CLEARSTREAM TECHNOLOGIES LIMITED et al.

Patent Trials and Appeals BoardJun 28, 2021

2020006677 (P.T.A.B. Jun. 28, 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. 14/758,617 06/30/2015 Richard K. ELTON P-18281.US02 / 1626A-065 5028 138315 7590 06/28/2021 C. R. Bard, Inc./ClearStream/K&S KING & SCHICKLI, PLLC 800 CORPORATE DRIVE SUITE 200 LEXINGTON, KY 40503 EXAMINER LEE, WENG WAH ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 06/28/2021 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): uspto@iplaw1.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte RICHARD K. ELTON ____________ Appeal 2020-006677 Application 14/758,617 Technology Center 3700 ____________ Before CHARLES N. GREENHUT, WILLIAM A. CAPP, and MICHAEL L. WOODS, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 15, 24–29, and 35–37 as unpatentable under 35 U.S.C. § 112(b) as indefinite; and claims 15, 24–29, and 36–39 under 35 U.S.C. § 102(b) as anticipated by Sullivan (US 7,033,325 B1, iss. Apr. 25, 2006); and claim 35 over Sullivan and Miraki (US 5,383,890, iss. Jan. 24, 1995). 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). Appellant identifies Richard K. Elton and Clearstream Technologies Limited as the applicant and Clearstream Technologies Limited as the real party in interest. Appeal Br. 2. Appeal 2020-006677 Application 14/758,617 2 CASE POSTURE This application was previously before us in the case of In re Elton, Appeal No. 2019-001399 (PTAB, Sept. 23, 2019) (the “Prior Appeal”). In the Prior Appeal, we entered a new ground of rejection for all pending claims under 35 U.S.C. § 112(b) as indefinite and reversed pro forma the Examiner’s art rejections over Sullivan and Miraki. Thereafter, Appellant continued prosecution before the Examiner and submitted a claim amendment together with accompanying remarks. See Nov. 21, 2019 Amendment. Appellant amended claim 15, by adding a new phrase immediately prior to the word “comprising.” Id. The specific language added to claim 15 is identified by italics where claim 15 is reproduced below in this Decision. In Appellant’s remarks that accompanied the amendment, Appellant argued that the amended claim language resolved the indefiniteness issue raised in our new ground of rejection. Id. pp. 7–11. Thereafter, on December 12, 2019, the Examiner rejected all pending claims under Section 112(b) and, just as in the final rejection leading to the Prior Appeal, rejected all pending claims except claim 35 under Section 102 as anticipated by Sullivan. Final Act. 2–6. Also, as before, the Examiner rejected claim 35 over Sullivan and Miraki. Id. at 7–8. This appeal is taken from the Examiner final rejection of December 12, 2019. THE INVENTION Appellant’s invention relates to balloon catheters. Spec. 1. Claim 15, reproduced below with paragraph indentation added and language added by amendment after the Prior Appeal highlighted in italics, is illustrative of the subject matter on appeal. Appeal 2020-006677 Application 14/758,617 3 15. An apparatus for treating a treatment area in the vasculature using a catheter having a balloon including a working surface having a length for engaging the treatment area, the working surface being a surface along a portion of the balloon that is used to achieve a treatment effect, comprising: a guidewire for guiding the balloon to the treatment area, said guidewire including one or more radiopaque markings corresponding to the length of the working surface of the balloon, the correspondence being a correspondence in size. OPINION Section 112(b) Indefiniteness In determining whether a claim is definite under 35 U.S.C. § 112(b), “[t]he USPTO, in examining an application, is obliged to test the claims for reasonable precision.” In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014). The test for definiteness under 35 U.S.C. § 112, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations omitted). The PTO can properly reject a claim as indefinite if the claim is ambiguous, vague, incoherent, opaque, or otherwise unclear. Packard, 751 F.3d at 1311. This includes claims that are “amenable to two or more plausible claim constructions.” Ex parte Miyazaki, 2008 WL 5105055 at *5 (BPAI Nov. 19, 2008) (precedential). The Examiner takes the position that the claim limitation “length of the working surface” in claims 15 and 24 renders the claim indefinite. Final Act. 2. According to the Examiner, Appeal 2020-006677 Application 14/758,617 4 [I]t does not provide clarity on the specific structure that relates to the working surface. Insofar as the working surface being a surface along a portion of the balloon, as claimed, one cannot determine what portion of the balloon is considered the working surface. Furthermore, it cannot be determined what the length of the working surface of the balloon is because the size of the treatment area varies from person to person and procedure to procedure, rendering the length of the working surface unclear. Id. at 2–3. An analysis of claim indefiniteness under § 112 is inextricably intertwined with claim construction. Energizer Holdings, Inc. v. International Trade Comm’n, 435 F.3d 1366, 1368 (Fed. Cir. 2006). Here, the dispute between the Examiner and Appellant over the amended claim language is largely a matter of claim construction. During examination of a patent application, pending