KARL STORZ Imaging, Inc.

Patent Trials and Appeals Board

Oct 5, 2021

2020004533 (P.T.A.B. Oct. 5, 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.
15/448,385 03/02/2017 Russell Granneman P16625US 7788
137495 7590 10/05/2021
The Culbertson Group, P.C.
2210 Western Trails Blvd.
Unit 104
Austin, TX 78745
EXAMINER
NEWLIN, TIMOTHY R
ART UNIT PAPER NUMBER
2424
NOTIFICATION DATE DELIVERY MODE
10/05/2021 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):
docket@tcg-ipl.com
patent@karlstorz.com
rculbertson@sbcglobal.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte RUSSELL GRANNEMAN
____________________

Appeal 2020-004533
Application 15/448,385
Technology Center 2400
____________________

Before ROBERT E. NAPPI, ELENI MANTIS MERCADER, and
JUSTIN BUSCH, Administrative Patent Judges.

NAPPI, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
final rejection of claims 1, 3 through 10, 12 through 22, 24, and 25. Claims
2 and 11 have been indicated as being allowable by the Examiner. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). According to Appellant, KARL STORZ Imaging, Inc. is
the real party in interest. Appeal Br. 3.
Appeal 2020-004533
Application 15/448,385

2
CLAIMED SUBJECT MATTER
The claims are directed to a method and device for operating a
medical system that is operable within at least two different medical device
regulatory classes. Spec., Abstr. Claim 1 is reproduced below.
1. A method of operating a medical system that is
operable within at least two different modes, the method
comprising:
receiving an indicator for performing at least one
medical procedure that utilizes a medical device;
based on the indicator, selecting one of multiple binary
images for booting a medical device control module, the
multiple binary images including at least a controlled type
binary image, for which updates are controlled by an external
authority, for operating as a first medical device and a non-
controlled type binary image for operating as a second medical
device;
if the selected binary image is the controlled type binary
image, booting the medical device control module from the
controlled type binary image and subsequently operating the
medical device control module as the first medical device for
performing the at least one medical procedure; and
if the selected binary image is a non-controlled type
binary image, booting the medical device control module from
the non-controlled binary image and subsequently operating the
medical device control module as the second medical device for
performing the at least one medical procedure.
Appeal 2020-004533
Application 15/448,385

3
REJECTIONS2
The Examiner rejected claims 3, 13 through 22, 24, and 25 under 35
U.S.C. § 112(b) as being indefinite. Final Act. 5–6.
The Examiner rejected claims 1, 3, 4, 10, 12, and 24 under 35 U.S.C.
§ 103 as unpatentable over Shimada (US 2009/0227839 A1; pub. Sept. 10,
2009) and Al-Ali et al. (US 2018/0247353 A1; pub. Aug. 30, 2018). Final
Act. 6–8.
The Examiner rejected claims 5 through 9 under 35 U.S.C. § 103 as
unpatentable over Shimada, Al-Ali, and Ueno (US 2002/0177751 A1; pub.
Nov. 28, 2002). Final Act. 9–10.

ANALYSIS
We have reviewed Appellant’s arguments in the Appeal Brief, the
Examiner’s rejections, and the Examiner’s response to Appellant’s
arguments. Appellant’s arguments have not persuaded us of error in the
Examiner’s rejection of claims 1, 4 through 10, and 12 under
35 U.S.C. § 103 or of claims 3, 18, 19, 24, and 25 under 35 U.S.C. § 112(b).
However, we are persuaded of error in the Examiner’s rejection of claims 3
and 24 under 35 U.S.C. § 103 and of claims 13 through 17 and 20 through
22 under 35 U.S.C. § 112(b).

