Trials@uspto.gov
`571.272.7822
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` Paper No. 30
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` Entered: April 26, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GENERAL ELECTRIC CO.,
`Petitioner,
`
`v.
`
`UNIVERSITY OF VIRGINIA PATENT FOUNDATION,
`Patent Owner.
`____________
`
`Case IPR2017-00109
`Patent RE45,725 E
`____________
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`
`
`Before KARL D. EASTHOM, TREVOR M. JEFFERSON, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`JEFFERSON, Administrative Patent Judge.
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`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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`INTRODUCTION
`On October 19, 2016, General Electric Co. (“GE”) filed a Petition
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`(Paper 1, “Pet.”) requesting inter partes review of claims 47–80 (“the
`challenged claims”) of U.S. Patent No. RE45,725 E (Ex. 1001, “the ’725
`Patent”). Patent Owner University of Virginia Patent Foundation
`(“UVAPF”) timely filed a Preliminary Response (Paper 7, “Prelim. Resp.”).
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`We instituted an inter partes review on all challenged claims. Paper
`10, “Inst. Dec.”). UVAPF filed a Patent Owner Response (Paper 13, “PO
`Resp.”), and GE filed a Petitioner Reply (Paper 18, “Pet. Reply”). UVAPF
`filed a sur-reply to GE’s reply (Paper 21, PO SR”) and GE filed a response
`to UVAPF’s sur-reply (Paper 23, “Pet. Resp. to SR”). The parties filed a
`Motion to Seal that is addressed below. An oral hearing was held on
`December 13, 2017. Paper 29 (“Tr.”).1
`
`We have jurisdiction under 35 U.S.C. § 6. This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. As
`explained below, GE has shown by a preponderance of the evidence that the
`challenged claims of the ’725 Patent are unpatentable.
`
`Related Proceedings
`A.
`GE identifies the following matters as related to its Petition: (1) Univ.
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`of Va. Patent Found. v. Gen. Elec. Co., No. 3:14-cv-00051-nkm (W.D. Va.);
`and (2) three inter partes reviews (IPR2016-00357, IPR2016-00358, and
`IPR2016-00359) of U.S. Patent No. RE44,644 E (“the ’644 Patent”), a
`related patent. Pet. 1–2. Final Written Decisions have issued in IPR2016-
`00357, IPR2016-00358, and IPR2016-00359. Gen. Elec. Co. v. Univ. of Va.
`
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`1 The parties raised objections to demonstrative exhibits presented at the oral
`hearing. Papers 26, 28. Upon review, all such objections are denied.
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`Patent Found., Case IPR2016-00357 (PTAB June 21, 2017) (“IPR2016-
`00357 FWD”); Gen. Elec. Co. v. Univ. of Va. Patent Found., Case IPR2016-
`00358 (PTAB June 21, 2017) (“IPR2016-00358 FWD”); Gen. Elec. Co. v.
`Univ. of Va. Patent Found., Case IPR2016-00359 (PTAB June 21, 2017)
`(“IPR2016-00359 FWD”). A decision denying rehearing in IPR2017-00357
`was issued. Gen. Elec. Co. v. Univ. of Va. Patent Found., Case IPR2016-
`00357 (PTAB Sep. 19, 2017) (“IPR2016-00357 Reh. Dec.”)
`
`The ’725 Patent
`B.
`The ’725 Patent relates to nuclear magnetic resonance imaging
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`(“MRI”) technology. Ex. 1001, 1:52–56. In particular, the ’725 Patent
`relates to spin echo MRI, which provides “a wide range of useful image
`contrast properties that highlight pathological changes and are resistant to
`image artifacts from a variety of sources such as radio-frequency or static-
`field inhomogeneities.” Id. at 1:62–67.
`
`In spin echo MRI, one or more spin echo magnetic resonance (“MR”)
`signals are generated after an initial “excitation radio-frequency (RF) pulse.”
`See id. at 2:1–6. Data about the imaged subject in k-space may be collected
`periodically in conjunction with a series of spin echoes (i.e., a spin echo
`train), using gradient magnetic fields for spatial encoding, to produce an
`image of the subject. See id. at 2:25–54. The spin echoes are generated
`using RF “refocusing” pulses, which are characterized by, among other
`things, a “flip angle.” See id. at 2:64–3:12. Conventional spin echo
`techniques at the time of the invention—including, for example, “fast spin
`echo” or “turbo spin echo” techniques—used high flip angle refocusing RF
`pulses, which limited the usable duration of the echo trains and, thus, the
`amount and/or quality of data obtained. See id. at 2:64–3:24.
