CONTAINS PROTECTIVE ORDER MATERIAL Paper _____
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner.
`
`
`_______________
`
`Case IPR2016-00006
`Patent 8,497,393
`_______________
`
`
`Patent Owner Response to Petition
`
`
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Response
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`TABLE OF CONTENTS
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`I.(cid:3)
`INTRODUCTION ......................................................................................... 1(cid:3)
`SUMMARY OF THE ARGUMENT ........................................................... 1(cid:3)
`II.(cid:3)
`III.(cid:3) STRUCTURAL/FUNCTIONAL DIFFERENCES OF THE
`CLAIMED PRODUCTS OVER THE CITED ART .................................. 6(cid:3)
`A.(cid:3)
`The Importance of Purity in Pharmaceuticals ....................................... 7(cid:3)
`B.(cid:3)
`The ’393 Product Has A Different Impurity Profile and a Higher
`Purity Than Moriarty ............................................................................. 9(cid:3)
`The Differences In Impurity Profile And Average Purity Between
`The ’393 Product And Moriarty Are Functionally Important............. 12(cid:3)
`IV.(cid:3) CLAIM CONSTRUCTION ........................................................................ 13(cid:3)
`A.(cid:3)
`Intrinsic Evidence Can Override The Presumption That
`“Comprising” Creates An “Open” Claim Construction ...................... 13(cid:3)
`The Distinct Impurity Profile And Higher Purity Of the ’393
`Patent Product Were Clearly Considered Part of the Claimed
`Product During Prosecution ................................................................ 16(cid:3)
`V.(cid:3) GROUND 1: PHARES FAILS TO EXPLICITLY OR
`INHERENTLY DISCLOSE EACH AND EVERY LIMITATION
`OF CLAIMS 1-5, 7-9, 11-14 OR 16-20 ...................................................... 18(cid:3)
`A.(cid:3)
`SteadyMed Cannot Pick and Choose From Unrelated Portions of
`Phares to Establish Anticipation ......................................................... 19(cid:3)
`The Proper Construction of a “product comprising a compound
`[of/having] formula [I/IV] or a pharmaceutically acceptable salt
`thereof” Precludes A Finding That Phares Anticipates the Present
`Claims .................................................................................................. 20(cid:3)
`The Higher Melting Point of Phares’ Diethanolamine Salt Does
`Not Necessarily Mean That it is of Higher Purity Than the
`Diethanolamine Salts of the ’393 Patent ............................................. 22(cid:3)
`Phares Fails To Disclose the Claimed Process for Making
`Treprostinil or Any Purity or Impurity Profile for Treprostinil
`Diethanolamine ................................................................................... 24(cid:3)
`VI.(cid:3) GROUND 2: MORIARTY AND PHARES FAIL TO RENDER
`OBVIOUS CLAIMS 1-5, 7-9, 11-14, OR 16-20 ........................................ 27(cid:3)
`
`C.(cid:3)
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`B.(cid:3)
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`B.(cid:3)
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`C.(cid:3)
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`D.(cid:3)
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`B.(cid:3)
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`VII.(cid:3) GROUND 3: MORIARTY, PHARES, KAWAKAMI, AND E(cid:246)E
`FAIL TO RENDER OBVIOUS CLAIMS 6, 10, 15, 21, AND 22............ 33(cid:3)
`A.(cid:3)
`The Product of Claims 6, 15, and 21 Are Different Than the Prior
`Art Treprostinil Products ..................................................................... 33(cid:3)
`1.(cid:3)
`The ’393 Patent Product is Structurally and Functionally
`Distinct from Moriarty’s Product ............................................. 34(cid:3)
`There Is No Motivation For A POSA To Combine Moriarty and
`Phares with E(cid:247)e and Kawakami .......................................................... 34(cid:3)
`1.(cid:3)
`There Is No Motivation to Follow the Carboxylate Salt
`Formation With Regeneration of the Carboxylic Acid ............. 35(cid:3)
`Kawakami Would Have Motivated One of Ordinary Skill
`In The Art To Select A Dicyclohexyl Amine Salt, Teaching
`Away From The Diethanolamine Salt of Claims 14 and 18 ..... 41(cid:3)
`Kawakami Does Not Provide A Reasonable Expectation Of
`Success That Treprostinil Products Could Be Further
`Purified Because Different Impurities Are Targeted ................ 42(cid:3)
`Any “Close” Structural Similarity of the Moriarty Free
`Acid Does Not Render the Claims Obvious ............................. 45(cid:3)
`Additional Claim Limitations Are Not Disclosed by the
`Cited Prior Art ........................................................................... 45(cid:3)
`VIII.(cid:3) SECONDARY CONSIDERATIONS REBUT ANY POSSIBLE
`CASE OF OBVIOUSNESS ......................................................................... 47(cid:3)
`A.(cid:3)
`Long-Felt Unmet Need ............................................................. 47(cid:3)
`B.(cid:3)
`Unexpected Results ................................................................... 49(cid:3)
`IX.(cid:3) CONCLUSION ............................................................................................ 49(cid:3)
