Trials@uspto.gov
`571-272-7822
`
`
`
` Paper 8
` Entered: December 22, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INGURAN, LLC d/b/a SEXING TECHNOLOGIES,
`Petitioner,
`
`v.
`
`PREMIUM GENETICS (UK) LTD.,
`Patent Owner.
`____________
`
`Case PGR2015-00017
`Patent 8,933,395 B2
`
`
`
`Before KEN B. BARRETT, KRISTEN L. DROESCH,
`TRENTON A. WARD, Administrative Patent Judges.
`
`
`DROESCH, Administrative Patent Judge.
`
`
`
`DECISION
`
`Institution of Post-Grant Review
`35 U.S.C. § 324, 37 C.F.R. § 42.208
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
` Paper 8
` Entered: December 22, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INGURAN, LLC d/b/a SEXING TECHNOLOGIES,
`Petitioner,
`
`v.
`
`PREMIUM GENETICS (UK) LTD.,
`Patent Owner.
`____________
`
`Case PGR2015-00017
`Patent 8,933,395 B2
`
`
`
`Before KEN B. BARRETT, KRISTEN L. DROESCH,
`TRENTON A. WARD, Administrative Patent Judges.
`
`
`DROESCH, Administrative Patent Judge.
`
`
`
`DECISION
`
`Institution of Post-Grant Review
`35 U.S.C. § 324, 37 C.F.R. § 42.208
`
`
`
`
`
`
`
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`I. INTRODUCTION
`
`
`
`Inguran, LLC d/b/a/ SEXING Technologies (“Petitioner”) filed a
`
`Petition for post-grant review of claims 1–14 (“the challenged claims”) of
`
`U.S. Patent No. 8,933,395 B2 (“the ’395 Patent”). Paper 1 (“Petition” or
`
`“Pet.”). See 35 U.S.C. §§ 321–322. Premium Genetics Ltd. (“Patent
`
`Owner”) filed a Preliminary Response. Paper 6 (“Prelim. Resp.”). See 35
`
`U.S.C § 323. We have statutory authority under 35 U.S.C. § 324, which
`
`provides that post-grant review shall not be instituted unless it is determined
`
`that “the information presented in the petition filed under section 321, if
`
`such information is not rebutted, would demonstrate that it is more likely
`
`than not that at least 1 of the challenged claims in the petition is
`
`unpatentable.” 35 U.S.C. § 324(a).
`
`
`
`For the reasons provided below, and for purposes of this decision, we
`
`are persuaded by Petitioner that it is more likely than not that the challenged
`
`claims are unpatentable.
`
`The ’395 Patent (Ex. 1001)
`
`
`
`The ’395 Patent issued from Application No. 14/169,927 filed on
`
`January 31, 2014. Ex. 1001, 1. The ’395 Patent claims benefit under 35
`
`U.S.C. §§ 119(e), 120, 121 to filing dates of several provisional and non-
`
`provisional applications filed before March 16, 2013, including Application
`
`No. 13/412,969, filed March 6, 2012 (“the ’969 Application”). Ex. 1001, 1–
`
`2, Ex. 1013, 849–850,1 see Pet. 11.
`
`
`
`The ’395 Patent discloses “a method and apparatus to identify at least
`
`one component from a plurality of components in a fluid mixture,” including
`
`
`
`1 Exhibit 1013 does not include page numbers. The page numbers listed
`correspond to the pagination in Patent Review Processing System (PRPS).
`
`2
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`“a detector apparatus which detects and identifies selected components” and
`
`“a laser which emits a laser beam which damages or kills selected
`
`components of the plurality of components.” Ex. 1001, Abs.
`
`
`
`Figure 1 of the ’395 Patent is reproduced below:
`
`
`
`Figure 1 depicts apparatus 100 including sorting channel 110, plurality of
`
`inlets 120, plurality of outlets 130, and corresponding fluid flows W, X, Y,
`
`and Z. Ex. 1001, 13:20–28. Flow W can be a sample fluid, and flows X, Y,
`
`and Z can be buffer solutions. Id. at 16: 11–13. Apparatus 100 may be
`
`incorporated into a system to allow cell identification, and cell killing by
`
`high intensity laser exposure. Id. at Fig. 26, 23:26–24:42; see id. 33:58–64,
`
`40:10–23. Apparatus 100 “may contain regions which align cells or
`
`materials in a certain way . . . sometimes done through shear flows.” Id. at
`
`21:21–25; see id. at 14:6–23, 41:32–36.