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`Unlike most conventional spin echo techniques, which used constant
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`flip angles, the ’725 Patent describes the use of variable flip angles for the
`refocusing RF pulses. Id. at 3:66–4:6. According to the ’725 Patent,
`variable flip angle pulse sequences according to the claimed invention can
`extend the duration of usable spin echo trains, which in turn can improve
`spatial resolution and/or reduce the time needed to acquire images. Id. at
`4:6–11. Further, the variable flip angle sequences of the ’725 Patent use flip
`angles that, typically, are less than the 180° flip angles common in
`conventional spin-echo techniques, permitting less power to be applied to
`human subjects and, thus, enhancing patient safety. Id. at 5:55–67.
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`Prosecution History of the ’725 Patent
`C.
`The ’725 Patent is a reissue patent from U.S. Patent Application No.
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`14/053,190, which is a continuation of U.S. Patent Application No.
`12/354,471 (“the ’471 Application”). Ex. 1001, at [21], [63]. The ’471
`Application issued as the ’644 Patent, which was a reissue of U.S. Patent
`No. 7,164,268 (“the ’268 Patent”). Id. at [63]. The ’268 Patent was issued
`on January 16, 2007, from a PCT application filed on December 21, 2001.
`Id. at [64]. The ’268 Patent—and, thus, the ’725 Patent—claims priority to
`U.S. Provisional Application No. 60/257,182 (“the ’182 Application”),
`which was filed on December 21, 2000. Id. at [60].
`
`Instituted Grounds of Unpatentability and Illustrative Claim
`D.
`We instituted inter partes review on the grounds that claims 47–80 of
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`the ’725 Patent are unpatentable under 35 U.S.C. § 102 as anticipated by
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`Mugler 2000;2 and that claims 47–80 of the ’725 Patent are unpatentable
`under 35 U.S.C. § 103(a) as obvious over Mugler 2000 and Mugler
`Overview.3 GE also relies on the Declaration of Professor Norbert J. Pelc
`(Ex. 1009).
`
`UVAPF submits the Declarations of Dr. John P. Mugler, III
`(Ex. 2007), Dr. Berthold Kiefer (Ex. 2013), and Dr. Klaus Jürgen Hennig
`(Ex. 20234 and Ex. 2025) as well as other evidence.
`
`Claims 47, 57, 67, 73, 79, and 80 are independent claims, and all other
`challenged claims depend, directly or indirectly, from those independent
`claims. Independent claim 47 (Ex. 1001, 21:53–22:44) is illustrative:
`47. A method of generating a spin-echo-train pulse sequence
`used in operating a magnetic resonance imaging apparatus
`configured for imaging an object, said method comprising:
`providing a data-acquisition step based on said spin-echo-train
`pulse sequence, said data-acquisition step comprises:
`providing an excitation radio-frequency pulse;
`providing at least two refocusing radio-frequency pulses,
`each having a flip angle and phase angle,
`wherein, in order to permit during said data-
`acquisition step lengthening usable echo-train
`duration,
`reducing
`power
`deposition
`and
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`2 John P. Mugler III et al., Three-Dimensional T2-Weighted Imaging of the
`Brain Using Very Long Spin-Echo Trains, Proceedings of the Int’l Soc. for
`Magnetic Resonance in Med., 8th Meeting (Apr. 2000) (Ex. 1002, “Mugler
`2000”).
`3 John P. Mugler III, Overview of MR Imaging Pulse Sequences, in
`MAGNETIC RESONANCE IMAGING CLINICS OF NORTH AMERICA: PHYSICS OF
`MR IMAGING 661–697 (Scott A. Mirowitz and J. Paul Finn eds., 1999) (Ex.
`1005, “Mugler Overview”).
`4 Dr. Hennig’s Declaration (Ex. 2023) is a copy of a declaration filed in inter
`partes review proceedings related to the ’644 Patent, and does not address
`directly the ’725 Patent.
