Paper No. 56
`Date Filed: August 7, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ OPPOSITION TO PETITIONERS’ MOTION TO
`EXCLUDE EVIDENCE
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ...........................................................................................1
`
`ARGUMENT...................................................................................................1
`
`A.
`
`The CMC Exhibits, Dr. Berkland’s Declaration (Exh. 2014),
`and Dr. Gehrke’s Declaration (Exh. 2059) should not be
`excluded.................................................................................................1
`
`1.
`
`2.
`
`3.
`
`Neither the CMC Exhibits (Exhs. 2034, 2036, 2038–
`2040, and 2052), nor Declarations which rely on them,
`should be excluded as hearsay. ...................................................1
`
`Petitioners have not shown that the CMC Exhibits are
`inauthentic under F.R.E. 901. .....................................................4
`
`The CMC Exhibits, Dr. Berkland’s Declaration (Exh.
`2014), and Dr. Gehrke’s Declaration (Exh. 2059) are
`clearly not irrelevant. ..................................................................8
`
`B.
`
`C.
`
`D.
`
`Exhibit 2049 Should Not Be Excluded as Hearsay.............................12
`
`Exhibits 2022–2030, 2035, 2037, 2042 and 2044 Should Not
`Be Excluded. .......................................................................................12
`
`Exhibits 2020–2021, 2047, and 2056–2058 Should Not Be
`Excluded..............................................................................................14
`
`III. CONCLUSION..............................................................................................15
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`Bianco v. Globus Med., Inc., U.S. Dist. LEXIS 3430 (E.D. Tex. Jan. 12,
`2014) ................................................................................................................2
`
`Monsanto Co. v. David, 516 F.3d 1009 (Fed. Cir. 2008) ..........................................4
`
`OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396 (Fed. Cir. 1997) ............8, 13
`
`Par Pharm., Inc. v. TWi Pharms., Inc., 773 F.3d 1186 (Fed. Cir. 2014) ................10
`
`Schering Corp. v. Geneva Pharm., 339 F.3d 1373 (Fed. Cir. 2003).......................10
`
`United States v. Grossman, 614 F.2d 295 (1st Cir. 1980).........................................2
`
`Patent Trial and Appeal Board Cases
`Biomarin Pharm. Inc. v. Genzyme Therapeutic Prods. Ltd. P’ship, IPR No.
`2013-00537, Paper 79 (P.T.A.B. Feb. 23, 2015)...........................................12
`
`Ericsson Inc. v. Intellectual Ventures II LLC, IPR No. 2014-01149, Paper
`68 (P.T.A.B. Dec. 9, 2015)..............................................................................5
`
`Google, Inc. v. Michael Meiresonne, IPR No. 2014-01188, Paper 38
`(P.T.A.B. Jan. 20, 2016)..................................................................................3
`
`Johns Manville Corp. v. Knauf Insulation, Inc., IPR No. 2016-00130, Paper
`35 (P.T.A.B. May 8, 2017)..............................................................................2
`
`Laird Techs., Inc. v. GrafTech Int’l Holdings, Inc., IPR No. 2014-00025,
`Paper 45 (P.T.A.B. Mar. 25, 2015) ...........................................................8, 13
`
`SAP Am., Inc., v. Lakshmi Arunachalam, IPR No. 2013-00195, Paper 60
`(P.T.A.B. Sept. 18, 2014) ................................................................................7
`
`Shimano v. Globeride, Inc., IPR No. 2015-00273, Paper 40 (P.T.A.B. June
`16, 2016)..........................................................................................................3
`
`TRW Auto. U.S. LLC v. Magna Elecs. Inc., IPR No. 2014-01348, Paper 25
`(P.T.A.B. Jan. 15, 2016)..................................................................................5
`
`

