Sirona Dental Systems GmbH v. Institut Straumann AG, Dental Wings Inc.


Docket No. 2017-1341, -1403 (IPR2015-01190)

PROST, MOORE, STOLL
June 19, 2018

Brief summary: Board’s finding of obviousness of claims 1-8, and non-obviousness of claims 9-10 affirmed. Board found to have erred because the pre-Aqua (FC 2017) FWD “improperly placed the burden on Sirona to demonstrate that the proposed substitute claims were patentable.”

Summary: Sirona appealed Board final written decision (FWD) finding claims 1-8 of US 6,319,006 relating to “a method for producing a [dental] drill assistance device” obvious over the combination of the “Bannuscher” (DE 195 10 294) and “Truppe” (US 5,842,858) and denying its contingent motion to amend the claims. ISA cross-appealed FWD holding claims 9-10 patentable. The FC panel reviewed “the Board’s legal determination of obviousness de novo” (Arctic Cat, FC 2017) “and its factual findings for substantial evidence” (Outdry, FC 2017) and “its procedures for compliance with the [APA] de novo”, explaining it “must set aside Board decisions if they are ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law’” (5 USC § 706; EmeraChem, FC 2017). Challenged claim 1, upon which patentability for claims 2-8 depends because “Sirona did not raise separate patentability arguments” for those claims, includes the limitation of “carrying out a three-dimensional optical measuring of the visible surfaces of the jaw and of the teeth and compiling a corresponding measured data record”. The FC panel explained that the parties “filed different translations of Bannuscher”, both describing “inputting plaster models from impressions taken of the ‘patient’s oral situation’ into a computer, but do so differently”, and therefore “dispute whether Bannuscher digitally inputs structures of the mouth or movements of the jaw into the simulation.” Truppe is explained to relate to planning for surgery that “incorporates ‘representations from imaging methods.’” Sirona did not challenge the Board’s legal analysis but argued the combination of references did not disclose the “three dimensional optical measuring…and compiling a corresponding measured data record”, and whether there was a motivation to combine the references. The Board found “that Bannuscher digitally inputs the structures from the plaster model for correlation and not simply jaw movement”, and the FC panel concluded this was supported by substantial evidence. The FC panel also found that substantial evidence supported the Board’s finding that Truppe discloses “three-dimensional optical measuring”, and not just 2-D as Sirona argued. The FC panel also found substantial evidence supported the Board’s finding that there was a motivation to combine the references, based in part on expert testimony. The Board’s conclusion of obviousness of claims 1-8 was therefore affirmed. Sirona also argued “that the Board relied on theories that first appeared in the” FWD (SAS, US 2018 (Director does not “enjoy[] a license to depart from the petition and institute a different [IPR] of his own design”), but the FC panel disagreed (e.g., “[t]he Board did not change theories simply because the petition did not use the exact words ‘geometery data’” (Rambus, FC 2013). Sirona also argued the Board erred in denying its contingent motion to amend, and the FC panel agreed since the pre-Aqua (FC 2017) FWD “improperly placed the burden on Sirona to demonstrate that the proposed substitute claims were patentable.” The FC panel also concluded that the Board did not err in not applying “findings from its analysis of Sirona’s motion to amend to its analysis of claims 9-10” and therefore affirmed the Board’s decision that claims 9-10 are patentable.

Posted in Inter Parties Review (IPR), IPR, Obviousness-Teaching Away | Leave a comment

Mobileye Vision Technologies Ltd. v. iOnRoad, Ltd.


Docket No. 2017-1984

LOURIE, CLEVENGER, REYNA
June 12, 2018

Non-precedential

Brief summary: Board decision following inter partes reexamination affirming the examiner’s rejection of Mobileye’s claim for estimating a time-of-contact between a moving vehicle and an obstacle” as obvious affirmed.

