CUE HEALTH INC.Download PDFPatent Trials and Appeals BoardFeb 17, 20212020000716 (P.T.A.B. Feb. 17, 2021) Copy Citation 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 Appellant identifies the real party in interest as Cue Health Inc. Br. 3. 2 Claims 28–30 are withdrawn from consideration.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. Appeal 2020-000716 Application 15/336,502 2 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. Appeal 2020-000716 Application 15/336,502 3 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 Appeal 2020-000716 Application 15/336,502 4 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. Appeal 2020-000716 Application 15/336,502 5 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 Appeal 2020-000716 Application 15/336,502 6 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 Appeal 2020-000716 Application 15/336,502 7 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. Appeal 2020-000716 Application 15/336,502 8 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 Appeal 2020-000716 Application 15/336,502 9 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 Appeal 2020-000716 Application 15/336,502 10 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. Appeal 2020-000716 Application 15/336,502 11 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. Appeal 2020-000716 Application 15/336,502 12 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. Appeal 2020-000716 Application 15/336,502 13 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 Copy with citationCopy as parenthetical citation