`

`Rules and Statutes
`
`37 C.F.R. § 42.64 .......................................................................................................1
`
`F.R.E. 401 ..................................................................................................... 8, 12, 14
`
`F.R.E. 402 ..................................................................................................................8
`
`F.R.E. 703 ..................................................................................................................4
`
`F.R.E. 803 ................................................................................................... 1, 2, 3, 12
`
`F.R.E. 901 ..............................................................................................................4, 7
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756 ........................................12
`
`

`

`I.
`
`INTRODUCTION
`
`In accordance with 37 C.F.R. § 42.64, Patent Owners Alkermes Pharma
`
`Ireland LTD and Alkermes Controlled Therapeutics, Inc., respectfully oppose the
`
`Motion to Exclude filed by Petitioners Luye Pharma Group Limited, Luye Pharma
`
`(USA) Limited, Shandong Luye Pharmaceutical Company, Limited and Nanjing
`
`Luye Pharmaceutical Co., Limited (Paper 47).
`
`II.
`
`ARGUMENT
`
`A. The CMC Exhibits, Dr. Berkland’s Declaration (Exh. 2014), and
`Dr. Gehrke’s Declaration (Exh. 2059) should not be excluded.
`
`1. Neither the CMC Exhibits (Exhs. 2034, 2036, 2038–2040,
`and 2052), nor Declarations which rely on them, should be
`excluded as hearsay.
`
`Petitioners challenge the so-called “CMC Exhibits” as inadmissible hearsay.
`
`(Paper 47 at 2–3.) These exhibits are offered for their truth, but they fall within the
`
`hearsay exception set forth in F.R.E. 803(17). Under this exception, various
`
`commercial publications are admissible because a profession relies upon the
`
`accuracy of the data compiled, giving the compiler an incentive to be accurate.
`
`F.R.E. 803 Notes of Advisory Committee on Proposed Rules. Each of the “CMC
`
`Exhibits” is a commercial publication relied upon by professionals in fields such as
`
`materials science or biochemistry. As such, they fall within this hearsay exception,
`
`1
`
`

`

`F.R.E. 803(17), and should not be excluded. The Declarations which rely upon
`
`them also should not be excluded.
`
`Exhs. 2034 and 2038 are published product brochures, which offer
`
`consumers detailed specifications of CMC and other chemical products. Similarly,
`
`Exhs. 2036, 2039, 2040 are specification sheets for individual CMCs, which also
`
`provide detailed product information. As such, each facially meets the
`
`requirements of F.R.E. 803(17). The Board has also found that these types of
`
`materials satisfy the requirements of F.R.E. 803(17). See Johns Manville Corp. v.
`
`Knauf Insulation, Inc., IPR No. 2016-00130, Paper 35 at 19 (P.T.A.B. May 8,
`
`2017) (holding that product brochures met the F.R.E. 803(17) exception to
`
`hearsay); see also United States v. Grossman, 614 F.2d 295, 297 (1st Cir. 1980)
`
`(admitting a catalogue of a particular company’s products).
`
`Exh. 2052 is an announcement of Ashland’s acquisition of Hercules in 2008,
`
`with accompanying financial disclosures from Ashland and Hercules; it is cited by
`
`Dr. Berkland (Exh. 2014 at 19) to corroborate the 2008 merger. Exh. 2052
`
`qualifies as a market report or commercial publication under F.R.E. 803(17)
`
`because the entire purpose of the press release was to inform the public and
`
`shareholders of Johnson & Johnson’s performance. See Bianco v. Globus Med.,
`
`Inc., U.S. Dist. LEXIS 3430 at *3–4 (E.D. Tex. Jan. 12, 2014) (noting that under
`
`803(17) market documents are admissible as long as they contained “objective
`
`2
`
`