Summary: Mobileye appealed Board decision following inter partes reexamination (requested by iOnRoad) affirming the examiner’s rejection of claims 1-7 of US 7,113,867 “directed to a system for estimating a time-of-contact between a moving vehicle and an obstacle” as obvious. The decision was only appealed with respect to ‘867 claim 6. The system functions “by recording successive images and analyzing ‘the rate at which the separation between the vehicle and obstacle’ is changing”, relying on “the lateral displacement” which “will ‘uniformly approach zero’…indicating that the vehicle and obstacle will collide” (claimed in appealed claim 6). iOnRoad argued that claim 6 would have been obvious over three references: “Matthews” (1994), “Lee” (1976), and “Goodrich” (US 4,257,703). Mobileye only appealed the Board’s findings regarding Goodrich, which the FC panel opinion explained “teaches a collision avoidance system that uses the ‘lateral translation of the block’ to predict ‘whether or not at its current lateral velocity, the block will clear or intersect [with] the vehicle’” (and the Board found “substantially uniformly approaches zero”). The FC panel reviewed the Board’s decision de novo (In re Elsner, FC 2004; Randall Mfg., FC 2013 citing KSR, US 2007 (obviousness)) and its underlying factual findings for substantial evidence (In re Gartside, FC 2000; Consol. Edison, US 1938 (evidence that “a reasonable mind might accept the evidence to support the finding”)). The FC panel concluded that “the Board’s finding that Goodrich teaches the ‘substantially uniformly approached zero’ limitation is supported by substantial evidence”. Mobileye’s argument that claim 6 relates to “lateral displacement” while Goodrich only teaches “collision avoidance based on a lateral velocity” was found by the FC panel to be “a distinction without a difference.” Thus, the Board’s decision was affirmed.

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Medtronic Inc. v. Mark A. Barry


Docket No. 2017-1169, -1170 (IPR2015-00780, -00783)

TARANTO, PLAGER, CHEN
June 11, 2018

Brief summary: FC panel concluded that “[t]he record does not show that the Board fully considered all of the relevant factors” in determining whether slides presented at a meeting were publicly accessible. FN1 also explained that the FWDs did not address every ground raised by Medtronic, but that it understands the Board will consider all of those grounds on remand in view of SAS (US 2018).

Summary: Medtronic appealed Board final written decisions (FWDs) that Mr. Barry’s claims of US 7,670,358 and US 7,776,072 relating to methods for spinal alignment would not have been obvious over two references and that others were not publicly accessible prior art. Medtronic submitted “the ‘928 Application” disclosing “a tool (‘the ‘928 device’) for displacing vertebrae…during spinal surgery”), “a book chapter describing techniques of using pedicle screws in the thoracic and lumbar spine” (“MTOS”), and “Video and Slides” presented “to spinal surgeons at various industry meetings and conferences in 2003” (which the Board concluded were not “printed publications” under pre-AIA § 102). The FC panel explained that it reviewed the Boards’ legal conclusions de novo and its factual findings for substantial evidence (Ethicon, FC 2016; In re Applied Materials, FC 2012 (“as a reasonable mind might accept as adequate to support a conclusion”)). As to claims 1-5 of the ‘358 Patent, the FC panel found that substantial evidence (including expert testimony) supported the Board’s conclusion that “Medtronic failed to prove that the challenged claims would have been obvious over the combination of the ‘928 Application and MTOS” (e.g., the ‘928 Application provides “no disclosure…of scoliosis, scoliotic curvature, or twisting of the spine”, Medtronic and its expert failed to cite to any particular passage or figures from MTOS that ‘explicitly disclose[] the simultaneous application of manipulative force’” (i.e., the “Simultaneously Rotating” limitation of independent claim 1)). The Board’s analysis of the ‘072 patent focused on the “Derotation Tool” limitation, which the FC panel explained is required by all of the ‘072 claims. The FC panel found “no error in the Board’s analysis of the cited references or its decision to credit the testimony of the patent owner’s expert over that of Medtronic’s expert that the references did not disclose a derotation tool.”