`
`Illustrative Claims
`
`
`
`Claims 1 and 2 are independent. Claims 3–14 depend from claim 2.
`
`Claims 1 and 2 are illustrative:
`
`1. An apparatus to identify at least one component from a
`plurality of components in a fluid mixture, the apparatus
`comprising:
`a first input channel into which a first flow is introduced,
`said first flow which contains the fluid mixture of the
`plurality of components;
`
`3
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`a plurality of buffer input channels, into which additional
`flows of buffer solution are introduced, said plurality of
`buffer channels which are disposed on either side of said
`first input channel;
`wherein said first flow and said additional flows have a flow
`direction along a length of the apparatus from one end of
`the apparatus to another end of the apparatus;
`a detector apparatus which detects and identifies selected
`components of the plurality of components;
`a laser which emits a laser beam which damages or kills
`selected components of the plurality of components; and
`at least one channel disposed at said another end of the
`apparatus, said at least one channel which is adapted to
`receive said first flow and said additional flows after
`operation of said laser on said selected components.
`
`2. A method for examining and selectively operating on
`cells, comprising:
`inputting a stream of sample fluid into an inlet adapted to
`received said sample fluid, into an input region of a flow
`chamber, said sample fluid containing cells to be
`processed;
`inputting a plurality of streams of sheath fluids into a
`plurality of inlets adapted to receive said plurality of
`streams of sheath fluids, into said input region of said
`flow chamber;
`wherein said sample fluid is in a contiguous relationship on
`all available sides with said sheath fluids, from said input
`region through to a selective operation region of said
`flow chamber;
`wherein at least one of flow rates or pressures of said sheath
`fluids are chosen such that said sample fluid is
`constricted in two orthogonal directions, thereby
`allowing said sample fluid to form a relatively narrow
`stream in at least a detector region of said flow chamber,
`thereby causing the cells to be flattened and aligned such
`that flat sides of the cells are oriented parallel to
`confronting walls of the flow chamber;
`distinguishing target cells from non-target cells in said
`detector region using a detector apparatus; and
`
`4
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`damaging or destroying said target cells in said sample fluid
`using a laser beam, in said selective operation region of
`said flow chamber which is disposed downstream from
`said detector region.
`
`Asserted Grounds of Unpatentability
`
`Claim(s) Statutory Basis
`1–14
`§ 112(a) Enablement
`1–14
`§ 112(b) Indefiniteness
`1–13
`§ 102(a)(1)
`14
`§ 103
`1
`§ 102(a)(1)
`1
`§ 102(a)(1)
`2–14
`§ 103
`
`Reference(s)
`
`
`Mueth2
`Mueth alone, or Mueth and Durack3
`Frontin-Rollet4
`Durack
`Wada5, Durack, and Kachel6
`
`II. ANALYSIS
`
`A. Claim Construction
`
`
`
`Claims of an unexpired patent are interpreted using the broadest
`
`reasonable interpretation in light of the specification. 37 C.F.R. § 42.200(b);
`
`see In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed. Cir.
`
`2015). Claim terms also are given their ordinary and customary meaning, as
`
`would be understood by one of ordinary skill in the art in the context of the
`
`entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
`
`Cir. 2007). Petitioner and Patent Owner do not provide explicit claim
`
`
`
`2 Ex. 1008, U.S. Patent No. 7,355,696 B2, issued Apr. 8, 2008, filed Feb. 1,
`2005 (“Mueth”).
`3 Ex. 1005, WO 2004/088283 A2, published Oct. 14, 2004 (“Durack”).
`4 Ex. 1007, WO 2005/075629 A1, published Aug. 18, 2005 (“Frontin-
`Rollet”).
`5 Ex. 1009, U.S. Patent No. 6,506,609 B1, issued Jan. 14, 2003 (“Wada”).
`6 Ex. 1012, Kachel, UNIFORM LATERAL ORIENTATION, CAUSED BY FLOW
`FORCES, OF FLAT PARTICLES IN FLOW-THROUGH SYSTEMS, J. Histochemistry
`and Cytochemistry, vol. 25, no. 7, 1977, 774–780 (“Kachel”).