`

`factual data” without subjective analysis). Ashland had ample business and legal
`
`reasons to compile the information in the article accurately and objectively.
`
`Petitioners have pointed to two cases which they claim stand for the opposite
`
`proposition. They misread both cases. They first cite Google, Inc. v. Michael
`
`Meiresonne, IPR No. 2014-01188, Paper 38 (P.T.A.B. Jan. 20, 2016) for barring as
`
`hearsay printouts of webpages. (Paper 47 at 4.) But the F.R.E. 803(17) exception
`
`was not even at issue. The Board barred the evidence in that case not because it
`
`was a printout of a webpage, but because the printed material comprised two
`
`popular articles from Forbes.com and Mashable.com that did not fall into any
`
`hearsay exception or exclusion. Meiresonne, IPR No. 2014-01188 at 10. The
`
`second case, Shimano v. Globeride, Inc., IPR No. 2015-00273, Paper 40 (P.T.A.B.
`
`June 16, 2016), also dealt mostly with popular articles, not commercial
`
`publications, and the proponent of the evidence failed to offer any argument at all
`
`for why the articles were not hearsay. Id. at 27. F.R.E. 803(17) was not discussed
`
`in Shimano either. Neither case bears on the market reports and commercial
`
`publications at issue here.
`
`Petitioners have also moved to exclude Dr. Gehrke’s entire declaration (Exh.
`
`2059) and many paragraphs of Dr. Berkland’s Declaration (Exh. 2014) for relying
`
`upon the “CMC Exhibits”. (Paper 47 at 3.) Since the “CMC Exhibits” are not
`
`excludable hearsay, these Declarations should not be excluded. Further, in
`
`3
`
`

`

`forming their opinions, experts may rely on material not admitted as evidence,
`
`including hearsay, as long as the evidence is of a type routinely relied upon by
`
`experts in the field. F.R.E. 703; see Monsanto Co. v. David, 516 F.3d 1009, 1015–
`
`16 (Fed. Cir. 2008). Neither the Declarations, nor the CMC Exhibits, should be
`
`excluded as hearsay.
`
`2. Petitioners have not shown that the CMC Exhibits are
`inauthentic under F.R.E. 901.
`
`Petitioners have claimed that Exhibits 2034, 2036, 2038, 2039 and 2040
`
`were not authenticated properly by a showing that they were commercially
`
`available as of the critical date. (Paper 47 at 5.) However, Patent Owners are not
`
`relying on these materials solely as evidence of commercial availability. Further,
`
`F.R.E. 901 requires only a sufficient showing “to support a finding that the item is
`
`what the proponent says it is” for authentication. Patent Owners have put forward
`
`sufficient evidence that each of the five CMC Exhibits is a true copy of the item.
`
`Where Patent Owners have claimed a particular CMC was available in the art, they
`
`have supported that finding1, and thus none of these exhibits should be excluded as
`
`inauthentic.
`
`1 Indeed, Petitioners’ expert, Dr. DeLuca, acknowledged that the CMCs tested by
`
`Dr. Gehrke were commercially available as of the time of the invention. (See Exh.
`
`2081 at 158:19–160:12, 167:4–7 (“Q. Okay. But it [the ’657 patent] does use
`
`4
`
`

`

`Petitioners do not dispute that Exh. 2034 is a true copy of the Aqualon
`
`Brochure. Hence, the exhibit should not be excluded. The Aqualon Brochure has
`
`a copyright date of 1999. (Exh. 2034 at 1.) Petitioners claim that the Aqualon
`
`Brochure was revised in 2002 based on a tag on the bottom of page 29, which
`
`reads: “250-10H REV. 4-02.” The Board has rejected similarly opaque arguments
`
`before. See TRW Auto. U.S. LLC v. Magna Elecs. Inc., IPR No. 2014-01348,
`
`Paper 25 at 9–10 (P.T.A.B. Jan. 15, 2016) (rejecting Petitioner’s claim that
`
`unexplained tag on the bottom of a page referred to an ISBN). Patent Owners have
`
`put forward sufficient evidence to support a finding that the CMCs in the Aqualon
`
`Brochure were available as of the critical date (see Paper 50 at 2–3; Exh. 2074 at
`
`2:16, 6:8, 6:51, 7:4; Exh. 2076 at 11:51, 15:46; and Exh. 2081 at 158:19–160:12,
`
`167:4–7), and Petitioners’ arguments to the contrary are more appropriately
`
`directed to the weight of the Aqualon Brochure. See Ericsson Inc. v. Intellectual
`
`Ventures II LLC, IPR No. 2014-01149, Paper 68 at 13 (P.T.A.B. Dec. 9, 2015)
`
`(“Conflicting evidence of authenticity goes to weight, not admissibility, as long as
`
`Blanose 7ULC® prior to the date of the ’061 patent, correct? A. Yes.”); Paper 50
`
`at 2–3; U.S. Pat. No. 6,475,632 (Exh. 2074) at 2:16, 6:8, 6:51, 7:4; U.S. Pat. No.
`
`6,231,657 (Exh. 2076) at 11:51, 15:46.)
`
`5
`
`