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`
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`2.(cid:3)
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`3.(cid:3)
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`4.(cid:3)
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`5.(cid:3)
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`Federal Cases
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`Patent Owner Response
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Atofina v. Great Lakes Chem. Corp.,
`441 F.3d 991 (Fed. Cir. 2006)..................................................................................................17
`
`In re Buszard,
`504 F.3d 1364 (Fed. Cir. 2007)................................................................................................15
`
`Crystal Semiconductor Corp. v. TriTech Microelectronics Int'l, Inc.,
`246 F.3d 1336 (Fed. Cir. 2001)................................................................................................13
`
`Day Intern., Inc. v. Reeves Brothers, Inc.,
`260 F.3d 1343 (Fed. Cir. 2001)................................................................................................14
`
`In re Fisher,
`427 F.2d 833 (C.C.P.A., 1970) ................................................................................................39
`
`In re Hoeksema,
`399 F.2d 269 (C.C.P.A. 1968) .................................................................................................45
`
`Knoll Pharm. Co., Inc. v. Teva. Pharm. USA, Inc.,
`367 F.3d 1381, (Fed.Cir. 2004)................................................................................................48
`
`In re Omeprazole Patent Litigation,
`536 F.3d 1361 (Fed. Cir. 2008)................................................................................................44
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008)................................................................................................39
`
`Purdue Pharma L.P. v. Endo Pharms. Ins.,
`438 F.3d 1123 (Fed. Cir. 2006)................................................................................................17
`
`SafeTCare Mfg., Inc. v.Tele-Made, Inc.,
`497 F.3d 1262 (Fed. Cir. 2007)................................................................................................14
`
`Standard Oil Co. v. American Cyanamid Co.,
`774 F.2d 448 (Fed. Cir. 1985)..................................................................................................14
`
`Toro Co. v. White Consol. Indus., Inc.,
`199 F.3d 1295 (Fed. Cir. 1999)................................................................................................14
`
`United States v. Adams,
`383 U.S. 39 (1966) ...................................................................................................................38
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`United Therapeutics Corp. v. Sandoz, Inc.,
`2014 WL 4259153 (D.N.J. Aug 29, 2014) ..............................................................................17
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`Patent Owner Response
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`
`
`In re Zletz,
`893 F.2d 319 (Fed. Cir. 1989)..................................................................................................15
`
`Federal Statutes
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`35 U.S.C. § 316(a)(8) .......................................................................................................................1
`
`35 U.S.C. § 316(e) .......................................................................................................................1, 6
`
`Regulations
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`21 C.F.R. § 600.3 (r) (2015) ............................................................................................................7
`
`37 C.F.R. § 42.120 ...........................................................................................................................1
`
`Other Authorities
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`Marti, E., Purity determination by differential scanning calorimetry ...........................................22
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`R. Adhiyaman, et.al., Crystal modification of dipyridamole using different
`solvents and crystallization conditions ....................................................................................23
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`I.
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`INTRODUCTION
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`
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`Patent Owner Response
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`United Therapeutics Corporation (“UTC”) submits this Response in
`
`accordance with 35 U.S.C. § 316(a)(8) and 37 C.F.R. § 42.120, responding to the
`
`instituted grounds of the Petition for Inter Partes Review filed by SteadyMed Ltd.
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`(“SteadyMed”) challenging claims 1-22 of U.S. Patent No. 8,497,393 (“the ’393
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`patent”). The Declaration of Dr. Williams (“Ex. 2020”) and of Dr. Ruffolo (“Ex.