`
`5
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`constructions for any claim term or phrase. See Pet. 9; see Prelim. Resp.
`
`passim. However, for purposes of this decision, we find it necessary to
`
`construe the terms “channel,” and “side,” and the phrase “said plurality of
`
`buffer channels which are disposed on either side of said first input
`
`channel.”
`
`1. “Channel”
`
`
`
`Claim 1 recites multiple instances of “channel” in the context of
`
`“input channel,” “buffer channels,” and “at least one channel.” Ex. 1001,
`
`44:42–62. The ’395 Patent discloses embodiments including a sorting
`
`channel, a plurality of inlets, and a plurality of outlets. Ex. 1001, Fig. 1,
`
`7:13–51, 13:20–28, 43:26–63. The ’395 Patent also utilizes the terms “input
`
`channel” and “output channel.” Id. at Figs. 11A–11B, 24A, 23:33–37, 27:1–
`
`30, 36:46–37:63; 42:48–55. The ’395 Patent discloses that the sorting
`
`channel has a length, width, and depth. Id. at Fig. 1, 15:27–41. An explicit
`
`definition for the term “channel” is not provided in the ’395 Patent.
`
`Therefore, we turn to the ordinary and customary meaning of “channel,”
`
`which is: “a long gutter, groove, or furrow.” MERRIAM WEBSTER ONLINE
`
`DICTIONARY, http://www.merriam-webster.com/dictionary/channel (last
`
`accessed December 21, 2015).
`
`
`
`
`
`We also observe that the ’395 Patent utilizes interchangeably the
`
`terms “channels” and “flows.” See Ex. 1001, 16:22–25, 16:43–45, 41:23–
`
`31. However, because claim 1 also recites multiple instances of “flow” (e.g.,
`
`“a first input channel into which a first flow is introduced”), we do not
`
`broadly construe “channel,” as recited in claim 1, to include the meaning of
`
`“flow.”
`
`6
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`
`
`Accordingly, for purposes of this decision, we construe the broadest
`
`reasonable interpretation of “channel” as “a long gutter, groove, or furrow”
`
`2. “Side”
`
`
`
`Claims 1 and 2 recite multiple instances of the term “side” in the
`
`context of “either side” and “all available sides.” Ex. 1001, 44:48–51, 45:5–
`
`8. An explicit definition for this term is not provided in the ’395 Patent.
`
`Therefore, we turn to the ordinary and customary meaning of “side” which
`
`is: “one of the longer bounding surfaces or lines of an object especially
`
`contrasted with the ends.” MERRIAM WEBSTER ONLINE DICTIONARY,
`
`http://www.merriam-webster.com/dictionary/side (last accessed December
`
`21, 2015).
`
`
`
`Accordingly, for purposes of this decision, we construe the broadest
`
`reasonable interpretation of the term “side” as “one of the longer bounding
`
`surfaces or lines of an object.”
`
`3. “Plurality of Buffer Channels Disposed on Either Side of the
`Input Channel”
`
`
`
`Claim 1 recites “said plurality of buffer channels which are disposed
`
`on either side of said first input channel.” Ex. 1001, 44:48–51. An explicit
`
`definition for this claim phrase is not provided in the ’395 Patent. Thus, we
`
`turn first to the ordinary and customary meaning of the term “either” in order
`
`to construe the claim phrase. The ordinary and customary meaning of
`
`“either” is: “one and the other of two,” and “one or the other of two.”
`
`MERRIAM WEBSTER ONLINE DICTIONARY, http://www.merriam-
`
`webster.com/dictionary/either (last accessed December 21, 2015). Based on
`
`the ordinary and customary meaning of “either,” and accounting for the
`
`ordinary and customary meanings of “side” and “channel,” discussed above,
`
`the ordinary and customary meaning of the claim phrase is: said plurality of
`
`7
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`buffer channels disposed on one or the other, or one and the other of the two
`
`longer bounding surfaces of the input channel. The ordinary and customary
`
`meaning is consistent with the ’395 Patent disclosure of a plurality of buffer
`
`channels (i.e., inlets corresponding to buffer flows X, Y, and Z) disposed on
`
`one side (i.e., bottom side) of the input channel (i.e., inlet corresponding to
`
`flow W). Ex. 1001, Fig. 1, 16:11–13. The ordinary and customary meaning
`
`of the claim phrase also is consistent with the disclosure of Figure 19 of the
`
`’395 Patent.