`

`some reasonable person could believe that the item is what it is claimed to be.”).
`
`Exh. 2034 thus should not be excluded.
`
`Petitioners do not dispute that Exh. 2036 is an accurate copy of the Dow
`
`CMC webpage; thus, the exhibit should not be excluded. Patent Owners offer Exh.
`
`2036 for the purpose of showing availability of a DOW CMC on or before the
`
`critical date. (Paper 33 at 23.) Exh. 2036 has a copyright date of 1995-2017.
`
`Patent Owners have offered sufficient evidence to support a finding that Exh. 2036
`
`is an accurate copy of the Dow CMC webpage dating from before May 25, 2000.
`
`Petitioners do not dispute that Exh. 2038 is a true copy of the Ashland
`
`Reference Guide, or that Exh. 2040 is a true copy of the Spectrum CA193
`
`specification. Hence, the exhibits should not be excluded. Patent Owners use
`
`Exhs. 2038 and 2040 to show the existence of CMCs that could fall outside the
`
`claimed range at 3% concentration and 20°C. (Paper 33 at 23.) Patent Owners
`
`have never claimed that either exhibit is dated on or before May 25, 2000. As this
`
`is the only basis Petitioners have offered for exclusion on authentication grounds,
`
`there remains no authenticity challenge to Exh. 2038 or Exh. 2040, and neither
`
`should be excluded.
`
`Exh. 2039 should not be excluded because Petitioners do not dispute that
`
`Exh. 2039 is an accurate copy of the Sigma specification for CMC No. 360384.
`
`Exh. 2039 has a revision date of June 2, 1998. Petitioners argue that it did not
`
`6
`
`

`

`exist then because it was not listed in some Sigma reagent catalogs. (Paper 47 at 6;
`
`Exhs. 1039–1041.) Petitioners have offered no evidence that these catalogs reflect
`
`the full product line available from Sigma at the relevant time, nor have they
`
`shown that there were no other Sigma catalogs available. There is more than
`
`sufficient evidence to support a finding that Exh. 2039 is an accurate copy of the
`
`Sigma specification and is used not only to show what may have been available at
`
`the time of the invention, but what was available at any time. Exh. 2039 should
`
`not be excluded.
`
`Petitioners also assert that Exhs. 2039, 2036 and 2052 should be excluded as
`
`inauthentic because they are printouts from webpages. (See Paper 47 at 5-6.) But
`
`Board decisions also emphasize that “under FRE 901(b)(4), a party may
`
`authenticate evidence using circumstantial evidence in conjunction with the
`
`appearance, contents, substance, internal patterns, or other distinctive
`
`characteristics of the evidence” or “dates, websites, trademarks, copyright notices,
`
`and URL links.” SAP Am., Inc., v. Lakshmi Arunachalam, IPR No. 2013-00195,
`
`Paper 60 at 22 (P.T.A.B. Sept. 18, 2014). Here, each of these exhibits also include
`
`the full, accessible URL. Also, Exh. 2036 has a copyright date; Exh. 2039 has a
`
`revision date of June 2, 1998; and Exh. 2052 is dated July 11, 2008. These
`
`elements corroborate authenticity.
`
`7
`
`

