “not
specific to any of the patients” is based on the content of a container label,
we find that limitation is not entitled to patentable weight.
Appellant’s argument that Hirschman does not teach a specific
amount of bulk such that it may be considered “a labeled unit dosage” as
recited by the claim is not persuasive of error because claim 1 does not
require a particular amount of radiopharmaceutical in the claimed “unit
dosage.” Limitations not appearing in the claims cannot be relied upon for
patentability. In re Self, 671 F.2d 1344, 1348 (CCPA 1982). We also find
unpersuasive Appellant’s argument that even if Hirschman’s bulk container
reads on the claimed unit dosage, Hirschman only discloses a singular
container rather than more than one container as required by claim 1. The
Examiner’s determination that it would have been obvious to a person
having ordinary skill in the art to provide multiple bulk containers (Ans. 7)
is supported by the well settled principle that “[a] mere duplication of parts
is not invention.” In re Marcum, 47 F.2d 377, 378 (CCPA 1931) (citing
Topliff v. Topliff, 145 U.S. 156, 163 (1892)). “It is well settled that the mere
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duplication of parts has no patentable significance unless a new and
unexpected result is produced.” In re Harza, 274 F.2d 669, 671 (CCPA
1960). Appellant does not direct us to any objective evidence of secondary
considerations (e.g., unexpected results) which our reviewing court guides
“operates as a beneficial check on hindsight.” Cheese Sys., Inc. v. Tetra Pak
Cheese and Powder Sys., Inc., 725 F.3d 1341, 1352 (Fed. Cir. 2013).
In sum, Appellant’s arguments are not persuasive of error in the
Examiner’s conclusion of obviousness. Accordingly, we affirm the
Examiner’s rejection of claim 1 as well as the rejection of claims 2–4, 6, 7,
9–11, and 13 under 35 U.S.C. § 103 over Hirschman.
Independent Claim 18
In addition to the findings made in connection with independent claim
1, the Examiner finds Hirschman discloses a technologist or any other
individual may perform dispensing and packaging of radiopharmaceuticals.
Non-Final Act. 5.
Appellant argues that the Examiner’s rejection should be reversed
because Hirschman’s unit dose “is specific to individual patients,” prepared
for individual patients, and is not dispensed into containers without an
amount dictated by a patient prescription as required by claim 18. Appeal
Br. 8 (citing Hirschman ¶¶ 9, 11, 12, 86, 187, 188).
Appellant’s arguments are not persuasive of error. As discussed
above, to the extent that Appellant’s argument distinguishing Hirschman is
based on the content of a container label, we find such a claim limitation is
not entitled to patentable weight.
Moreover, the record supports the Examiner’s finding (Ans. 7; Non-
Final Act. 5) that Hirschman teaches that a technologist as an alternative to a
pharmacist may perform various steps in Hirschman’s process. Hirschman
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¶¶ 86, 119, 124, 125, 150. Thus Appellant has not identified error in the
Examiner’s rejection of claim 18 as obvious over Hirschman. Accordingly,
we sustain the Examiner’s rejection of claims 18–20.
Dependent Claim 8
Claim 8 depends from claim 1 and recites “wherein packaging
comprises labeling the unit dose containers with a batch label for the vial
and a time and without any names of the patients.” Appeal Br. 12 (Claims
Appendix).
The Examiner finds Hirschman’s paragraph 124 discloses printing a
label that may provide the required information. Non-Final Act. 6.
Appellant argues that the Examiner’s rejection should be reversed
because Hirschman’s paragraph 124 is limited to including a patient name
and does not teach using a batch label. Appeal Br. 8.
We are not persuaded of error by Appellant’s arguments. Hirschman’s
paragraph 124 discloses printing a label for the container that may include
“human-readable text, bar code or 2D symbology, or a combination of text
and symbology as desired.” Thus the record supports the Examiner’s
determination that it would have been obvious to a person having ordinary
skill in the art to label unit dose containers with the desired information.
Moreover, as discussed above, to the extent that Appellant’s argument
distinguishing Hirschman is based on the content of a container label, we
find such a claim limitation is not entitled to patentable weight.
Because Appellant has not identified error in the Examiner’s
rejections of claim 8, we sustain the Examiner’s obviousness rejection.
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Dependent Claim 12
Claim 12 depends from claim 1 and recites “further comprising
aseptic simulation testing one of the unit does containers after distribution to
one of the different healthcare facilities.” Appeal Br. 12 (Claims Appendix).
The Examiner finds Hirschman’s paragraph 136 discloses aseptic
testing. Non-Final Act. 6.
Appellant argues that the Examiner’s rejection should be reversed
because Hirschman’s paragraph 136 discloses aseptic prevention or
avoidance by UV, swab, filtering, replacement, and surface treatment, but
not performing aseptic testing of the distributed syringes. Appeal Br. 9.
Appellant also argues that Hirschman’s disclosure in paragraph 135 of
optical testing for particle contamination is not a test for asepsis. Id.
We are not persuaded of error by Appellant’s argument because
Appellant acknowledges that Hirschman discloses quality control procedures
for addressing asepsis, which encompasses or at least suggests confirming
the effectiveness of the quality control procedures by testing for asepsis.
Appellant does not adequately explain why it would not have been obvious
to a person having ordinary skill in the art to test for asepsis in view of
Hirschman’s disclosure that the possibility of asepsis during packaging
requires necessary quality control procedures to be in place. Because
Appellant has not identified error in the Examiner’s rejections of claim 12,
we sustain the Examiner’s obviousness rejection.
CONCLUSION
For these reasons and those provided in the Final Office Action and
the Examiner’s Answer, we uphold the Examiner’s rejections of claims 1–4,
6–13, and 18–20.
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In summary:
Claim(s)
Rejected
35 U.S.C.
§ Reference(s)/Basis Affirmed Reversed
1–4, 6–13,
18–20 103 Hirschman
1–4, 6–13,
18–20
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)(iv).

AFFIRMED