`
`
`
`Figure 19 of the ’395 Patent is reproduced below:
`
`
`
`Figure 19 depicts buffer input channel disposed on one side (i.e., top side) of
`
`input channel, and a second buffer input channel disposed on the other side
`
`(i.e., bottom side) of input channel.
`
`
`
`Accordingly, for purposes of this decision, we construe the broadest
`
`reasonable interpretation of the claim phrase as “said plurality of buffer
`
`channels disposed on one or the other, or one and the other of the two longer
`
`bounding surfaces of the input channel.”
`
`B. Standing
`
`
`
`Pursuant to 37 C.F.R. § 42.204(a), the petitioner bears the burden of
`
`setting forth grounds for standing for post-grant review. Specifically, “[t]he
`
`petitioner must certify that the patent for which review is sought is available
`
`for post-grant review and that the petitioner is not barred or estopped from
`
`requesting a post-grant review challenging the patent claims on the grounds
`
`8
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`identified in the petition. Id.; see 37 C.F.R. §§ 42.201, 42.202. Post-grant
`
`review is limited “only to patents described in section 3(n)(1)” of the Leahy-
`
`Smith America Invents Act (“AIA”)–––patents subject to the first inventor
`
`to file provisions of the AIA. AIA § 6(f)(2)(A), 125 Stat. 284, 311 (2011).
`
`In addition, “[a] petition for a post-grant review may only be filed not later
`
`than the date that is 9 months after the date of the grant of the patent.”
`
`35 U.S.C. § 321(c); see 37 C.F.R. § 42.202(a).
`
`
`
`Patent Owner does not dispute the Petition was filed within 9 months
`
`following the grant of the ’395 Patent on January 13, 2015. See Pet. 2; see
`
`Prelim. Resp. passim. Patent Owner also does not dispute Petitioner’s
`
`representations that it is not barred or estopped from requesting a post-grant
`
`review of the ’395 Patent. See Pet. 1; see Prelim. Resp. passim. The only
`
`dispute is whether the ’395 Patent is subject to the first inventor to file
`
`provisions of the AIA. See Pet. 3–4, 10–22; see Prelim. Resp. passim.
`
`1. Discussion
`a. First Inventor To File Provisions of AIA § 3(n)(1)
`
`
`
`Section 3(n)(1) establishes that the first inventor to file (“FITF”)
`
`provisions of the AIA “shall apply to any application for patent, and to any
`
`patent issuing thereon, that contains or contained at any time––
`
`(A) a claim to a claimed invention that has an effective
`
`filing date as defined in section 100(i) of title 35, United States
`Code, that is on or after the [March 16, 2013] effective
`date . . . ; or
`
`(B) a specific reference under section 120, 121, or 365(c)
`of title 35, Unites States Code, to any patent or application that
`contains or contained at any time such a claim.
`
`AIA § 3(n)(1), 125 Stat. at 293.
`
`9
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`b. Effective Filing Date
`
`
`
`The term “effective filing date” for a claimed invention in a patent or
`
`application for patent means “the filing date of the earliest application for
`
`which the patent is entitled, as to such invention, to a right of priority under
`
`section 119, 365(a), or 365(b) or to the benefit of an earlier filing date under
`
`section 120, 121, or 365(c).” 35 U.S.C. § 100(i)(1); see also AIA § 3(a),
`
`125 Stat. at 285 (amending 35 U.S.C. § 100).
`
`c. Benefit under §§ 119, 120, 121, or 365 and Disclosure under § 112(a)
`
`
`
`Entitlement to the benefit of an earlier date under §§ 119, 120, 121,
`
`and 365, is premised on disclosure of the claimed invention “in the manner
`
`provided by § 112(a)7 (other than the requirement to disclose the best
`
`mode)” in the application for which the benefit of the earlier filing date is
`
`sought. See 35 U.S.C. §§ 119(e), 120. Certain patent applications filed on
`
`or after March 16, 2013, claiming the benefit under §§ 119, 120, 121, or 365
`
`of an earlier filing date prior to March 16, 2013, (“transition applications”),
`
`may be subject to either the AIA FITF statutory provisions or the pre-AIA
`
`first to invent statutory provisions. See MPEP §§ 2159.03–2159.04.