claims are given their broadest reasonable construction consistent with the specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under the broadest reasonable interpretation standard, claim terms are given their ordinary and customary meaning as would be understood by one of ordinary skill in the art in the context of Appellant’s entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Appellant’s Specification discloses balloon 12, which is comprised of three sections, namely: (1) proximal end section 18, (2) distal end section 20, and (3) intermediate section 16. Spec. 5, Fig 3. According to Appellant’s Specification, intermediate section 16 is referred to as a “barrel” comprised of working surface “W.” Id. Appellant’s guidewire 26 includes radiopaque markings corresponding to and adapted to align with working surface W of balloon 12 when inflated. Id. In Appellant’s own words: “the balloon 12 has an intermediate section 16, or “barrel” having the working Appeal 2020-006677 Application 14/758,617 5 surface W, and end sections 18, 20.” Id. Such “working surface” corresponds with a “treatment area.” Id. at 6. Unlike claims 15 and 24, claims 38 and 39 were not subject to the Examiner’s indefiniteness rejection. Claims 38 and 39 contain language similar in nature to the portion of the Specification discussed above. Thus, it is abundantly clear that if Appellant wished to limit the scope of protection sought by claim 15 or 24 to an arrangement wherein the “working surface” was structurally defined to be coextensive with a barrel section of a balloon (Appeal Br. 6 (“the definition of ‘working surface’ provided in the specification . . . clearly describes (including by illustration) that it is the barrel section of the type of balloon shown that performs the function”)) language was readily available for Appellant to do so. However, Appellant chose not include such language in claim 15 or 24. Our reviewing court has “cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.” In re American Academy of Science Tech Center, 367 F.3d 1359, 1369 (Fed. Cir. 2004) (citations omitted). Our reviewing court has also recognized that “the doctrine of claim differentiation creates a presumption that each claim in a patent has a different scope . . . . The difference in meaning and scope between claims is presumed to be significant to the extent that the absence of such difference in meaning and scope would make a claim superfluous.” Free Motion Fitness, Inc. v. Cybex Int’l, Inc., 423 F.3d 1343, 1351 (Fed. Cir. 2005). The express language of claims 15 and 24 defines the “working surface” not as the barrel but as “a surface along a portion of the balloon that Appeal 2020-006677 Application 14/758,617 6 is used to achieve a treatment effect” (emphasis added). Appellant is correct that there is nothing wrong with defining an apparatus functionally. Appeal Br. 6. However, functional language in an apparatus claim is only clear and definite when it informs the reader as to the structure encompassed by the claim. K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1363 (Fed. Cir. 1999). That is not the case here. The recited “is used to” is not coupled with any language connoting structure or mere intent. Rather the “is used to” language suggests the working surface is actually defined based on the use to which the apparatus is put. That would enable a device to become infringing or non-infringing based on its method of use. The phrase “used to” makes infringement dependent upon the particular patient and particular procedure in which the device is “used.” A potential infringer who might make, sell, or import this device, does not necessarily know the particular manner in which this device will be “used” or which particular patient or procedure to use as a basis for conducting an infringement analysis. See, e.g., IPXL Holdings v Amazon.com, 430 F.3d 1377, 1384 (Fed. Cir. 2005) (“[A] manufacturer or seller of the claimed apparatus would not know from the claim whether it might also be liable for contributory infringement because a buyer or user of the apparatus later performs the claimed method of using the apparatus.”). Thus, claim 15 does not provide adequate notice as to “whether or not [‘the working area’] is limited to the barrel section of the balloon” or not, as indicated by the Examiner. Ans. 4. Additionally, as we understand Appellant’s amended claim, balloon 12 may be “used to” treat vascular restrictions that may be longer or shorter than the length of the barrel section of balloon 12. This presents an Appeal 2020-006677 Application 14/758,617 7 internal inconsistency within claims 15 and 24. On the one hand, the portion of the balloon that is “used to achieve a treatment effect” could vary from patient to patient depending on the length of a patient’s plaque deposit and the medical practitioner’s technique. This means that the length of the “working surface” could vary depending on the patient’s condition and/or practitioner’s usage. On the other hand, claims 15 and 24 recite “radiopaque markings.” Claims App. According to the Specification, the markings are fixed to and/or incorporated into the guidewire. Spec. 5, Fig 4. The length of such markings (or the spacing between such markings) being fixed, it is difficult to imagine that one skilled in the art reading the claims in light of