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`incorporating desired image contrast into the signal
`evolutions, said flip angle is selected to vary, among
`a majority of the total number of said refocusing
`pulses applied during the echo train, by decreasing
`to a minimum value and later increasing in order to
`yield a signal evolution pertaining to the associated
`train of spin echoes of at least one first substance of
`interest in said object, with corresponding T1 and
`T2 relaxation times and spin density of interest, and
`in order to yield a signal evolution pertaining to the
`associated train of spin echoes of at least one second
`substance of
`interest
`in said object, with
`corresponding T1 and T2 relaxation times and spin
`density of interest
`wherein said varying flip angle results in a reduced
`power deposition compared to the power deposition
`that would be achieved by using refocusing radio-
`frequency pulses with constant flip angles of 180
`degrees,
`wherein said signal evolutions result in a T2-
`weighted contrast in the corresponding image(s)
`that is substantially the same as a T2-weighted
`contrast that would be provided by imaging said
`object using a conventional spin-echo pulse
`sequence,
`wherein an effective echo time corresponding to
`said spin-echo trains with said signal evolutions of
`said substances is at least twice an echo time of said
`convention spin-echo pulse sequence, and
`wherein: said effective echo time corresponding to
`said spin-echo trains with said signal evolutions of
`said substances is at least on the order of 300
`milliseconds; and/or the duration of said spin-echo
`trains with said signal evolutions of said substances
`is at least on the order of 600 milliseconds;
`providing magnetic-field gradient pulses that perform at
`least one of encoding spatial information into at least one
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`of the radio-frequency magnetic resonance signals that
`follow at least one of said refocusing radio-frequency
`pulses and dephasing transverse magnetization associated
`with undesired signal pathways in order to reduce or
`eliminate a contribution of said transverse magnetization
`into sampled signals; and
`providing data sampling, associated with magnetic-field
`gradient pulses that perform spatial encoding; and
`repeating said data-acquisition step until a predetermined extent
`of spatial frequency space has been sampled.
`ANALYSIS
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`Claim Construction
`A.
`In an inter partes review, claim terms in an unexpired patent are given
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`their broadest reasonable construction in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b); see Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2142–46 (2016).
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`GE and UVA propose constructions for a number of terms in the
`challenged claims. Pet. 24–28; Prelim. Resp. 4–9. Our institution decision
`construed “effective echo time” as “the time period from the excitation RF
`pulse to the collection of data corresponding to substantially zero-spatial
`frequency (the center of k space).” Inst. Dec. 7–8.5 Neither party disputed
`this preliminary construction during trial, or provided any further argument
`or evidence regarding the proper construction of this term. Accordingly, for
`the same reasons explained in the Decision on Institution (Inst. Dec. 7–8),
`
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`5 We note that in IPR2016-00357, our Final Written Decision also construed
`the claim term “effective echo time” in the ’644 Patent as “the time period
`from the excitation RF pulse to the collection of data corresponding to
`substantially zero-spatial frequency (the center of k space).” Gen. Elec. Co.
`v. Univ. of Va. Patent Found., Case IPR2016-00357, slip op. at 8 (PTAB
`June 21, 2017).
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`we maintain our earlier construction of this term. No other claim terms
`require express construction for purposes of this Final Written Decision. See
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999).
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`Level of Ordinary Skill
`B.
`According to GE’s expert witness, Dr. Norbert J. Pelc, a person of
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`ordinary skill in the art would have had “significant working knowledge of
`MR spin-echo imaging, especially fast-spin-echo imaging,” as well as “a
`Ph.D. in a physical science (e.g., electrical or biomedical engineering or
`medical physics) with experience in the development of MR imaging
`techniques, or an M.D. degree or an M.S. degree in a physical science with
`significant (3–5 years) of work experience in the development of MR
`imaging techniques.” Ex. 1009 ¶ 92. UVAPF’s expert witness, Dr. Klaus
`Jürgen Hennig, concurs generally with Dr. Pelc’s description, but adds that a
`person of ordinary skill would have been
`familiar with (1) using variable flip angles to extend the echo
`train length, to the extent that this technology was described in
`the art of the time; (2) preexisting spin-echo-train imaging
`techniques, such as RARE, fast-SE, and GRASE; and (3)
`techniques for extending the echo train length described in
`Alsop (Ex. 1004) and Hennig (Ex. 2024).
`Ex. 2025 ¶ 8.