`
`2022”) are filed herewith in support of the Response (Ex. 2020 and Ex. 2022,
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`respectively). The Board should conclude that SteadyMed has failed to prove by a
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`preponderance of the evidence that the instituted claims are unpatentable, as
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`required under 35 U.S.C. § 316(e).
`
`II.
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`SUMMARY OF THE ARGUMENT
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`SteadyMed’s anticipation and obviousness arguments are flawed for two
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`fundamental reasons. First, SteadyMed’s arguments rely on Moriarty (Moriarty et
`
`al., J. Org. Chem. 2004, 1890-1902; Ex. 1004) and Phares (International
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`Publication No. WO 2005/007081; Ex. 1005), but neither reference discloses the
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`same highly pure treprostinil or treprostinil diethanolamine product claimed by the
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`’393 patent when properly construed, let alone the same synthesis recited in the
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`instituted claims. In fact, the Office considered both references during prosecution
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`of the ’393 patent, and the Office construed the claims of the ’393 patent in a way
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`that distinguished the product of the ’393 patent specifically from the Moriarty
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`product. Moreover, a person of ordinary skill in the art (“POSA”) would not look
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`Patent Owner Response
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`to either E(cid:247)e (Seyhan N. E(cid:247)e, Organic Chemistry 543-547 (2d ed. 1989) (Ex.
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`1008) or Kawakami (JP 56-122328A) (Ex. 1007) as neither reference is relevant to
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`further purification of the complex treprostinil carboxylic acid structure that is at
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`issue in the ’393 patent, and a POSA would have no reasonable expectation of
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`success in combining these references with either Moriarty or Phares.
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`Second, SteadyMed’s anticipation and obviousness arguments are flawed
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`because they misunderstand, both the error associated with such measurements and
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`the difference between “assay purity” against a standard and measurements of
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`purity that directly measure the level of impurities. As explained in the Williams
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`and Ruffolo Declarations, this misunderstanding resulted in Petitioner’s incorrect
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`assertion that there are inconsistencies between the purity values recited in the ’393
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`specification, the Walsh Declaration, and the Moriarty prior art. Ex. 2020 at ¶¶88-
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`89; Ex. 2022 at ¶¶73-74. Dr. Williams notes that the ’393 patent itself expressly
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`refers to assay purity values as “HPLC (assay)” values whenever it uses such
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`measurements, as opposed to other purity values based on measuring amount of
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`impurities. Ex. 2020 at ¶89. Dr. Ruffolo further explains that FDA drug approval
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`system rests on precise measurements of individual impurities that make up a
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`purity “specification” for a drug, which can be reliably determined within the
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`detection limits of HPLC measurements. Ex. 2022 at ¶¶32-35 and 44-50. Dr.
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`Ruffolo also specifically notes that it is routine to have assay purity values above
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`100% because it is a relative value measurement. Ex. 2022 at ¶53.
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`SteadyMed’s purported expert, Dr. Winkler, confirmed this
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`misunderstanding. Dr. Winkler acknowledged at his deposition that FDA’s purity
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`specification of less than 0.1% for the impurity 2AU90 indicates that precise
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`measurements of impurities are possible: “I would think that the error in the
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`measurement for 2AU90 would be, should be less than 0.1 percent.” Ex. 2051 at
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`64:7-9. Dr. Winkler further acknowledged that he did not know how the
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`treprostinil purity specification adopted by FDA could change from 101% to 102%
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`and stated that he viewed purity levels above 100% as errors: “I think the thing
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`that I am able to conclude from the data that is on page 6 of this, of this letter [Ex.
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`2006] is that the error in the HPLC assay could be as high as percent in the first
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`column and by my analysis could be as high as percent in the second column.”
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`Ex. 2051 at 86:15-21; 24-25; 87:2-9. As Dr. Williams explained, Dr. Winkler’s
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`conclusions on this point appear “to arise from Dr. Winkler’s fundamental
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`misunderstanding of how assay purity values are calculated.” Ex. 2020 at ¶¶90-92;
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`see also Ex. 2022 at ¶¶74. Moreover, Dr. Winkler admitted he did not know what
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`the actual error was associated with the measurements submitted in the Walsh
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`declaration. Ex. 2051 at 62:16-25; 63:2-14. Because Dr. Winkler does not
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`understand the basic differences in types of purity measurements and their related
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`errors that are used in the ’393 patent, discussed in the Walsh Declaration, and
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`which form the basis for FDA’s regulation of drug product manufacturing, his
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`declaration should not be credited.