2 Throughout this Decision we refer to the Appeal Brief filed November 11,
2019 (“Appeal Br.”); Reply Brief filed May 7, 2020 (“Reply Br.”); Final
Office Action mailed June 11, 2019 (“Final Act.”); and the Examiner’s
Answer mailed February 19, 2020 (“Ans.”).
Appeal 2020-004533
Application 15/448,385

4
Rejection under 35 U.S.C. § 112(b)
The Examiner rejects claims 3, 13 through 22, 24, and 25 under 35
U.S.C. § 112(b) as the claims:
recite as a limiting principle that the devices correspond to
certain FDA regulatory classes at the time of filing. However,
the nature of government regulation is that the government
agency must determine which class a particular existing (not
merely claimed) device will be regulated under. The claimed
devices are recited as a category of devices; they are not
specific existing devices that were definitely regulated under a
certain class at the time of filing. As such, they are not definite,
since the class of device cannot be determined from the claims
or by reference to a fixed classification that existed at the time
of filing.
Final Act. 5
Appellant argues the Examiner’s rejection of claims 3, 13 through 22,
24, and 25 under 35 U.S.C. § 112(b) is in error as “the claims to refer to the
regulations at the time of filing” and that “the phrase is a term of art with a
well-understood meaning set forth in the FDA regulations.” Appeal Br. 7.
Further, Appellant argues that the use of standards in patent claims is
common and cites several patents which recite standards in the claims.
Appeal Br. 8.
Claims 13 through 17 and 20–22
At the outset, we note that there is some confusion as to whether the
rejection of claims 13 through 17 and 20 through 22 based upon 35 U.S.C.
§ 112(b) are before us. In the Advisory action, dated October 21, 2019, the
Examiner states that the antecedent basis rejections of claims 13 through 22
is withdrawn and that the other 112 rejections related to reciting regulatory
class are maintained. Thus, the rejection of claims 13 through 22 based
upon the recitation of regulatory class is before us. Moreover, in response to
Appeal 2020-004533
Application 15/448,385

5
Appellant’s arguments, in the Answer, the Examiner addresses the 35 U.S.C.
§ 112(b), based upon the interpretation of the regulatory class limitation, as
applicable to claims 3, 18, 19, 24, and 25. As the Examiner has not
expressly identified this rejection as withdrawn, we consider it to be before
us.
As discussed above the Examiner’s rejection of these claims is
premised upon the recitation of the system being within a FDA Class I, II, or
III regulation at the time of filing. Because claims 13 through 17 and 20
through 22 do not recite such a limitation, the Examiner’s rationale to reject
these claims under 35 U.S.C. § 112(b) does not apply, and we do not sustain
the Examiner’s rejection of these claims.
Claims 3, 18, 19, 24, and 25.
Each of these claims recite a limitation directed to the medical device
within different regulatory classes including an “FDA Class III regulation at
the time of filing” and an “FDA Class I or Class II regulation at the time of
filing.” Appellant’s Specification does not address what is meant by “at the
time of filing but discusses the FDA Class I, II, and III as requiring different
levels of approval from the Food and Drug Administration. Spec. ¶¶ 2–4, 9.
Thus, suggesting that the “at the time of filing” limitation refers to the filing
of a request for approval of the device by the FDA. However, when the
Appellant made the amendment it was identified as to “refer to the present
regulations” suggesting that the claim limitations are referring to the FDA
regulations in effect at the time of filing the instant patent application or the
amendment to the patent application. See Amdt 11, submitted Dec. 27, 2018.
Thus, there is more than one possible interpretation of the limitations in the
claims and, as such, the scope of the claim is ambiguous. “[I]f a claim is
Appeal 2020-004533
Application 15/448,385

6
amenable to two or more plausible claims constructions, the USPTO is
justified in requiring the applicant to more precisely define the metes and
bounds of the claimed invention by holding the claim unpatentable under 35
U.S.C. § 112 second paragraph.” Ex parte Miyazaki, 89 USPQ2d 1207,
1211 (BPAI 2008) (precedential); see also Ex parte McAward, Appeal No.
2015-006416, 2017 WL 3669566, at *2 (PTAB Aug. 25, 2017)
(precedential). Accordingly, we sustain the Examiner’s rejection of claims
3, 18, 19, and 24 under 35 U.S.C. § 112(b).