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`Based on Dr. Pelc’s credible testimony, we find that a person of
`ordinary skill in the art would have met Dr. Pelc’s description. We further
`find that Dr. Hennig’s testimony on this issue does not differ materially from
`that of Dr. Pelc, and, in any event, our analysis in this Decision would be
`unchanged were we to apply Dr. Hennig’s description.
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`Asserted Prior Art & Priority Date
`1. Mugler 2000 as Prior Art under 35 U.S.C. § 102(b)
`GE contends that the ’725 Patent should not receive the benefit of the
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`filing date of the ’182 Application, and its effective priority date should be
`December 21, 2001, as a result. Pet. 6–8. As a result, according to GE, the
`Mugler 2000 reference is prior art under 35 U.S.C. § 102(b) because it was
`published in April 2000, more than one year earlier. Id. at 19. GE asserts
`that the written description of the ’182 Application does not support
`sufficiently the challenged claims of the ’725 Patent in several respects. Pet.
`8–18.
`In response, UVAPF argues that Mugler 2000 is not prior art under 35
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`U.S.C. § 102(b) because the claims do not provide adequate written
`description support for “effective echo time ratio” limitation in the
`challenged claims. PO Resp. 1–2, 4–9; see Pet. 15–18.
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`Our prior decisions in cases related to the ’725 Patent concluded that
`Mugler 2000 is not prior art under § 102(a), but that it qualifies as prior art
`under § 102(b). See IPR2016-00357 FWD at 11–22; IPR2016-00357 Reh.
`Dec. at 2–8 (PTAB Sep. 19, 2017) (rehearing decision); IPR2016-00358
`FWD at 9–21; IPR2016-00359 FWD at 9–20.
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`For a patent to claim priority to the filing date of its provisional
`application, the written description of the provisional application must be
`sufficient to support the relevant claims of the patent under 35 U.S.C. § 112.
`Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015) (citing New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298
`F.3d 1290, 1294 (Fed. Cir. 2002)). Sufficient written description support
`requires providing enough information in the application to indicate to a
`person of ordinary skill that the inventor had possession of the full scope of
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`the claims. In re Wertheim, 541 F.2d 257, 262–64 (C.C.P.A. 1976). The
`disclosure need not recite the claimed invention in haec verba, but a
`disclosure that “merely renders the invention obvious” is insufficient. Ariad
`Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en
`banc).
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`With respect to § 102(b), GE bears the burden to prove that Mugler
`2000 is prior art under § 102(b) as part of its overall burden of persuasion to
`prove unpatentability. See Dynamic Drinkware, 800 F.3d at 1378. GE also
`bore the initial burden of production, but satisfied that burden by asserting
`that Mugler 2000 is prior art under § 102(b). See id. at 1379. The burden
`then shifted to UVAPF to produce evidence that the challenged claims of the
`’725 Patent are entitled to an earlier priority date. See id. at 1380.
`
`UVAPF does not dispute that Mugler 20000 was publicly presented,
`published and distributed as part of the conference proceedings in April
`2000 (Pet. 19; Ex. 1009 ¶ 115). Instead, UVAPF argues that the ’182
`Application provides sufficient written description for the effective echo
`time ratio limitation, which requires that “an effective echo time of the
`claimed pulse sequence ‘is at least twice’ either ‘an echo time of said
`conventional spin-echo pulse sequence’ (claims 47, 57, and 79) or ‘an
`effective echo time of said [TSE] pulse sequence or [FSE] pulse sequence’
`(claims 67, 73, and 80).” PO Resp. 4–5. Specifically, UVAPF argues that
`the ’182 Application provides support for a spin-echo-train pulse sequence
`that produced images having T2-weighted contrast that is comparable to
`images produced with given flip angles, but that also use a longer echo-train
`duration than prior art techniques. PO Resp. 5–6. Thus, UVAPF points to
`the ’182 Application’s disclosure of limitations—namely, “echo train
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`duration” and “substantially the same contrast”— as written description
`support for the effective echo time ratio limitations. Id. at 5–8.
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`Our prior related decisions rejected UVAPF’s contention that the
`relationship between echo train duration and desired image contrast was
`sufficient to direct an ordinarily skilled artisan to the claimed echo train ratio
`recited in the ’725 Patent and provided sufficient written description support.
`See IPR2016-00357 FWD at 21–22 (PTAB June 21, 2017); IPR2017-00357
`Reh. Dec. at 5. UVAPF has not provided sufficient or persuasive argument
`or evidence to reach a different conclusion in the present case.