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`Moreover, the Williams Declaration establishes that there are measurable
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`structural differences between the average impurity profiles of the Moriarty
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`product and the claimed product based on data obtained from 175 batches. Ex.
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`2020 ¶¶94-99, Appendices A-B; see also Ex. 2005, Ex. 2036, Ex. 2037, Ex. 2052,
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`Ex. 2053. The average impurity profiles show that Moriarty process and the ’393
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`process produce two physically distinct products that contain different total and
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`specific impurities. Id. Specifically, the claimed product essentially lacks certain
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`impurities found in the Moriarty product, such as 97W86, 1AU90, and 2AU90.
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`Ex.2020 at ¶¶96-97. The claimed product also contains much smaller amounts of
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`other impurities that are found in the Moriarty product, such as methyl ester,
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`751W93, 750W93, and 3AU90. Id. at ¶96.
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`Furthermore, based on the same 175 batches, the average purity of the ’393
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`product is 0.7% greater than the average purity of the Moriarty product, thereby
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`corroborating that the Moriarty process and the ’393 process produces two
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`physically distinct products that contain measurable and significant structural
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`differences. Id. at ¶98.
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`Finally, the initial claim construction of the preamble “a product…
`
`comprising” urged by SteadyMed and adopted by the Board would violate the
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`canon that patent claims may not be construed to encompass material that was
`
`clearly disavowed in order to obtain allowance of claims. Even under the broadest
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`reasonable interpretation standard, the Board has found in its own cases that the
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`prosecution history may limit the plain meaning of a limitation in a claim, which
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`otherwise is presumed to apply. The ’393 claims were allowed after submission of
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`the Walsh Declaration, which established the differences between the ’393
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`products and the Moriarty product. This disavowal of the Moriarty subject matter
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`is further reinforced by additional intrinsic evidence. The ’393 patent includes a
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`side-by-side comparison in Example 6 to show the difference between the Moriarty
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`product and the ’393 product and repeatedly references higher purity and different
`
`impurity profile compared to Moriarty. In the face of this disavowal, it is improper
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`to construe “a product …comprising” to allow the impurities “without limitation,”
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`as such a construction would encompass the impurity profile of Moriarty.
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`In addition, the Williams Declaration explains why Phares cannot anticipate the
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`claimed products because of the particular conditions used to prepare the Phares
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`product for polymorph screening and because of the uncertain provenance of
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`starting treprostinil used to make the diethanolamine salt.
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`As to instituted grounds 2 and 3, Dr. Williams also explains why the references
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`in the instituted obviousness grounds would not have been combined in the
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`asserted manner due to lack of motivation and the failure of the references to
`
`provide an expectation of success for achieving the purity level and impurity
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`profile of the ’393 patent in the specific case of treprostinil. Kawakami teaches
`
`away from the selection of diethanolamine, the salt specifically claimed in claims
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`14 and 18. Lastly, secondary considerations of long-felt need and unexpected
`
`results would rebut any case of obviousness as to grounds 2 and 3.
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`
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`In view of the foregoing, SteadyMed has not met its burden of proving the
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`unpatentability of claims 1-22 by a preponderance of the evidence, as required
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`under 35 U.S.C. § 316(e).
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`III.
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`STRUCTURAL/FUNCTIONAL DIFFERENCES OF THE CLAIMED
`PRODUCTS OVER THE CITED ART
`
`The combined Declarations of Dr. Williams and Dr. Ruffolo establish that
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`the ’393 product has a different impurity profile than the Moriarty product, and in
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`fact, that the ’393 product has higher average purity. These differences matter.
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`FDA uses both overall purity and levels of individual impurities (“purity
`
`specification”) as a basis to regulate the manufacturing of pharmaceuticals.
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`Batches that fall outside of the purity specification cannot be sold or used to treat
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`patients. Thus, differences in purity and impurity profile are not merely academic,
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`Patent Owner Response
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`but critical to the successful manufacture of a clinical product.
