CUE HEALTH INC.

Patent Trials and Appeals Board

Feb 17, 2021

2020000716 (P.T.A.B. Feb. 17, 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.
15/336,502 10/27/2016 Ayub Khattak 107057-0602 1638
38706 7590 02/17/2021
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
TURK, NEIL N
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
02/17/2021 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AYUB KHATTAK, CLINTON SEVER,
PAUL NELSON, RYAN COOPER, THOMAS CONGDON,
JUSTIN DEMARTINO, RAPHAEL SHAPIRO, and
MARK DUNCAN
Appeal 2020-000716
Application 15/336,502
Technology Center 1700
Before JAMES C. HOUSEL, MICHELLE N. ANKENBRAND, and
JULIA HEANEY, Administrative Patent Judges.
HEANEY, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–27.2 See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

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 Cue Health Inc.
Br. 3.
2 Claims 28–30 are withdrawn from consideration. Final Act. 2.
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CLAIMED SUBJECT MATTER
The claims are directed to a sample analysis cartridge for detecting at
least one of a presence, absence, or quantity of one or more analytes. Spec.
¶ 7. Claim 1 is the sole independent claim on appeal. Claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A sample analysis cartridge comprising:
a housing;
an input tunnel that extends from an aperture in the
housing, the input tunnel configured to permit insertion of a
sample collection device having a distal portion adapted to be
exposed to a sample;
a reservoir disposed within the housing adjacent to the
input tunnel and configured to hold a fluid, the reservoir further
configured to receive the sample collected by the sample
collection device;
a sealing material configured to fluidicly seal the fluid
within the reservoir; and
a seal piercer comprising an engager, a slot, and a piercer,
the seal piercer disposed within the housing such that the piercer
is adjacent to the reservoir and the engager is within the input
tunnel, the engager configured to be contacted by the sample
collection device within the input tunnel to slide the seal piercer
via the slot during insertion of the sample collection device in the
input tunnel, responsive to force applied by the sample collection
device, such that the piercer moves in a first direction and a
second direction, different from the first direction, to pierce the
sealing material to vent the fluid in the reservoir.

REJECTIONS
The Examiner maintains the following rejections on appeal:
1. Claims 1–27 under 35 U.S.C. § 112(b) as being indefinite.
Ans. 3–4.
2. Claim 5 under 35 U.S.C. § 112(b) as being indefinite. Id. at 4.
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3. Claim 10 under 35 U.S.C. § 112(b) as being indefinite. Id. at
4–5.
4. Claim 15 under 35 U.S.C. § 112(b) as being indefinite. Id. at 5.
5. Claim 16 under 35 U.S.C. § 112(b) as being indefinite. Id. at 6.
OPINION
Rejection 1
The Examiner concludes the following claim limitations are means-
plus-function limitations under 35 U.S.C. § 112(f): (1) “the engager
configured to . . .,” (2) “the piercer . . .to pierce the sealing material,”
(3) “second piercer configured to pierce the sealing material” (claim 2);
(4) “third piercer . . . to pierce the sealing material” (claim 9); (5) “slider
configured to move” (claim 6); and (6) “locking members configured to
couple” (claim 16). Final Act. 2–4. The Examiner further concludes that
claims 1–27 are indefinite because Appellant’s disclosure does not clearly
and sufficiently provide corresponding structures for the means-plus-
function limitations. Ans. 3–4.
Appellant contends one of ordinary skill in the art would understand
that the above limitations connote sufficiently definite structure to avoid
interpretation under 35 U.S.C. § 112(f) and that the limitations should not be
interpreted under 35 U.S.C. § 112(f). Br. 6–16.
Appellant’s arguments are persuasive. Failure to use the word
“means” creates a rebuttable presumption that § 112(f) does not apply.
Williamson v. Citrix Online, LLC., 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en
banc). This presumption can be overcome and § 112(f) will apply, despite
the lack of the word “means,” if “the challenger demonstrates that the claim
term fails to ‘recite sufficiently definite structure’ or else recites ‘function
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without reciting sufficient structure for performing that function.’” Id. at
1349 (quoting Watts v. XL Sys., Inc., 232 F.3d 877, 880 (Fed. Cir. 2000)).
Here, none of the disputed limitations use the word “means.”
Therefore, Examiner, as challenger, bears the burden of demonstrating that
§ 112(f) should apply to the claim terms. The Examiner finds the terms “are
nonce-type terms that are of Applicant’s own design, and recitations thereto
do not provide a clear and sufficient structure as such recitations are drawn
to vague descriptors.” Ans. 3–4. The record, which includes the claim
language and Appellant’s disclosure, does not support the Examiner’s
findings or conclusion that § 112(f) should apply for the disputed terms.3
When analyzing whether the presumption against applying § 112(f) is
overcome, we consider how a claim limitation is “used in the context of the
relevant claim language.” Advanced Ground Info. Sys., Inc. v. Life360, Inc.,
830 F.3d 1341, 1348 (Fed. Cir. 2016). Further, “[i]n undertaking this
analysis, we ask if the claim language, read in light of the specification,
recites sufficiently definite structure,” which avoids application of § 112(f).
Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1372–
73 (Fed. Cir. 2015) (analyzing specification to determine if term was
described in specific structural terms). We address the interpretation of each
of the disputed limitations below.