Medtronic also unsuccessfully challenged the ‘358 and ‘072 claims would have been obvious over the ‘928 Application, MTOS, and the Video and Slides. As mentioned above, the Board determined the Video and Slides were not prior art (printed publications within the meaning of 35 U.S.C. § 102(b)). “A CD containing the video was distributed at three separate programs in 2003”, the earliest being “limited to SDSG [Spinal Deformity Study Group] members” while two later meetings “were open to other surgeons.” The FC panel explained that under 35 U.S.C. § 102(b) “[a] reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skill in the subject matter or art exercising reasonable diligence[] can locate it” (Blue Calypso, FC 2016 (citing Kyocera Wireless, FC 2008); Suffolk Techs., FC 2014 (“need not be easily searchable after publication if it was sufficiently disseminated”); MIT, FC 1985 (oral presentation “to a group of cell culturists interested in the subject matter was considered a ‘printed publication’); Cordis, FC 2009 (research papers distributed by a doctor to certain colleages and two commercial entities not publicly accessible; “the record contained clear evidence that academic norms gave rise to an expectation that dislcosures would remain confidential”); In re Klopfenstein, FC 2004 (four factors to be considered: “the length of time the display was exhibited”; “the expertise of the target audience”; “the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied”, and “the simplicity and ease with which the material could have been copied”)). The FC panel concluded that “[t]he record does not show that the Board fully considered all of the relevant factors” and therefore vacated its finding on this point and remanded it.

FN1 of the FC panel opinion explained that the FWDs did not address every ground raised by Medtronic, but that it understands from the PTO’s April 2018 “Guidance on the impact of SAS (US 2018) on AIA trial proceedings” that the Board will consider all of those grounds on remand.

Posted in Anticipation (35 USC 102), Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

PTO Memorandum “Recent Subject Matter Eligibility Decision: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals”


PTO Memorandum regarding Vanda Pharm. Inc. v. West-Ward Pharm. Int. Ltd. et al.

Update: In the previously summarized Vanda decision (April 2018; FC Docket Nos. 2016-2707, -2708), the FC panel found claims to “[a] method for treating a patient….comprising the steps of: determining whether the patient is a CYP2D6 poor metabolizer” and then “administering iloperidone” to be patentable subject matter under § 101. The FC panel explained that “[t]his case…is not Mayo” as “the claims in Mayo were not directed to a novel method of treating a disease”. The FC panel explained that even though “[t]he inventors recognized the relationships between iloperidone” and “CYP2D6 metabolism”, “the ‘610 patent claims are directed to a method of using iloperidone to treat schizophrenia” (“an application of that relationship…‘a new way of using an existing drug’ that is safer” (Mayo, US 2012)). In addition, “unlike the claim in Mayo” which “did not do beyond recognizing (i.e., ‘indicates’) a need to increase or decrease a dose”, “to the extent that preemption is a concern, the ‘610 patent claims do not ‘tie up the doctor’s subsequent treatment decision’” (CellzDirect, FC 2016). Judge Prost dissented on this point.

On June 7, 2018, the PTO issued a Memorandum entitled “Recent Subject Matter Eligibility Decision: Vanda Pharmaceuticals Inc. v. West-Ward Pharmacueticals” and addressing method of treatment claims in light of this Vanda decision. The PTO explained that “(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible undr Step 2A of the USPTO’s subject matter eligibility guidance; and (2) it is not necessary for the ‘method of treatment’ claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S.C. § 101” (e.g., “claims 5 and 6 of USPTO Example 29 (Diagnosing and Treating Julitis) should be considered patent eligible under Step 2A…in light of…Vanda” (PTO’s claims 5 and 6 include “obtaining a plasma sample”, “detecting whether JUL-1 is present”, “diagnosing…julitis” based on that determination, and “administering an effective amount…of vitamin D” or anti-TNF antibodies, respectively; no change from eligibility determination for those claims in the PTO’s May 2016 “Subject Matter Eligibility Examples: Life Sciences”)).

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PGS Geophysical AS v. USPTO


Docket No. 2016-2470, -2472, -2474 (IPR2015-00309, -00310, -0311)

WALLACH, TARANTO, STOLL
June 7, 2018

Brief summary: PTAB decision of obviousness affirmed. PTAB decision to only review certain claims and grounds included in IPR Petition not to be error in view of SAS Inst. (US 2018) but the FC panel decided it “need not…sua sponte revive the ‘non-instituted’ claims and grounds”.