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`A.
`
`The Importance of Purity in Pharmaceuticals
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`As noted by the ’393 patent itself, “because Treprostinil, and other
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`prostacyclin derivatives are of great importance from a medicinal point of view, a
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`need exists for an efficient process to synthesize these compounds on a large scale
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`suitable for commercial production.” Ex. 1001, col. 1:57-61. The invention
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`therefore “provides for a process that is more economical, safer, faster, greener,
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`easier to operate, and provides higher purity.” Id., col. 5:47-50. As the treprostinil
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`product is a drug product subject to the rules of FDA, the reduction of impurities is
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`of great importance in the drug. Drug purity is defined by FDA as “relative
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`freedom from extraneous matter in the finished product, whether or not harmful to
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`the recipient or deleterious to the product.” See, Ex. 2022 at ¶33; see also 21
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`C.F.R. §600.3 (r) (2015). The purity of a drug is of such importance to FDA that
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`the purity level of a drug substance must appear in the drug product specification,
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`which is a collection of data about the drug required by FDA. See, Ex. 2022 at
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`¶¶32-34. “Regulatory agencies have also sought to increase levels of purity, and
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`consequently decrease levels of impurities, in order to provide to the maximum
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`extent possible, the highest level of safety to patients.” Id. at ¶36. This is due to
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`the fact that even trace amounts of impurities can sometime pose serious health
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`Patent Owner Response
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`concerns.
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`For example, the drug penicillin is one of the best known and extensively
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`studied examples of trace impurities that can cause serious, life-threatening adverse
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`events. Id. at ¶62. While penicillin is safe and effective for most people, it can
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`cause serious allergic reactions resulting in anaphylaxis and death. Id. Because the
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`amount of trace impurity of penicillin needed to cause an allergic reaction is so
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`low, FDA has mandated the production of penicillin active pharmaceutical
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`ingredient (API ) and finished product to be made in buildings entirely separate
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`from buildings that manufacture other APIs or finished drug product. Id., see also
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`FDA Guidance for Industry, Non-Penicillin Beta-Lactam Drugs: A CGMP
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`Framework for Preventing Cross-Contamination, (2013) (Ex. 2047) at 1-6. The
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`same is true for the drug cephalosporin. Ex. 2022 at ¶63; see also Ex. 2047 at 1-6.
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`Additionally, human insulin is another example. For many years, human
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`insulin was derived from pig pancreases, but then it became possible to produce
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`human insulin in the bacteria E. coli using large bioreactors. Ex. 2022 at ¶64. Even
`
`though the human insulin derived from E. coli was highly pure, it contained very
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`small trace amounts of E. coli, a very dangerous bacteria causing reactions
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`(directly from the trace amounts of bacteria, and not due to infection) in some
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`people even in trace amounts. Id. As a result, the product needed to be even more
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`highly purified to further minimize or eliminate the trace bacterial contaminants.
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`Id. These examples highlight the importance of drug purity in pharmaceutical
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`formulations and the potential risks to patients between two products that differ in
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`their impurity profile and purity. By having a different impurity profile and overall
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`purity, two products are structurally and functionally different.
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`B.
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`The ’393 Product Has A Different Impurity Profile and a Higher
`Purity Than Moriarty
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`As detailed in Dr. Williams’ Declaration and supporting exhibits, comparing
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`the average impurity profiles for the ’393 product and the Moriarty product using
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`data obtained from over 175 batches reveals measurable structural differences, as
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`the two processes produce physically different products which contain different
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`total and specific amounts of impurities. Ex. 2020 ¶¶94-99 and Appendices A-B;
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`see also Ex. 2005, Ex. 2036, Ex. 2037, Ex. 2052, Ex. 2053. The batch reports
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`show that the Moriarty product and the claimed product exhibit different impurity
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`profiles and that the claimed product has a higher average purity than Moriarty’s
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`product. Id.