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`UVAPF argues:
`The ’182 Application compares the T2-weighted contrast
`between the images: The “contrast characteristics appear very
`similar to those for conventional T2-weighted SE images (Fig.
`4a).” Id. at 10 (emphasis added). The ’182 Application also
`explains that “the overall image quality for the very long spin-
`echo-train and conventional-SE images is similar . . . .” Id.
`The ’182 Application states that the echo time of the
`conventional spin-echo sequence was 80 ms and the effective
`echo time for the claimed sequence was 328 ms. Ex. 1014[,]
`Fig. 4. Thus, the effective echo time ratio for this example is
`4.1. Decision (Paper 10) at 10.
`. . . .
`A person of ordinary skill understands that increasing the
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`echo-train duration for the claimed pulse sequence necessarily
`increases the effective echo time that yields images having the
`same T2-weighted contrast. Thus, if the echo-train duration for
`the claimed pulse sequence, which the ’182 Application
`explains was 656 ms, is doubled to 1312 ms, for example, the
`effective echo time that generates images having substantially
`the same contrast as the images in Figures 4(a)-(d) will increase
`from 328 ms to approximately 500 ms. Ex. 2025 ¶ 15. Thus,
`the effective echo time ratio, which reflects the amount by
`which the echo-train duration has been extended while
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`generating images with substantially the same contrast, will
`have risen from 4.1 to 6.3. Id. The effective echo time of the
`claimed pulse sequence corresponding to a particular T2-
`weighted contrast must increase as the echo-train duration
`increases. Id. ¶ 14. The effective echo time ratio represents the
`increase in echo-train duration for which a particular T2-
`weighted contrast—that is substantially the same as that from a
`180° flip-angle pulse sequence—is obtained, and thus directly
`reflects a primary objective of the invention in the ’182
`Application.
`PO Resp. 8–9 (footnote omitted).
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`Patent Owner’s argument is not commensurate with the scope of the
`construction for “effective echo time” as “the time period from the excitation
`RF pulse to the collection of data corresponding to substantially zero-spatial
`frequency (the center of k space).” This construction requires no particular
`image contrast or echo train duration.
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`In addition, UVAPF has not provided persuasive argument or
`evidence that supports its contention that “[a] person of ordinary skill [would
`have understood from the ’182 Application] that increasing the echo-train
`duration for the claimed pulse sequence necessarily increases the effective
`echo time that yields images having the same T2-weighted contrast.” PO
`Resp. 8 (emphasis added). UVAPF’s expert testified that there is not a
`direct relationship between echo-train duration and effective echo time
`because the effective echo time may be set to any value to obtain a suitable
`image. Ex. 1048, 66:23–67:4, 68:23–69:4, 69:19–70:5; see also Ex. 1005,
`Fig. 9 (showing TEeff set). UVAPF’s argument that increasing the echo train
`duration necessarily increases the effective echo time for a suitable image
`rest on a series of assumptions and conditions that do not dictate effective
`echo time absent those assumptions. See Ex. 1048, 277:14–279:22 (ratio of
`TEeff to echo-train duration is the same for the claimed sequence as for the
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`conventional sequence); Ex. 2025 ¶14 n.3 (“same signal evolution shape,
`scaled to be shorter or longer, is used.”); Ex. 1048, 280:13–281:16 (same);
`id. at 282:5–7 (same echo spacing); id. at 282:18–283:5 (four-step algorithm
`used to calculate flip angles); id. at 285:4–286:3, 296:3–24 (discussing
`assumptions and noting that they are not required). In addition, UVAPF’s
`expert admits that there are ways to increase or decrease echo-train
`duration that do not change the effective echo time of the claimed sequence.
`Id. at 301:18–302:2, 307:13–308:16.
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`UVAPF also has not shown persuasively that obtaining images with
`substantially the same contrast discloses the effective echo time ratios. The
`similar contrast characteristics discussed in the ’182 Application (PO Resp.
`7–8) were not tied to echo train ratios and evidence shows that effective
`echo time duration is selectable and not subject to any particular ratio. Ex.
`1048, 66:23–67:4, 68:23–69:4, 69:19–70:5; see also Ex. 1005, Fig. 9.
