`571-272-7822
`
`
`Paper 70
`Entered: September 2, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEW WORLD MEDICAL, INC.,
`Petitioner,
`
`v.
`
`MICROSURGICAL TECHNOLOGY, INC.,
`Patent Owner.
`____________
`
`IPR2020-01573
`Patent 9,107,729 B2
`____________
`
`
`
`Before JAMES A. TARTAL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing of Final Written Decision
`37 C.F.R. § 42.71(d)
`
`
`
`
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`IPR2020-01573
`Patent 9,107,729 B2
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`
`INTRODUCTION
`I.
`MicroSurgical Technology, Inc. (“Patent Owner”) is the owner of
`U.S. Patent 9,107,729 B2 (“the ’729 patent,” Ex. 1001). Paper 29, 1
`(“Response” or “Resp.”). New World Medical, Inc. (“Petitioner”) filed a
`Petition for an inter partes review of claims 1–10 (all claims) of the ’729
`patent. Paper 1 (“Pet.”). Trial was instituted on March 16, 2022. Paper 22
`(“Institution Decision” or “DI”). The parties presented their positions and
`arguments on patentability and the evidence of record in a Petition (Paper 1),
`Patent Owner’s Response (Paper 29), Petitioner’s Reply (Paper 35), and
`Patent Owner’s Sur-Reply (Paper 44). After considering the parties’
`positions and arguments, and the evidence of record, we concluded that
`Petitioner proved by a preponderance of the evidence that claims 1–10 of the
`’729 patent are unpatentable because they would have been obvious under
`35 U.S.C. § 103 over Quintana and Lee.1, 2 Paper 64 (“Final Decision” or
`“FD”).
`Patent Owner timely filed a request for rehearing of our Final
`Decision. Paper 65 (“Request” or “Req.”). Patent Owner argues we erred in
`concluding the claims are unpatentable because: (1) Quintana fails to teach
`“first and second cutting edges concurrently cutting, from the trabecular
`meshwork, a strip of tissue,” as recited by claim 1; (2) it was impermissible
`hindsight to rely on Exhibits 1031–1033 (“the Netland videos”); (3) there
`would not have been motivation for the ordinarily skilled artisan to combine
`
`
`1 Manuel Quintana, Gonioscopic Trabeculotomy. First Results in
`DOCUMENTA OPHTHALMOLOGICA PROCEEDINGS SERIES 43, SECOND
`EUROPEAN GLAUCOMA SYMPOSIUM 265–71 (E.L. Greve et al. eds. 1985).
`Ex. 1004 (“Quintana”).
`2 U.S. Patent 4,900,300 (issued Feb. 13, 1990). Ex. 1006 (“Lee”).
`
`2
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`Patent 9,107,729 B2
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`Quintana and Lee; (4) Quintana and Lee fail to teach “a dual blade device”
`(that concurrently cut trabecular meshwork) as recited by claim 1; (5) we
`substituted expert witness assertions for claim elements missing from
`Quintana and Lee; and (6) we substituted our own analysis regarding Lee
`teaching an angled tip of its device where that fact was not raised by
`Petitioner. See generally Req. Our discussion below addresses these issues
`with the understanding that Patent Owner presents specific arguments on
`these points throughout its Request.
`II. STANDARD OF REVIEW
`The standard applicable to a request for rehearing of a Board decision
`is provided in Rule 42.71(d), which states in pertinent part:
`The burden of showing a decision should be modified lies with
`the party challenging the decision. The request must
`specifically identify all matters the party believes the Board
`misapprehended or overlooked, and the place where each
`matter was previously addressed in a motion, an opposition, or
`a reply.
`37 C.F.R. § 42.71(d) (2021). A request for rehearing is not an opportunity to
`present new arguments or evidence or merely to disagree with the panel’s
`assessment of the arguments or weighing of the evidence.
`III. DISCUSSION
`For the reasons that follow, we find Patent Owner has not shown we
`misapprehended or overlooked any matter in the Final Decision. We
`address Patent Owner’s arguments below.