Summary: PGS appealed PTAB (Board) conclusion that certain claims of US 6,906,981 relating to “methods and systems for performing ‘marine seismic surveying’ to determine the structure of earth formations below the seabed” are invalid for anticipation or obviousness. During the IPRs, the PTAB “specified for review only some of the claims [petitioner] WesternGeco challenged and only some of the grounds”. WesternGeco chose not to participate in this appeal and the PTO intervened. The FC panel opinion first explained that, although the PTAB’s limited review was error in view of SAS Inst. (US 2018 (“[n]othing suggests the Director enjoys a license to depart from the petition and institute a different [IPR] of his own design”)), the FC had “jurisdiction to address the merits of the Board’s final written decisions and that [it] need not, and will not, sua sponte revive the ‘non-instituted’ claims and grounds” since, e.g., “[n]either PGS nor the Director asks for any SAS-based action” (and nor did WesternGeco). Each of the three PTAB FWDs included “substantially similar” reasoning. PGS only appealed the PTAB’s finding that certain claims were obvious over US 5,924,049 (Beasley) and US 4,953,657 (Edington). The FC panel first explained that it has jurisdiction since, e.g., “the combination of non-institution decisions and the [FWDs] on the instituted claims and grounds ‘terminated the IPR proceeding[s]’ that are now on appeal” ((28 USC § 1295(a)(4)(A); In re Arunachalam, FC 2016; Arthrex, FC 2018; APA 5 USC § 704 (“[t]he standard for ‘final agency action’…is met”)), stating that “[s]ome of what the Board did is now seen to be legally erroneous under SAS, but legal error does not mean lack of finality.” Regarding obviousness, the FC panel explained that “PGS does not here dispute that the combination of Beasley and Edington teaches all of the limitations of the challenged claims”, and the Board found “any contrary argument for all claims now on appeal except claims 36 and 37” to be waived. However, PGS argued “that the Board erred regarding the needed motivation to combine” the references “by not adequately addressing the problem of smearing” (resulting from pictures of sea floor being taken from slightly different locations when the pictures are “later summed together”). The FC panel concluded the Board’s findings of what Beasley and Edington teach were reasonable (In re Fulton, FC 2004 (what a reference teaches is a factual question)). The FC panel also concluded that “the Board did not fail to address the motivation question” by, e.g., “affirmatively focus[ing] on the ‘other types of encoding’ language of Beasley as an affirmative suggestion to look elsewhere, especially a time-delay reference, in view of Beasley’s contemplation of small time delays” (Bowman, US 1974 and In re NuVasive, FC 2016 (“we will uphold a decision of less than ideal clarity if the agency’s path may reasonably be discerned”); SIBIA, FC 2000 (“[t]he motivation to modify a referenc can come from the knowledge of those skilled in the art, from the prior art reference itself, or from the nature of the problem to be solved”)). The FC panel also found “no reversible error” with the Board’s conclusion that there was no teaching away since, e.g., “neither party offered evidence as to the degree of smearing that could be tolerated in the marine context” (Panduit, FC 1987). Thus, the Board’s FWDs were affirmed.

Posted in Appeal, Inter Parties Review (IPR), IPR, Obviousness, Obviousness-Teaching Away | Leave a comment

Merck Sharp & Dohme Corp. v. Wyeth LLC

Case Nos. IPR2017-00378, -00380, and -00390 (Final Written Decisions regarding US 8,562,999)
June 8, 2018

Brief summary: Claims 1-17 and 19-22, but not claim 18, of Wyeth’s US 8,562,999 relating to its PREVNAR® vaccine found invalid for obviousness in three separate PTAB Final Written Decisions (FWDs).

Summary: MSD challenged Wyeth’s US 8,562,999 relating to Wyeth’s/Pfizer’s “Prevenar vaccine” including seven S. pneumoniae serotype polysachharides conjugated to a genetically detoxified form of diphtheria toxin (CRM197) (marketed as PREVNAR®) on different combinations of prior art:

• ‘378 IPR: “Chiron” (WO 2003/009869A1), “Smith” (J. Parenteral Sci. & Tech. (1988)), and “Elan” (WO 2004/071439 A2) with or without “Peña” (Pediatrika (2004));
• ‘380 IPR “Prevenar” (“Summary of Product Characteristics…” (2005)); and “Chiron” with or without “Peña”; and,
• ‘390 IPR: Chiron, Smith, and Elan; Prevenar and Chiron; or “Merck” (WO 2011/100151 A1) and US 7,935,787B2.