`
`
`
`The inquiry into whether a patent issued from a transition application
`
`is subject to the AIA FITF statutory provisions and, thus, available for post-
`
`grant review turns on whether the patent contains, or the corresponding
`
`application contained at any time, a claim that has an effective filing date on
`
`or after March 16, 2013. See AIA § 3(n)(1); 35 U.S.C. § 100(i). In other
`
`words, the issue turns on whether the patent contains, or the corresponding
`
`application contained at any time, a claim that is not entitled to the benefit
`
`
`
`7 Section 4(c) of the AIA redesignated 35 U.S.C. § 112 ¶ 1 as 35 U.S.C.
`§ 112(a). 125 Stat. at 296.
`
`10
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`under §§ 119, 120, 121, or 365 to an earlier filing date prior to March 16,
`
`2013. See id. Therefore, a patent granted from a transitional application
`
`would be available for post-grant review, if the patent contains, or the
`
`corresponding application contained at any time, at least one claim that was
`
`not disclosed in compliance with the written description and enablement
`
`requirements of § 112(a) in the earlier application for which the benefit of an
`
`earlier filing date prior to March 16, 2013 was sought. See id.
`
`2. Analysis of the Effective Filing Date of the ’395 Patent
`
`
`
`The parties agree the ’395 Patent Specification is identical to the
`
`Specification for U.S. Patent No. 7,118,676 (Ex. 1018), issued from
`
`Application No. 10/934,597 filed September 3, 2004, and all of the
`
`intervening Patents, including U.S. Patent No. 8,653,442 (Ex. 1004), issued
`
`from the ’969 Application. Pet. 11, 13, 17; Prelim Resp. 2, 4, 5. Petitioner
`
`asserts the ’395 Patent is available for post-grant review pursuant to AIA
`
`§ 3(n)(1) because the challenged claims have an earliest effective filing date
`
`of January 31, 2014, because independent claims 1 and 2 were not disclosed
`
`in the manner required by § 112(a) in the applications having filing dates
`
`before March 16, 2013. Pet. 3, 10–12 (citing Ex. 1013, 842–846), 12–22.
`
`Patent Owner disagrees, and contends the ’395 Patent is entitled to a pre-
`
`AIA effective filing date because it claims the benefit of the filing dates
`
`going back to at least September 3, 2004. Prelim. Resp. 1–2, 4–5.
`
`
`
`We have considered Patent Owner’s arguments that an effective filing
`
`date analysis is not warranted at the institution stage based on the
`
`prosecution history. See Prelim. Resp. 2–4. However, in view of 35 U.S.C.
`
`§ 324, we are not persuaded that no effective filing date analysis by the
`
`Board is warranted in this case. Patent Owner also argues Petitioner’s
`
`11
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`citation to SAP Am., Inc. v. Pi–Net Int’l, Inc., Case IPR2014-00414, slip op.
`
`11–16 (PTAB Aug. 18, 2014) (Paper 11) (see Pet. 10) to support the
`
`proposition that an effective filing date analysis is an appropriate part of an
`
`institution decision is not applicable to post-grant reviews because the
`
`effective filing date is not a threshold issue in inter-partes review. Id. at 3–
`
`4. We are not persuaded by Patent Owner’s distinction between an effective
`
`filing date analysis of a challenged patent in a decision on institution of inter
`
`partes review for establishing a reference as prior art (see SAP Am., Case
`
`IPR2014-00414, slip op. 11–16), and an effective filing date analysis of a
`
`challenged patent in a decision on institution of post-grant review for
`
`establishing standing. Lastly, Patent Owner’s argues:
`
`it would be both inefficient and unfair to force a patent owner to
`undergo a post-grant review proceeding of a pre-AIA patent
`only to have the Board ultimately conclude that a patent was
`ineligible for post-grant review and that [Petitioner lacked
`standing]. The procedures for post-grant review themselves
`buttress this conclusion, as they allow the Petitioner to present
`expert witness testimony on this issue, while the Patent Owner
`ordinarily cannot do the same at the institution stage. This
`[standing] issue should not be decided on such unbalanced
`evidence.