`
`3
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`Patent 9,107,729 B2
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`A. QUINTANA TEACHES “FIRST AND SECOND CUTTING EDGES
`CONCURRENTLY CUTTING, FROM THE TRABECULAR MESHWORK, A
`STRIP OF TISSUE”
`Patent Owner argues that that Quintana does not teach the successful
`removal of a strip of trabecular meshwork. Req. 3–4.3 Patent Owner further
`argues there is no evidence in the record to support that Quintana teaches
`“creating a strip of TM using a slightly, bent hypodermic needle tip, much
`less by the concurrent cutting of the beveled sides of the needle tip.” Id. at
`5.
`
`We address in the Final Decision the question of whether Quintana
`teaches “first and second cutting edges concurrently cutting, from the
`trabecular meshwork, a strip of tissue,” as recited by claim 1, which is an
`issue previously raised by Patent Owner. FD 45–47; see also id. at 33–43
`(addressing whether and determining that Quintana and Lee teach “obtaining
`a dual blade device,” as also recited by claim 1, upon which this limitation is
`
`
`3 Patent Owner’s argument focuses on whether Quintana teaches the claimed
`subject matter and ignores (1) that Petitioner’s ground for unpatentability is
`based on obviousness and a combination of Quintana and Lee, (2) that it is
`over this ground that we found the claims unpatentable as obvious, and
`(3) that we found Lee, like Quintana, teaches a trabecular meshwork
`stripping device having two cutting edges, as claimed. See FD 15–18, 32–
`43; see also DI 10–12, 21–23 (discussing such teachings of Quintana and
`Lee). “Non-obviousness cannot be established by attacking references
`individually where [unpatentability] is based upon the teachings of a
`combination of references. . . . [The references] must be read, not in
`isolation, but for what [they] fairly teach[] in combination with the prior art
`as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
`Nevertheless, we address here Patent Owner’s arguments as presented.
`Patent Owner also argues that we were incorrect in finding the ordinarily
`skilled artisan would have been motivated to combine Quintana and Lee; we
`address this argument below.
`
`4
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`based). As addressed in the Final Decision, Petitioner asserts Quintana
`teaches a dual blade device having first and second cutting edges as a bent-
`tip needle having a beveled tip with two sharp sides and further teaches a
`process where that device is advanced through Schlemm’s canal resulting in
`a strip of trabecular meshwork tissue having a width matching the distance
`between the cutting edges. Id. at 45. The Final Decision also addresses
`Petitioner’s assertion that such a procedure was well known by 2003 and
`that Lee also teaches such a procedure, which cuts and extracts segments of
`trabecular meshwork. Id.
`In the Final Decision we address Patent Owner’s argument that
`Quintana did not teach these limitations, as Patent Owner repeats in its
`Request. Id. at 45–46. The same points that Patent Owner makes in its
`Request now were addressed in the Final Decision. For example, we
`address Quintana’s use of the term “stripped” in several portions of the Final
`Decision. Id. at 37, 45–46. The Final Decision identifies that Quintana’s
`procedure teaches “the TM is stripped slowly, gently, and easily from the
`canal’s lumen . . . as the needle progresses.” Id. at 37 (citing Ex. 1004, 4);
`see also id. at 45–46. We found that Quintana’s disclosure that “TM is
`stripped . . . from the canal’s lumen” evidences the tissue’s removal.4 See
`id. at 37 (citing Ex. 1004, 4, caption to Figure 2; crediting Ex. 1030 ¶¶ 7–
`10). We further explain Quintana’s reference to “acheiv[ing] a section of the
`trabecular meshwork,” and to conducting studies “of the sectioned trabecular
`
`
`4 Further, we found that Lee’s disclosure supported our determination and
`that Dr. Netland’s experiments confirmed that Quintana’s disclosed
`procedure functions to cut a strip of trabecular meshwork from the eye.
`FD 46.
`
`5
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`Patent 9,107,729 B2
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`meshwork,” to similarly evidence cutting a strip of tissue and tissue
`removal.5 Id. at 13 (citing Ex. 1004, 3), 14 (citing Ex. 1004, 8). Quintana
`(and, for that matter, Lee) teaches creating a strip of trabecular meshwork
`using an instrument with blades on two (dual) sides as described above and
`as discussed in the Final Decision. See id. at 42–43.