the Specification would understand them to have the ability to vary based on what portion of the balloon is “used to achieve a treatment effect” like the working surface. Claims 15 and 24, therefore, present an ambiguity as to the length of the working surface. In other words, does the length of working surface “W” correspond to: (1) the length of the patient’s plaque deposit treatment area, or (2) the length of (or spacing between) the radiopaque marking(s)? Taking the foregoing into account, we agree with the Examiner that claims 15 and 24 are indefinite. Therefore, we sustain the Examiner’s Section 112 indefiniteness rejection of claims 15, 24–29, and 35–37. Anticipation of Claims 15, 24–29, and 36–39 by Sullivan Claims 15, 24–29, 36, and 37 It is settled law that “a claim cannot be both indefinite and anticipated.” Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir. 2010). Because we have concluded that claims 15, 24–29, 36, and 37 are indefinite, the prior art rejection of these claims must fall because Appeal 2020-006677 Application 14/758,617 8 they are necessarily based on a speculative assumption as to the meaning of the claims. In re Steele, 305 F.2d 859, 862 (CCPA 1962). Consequently, we do not sustain the Examiner’s Section 102 anticipation rejection of claims 15, 24–29, 36, and 37. Claim 38 Claim 38 is an independent claim that differs from claims 15 and 24 in that the balloon includes a barrel section and radiopaque markings of the guidewire that correspond to the length of that barrel section. Claims App. Appellant argues that what is claimed in claim 38 is patentably distinct from Sullivan’s balloon and the spacing of the radiopaque markings on its guidewire. Appeal Br. 11. We agree. Sullivan discloses a balloon catheter that features a distensible balloon with tapered ends and an intermediate section referred to as distensible balloon segment 38. Sullivan, col. 3, ll. 61–63. Sullivan also features radiopaque markings on its guidewire. Id. col. 4, ll. 4–22. Thus, Sullivan is remarkably similar to Appellant’s invention, but is not, however, similar enough to anticipate claim 38. Sullivan’s guidewire 18 has radiopaque spring coils 50 that are spaced apart by distance “D.” Id. Distance D also represents a portion of the axial length of balloon 16 measured from the distal end of catheter 10 to a point that is “near a longitudinal center of balloon member 16.” Id. In operation, Sullivan’s balloon 16 is slid along guidewire 18 under radiopaque marker 43, which is disposed on balloon 16, is properly positioned vis-à-vis radiopaque markers 50 disposed on guidewire 18. Id. col. 4, l. 40 – col. 5, l. 17. There is no teaching in Sullivan, however, that distance D corresponds with the axial length of the barrel section of the balloon. The Examiner posits that the “barrel portion” Appeal 2020-006677 Application 14/758,617 9 of Sullivan’s balloon is not necessarily limited to the cylindrical portion and may include the tapered portions of distensible balloon segment 38. Ans. 7. However, as Appellant points out, the definition proffered by Appellant, which is the only evidence entered into the record that speaks to this point, indicates that the ordinary and customary meaning of “barrel” refers to a structure that is generally cylindrical. Reply Br. 6 (citing Merriam-Webster Dictionary, © 2020)). For a prior art reference to anticipate a claim, it must disclose all of the limitations of the claim, “arranged or combined in the same way as in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008). Sullivan does not anticipate claim 38 because Sullivan and Appellant use two different, patentably distinct means for spacing radiopaque markers on a guidewire. The Examiner’s findings of fact and are not supported by a preponderance of the evidence. Consequently, we do not sustain the Examiner’s Section 102 anticipation rejection of claim 38. 2 Claim 39 Claim 39 is an independent claim that has a limitation directed to correspondence between guidewire markings and the barrel section of a balloon. Claims App. The Examiner’s rejection of claim 39 suffers from 2 In reversing the Examiner’s Section 102 rejections herein, we note the substantial similarity between the teachings of Sullivan and the subject matter claimed in Appellant’s independent claims 15, 24, 38, and 39. However, we express no opinion as to whether such claims are unpatentable under Section 103 as obvious over Sullivan. The Board enters a new ground of rejection at its discretion, and no inference should be drawn from a failure to exercise that discretion. See 37 C.F.R. § 41.50(b); MPEP § 1213.02. Appeal 2020-006677 Application 14/758,617 10 the same infirmity that was identified above with respect to claim 38. Consequently, we do not sustain the rejection of claim 39. Unpatentability of Claim 35 over Sullivan and Miraki Claim 35 depends from claim 24, which we have determined to be indefinite. Claims App. For reasons articulated above with respect to claim 24, we do not sustain the Examiner’s Section 103 unpatentability rejection of claim 35. Steele, 305 F.2d at 862. CONCLUSION Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 15, 24-29, 35-37 112 Indefiniteness 15, 24-29, 35-37 15, 24-29, 36-39 102 Sullivan 15, 24-29, 36-39 35 103 Sullivan, Miraki 35 Overall Outcome 15, 24-29, 35-37 38, 39 AFFIRMED IN PART