`
`Prelim. Resp. 4–5. We are not persuaded by these arguments because Patent
`
`Owner is not precluded from challenging standing, with supporting
`
`testimonial evidence, in its patent owner response. See Rules of Practice for
`
`Trials Before the Patent Trial and Appeal Board and Judicial Review of
`
`Patent Trial and Appeal Board Decisions; Final Rule, 77 Fed. Reg. 48,612,
`
`48,695 (Aug. 14, 2012) (“After institution, standing issues may still be
`
`raised during trial.”), id. at 48,709 (“Once a proceeding is initiated, a
`
`party . . . may challenge standing in its patent owner response.”).
`
`12
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`
`
`In addition to the arguments above, Petitioner presents specific
`
`contentions regarding written description support in the ’969 Application for
`
`independent claims 1 and 2, which are disputed by Patent Owner. See Pet
`
`12–23; Prelim. Resp. 2–17. We address below the parties’ respective
`
`contentions regarding claims 1 and 2.
`
`a. Claim 1
`
`Petitioner asserts “at least one channel disposed at said another end of
`
`the apparatus is adapted to receive said first flow and said additional flows
`
`after operation of said laser on said selected components,” is not disclosed in
`
`the ’969 Application. Pet. 13. Petitioner contends “claim 1 expressly
`
`encompasses one output channel and covers an apparatus where the fluid
`
`sample containing the cells or other components is combined with the buffer
`
`solution from the ‘plurality of buffer input channels’ into a single channel.”
`
`Id. Petitioner argues “[t]here is no single channel adapted to receive these
`
`multiple flows ‘after operation of said laser on said selected components.’”
`
`Id. (citing Ex. 1002 ¶ 86); see id. at 15–18. Petitioner also argues that two
`
`passing references in the ’969 Application to “one or more channels” and the
`
`use of “any number of flows” are not sufficient to disclose the use of a
`
`single, combined receiving channel after operation of the laser, as recited in
`
`claim 1. Id. at 16 (citing Ex. 1004, 11:66–12:4, 16:22–25).
`
`We agree with Patent Owner that Petitioner’s arguments are premised
`
`on an incorrect reading of claim 1. See Prelim. Resp. 7, 9–10, 12.
`
`Specifically, we agree that claim 1 does not require combining flows into a
`
`single flow, and does not require a single output channel. See id. at 7–8, 11.
`
`Claim 1 recites “at least one channel,” therefore encompassing one channel,
`
`and more than one channel. The recitation of “at least one channel” does not
`
`13
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`include any qualifiers such that it is limited to output channel(s). The only
`
`qualifiers for the at least one channel required by claim 1 are: (1) disposed
`
`at said another end of the apparatus, and (2) adapted to receive said first flow
`
`and said additional flows after operation of said laser.
`
`
`
`As pointed out by Patent Owner, Figure 1 of the ’969 Application
`
`explains element 110 is a sorting channel containing four flows, and
`
`demonstrates that sorting channel 110 can have numerous inputs 120 and
`
`outputs 130. Id. at 8 (citing Ex. 1001, 13:21–2), 11. Patent Owner further
`
`asserts the ’395 Patent (and ’969 Application) “contemplates embodiments
`
`with only a single channel.” Id. at 11 (citing Ex. 1001, 11:66–12:4 (“The
`
`various embodiments, as described below, utilize one or more sorting
`
`channels, having a plurality of substantially laminar flows.”)). The ’395
`
`Patent and the ’969 Application disclose apparatus 100 of Figure 1 can be
`
`used in conjunction with the laser apparatus for killing cells, and explains all
`
`or a portion of the central sorting region (i.e., sorting channel) may be
`
`covered with glass to allow laser killing of samples. Ex. 1001, 23:26–40,
`
`24:1–38, Fig. 26; Ex. 1004; 23:26–67, 24:1–13, Fig. 26. For purposes of
`
`this decision, “at least one channel disposed at said another end of the
`
`apparatus [] adapted to receive said first flow and said additional flows after
`
`operation of said laser on said selected components” is disclosed sufficiently
`
`in at least Figure 1 of the ’969 Application by the portion of sorting channel
`
`110 located adjacent to outputs 130.