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`Despite UVAPF’s argument to the contrary (see PO Resp. 9–14), in
`our view, the operative facts here closely parallel those of Purdue Pharma
`L.P. v. Faulding Inc., 230 F.3d 1320 (Fed. Cir. 2000). In Purdue Pharm, the
`patent at issue claimed a method of treating pain by administering an opioid
`only once a day in an oral sustained release dosage form. Purdue Pharma,
`230 F.3d at 1322. The relevant claims recited a ratio of “more than twice”
`between maximum plasma concentration of the opioid (Cmax) and the plasma
`level of the opioid 24 hours after administration (C24). Id. The patentee
`argued the written description provided adequate support under § 112
`because of two examples in the specification in which the Cmax/C24 ratio was
`greater than two. Id. at 1326. The court, however, upheld the district court’s
`finding that the written description was insufficient:
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`Although the examples provide the data from which one can
`piece
`together
`the Cmax/C24
`limitation, neither
`the
`text
`accompanying the examples, nor the data, nor anything else in
`the specification in any way emphasizes the Cmax/C24 ratio. The
`district court therefore reasonably concluded that one of ordinary
`skill in the art would not be directed to the Cmax/C24 ratio as an
`aspect of the invention. . . . [T]he disclosure of the ’360 patent
`discloses a multitude of pharmacokinetic parameters, with no
`blaze marks directing the skilled artisan to the Cmax/C24 ratio or
`what value that ratio should exceed.
`Id. The court held that the written description requirement was not met,
`stating that “[b]ecause the specification does not clearly disclose to the
`skilled artisan that the inventors of the ’360 patent considered the Cmax/C24
`ratio to be part of their invention, it is immaterial what range for the Cmax/C24
`ratio can be gleaned from the examples when read in light of the claims.”
`Id. at 1328. Likewise, here, nothing in the ’182 Application would direct an
`ordinarily skilled artisan to the effective echo time ratios as an aspect of the
`invention. Even if UVAPF is correct that the effective echo time ratios
`claimed in the ’725 Patent could be derived or calculated from information
`in the ’182 Application, the ’182 Application lacks any blaze marks
`directing the skilled artisan to make that calculation to arrive at the effective
`echo time ratios.
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`UVAPF argues that “[u]nlike the specification in Purdue Pharma, in
`which ‘neither the text accompanying the examples, nor the data, nor
`anything else in the specification emphasize[d]’ the plasma concentration
`ratio, the ’182 Application explains that increasing the effective echo time
`ratio beyond prior art techniques is a primary objective of the invention as
`discussed above.” PO Resp. 10 (citing Purdue Pharma, 230 F.3d at 1326).
`UVAPF also argues that none of the examples in the specification in Purdue
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`Pharma were in the range, but examples in the ’182 Application fall within
`the claimed range. PO Resp. 10–11 (citing Purdue Pharma, 230 F.3d at
`1326).
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`In addition, UVAPF argues that the Board’s decision in MotionPoint
`Corp. v. Transperfect Global, Inc., CBM2014-00066, Paper 8 at 24 (PTAB
`July 23, 2014), rejected applying Purdue Pharma as requiring explicit
`identification of a feature as relevant or important, and instead endorsed the
`proper standard under Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d
`1570, 1575–76 (Fed. Cir. 1985), that a specification could provide adequate
`written description by describing a value for a feature and teaching that it
`could be adjusted to obtain other values. PO Resp. 11–12. We disagree.
`
`The specification of the ’182 Application does not direct a skilled
`artisan to any particular ratio, or range of ratios, between the effective echo
`time of the claimed pulse sequences and the echo time of a conventional spin
`echo sequence (or the effective echo time of a turbo spin echo or fast spin
`echo sequence). UVAPF does not identify any such blaze marks, and
`instead argues without citation that the “’182 Application makes clear that
`the effective echo train ratio is an important feature of the invention.” PO
`Resp. 11. UVAPF asserts that a skilled artisan could have readily derived
`the ratios from the examples in the specification and relies on cases to
`support the adequacy of such disclosure. PO Resp. 11–12 (citing Ralston
`Purina, 772 F.2d at 1575–6; Waddington N. Am., Inc. v. Sabert Corp., No.