`

`Patent Owners have also offered these exhibits to show that the products
`
`they advertise, or the events they recount, are attested to by the current versions of
`
`the webpages. Each exhibit is a printout of a webpage which remains online in the
`
`same form in which it was submitted. The contents of these exhibits can easily be
`
`verified by inserting the URL from the exhibit list into a search engine. Exhibits
`
`2034, 2036, 2038, 2039 and 2040 are not inauthentic and should not be excluded.
`
`3. The CMC Exhibits, Dr. Berkland’s Declaration (Exh. 2014),
`and Dr. Gehrke’s Declaration (Exh. 2059) are clearly not
`irrelevant.
`
`Petitioners assert that the “CMC Exhibits” and two declarations (Exhs. 2014,
`
`2059) are irrelevant under F.R.E. 401 and 402. A fact is relevant under F.R.E. 401
`
`if it has the tendency to make a material fact in the case more or less probable, and
`
`relevant evidence is presumptively admissible under F.R.E. 402 unless an
`
`exception applies. Both the Federal Circuit and the Board have recognized that
`
`there is a “low threshold for relevancy.” OddzOn Prods., Inc. v. Just Toys, Inc.,
`
`122 F.3d 1396, 1407 (Fed. Cir. 1997); Laird Techs., Inc. v. GrafTech Int’l
`
`Holdings, Inc., IPR No. 2014-00025, Paper 45 at 44 (P.T.A.B. Mar. 25, 2015).
`
`Petitioners have defined relevance in stark contradiction to how relevance is
`
`defined by the Federal Rules of Evidence.
`
`In six separate places in its Motion (Paper 47 at 9, 10, 11, 12, 14),
`
`Petitioners argue—without any support—that the “CMC Exhibits” and the two
`
`8
`
`

`

`declarations cannot be relevant absent Patent Owners showing that these CMCs
`
`were commercially available and accessible to a POSA at or before the critical
`
`date. Petitioners are mistaken about the Federal Rules of Evidence, as well as the
`
`concept of inherency. Each of the “CMC Exhibits” other than Exh. 2052 either
`
`shows, or discloses the existence of, a CMC with a viscosity outside the claimed
`
`range at concentrations near to or even greater than 3%. Exh. 2036; Exh. 2038 at
`
`40; Exh. 2039 at 1; Exh. 2040 at 1; Exh. 2034 at 6 (disclosing that CMCs with
`
`viscosities lower than 25 cp were available). These exhibits establish that the
`
`viscosities of the Johnson and Gustafsson injection vehicles, made with 3% CMC,
`
`fall outside the claimed range if certain CMCs are used to make the vehicles.
`
`Thus, the “CMC Exhibits” and related declarations are relevant, at least, to whether
`
`Petitioner proved inherency. At the very least, the evidence establishes that
`
`inherency is “less probable,” which is all that is required to establish relevance.
`
`Petitioners’ relevance objection seeks to exclude any evidence that disproves
`
`their flawed inherency argument. In both their Motion to Exclude, (Paper 47 at 9,
`
`10, 11, 12, 14) as well as in their Reply (Paper 40 at 8–15, 18–19), Petitioners have
`
`untimely argued that Patent Owners must provide a pharmaceutical grade CMC, of
`
`low—but not too low—viscosity, that was commercially available on or before
`
`May 25, 2000 to defeat inherency. But this demand assumes that Petitioners’
`
`grounds were predicated on a POSA selecting a specific type of CMC for use,
`
`9
`
`