`We do not find Patent Owner’s argument persuasive for the reasons
`stated in our Final Decision. See id. at 45–47. Accordingly, we did not
`overlook or misapprehend the plain language of the challenged claims or the
`evidence that Quintana, individually and also in view of Lee, discloses
`creating a strip of trabecular meshwork with a bent-tip needle comprising a
`dual blade.
`EXHIBITS 1031–1033 (“THE NETLAND VIDEOS”)
`B.
`Patent Owner argues that we used the Netland videos (Exhibits 1031–
`1033) to justify our decision based on a hindsight reading of Quintana. Req.
`6. Patent Owner further states it is “ambiguous at best whether the Netland
`videos show the creation of a strip of TM.” Id. at 10.
`Dr. Netland’s testimony that Quintana discloses cutting and removal
`of TM tissue (i.e., Quintana’s goniotrabeculotomy) is consistent with a plain
`reading of the reference, and we credit Dr. Netland’s explanation of how
`Quintana would have been understood by the ordinarily skilled artisan. See
`FD 33, 37–43, 46–47. Quintana discloses that, using the tip of the bent
`needle, “the TM is stripped slowly, gently and easily from the canal’s
`
`
`5 Additionally, we found that Lee discloses a procedure it calls “goniectomy,
`which includes using a dual-bladed, hollow tool to excise and remove tissue
`from the eye’s trabecular meshwork via access through the eye’s anterior
`chamber.” FD 32 (Ex. 1006, Abstract, 1:54–2:7, 3:50–57, 4:18– 48, 5:61–
`65, 6:14–27, Figs. 2, 3; Ex. 1003 ¶¶ 101–103).
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`lumen.” FD at 45–46 (citing Ex. 1004, 4) (emphasis added). That “TM is
`stripped . . . from the canal’s lumen” evidences tissue cutting and removal.
`See id. at 13 (citing Ex. 1004, 8, caption to Figure 2). We further view
`Quintana’s reference to “acheiv[ing] a section of the trabecular meshwork,”
`and conducting studies “of the sectioned trabecular meshwork,” to similarly
`evidence cutting a strip of tissue and tissue removal, rather than merely
`slicing through or pushing aside TM tissue. Id. at 13 (citing Ex. 1004, 3), 14
`(citing Ex. 1004, 8, caption to Figure 2).
`We are not persuaded by Patent Owner’s suggestion that, in crediting
`Dr. Netland’s experimental evidence, we improperly “substitut[e] the
`assertions of an expert witness for a missing element.” Req. 8. Rather, we
`looked first to what Quintana expressly discloses, and further considered
`Dr. Netland’s testimony on how one of ordinary skill in the art would have
`understood Quintana’s teachings, which corroborated the reference’s express
`disclosure.
`We also credit Dr. Netland’s experimental evidence (Exs. 1031–1033)
`and related testimony (Ex. 1030). His video-recorded experiment sought to
`perform the procedure taught by Quintana, and bolstered his original
`testimony by showing that Quintana’s bent needle, when used in Quintana’s
`procedure, cuts and removes a strip of trabecular meshwork from a human
`eye, just as he testified. See, generally, FD 39–42 (discussing Exs. 1031–
`1033). Patent Owner argues that, rather than showing a strip of tissue cut
`from the TM by the opposing beveled edges of the bent hypodermic needle,
`Dr. Netland’s demonstration could show “merely incising the TM and
`creating a separation between the TM and Schlemm’s canal.” Req. 9–10.
`Patent Owner bases this conjecture on the disclosure of a bent hypodermic
`
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`needle in the of-record, but secondary and unasserted Johnstone reference,
`which discussed “push[ing] a strip of meshwork ahead of itself in the
`manner of a plow.” Id. (citing Ex. 1005, 907).