`
`
`
`On this record, we are not persuaded that claim 1 is not disclosed in
`
`the ’969 Application in the manner required by 35 U.S.C. § 112 (a), and,
`
`therefore, we are not persuaded that claim 1 is not entitled to an effective
`
`filing date before March 16, 2013.
`
`14
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`
`
`Independent claim 2 recites:
`
`b. Claim 2
`
`at least one of flow rates or pressures of said sheath fluids are
`chosen such that said sample fluid is constricted in two
`orthogonal directions, thereby allowing said sample fluid to
`form a relatively narrow stream in at least a detector region of
`said flow chamber, thereby causing the cells to be flattened and
`aligned such that flat sides of the cells are oriented parallel to
`confronting walls of the flow chamber.
`
`Ex. 1001, 45:9–16 (“the constriction, alignment, and orientation recitation”).
`
`Petitioner asserts the ’969 Application and other prior applications do not
`
`“disclose choosing a flow rate or pressure that constricts the sample stream
`
`in a manner that ‘caus[es] the cells to be flattened and aligned such that the
`
`flat sides of the cells are oriented parallel to confronting walls of the flow
`
`chamber.’”8 Pet. 19. Petitioner asserts there is only a brief disclosure in the
`
`’969 Application that relates remotely to alignment of cells (id. at 19–20
`
`(citing Ex. 1004, 21:21–25)), and argues that the mere possibility of cell
`
`alignment through shear flows is insufficient to disclose cell alignment such
`
`that the flat sides of the cells are oriented parallel to confronting walls of the
`
`flow chamber (id. at 20 (citing Ex. 1002 ¶ 155)). Petitioner contends the
`
`first time the constriction and cell orientation elements were disclosed was
`
`when claim 2 was submitted in the preliminary amendment filed on January
`
`13, 2014. Id. at 21 (citing Ex. 1013, 844, Cl. 74, Ex. 1002 ¶¶ 64, 163).
`
`
`
`Patent Owner contends the ’969 Application discloses: (1) alignment
`
`of cells can be achieved by shearing the solution, and (2) the device may
`
`
`
`8 Petitioner gives patentable weight to the “thereby” clauses of claim 2.
`Patent Owner does not dispute the patentable weight accorded to the
`“thereby” clauses by Petitioner. See Prelim. Resp. 13–17.
`
`15
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`contain regions which align cells in a certain way, done through shear flows
`
`Prelim. Resp. 14 (citing Ex. 1004, 14:7–23, 21:21–25). Patent Owner
`
`further directs attention to U.S. Patent No. 5,007,732 (Ex. 2001, “Ohki”)
`
`cited during prosecution of the ’395 Patent, as providing the following
`
`disclosure:
`
`flow of the fluid in the capillary flow passage 8 is a laminar
`flow having a velocity gradient, i.e., a sheared flow. The cell
`13 subjected to the sheared flow, therefore, is deformed into a
`cell 13 which has a form symmetrical with respect to the axis
`thereof, as shown if Fig. 4. . . . As a result, all the cells, even if
`they may be flat, take the same posture when they pass through
`the measuring section, whereby any fluctuation of the measured
`data is avoided to ensure a high degree of precision of
`measurement.
`
`Id. at 16 (citing Ex. 2001, 4:14–26). Patent Owner concludes “[o]ne of
`
`ordinary skill in the art would understand that subjecting a sample to a shear
`
`flow causes cells to be flattened and aligned (i.e., to take the same posture),
`
`with the flat sides parallel to the walls, outside which the detector is
`
`disposed (e.g., Fig. 11B in ‘969 Application, Ex. 1004).” Id.
`
`
`
`In order to comply with the written description requirement of § 112,
`
`“a prior application itself must describe an invention, and do so in sufficient
`
`detail that one skilled in the art can clearly conclude that the inventor
`
`invented the claimed invention as of the filing date sought.” Lockwood v.
`
`Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also VasCath
`
`v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991) (“the applicant must
`
`convey with reasonable clarity to those skilled in the art that, as of the filing
`
`date sought, he or she was in possession of the invention . . . now claimed.”)