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`Moriarty Process Impurities (Average Percent Detected)
`
`ethyl
`ester
`1AU90 2AU90 3AU90 750W93 751W93 97W86
`0.0473 0.0407 0.2545 0.1646
`0.1025
`0.0405 0.0889
`’393 patent Process Impurities (Average Percent Detected)
`1AU90 2AU90 3AU90 750W93 751W93 97W86 ethyl
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`methyl
`ester
`0.1028
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`Total
`Related
`Substance
`0.9545
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`methyl
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`Total
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`ester
`
`ester
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`Related
`Substance
`0.2936
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`0.0004 0.0004 0.0455 0.0642
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`0.0488
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`0
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`0.1207
`
`0.005
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`In total, the ’393 product has 3.25 times fewer impurities than the Moriarty
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`product.1 Ex. 2020 ¶¶94-95. Additionally, certain specific impurities found in the
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`prior art Moriarty product are essentially eliminated in the ’393 product, as the
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`’393 product does not contain detectable amounts of the impurity 97W86, and
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`none of the commercial batches of the ’393 product contain detectable amounts of
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`1AU90 or 2AU90. Ex. 2020 ¶¶94, 96-97. Other impurities, including methyl ester,
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`751W93, 750W93, and 3AU90, are also greatly reduced in the ’393 product as
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`compared to the Moriarty product, while the level of the ethyl ester impurity is
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`slightly increased in the ’393 product. Ex. 2020 ¶96. These substantial differences
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`between the impurity profiles of the ’393 product and the Moriarty product
`
`constitute structural differences between the claimed product and the prior art.
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`Furthermore, the average purity based on data from over 175 batches is
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`higher for the ’393 product than that of Moriarty. As shown above, the average
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`purity of a Moriarty batch was 99.05% while the average purity of a ’393 batch
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`1 Moriarty Total Related Substances: 0.9545; ’393 patent Process Total Related
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`Substances: 0.2936
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`was 99.71%. Ex. 2020 ¶¶94-99. This is a marked improvement in overall purity.
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`Moreover, the purity analyzed in these batches – the total related substances – is
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`exactly the same type of analysis Dr. Walsh referred to in his declaration when
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`referring to purity of the ’393 patent process versus that of the Moriarty process.
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`Thus, this analysis is consistent with how the inventor interpreted the purity of the
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`’393 patent. And this analysis also persuaded the Office to allow the claims.
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`The Institution Decision cited to the Walsh Declaration for revealing “that
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`each of the impurities detected in [the tested batch of] Moriarty treprostinil was
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`present in an amount below that identified as acceptable in UTC’s own
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`specification for treprostinil produced according to the process disclosed in the
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`‘393 patent.” Paper 12 at 20-21. First, the above data shows that the average
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`amount of each impurity and the average purity is different between Moriarty
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`treprostinil and the ’393 product. Second, whether an isolated batch of Moriarty
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`treprostinil does or does not satisfy the new FDA purity specification is not
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`relevant to patentability. The question for patentability is whether or not a given
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`batch of starting Moriarty treprostinil (steps a and b of the ‘393 independent
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`claims) will be physically changed when step (c) is performed on that batch. The
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`above averages show that it does change, as do the large scale synthesis examples
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`4-6 in the ‘393 patent. While Moriarty treprostinil may show inter-batch variation
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`in overall purity and impurity profiles, the data of record establishes that
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`performing step (c) on a given starting batch of Moriarty treprostinil will lead to a
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`Patent Owner Response
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`
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`higher purity and a different impurity profile in the end product. Petitioner has not
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`established that any specific batch of Moriarty treprostinil is not physically
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`changed by performing step (c), and all the evidence suggests that it is.
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`C.
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`The Differences In Impurity Profile And Average Purity Between
`The ’393 Product And Moriarty Are Functionally Important
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`The higher purity of the claimed product resulted in FDA approving a new
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`assay purity for the treprostinil drug as noted in the January 2009 letter submitted
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`to FDA by UTC. Ex. 2006 at 4-6; Ex. 2022 at ¶¶66-68; Ex. 2020 at ¶91.
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`Furthermore, this change constitutes a “major” change according to the
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`classification system for manufacturing changes used by FDA. Ex. 2022 at ¶¶70-
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`72. FDA requires continuous testing of pharmaceutical batches to ensure that they
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`fall within the established purity specification. Ex. 2022 at ¶¶32-40. If a given
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`batch falls outside the established purity specification, then it will be rejected by
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`FDA and cannot be sold for patient use. Id. at ¶32. FDA is so concerned about
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`purity of pharmaceuticals that it requires companies to test for very tiny amounts of
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`individual known impurities carried over into the final product based on the
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`manufacturing process. Id. at ¶¶32-40. Thus, the change in the ‘393 product is
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`commercially important and has real-world value.