`In raising Johnstone, Patent Owner presents a new argument—one
`unsupported by evidence—regarding how one of ordinary skill in the art
`would have understood Johnstone’s plow analogy. Thus, to the extent we
`were to credit Patent Owner’s theory, it appears to be attorney argument
`unsupported by record evidence. We note, however, that Patent Owner
`mischaracterizes Johnstone because the preceding sentences in Johnstone
`explain that the instrument was positioned to
`present[] a triangular shape with its base facing the external
`wall of Schlemm's canal, and a sharp slanting edge engaging
`the trabecular meshwork. This was intended to cut the inner
`wall of the canal and the trabecular sheets from within the
`canal while limiting damage to the external wall of the canal.
`Ex. 1005, 907 (emphasis added); see also Ex. 2021, 129:10–133:14
`(Dr. Netland testifying that Johnstone used a bent needle to excise a strip of
`trabecular meshwork). We read Johnstone’s suggestion that the “sharp
`slanting edge” of the instrument would “cut the inner wall of the canal and
`the trabecular sheets from within the canal” as consistent with our
`conclusion that the beveled edges of Quintana’s bent needle tip would cut a
`strip of TM tissue from the eye, just as Dr. Netland’s testifies and as his
`evidentiary videos illustrate. Whether Johnstone’s tool thereafter pushes the
`cut tissue is immaterial.
`The determinations in the Final Decision are based on the disclosure
`of Quintana, individually and in view of Lee. See generally FD. We did not
`rely on impermissible hindsight.
`
`8
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`C.
`
`THERE WERE REASONS FOR THE ORDINARILY SKILLED ARTISAN TO
`COMBINE QUINTANA AND LEE
`Patent Owner argues that the devices of Quintana and Lee are not
`used for the same purpose because Quintana does not teach creating a strip
`of trabecular meshwork. Req. 6. Patent Owner further states that we
`identified that Quintana teaches “goniotomy” and Lee teaches “goniectomy”
`and then dismissed this nomenclature to arrive at our decision. Id. at 7.
`Patent Owner states the difference in terms “is critical and cannot be
`overcome without resorting to impermissible hindsight.” Id.
`In the Final Decision, the use of different terms in the art is addressed
`and, regardless of the term used in Quintana, the term “stripped” is also used
`to describe how Quintana’s procedure cuts and removes trabecular
`meshwork tissue. FD 46 (citing Ex. 1004, 4). Quintana clearly states “the
`TM is stripped slowly, gently and easily from the canal’s lumen.” Id. Not
`only does Quintana state “the TM is stripped,” but Quintana also specifically
`indicates this stripping is “from the canal’s lumen,” evidencing that a strip of
`tissue is created and removed. See Id.
`The Final Decision also addresses the ordinarily skilled artisan’s
`motivation to combine Quintana and Lee. Id. at 26–31. Both the modified
`hypodermic needle of Quintana and the tool taught by Lee are used in a
`substantially identical procedure and the Final Decision states that one of
`skill in the art would look to Lee “for details for a trabecular meshwork
`stripping tool and method because that is exactly what Lee teaches designing
`and using a tool for.” Id. at 30. Furthermore, the Decision also identifies
`that one of skill in the art would have modified Quintana in view of Lee
`based on “advantages expressed by the references themselves, such as
`providing sharp cutting edges to better excise tissue.” Id. at 29.
`
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`
`As discussed above, both Quintana and Lee teach using their tools to
`create a strip of trabecular meshwork. Id. at 26–31. Indeed, we noted that
`Lee expressly illustrates this process. Id. 33 (citing Ex. 1006, 1:50–54,
`5:55–6:45, Fig. 5). The Final Decision addresses the arguments Patent
`Owner raises now and we do not find the arguments persuasive for the
`reasons stated in the Final Decision. Id. at 45–47. Accordingly, the
`motivation to combine Quintana and Lee was previously addressed; we
`found there would have been motivation to combine the prior art references.
`THE QUINTANA AND LEE COMBINATION TEACHES “A DUAL
`D.
`BLADE DEVICE”
`Patent Owner further argues Lee does not teach a “dual blade,” but
`instead “a single more or less U-shaped cutting edge 14 integral with the
`sides of the shaft 10.” Req. 8. Patent Owner argues our finding “stands in
`direct contravention to its plain and ordinary meaning construction that ‘dual
`refers to two.’” Id. (citing FD 16).