`09-4883 GEB, 2011 WL 1098996, at *3 (D.N.J. Mar. 22, 2011)). The cases
`cited by UVAPF each disclosed and emphasized the feature in question, a
`value for the feature, and an indication of the range for such values. See id;
`Reply 4 n.3; see also Ralston Purina, 772 F.2d at 1576 (stating that “[t]he
`trial court also found that the parent [application], which disclosed [the
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`feature], indicated that [the feature] could be adjusted”). Indeed, the court in
`Waddington noted that the specification emphasized the importance of the
`feature and thus, distinguished the facts of that case from Purdue Pharma.
`Waddington, 2011 WL 1098996 at *6.
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`With respect to the ’182 Application, as in Purdue Pharma, “neither
`the text accompanying the examples, nor the data, nor anything else in the
`specification in any way emphasizes” the effective echo time ratios. See
`Purdue Pharma, 230 F.3d at 1326. Thus, it is “immaterial what range for
`the [recited ratios] can be gleaned from the examples” because the
`specification does not clearly indicate the specific ratios recited in the claims
`are part of the invention. See id. at 1328; see, e.g., Ex. 1051, 190:25–191:14
`(Dr. Hennig acknowledging that there is no indication of the specific TEeff
`ratio using the variable flip angle method to the TEeff obtained using a
`conventional SE or FSE sequence).6 We are not persuaded by and do not
`agree with UVAPF’s interpretation of Purdue Pharma as inapplicable. As
`discussed above, we also do not find that the specification of the ’182
`Application “inherently” or sufficiently describes the effective echo time
`
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`6 As we stated in the IPR2016-00357 with respect to the ’644 patent and the
`’182 Application:
`[T]he ’182 Application does not emphasize echo time ratios,
`ascribe any significance to them, or even identify any such
`ratios. Although the specification reports an effective echo time
`of 328 ms for a variable flip angle sequence and an echo time of
`80 ms for a conventional spin-echo sequence (among several
`other parameters), the ’182 Application does not compare those
`values, nor does it specify any ratio or other relationship
`between them.
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`ratios by referring generically to extending echo train duration and suitable
`contrast images.
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`We do not agree with UVAPF’s argument that the “at least twice”
`recitation in the claims is supported by prior art techniques in the Alsop
`reference. PO Resp. 14–17. UVAPF’s argues that
`[t]he ’182 Application explains that the invention seeks to
`extend the echo-train duration beyond that obtained by Dr.
`Hennig’s “constant, low flip angle” approach and Dr. Alsop’s
`“pseudosteady-state” approach: “In this disclosure, we describe
`a method for lengthening the usable echo-train duration for
`spin-echo-train imaging substantially beyond that achievable
`with the [Hennig] or [Alsop] approaches.” Ex. 1014 at 4. The
`’182 Application states that the echo-train duration for the brain
`images shown in Alsop was 400 ms. Id. (“An 80-echo train
`with a duration of 400 ms and asymptotic flip angles ranging
`from 17° to 90° were used.”). The ’182 Application also
`explains that the maximum echo-train duration typically used
`for 180° flip-angle pulse sequences is 200 ms (½ of Alsop’s
`echo-train duration) to 300 ms (¾ of Alsop’s echo-train
`duration)
`PO Resp. 14–15. UVAPF relies on the knowledge of a person of ordinary
`skill in the art understanding that Alsop describes an effective echo time
`ratio of 1.3 to 2 based on the ’182 Application’s discussion of Alsop. PO
`Resp. 15. We are also not persuaded by UVAPF’s argument that a person of
`ordinary skill in the art would understand the “inherent upper limitation of
`the ‘at least twice’ limitation is equal to the ratio of T1/T2” (PO Resp. 17–18
`(citing Ex. 2023 ¶ 61; Ex. 2025 ¶ 16), or readily derive the range of the
`effective echo time ratio (PO Resp. 19–23). We are also not persuaded that
`the effective echo time has a sufficient correspondence to the T2 relaxation
`times in the prior art that would provide written description support for the
`claimed ratio of at least twice, given that Patent Owner’s arguments and
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`evidence show variances. See PO Resp. 16 & n.5; Ex. 2023 ¶ 58; Ex. 2025
`¶ 18.
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`As discussed above, UVAPF has not established a connection
`between effective echo-train duration and the effective-echo-time ratio
`limitation. Whether a person of ordinary skill could derive the echo time
`ratio limitations from a discussion of admitted prior art in the ’182
`Application is immaterial when, as here, the disclosure does not identify, or
`direct a skilled artisan to, the recited echo time ratio as part of the claimed
`invention. See Purdue Pharm