`

`rather than the use of any CMC inherently resulting in the claimed range. By
`
`requiring Patent Owners affirmatively disprove Petitioners’ unsupported inherency
`
`argument, and then moving to exclude Patent Owners’ evidence related to lack of
`
`inherency as “irrelevant,” Petitioners seek to drastically shift the burden of proof.
`
`The evidence at issue is clearly relevant to whether Petitioners met their burden of
`
`proof for establishing inherency.
`
`Federal Circuit precedent holds that an inherent limitation of a product is
`
`one that “necessarily” exists in that product, Par Pharm., Inc. v. TWi Pharms., Inc.,
`
`773 F.3d 1186, 1195–96 (Fed. Cir. 2014), regardless of whether a POSA at the
`
`time recognized that the limitation was inherent. Schering Corp. v. Geneva
`
`Pharm., 339 F.3d 1373, 1377–78 (Fed. Cir. 2003) (denying the necessity of “past
`
`recognition of the inherent feature” and allowing recourse to opinions of skilled
`
`artisans after the fact to determine the scope of the prior art).
`
`Petitioners have the burden of proving that the Johnson and Gustafsson
`
`injection vehicles, made with any type of CMC at 3% concentration, would
`
`necessarily possess a viscosity in the claimed range. See Par Pharm., 773 F.3d at
`
`1195-96. This is clearly not the case. Patent Owners have provided many CMCs
`
`with viscosities outside the claimed range at 3% CMC concentration. (See Exh.
`
`2036; Exh. 2038 at 40; Exh. 2039 at 1; Exh. 2040 at 1; Exh. 2014 at ¶¶ 48–50, 58,
`
`122–24; Exh. 2059.) And as Dr. Gehrke demonstrated, not all CMC at a
`
`10
`
`

`

`concentration of 3% in combination with the Johnson and Gustafsson injection
`
`vehicles, necessarily lead to a vehicle viscosity within the claimed range. (See
`
`generally Exh. 2059; Exh. 2014 at ¶¶ 48–50, 122–24.) This did not suddenly
`
`become scientific fact on May 26, 2000; it is a characteristic of certain CMCs that
`
`was as true on and before May 25, 2000 as it is today. It is Petitioners’ burden to
`
`prove that there is no possible CMC in existence that would result in a product
`
`outside of the claimed range. However, Petitioners’ new argument that a POSA
`
`would only use a subset of CMCs in combination with the Johnson and Gustafsson
`
`injection vehicles does not make Patent Owners’ evidence irrelevant to the
`
`question of whether Petitioners met their burden of proving inherency.
`
`Petitioners have also moved to exclude Exh. 2052 as irrelevant. (Paper 47 at
`
`8–10.) Their sole basis for doing so appears to be that Exh. 2052 itself does not
`
`disclose a low viscosity, pharmaceutical grade CMC, commercially available on or
`
`before May 25, 2000, which would fall outside the claimed range. Exh. 2052 is a
`
`2008 press release announcing Ashland’s acquisition of Hercules. It illustrates that
`
`Hercules-branded CMC products offered in 1999 in the Aqualon Brochure (Exh.
`
`2034) are Ashland-branded CMC products today (Exh. 2038).
`
`The “CMC Exhibits,” Dr. Berkland’s Declaration, and Dr. Gehrke’s
`
`Declaration are relevant and should not be excluded.
`
`11
`
`

`

`B. Exhibit 2049 Should Not Be Excluded as Hearsay.
`
`Exhibit 2049 is a press release from Johnson & Johnson disclosing fourth-
`
`quarter sales figures and other financial data, including fourth quarter sales for
`
`Risperdal® Consta®. F.R.E. 803(17) provides an exception to hearsay for market
`
`reports or similar commercial publications. Exh. 2049 qualifies as a market report
`
`because the entire purpose of the press release was to inform the public and
`
`shareholders of Johnson & Johnson’s performance. Johnson & Johnson has
`
`incentive to compile this information accurately, not the least of which is
`
`compliance with federal securities law. Exh. 2049 has sufficient indicia of
`
`reliability that it should not be excluded as hearsay.
`
`C. Exhibits 2022–2030, 2035, 2037, 2042 and 2044 Should Not Be
`Excluded.
`
`Petitioners did not previously object to any exhibit under FRE 401 and thus
`
`did not properly preserve their right to object to any exhibit under FRE 401. (See
`
`Paper 35; Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756 at 48,767 (“A
`
`motion to exclude evidence must . . . [i]dentify where in the record the objection
`
`originally was made . . . .”).) Further, Petitioners’ arguments allegedly based on
`
`relevancy actually go to the weight of the evidence, not to the admissibility. See
`
`Biomarin Pharm. Inc. v. Genzyme Therapeutic Prods. Ltd. P’ship, IPR No. 2013-
`
`00537, Paper 79 at 24-25 (P.T.A.B. Feb. 23, 2015).
`
`12
`
`