`Patent Owner inaccurately characterizes Lee and does not consider the
`full description of Lee as discussed in the Final Decision. See FD 15–18
`(citing Ex. 1006, 7:34–35 (claim 1 reciting “rim is sharpened so as to form a
`cutting blade having side cutting edges and a distal tip”)). The Final
`Decision identifies that Lee teaches “edges,” plural, and thus two sides or a
`dual blade. See id.
`Patent Owner argues that Quintana also does not teach a dual blade,
`but instead a “typical single bevel at the needle tip.” Req. 9. Patent Owner
`also argues that our characterization of the “needle tip as cutting edges . . .
`does not comport with the intended use of a standard hypodermic needle for
`medicament delivery.” Id. Patent Owner also argues that our
`characterization is inconsistent with the prior art. Id.
`
`10
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`
`Contrary to Patent Owner’s position, Quintana does not disclose “the
`intended use of a standard hypodermic needle.” See, e.g., id. at 13–14.
`Quintana’s bent needle tip, used to strip trabecular meshwork, is addressed
`in the Final Decision and Dr. Netland, and even Dr. Condon (Patent Owner’s
`witness), described the bent needle tip as having two sides. FD 38
`(reproducing diagrams annotated by Dr. Netland and Dr. Condon, each
`pointing to two sides).
`As discussed above, both Quintana and Lee teach a dual blade device,
`each used for essentially the same purpose––cutting and stripping Trabecular
`Meshwork. Id. at 37–39. The Final Decision addressed the arguments
`Patent Owner now raises and we do not find these arguments persuasive for
`the reasons stated in the Final Decision. Id. As such, Patent Owner
`identifies no argument or evidence overlooked or misapprehended in the
`Final Decision.
`E. WE DID NOT SUBSTITUTE EXPERT WITNESS ASSERTIONS FOR
`CLAIM ELEMENTS MISSING FROM QUINTANA AND LEE
`Patent Owner argues that there is no teaching of “excising TM in
`Quintana, much less any disclosure of creating a strip of TM.” Req. 11.
`Patent Owner states that there is nothing in Quintana to suggest a section
`was removed because no data was collected regarding tissue removal. Id.
`Patent Owner further argues that we relied on “Petitioner’s expert that the
`words ‘achieving a section’ and ‘stripped slowly, gently and easily from the
`canal’s lumen’ must mean a strip of TM was created, and ignores all
`contrary evidence of record.” Id. Patent Owner also argues that the beveled
`sides of the Quintana bent needle would not be able to cut the trabecular
`meshwork as opposed to the sharp point of the needle tip. Id.
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`
`Dr. Netland’s testimony that Quintana discloses removal of TM tissue
`(i.e., a goniotrabeculotomy), is consistent with our reading of the reference,
`and we credit Dr. Netland’s explanation of how Quintana would have been
`understood by the ordinarily skilled artisan. Quintana discloses that when
`using the tip of the bent needle, “the TM is stripped slowly, gently and
`easily from the canal’s lumen.” FD at 45–46 (citing Ex. 1004, 4) (emphasis
`added). Again, that “TM is stripped . . . from the canal’s lumen” evidences
`tissue is cut and removed. See id. at 13 (citing Ex. 1004, 8, caption to
`Figure 2). We further view Quintana’s reference to “achiev[ing] a section of
`the trabecular meshwork,” and conducting studies “of the sectioned
`trabecular meshwork,” to similarly evidence cutting a strip of tissue and
`tissue removal, rather than merely slicing through or pushing aside TM
`tissue. Id. at 13 (citing Ex. 1004, 3), 14 (citing Ex. 1004, 8, caption to
`Figure 2).
`For the reasons set forth in the Final Decision, we find that Quintana
`teaches cutting a strip of trabecular meshwork from the eye within the four
`corners of the reference. See id. at 13, 45–47. As such, Patent Owner
`identifies no argument or evidence overlooked or misapprehended in the
`Final Decision.