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`IV. CLAIM CONSTRUCTION
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`Patent Owner Response
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`In the Decision on Institution (Paper 28), the preliminary claim construction
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`construes “[a] product comprising a compound [of/having] formula [I/IV] or a
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`pharmaceutically acceptable salt thereof” and “product” in an unreasonably broad
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`manner. The Board is not bound by that preliminary construction based on an
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`incomplete record. See e.g., The Scotts Co., LLC v. Encap, LLC, IPR2013-00110,
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`Paper 79 (PTAB June 24, 2014) (overturning preliminary claim construction in
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`final written opinion) (Ex. 2024). On the fuller record now available to it, the
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`Board should adopt UTC’s construction of the disputed terms.
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`A.
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`Intrinsic Evidence Can Override The Presumption That
`“Comprising” Creates An “Open” Claim Construction
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`The claims at issue in an IPR must be given their broadest reasonable
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`interpretation (BRI) in light of the specification, but the Board must still interpret
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`claim terms according to established principles. The transition phrase
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`“comprising” is only presumed to be an “open” phrase. Crystal Semiconductor
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`Corp. v. TriTech Microelectronics Int'l, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001)
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`(“In the parlance of patent law, the transition ‘comprising’ creates a presumption
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`that the recited elements are only a part of the device, that the claim does not
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`exclude additional, unrecited elements.”). “While it is true that, as a general rule,
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`the words of a patent claim are to be given their plain, ordinary and accustomed
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`meaning to one of ordinary skill in the relevant art, Toro Co. v. White Consol.
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`Patent Owner Response
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`
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`Indus., Inc., 199 F.3d 1295, 1299 (Fed. Cir. 1999), a court must nevertheless
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`examine the remaining intrinsic evidence to determine whether the patentee has set
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`forth an explicit definition of a term contrary to its ordinary meaning, has
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`disclaimed subject matter, or has otherwise limited the scope of the claims.” Day
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`Intern., Inc. v. Reeves Brothers, Inc., 260 F.3d 1343, 1349 (Fed. Cir. 2001).
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`The intrinsic record, both the specification and the prosecution history, must
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`be reviewed to determine if there are limits to terms in the claims that would
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`otherwise be given their presumptive plain meanings. Prosecution history “limits
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`the interpretation of claims so as to exclude any interpretation that may have been
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`disclaimed or disavowed during prosecution in order to obtain claim allowance.”
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`Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448, 452 (Fed. Cir. 1985).
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`Similarly, the specification may contain repeated statements distinguishing the
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`prior art that limit the claims. SafeTCare Mfg., Inc. v.Tele-Made, Inc., 497 F.3d
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`1262, 1269-70 (Fed. Cir. 2007) (finding disclaimer where the specification
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`repeatedly indicated that the invention operated by “pushing (as opposed to
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`pulling) forces,” and then characterized the “pushing forces” as “an important
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`feature of the present invention”).
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`Under the BRI standard, the Board should take into account both the
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`specification and the prosecution history because the patent examiner and the
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`applicant have already worked together to determine the scope of the claimed
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`Patent Owner Response
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`invention. See In re Buszard, 504 F.3d 1364, 1366-67 (Fed. Cir. 2007) (“The
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`patent examiner and the applicant, in the give and take of rejection and response,
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`work toward defining the metes and bounds of the invention to be patented.”); In
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`re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (“When the applicant states the
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`meaning that the claim terms are intended to have, the claims are examined with
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`that meaning, in order to achieve a complete exploration of the applicant's
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`invention and its relation to the prior art.”).
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`The Board has followed these principles of claim construction in other IPR
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`proceedings. See, e.g., The Scotts Co., LLC v. Encap, LLC, IPR2013-00110, Ex.
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`2024 at 14-16. In Scotts, the Board changed its preliminary claim construction of
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`“being in a solid state at time of coating” because the Board found that the patent
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`owner had disavowed claim scope during prosecution in order to overcome a
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`specific prior art reference. Ex. 2024 at 15. The Board relie