3 The Examiner states that the claim interpretation portion of the Final
Office Action is not an appealable matter. Ans. 6. The Examiner’s claim
interpretation includes whether the disputed limitations are interpreted as
means-plus-function limitations. The Examiner’s statement is incorrect.
Claim interpretation is an initial step when determining whether claims
should be rejected under statutory grounds (e.g., under §§ 102, 103, and/or
112), which are appealable matters.
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1. “engager”
The “engager” is used in a structural manner in the context of claim 1.
Specifically, claim 1 recites that the engager is “configured to be contacted
by the sample collection device within the input tunnel to slide the seal
piercer.” Br. 23. In addition, the “engager,” when read in light of the
Specification, recites sufficiently definite structure. For instance, Appellant
argues (Br. 6–7) that an engager 380 is shown in Figure 10D of Appellant’s
disclosure, which is reproduced below.

Figure 10D shows engagement between a sample collection device and a
slider of a seal piercer

According to Appellant’s Specification, as sample collection device
200 is moved distally through input tunnel 301, slider 322 may engage
sample collection device 200 by temporarily or permanently coupling
engager 380 of slider 322 to engagement zone 209 of sample collection
device 200. Spec. ¶ 264. This description of engager 380 interacting with
other structures, namely sample collection device 200, and its depiction in
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Appellant’s drawings as a structure engaging sample collection device 200,
demonstrates that claim 1 recites the “engager” in sufficiently definite
structure and avoids application of § 112(f).
2. “piercer”
Similarly, § 112(f) should not apply for claim 1’s limitation of “the
piercer. . . to pierce the sealing material,” claim 2’s limitation of a “second
piercer configured to pierce the sealing material,” or claim 9’s limitation of a
“third piercer . . . to pierce the sealing material.” The Examiner finds that
Appellant’s disclosure is unclear as to what structure constitutes the piercers.
Ans. 10. Claim 1, claim 2, and claim 9 each recite that the relevant piercer
is used to interact with another structure (i.e., is used to pierce a sealing
material). Therefore, claims 1, 2, and 9 recite the piercers in a structural
context.
Appellant’s disclosure also describes the piercers in a structural
manner. Appellant’s Figure 10C is reproduced below.

Figure 10C is a top view of piercing elements
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Appellant’s Specification states that piercer 323 may have first piercing
element 381, second piercing element 382, and third piercing element 383.
Spec. ¶ 263. Appellant’s Figure 10G, which is reproduced below, illustrates
the position of a piercer before it pierces a sealing material (i.e., in a pre-
mixing and pre-venting position).

Figure 10G depicts a pre-mixing and pre-venting position

As shown above, piercing element 381 and track 384 are not in
contact with one another and sealing material 320 still seals reservoir 317.
Id. ¶ 266. Appellant’s Figure 10J is reproduced below.
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Figure 10J shows a piercing element piercing a sealing material

As depicted in Figure 10J, track 384 may contact piercing element 381 as
slider 322 (not shown in Figures 10G or 10J), which includes track 384, is
moved due to engagement between slider 322 and sample collection device
200 (not shown in Figures 10G or 10J). Id. ¶ 269. Track 384 moves
piercing element 381 downward into a piercing position and piercing
element 381 pierces sealing material 320. Id. ¶ 270.
3. “slider”
With regard to claim 6’s limitation of a “slider configured to move,”
claim 6 recites that the slider is “configured to move in the first direction to
cause the piercer to move in the second direction to pierce the sealing
material.” Br. 24. This relationship between the slider, piercer, and sealing
material provides a structural context for the slider. Appellant’s disclosure
also describes the slider in a structural manner. As shown above in Figure
10D, slider 322 may include first track 384 configured to engage a first
piercer, second track 384 to engage a second piercer, third track 385 to
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engage a third piercer, and engager 380 to contact sample collection device.
Spec. ¶ 264.
4. “locking members”
Finally, claim 16 provides a structural context by reciting “locking
members configured to couple to the sample collection device to irreversibly
lock the sample collection device within the input tunnel in the second
position.” Br. 26. Thus, the locking members are configured to interact
with another structure (i.e., the sample collection device) and lock it in
place. In addition, Appellant’s disclosure describes the locking members in
a structural manner. Appellant’s Figure 10K is reproduced below.