`F. WE DID NOT SUBSTITUTE OUR OWN ANALYSIS REGARDING LEE
`TEACHING AN ANGLED TIP OF ITS DEVICE
`Patent Owner argues that our “substitution of [our] own analysis
`regarding the purported angle cutting edge 14 in Lee is also improper”
`because it was not raised by Petitioner. Req. 13. Patent Owner further states
`that we disregarded Petitioner’s expert stating that a roughly 90° bend would
`not achieve the same results. Id. at 14. Patent Owner also asserts that our
`
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`conclusion regarding the bend angle based on the surgeon’s desires and
`surgical requirements is contradicted by the record. Id.
`As an initial matter, we did not rely on Lee’s teaching of bending its
`devices tip at any certain angle to render the claims obvious. The Final
`Decision explains that Quintana teaches “bending its needle’s tip up to 30°,
`which is less than the claimed 90°.” FD 54. As further explained, Lee is
`combined with Quintana to provide “supporting information” and a teaching
`that the tip of the device can be bent at any angle needed for the particular
`surgery. Id. at 30. Quintana teaches and renders obvious the limitations of
`claims 9 and 10, and our Final Decision takes note that Lee is fully
`supportive of teaching bending the end of a trabecular meshwork excising
`device at any necessary angle. Id. at 54–56.
`Our determination regarding claims 9 and 10 does not amount to a
`new ground of unpatentability not raised by Petitioner in the Petition.
`IV. CONCLUSION
`Having considered Patent Owner’s arguments, we are unpersuaded
`that the Request for Rehearing demonstrates that we misapprehended or
`overlooked any matters. See summary charts below:6
`Outcome of Decision on Rehearing:
`
`Claims
`
`35 U.S.C. § References
`
`Denied
`
`Granted
`
`1–4, 7–9
`
`102
`
`Quintana
`
`
`
`
`
`
`6 As reflected in these charts, Petitioner’s grounds for unpatentability based
`on Quintana’s anticipation, obviousness over Quintana alone, and over the
`Jacobi reference were not reached because all claims were found to be
`unpatentable as obvious over Quintana and Lee.
`
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`
`Claims
`
`35 U.S.C. § References
`
`Denied
`
`Granted
`
`4–6, 10
`
`1–4, 7–9
`
`4–6, 10
`
`1–4, 7, 8
`
`5, 6, 9, 10
`Overall
`Outcome
`
`103
`
`103
`
`103
`
`102
`
`103
`
`
`
`Quintana
`
`Quintana,
`Lee
`Quintana,
`Lee
`
`Jacobi
`
`Jacobi
`
`
`
`1–4, 7–9
`
`4–6, 10
`
`
`
`
`
`
`
`1–10
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Outcome of Final Written Decision after Rehearing:
`Claims
`Shown
`Unpatentable
`
`
`Claims
`
`35 U.S.C. § References
`
`1–4, 7–9
`
`102
`
`Quintana
`
`Claims Not
`Shown
`Unpatentable
`
`
`4–6, 10
`
`1–4, 7–9
`
`4–6, 10
`
`1–4, 7, 8
`
`5, 6, 9, 10
`Overall
`Outcome
`
`
`103
`
`103
`
`103
`
`102
`
`103
`
`
`
`Quintana
`
`Quintana,
`Lee
`Quintana,
`Lee
`
`Jacobi
`
`Jacobi
`
`
`
`1–4, 7–9
`
`4–6, 10
`
`
`
`
`
`
`
`1–10
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`ORDER
`
`Accordingly, it is hereby:
`ORDERED that Patent Owner’s Request for Rehearing is denied.
`
`
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`For PETITIONER:
`
`Todd R. Tucker
`Kyle T. Deighan
`CALFEE, HALTER & GRISWOLD LLP
`ttucker@calfee.com
`kdeighan@calfee.com
`
`
`For PATENT OWNER:
`
`Lawrence M. Sung
`Mary Sylvia
`Teresa M. Summers
`WILEY REIN LLP
`lsung@wileyrein.com
`msylvia@wileyrein.com
`tsummers@wileyrein.com
`
`
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