Rejections under 35 U.S.C. § 103
Appellant argues the Examiner’s rejection is in error as the
combination of the references does not teach one binary image to operate in
one regulatory class and another to operate in another regulatory class.
Appeal Br. 10–13. Specifically, Appellant argues that Shimada which the
Examiner relies upon to teach this limitation:
cannot be interpreted to teach both of the limitations from the
final two paragraphs of claim 1: “subsequently operating the
medical device control module as the first medical device for
performing the at least one medical procedure” and
“subsequently operating the medical device control module as
the second medical device for performing the at least one
medical procedure.” Shimada only has one mode that operates
for performing procedures, and does not address booting from
images under different regulatory control requirements.
Appeal Br. 11–12.
Appellant’s arguments are not persuasive of error as they are not
commensurate with the scope of claim 1. Appellant acknowledges that
Shimada teaches the device has one mode that operates for performing
medical procedures. This teaching meets the claim as the broadest
Appeal 2020-004533
Application 15/448,385

7
reasonable interpretation of method claim 1 is that the second mode need not
be performed. Method claim 1 recites a condition precedent, whether the
selected binary image is: a) of the controlled type or b) is of a non-controlled
type; and then operating the medical control device as either the first or
second medical device to perform the at least one medical procedure. Thus,
in considering the broadest reasonable interpretation of method claim 1, the
step of operating the medical device control module as the second medical
device for performing the at least one medical procedure, would not be
invoked necessarily. As such, it is not incumbent upon the Examiner to
show that the art performs those steps. See Ex parte Schulhauser, No. 2013-
007847, 2016 WL 6277792, at *3–4 (PTAB Apr. 28, 2016) (precedential)
(holding that in a method claim, a step reciting a condition precedent does
not need to be performed if the condition precedent is not met). See also
MANUAL OF PATENT EXAMINING PROCEDURE (MPEP) §
2111.04(II) (9th ed. Rev. 08.2017, Jan. 2018) (citing Schulhauser); In re
Johnston, 435 F.3d 1381, 1384 (Fed. Cir. 2006). “[O]ptional elements do
not narrow the claim because they can always be omitted.” Gary M. Katz,
Appeal No. 2010-006083, 2011 WL 1211248, at *2 (BPAI Mar. 25, 2011)
(citing In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir.
2004)). Accordingly, Appellant’s arguments directed to claim 1 are not
commensurate with the broadest reasonable interpretation of independent
claim 1 and have not persuaded us of error in claim 1 or dependent claims 4,
10, and 12.
Appellant has not presented separate argument directed to the
rejection of claims 5 through 9, accordingly, we similarly sustain the
Examiner’s rejection of these claims.
Appeal 2020-004533
Application 15/448,385

8
Regarding independent claim 24 and dependent claim 3, Appellant
argues the different FDA classes are not taught by the combination of
Shimada and Al-Ali. Appeal Br. 13. As discussed above, we concur with
the Examiner’s conclusion that these limitations of the claims are indefinite.
As such, to determine the scope of the claim would require speculation. Our
reviewing court has said that it is wrong to rely upon speculative
assumptions as to the meaning of claims when considering a rejection over
prior art. In re Steele, 305 F.2d 859, 863 (CCPA 1962). Accordingly, we
will not sustain the Examiner’s art rejections under 35 U.S.C. § 103 of
claims 3, and 24.
CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§ 
Reference(s)/Basis Affirmed Reversed
3, 13–22, 24,
25
112(b) Indefiniteness 3, 18, 19, 24,
25
13–17,
20–22
1, 3, 4, 10,
12, 24
103 Shimada, Al-Ali 1, 4, 10, 12 3, 24
5–9 103 Shimada, Al-Ali,
Ueno
5–9
Overall
Outcome
1, 3–10, 12,
18, 19, 24
13–17,
20–22
TIME PERIOD FOR 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)(1)(iv). See 37
C.F.R. § 41.50(f).
AFFIRMED IN PART