Figure 10K is a sectional side view of a sample collection device

Appellant’s Specification discloses that locking member 387 is
configured to irreversibly lock sample collection device 200, such as by
engaging a locking end of locking member 387 with sample collection
device 200. Spec. ¶ 274. For instance, the locking end “may be a protrusion
sized to fit within a groove of engagement zone 209,” as depicted in Figure
10K. Id.
For the reasons discussed above, the presumption against applying
§ 112(f) has not been overcome, and § 112(f) should not apply to the
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disputed limitations. As a result, there is no need to analyze whether
Appellant’s Specification sufficiently describes corresponding structures to
satisfy § 112(b). Accordingly, we reverse the rejection of claims 1–27 under
§ 112(b).

Rejection 2
The Examiner concludes claim 5 is indefinite because it “presents
additional element(s) of one or more ramps to the sample analysis cartridge,
however the relative structural disposition of the one or more ramps within
the analysis cartridge . . . is indefinitely defined at present.” Ans. 4.
Appellant argues that one of ordinary skill in the art would have
understood claim 5. Br. 16–17. Appellant’s arguments are persuasive. The
Examiner’s rejection does not sufficiently explain why the meaning of the
claim terms is unclear or why the scope of claim 5 is indefinite. The
Examiner’s rejection instead appears to reject claim 5 for an insufficient
amount of structure or detail. However, “breadth is not to be equated with
indefiniteness.” In re Miller, 441 F.2d 689, 693 (CCPA 1971). As a result,
the Examiner has not set forth a prima facie rejection for indefiniteness.
Accordingly, we reverse this rejection.

Rejection 3
The Examiner concludes claim 10 is indefinite because “[t]he metes
and bounds of the structural constitution between the ramps and piercers
with respect to a ‘pre-venting’ position is indefinitely defined at present” and
the “‘preventing’ position is an undefined, positive element and is drawn to a
conditional narrative within the apparatus.” Ans. 4–5.
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Appellant argues that one of ordinary skill in the art would have
understood claim 10. Br. 17–18. Appellant’s arguments are persuasive.
This rejection does not sufficiently explain how the meaning of the terms in
claim 10 is unclear or how the scope of claim 10 is indefinite. One of
ordinary skill in the art would understand the meaning and scope of a “pre-
venting position” in light of Appellant’s disclosure, such as the discussion of
a pre-venting position in paragraph 266 of the Specification and in view of
Figure 10G. In addition, tracks and piercing elements may have different
positions, as shown in Figures 10D and 10C above, and thus different
distances between pairs of tracks and piercers so reservoirs are pierced in a
certain order. See Spec. ¶¶ 313, 316. Accordingly, we reverse this rejection.

Rejection 4
The Examiner concludes claim 15 is indefinite because “[i]t is unclear
how the shuttle is configured to receive the sample via the sample collection
device at the second end given that the shuttle is defined as comprising a
body having a first end and a second end.” Ans. 5.
Appellant asserts that one of ordinary skill in the art would have
understood claim 15. Br. 19–20. Appellant’s arguments are persuasive.
The Examiner’s statement above appears to be based on a second end of the
shuttle being incapable of receiving the sample collection device. Claim 15,
however, does not require that the second end is closed or otherwise
incapable of performing this function. Similar to the above rejections, the
Examiner’s rejection of claim 15 does not sufficiently explain why the
meaning of the terms in claim 15 is unclear or why the scope of claim 15 is
indefinite. Accordingly, we reverse this rejection.
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Rejection 5
The Examiner concludes claim 16 is indefinite because “the relative
structural disposition of the one or more locking members within the
analysis cartridge . . . is indefinitely defined at present.” Ans. 6.
Appellant contends that one of ordinary skill in the art would have
understood claim 16. Br. 20–21. Appellant’s arguments are persuasive.
Similar to the rejection claim 5 above, the Examiner appears to reject claim
16 for an insufficient amount of structure or detail. However, “breadth is not
to be equated with indefiniteness.” In re Miller, 441 F.2d at 693.
Accordingly, we reverse this rejection.
CONCLUSION
The Examiner’s rejections are reversed.

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DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § References/Basis Affirmed Reversed
1–27 112(b) Indefiniteness 1–27
5 112(b) Indefiniteness 5
10 112(b) Indefiniteness 10
15 112(b) Indefiniteness 15
16 112(b) Indefiniteness 16
Overall
Outcome

1–27

REVERSED