`
`(emphasis added). A description which renders obvious the invention for
`
`which an earlier filing date is sought is not sufficient.” Lockwood, 107 F.3d
`
`16
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`at 1572. Thus, the relevant inquiry here is whether the ’969 Application
`
`conveys that Patent Owner was in possession of the invention set forth in
`
`claim 2.
`
`
`
`For purposes of this decision, we determine the descriptions of
`
`aligning cells through shear flows in the ’969 Application (see Ex. 1004,
`
`14:7–23, 21:21–25), do not disclose the invention in sufficient detail such
`
`that one skilled in the art could conclude clearly that before March 16, 2013,
`
`the inventor was in possession of the claimed subject matter in dispute.
`
`Patent Owner cites to an unrelated prior art reference, Ohki, to allegedly
`
`demonstrate that one with ordinary skill in the art would understand that
`
`cells subjected to a shear flow would have the same posture when they pass
`
`through a measuring section. Prelim. Resp. 16 (citing Ex. 2001, 4:14–26).
`
`Patent Owner fails to identify sufficiently how a person of ordinary skill in
`
`the art aware of Ohki would understand, in view of the ’969 Application,
`
`that Patent Owner was in possession of the specific constriction and cell
`
`orientation elements recited in claim 2. Accordingly, we are not persuaded
`
`that the ’969 Application discloses the invention in sufficient detail such that
`
`one skilled in the art could conclude the inventor possessed before March
`
`16, 2013 the subject matter of claim 2 including “at least one of flow rates or
`
`pressures of said sheath fluids are chosen such that said sample fluid is
`
`constricted in two orthogonal directions, . . . thereby causing the cells to be
`
`flattened and aligned such that flat sides of the cells are oriented parallel to
`
`confronting walls of the flow chamber.”
`
`
`
`On this record, and for purposes of this decision, we are persuaded
`
`claim 2 is not disclosed in ’969 Application in the manner required by 35
`
`U.S.C. § 112(a), and, therefore, we are persuaded the ’395 Patent is not
`
`17
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`entitled to an effective filing date before March 16, 2013. Accordingly, for
`
`purposes of this decision, Petitioner demonstrates the ’395 Patent is
`
`available for post-grant review, and has set forth sufficient grounds for
`
`standing.
`
`C. Grounds of Unpatentability
`
`1. Enablement under 35 U.S.C. § 112(a)
`Claim 1
`
`
`
`Petitioner argues the ’395 Patent “lacks any example showing a single
`
`output channel, making it impossible for those in the art to make and use the
`
`invention without undue experimentation.” Pet. 75–76. Petitioner asserts
`
`the teachings of the ’395 Patent are contrary to, and teach away from, the
`
`use of a single outlet channel. Id. at 76 (citing Ex. 1001, 1:65–2:1, 5:50–54,
`
`6:9–19, 11:66–12:4; 14:66–15:6, Ex. 1002 ¶¶ 102–104, 106–107).
`
`
`
`A specification is not enabling if one with ordinary skill in the art
`
`would be unable to practice the invention without “undue experimentation.”
`
`In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Factors relevant to
`
`determining whether undue experimentation would be necessary include:
`
`(1) the quantity of experimentation necessary, (2) the amount of direction or
`
`guidance presented, (3) the presence or absence of working examples, (4)
`
`the nature of the invention, (5) the state of the prior art, (6) the relative skill
`
`of those in the art, (7) the predictability or unpredictability of the art, and
`
`(8) the breadth of the claims. Id.
`
`
`
`Petitioner’s arguments are misplaced because they are not
`
`commensurate in scope with the limitations of claim 1. As explained above
`
`in Section II.B.2.a., claim 1 does not recite a single output channel. Claim 1
`
`instead recites “at least one channel,” and, therefore, encompasses one
`
`channel and more than one channel, without an output designation. Also as
`
`18
`
`
`
`PGR2015-00017
`Patent 8,933,395 B2
`
`explained above in Section II.B.2.a., “at least one channel disposed at said
`
`another end of the apparatus [] adapted to receive said first flow and said
`
`additional flows after operation of said laser” is disclosed Figure 1 of the
`
`’969 Application by the portion of sorting channel 110 located adjacent to
`
`outputs 130. Petitioner further fails to present
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