`

`Still, Petitioners have not shown that the so-called “CMC Properties
`
`Exhibits” are irrelevant. Both the Federal Circuit and the Board have recognized
`
`that there is a “low threshold for relevancy.” OddzOn Prods., Inc., 122 F.3d at
`
`1407; Laird Techs., Inc., IPR No. 2014-00025 at 44. Petitioners provide no reason
`
`a higher standard for relevance should apply in this case.
`
`Exhs. 2022–2030 show the routine use of low concentrations of CMC in
`
`formulations comprising risperidone microparticles. This makes it less likely that
`
`a POSA would have been motivated to combine Ramstack’s risperidone
`
`microparticles and the CMC concentration of Gustafsson’s injection vehicle
`
`because it shows that vehicles comprising lower concentrations were known and
`
`used in the art. (Paper 33 at 55–56.)
`
`Exh. 2035 shows that the order of addition of CMC can affect viscosity of
`
`the injection vehicle, potentially enough to result in a viscosity outside the claimed
`
`range. This evidence makes it less likely that Petitioners have met their burden of
`
`proof regarding inherent disclosure of viscosity. (Paper 33 at 26, 32, 41.)
`
`Exhs. 2037, 2042, and 2044 confirm that the viscosity of a given CMC can
`
`vary widely depending upon its molecular structure and potential for entanglement
`
`and other inter- and intra-molecular interactions. (Exh. 2014 at ¶¶ 38, 51, 67-68,
`
`125.) As Dr. DeLuca noted, the molecular structure of a CMC, reflected in its
`
`grade and lot number, could determine whether the Johnson vehicle falls outside
`
`13
`
`

`

`the claimed range. (Exh. 2016, DeLuca Tr. at 176:2–24; see also Exh. 1022 at
`
`288.) Exhs. 2037, 2042, and 2044 make it less likely that Petitioners have met
`
`their burden of proof regarding inherent disclosure of viscosity.
`
`Thus, all of the “CMC Properties Exhibits” exhibits are relevant and should
`
`not be excluded.
`
`D. Exhibits 2020–2021, 2047, and 2056–2058 Should Not Be
`Excluded.
`
`Again, no exhibits have been objected to under FRE 401, and thus the
`
`motion to exclude is improper. Even if the Board finds Petitioners’ objections
`
`were not deficient, these exhibits should not excluded because they relate to issues
`
`in this proceeding.
`
`Exhs. 2020–2021 discuss Dr. DeLuca’s own prior use of risperidone PLGA
`
`microparticles and are relevant at least to the microparticle limitation in claim 1, as
`
`well as the risperidone limitation in claims 20 and 21. Exh. 2047 demonstrates the
`
`potential for CMC molecules to form hydrogen bonds which could affect the
`
`viscosity of the overall solution. Exhs. 2056–2058 disclose the history and
`
`existence of companies that manufacture CMC and show that they existed and sold
`
`CMC before and around the time of the invention. These exhibits are relevant and
`
`should not be excluded.
`
`14
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`

`

`III. CONCLUSION
`
`For the foregoing reasons, this evidence should not be excluded.
`
`August 7, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`15
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`

`

`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNERS’ RESPONSE was served on August 7, 2017 by causing it to
`
`be sent by email to counsel for Petitioner at the following email addresses:
`
`wmentlik.ipr@lernerdavid.com
`
`pkochanski@lernerdavid.com
`
`tvanbuskirk@lernerdavid.com
`
`nvaleyko@lernerdavid.com
`
`August 7, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`FCHS_WS 13257838v1.doc
`
`16
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`