Expert declarations were also submitted by each of MSD and Wyeth in each IPR.

Claim terms construed in all three IPRs:

• “polysaccharide” was determined to be defined by “the Specification…with reasonable clarity, deliberateness, and precision” (e.g., “any antigenic saccharide element (or antigenic unity commonly used in immunologic and bacterial vaccine arts”);
• “polysaccharide-protein conjugates”: specification determined not to “provide a similarly precise definition” but to “generally describe[] such conjugates in a manner that is consistent with the plain and ordinary meaning”; broadest reasonable construction (BRC) determined to be “an immunogenic composition resulting from reacting” a “polysaccharide” as defined above “with a carrier protein amenable to standard conjugation procedures”, disagreeing with Wyeth that “the claims require ‘measuring antigenicity’”; and,
• “the formulation…inhibits aggregation induced by the silicon container means”: as claim 1 begins with “[a] formulation comprising”, BRC includes formulations comprising additional, unrecited ingredients, and such additional ingredients may contribute to the required aggregation inhibition by the formulation” (In re Baxter, CCPA 1981; CIAS, FC 2007) and does not “require[] maintaining any specific level of antigenicity of the conjugate”.

Level of Ordinary Skill in the Art for all three IPRs: “one having ordinary skill in the art of formulating polysaccharide-protein conjugate immunogenic compositions” and “silicone-induced interactions/aggregations in pharmaceuticals…a Ph.D. degree in the pharmaceutical sciences, physical chemistry or protein chemistry, at least two years of work experience involving researching silicone-induced interactions/aggregation in pharmaceuticals, or (b) a Master’s degree in” the same areas and “at least four years” of the same work experience.

Obviousness analyses:

In the ‘378 IPR, the PTAB found that Chiron “teaches or suggests every ingredient in recited in the formulations of claims 1-6, 10, 11, 14, 19 and 20”, the “histidine buffer” being “inherently within the scope of the claim limitation requiring the buffer to have a pKa of about 3.5 to about 7.5” and, based in part on expert testimony, that “substantial evidence supports” MSD’s argument that storing “Chiron’s formulations in siliconized container means”, including using “rubber stoppers that were siliconized” would have been obvious (e.g., Chiron “had previously done so for other conjugate vaccines including similar ingredients” and “prepared the formulation not simply for research purposes, but instead with a goal of ultimately…distributing it in siliconized containers”; Smith teaches “parental drug packaging components”; Elan teaches “including a surfactant” to “address silicone-induced protein aggregation”; and, the ‘999 “Background of the Invention” section and prosecution history statement that “[i]t was known at the time of the invention that silicone oil causes aggregation/precipitation”; In re O’Farrell, FC 1988 (“a proper obviousness requirement focuses on reasonable expectations”)). The PTAB also found, based in large part on expert testimony, that “the preponderance of the evidence” supports MSD’s obviousness arguments regarding claim 17 requiring seven different polysachharide/CRM197 conjugates (4, 6B, 9V, 14, 18C, 19F, 23F) since, e.g., Prevnar was already known. The PTAB found, however, that MSD did not show by a preponderance of the evidence that claim 18, requiring 13 different polysachharide/CRM197 conjugates is invalid for obviousness “even though” those 13 “serotypes…were known in the art”, rejecting MSD’s “natural progression” arguments (i.e., “from 7-valent Prevnar®, to 9- and 11-valent iterations”), citing Kinetic Concepts (FC 2012 (impermissible hindsight)). The PTAB also explained that it was “unable to assess whether” Peña’s “study involved a formulation comprising each of the thirteen known serotypes conjugated to a CRM197 polypeptide, as required by the claim”.

In the ‘380 IPR, the PTB found the combination of the Prevenar vaccine
“provided in a ‘pre-filled syringe (Type I glass),’ which was known to be siliconized” and Chiron’s disclosure of “aluminum-adjuvanted pneumococcal CRM197 conjugate formulations comprising a sodium salt such as sodium chloride and a histidine buffer” and its benefits (“particularly advantageous for acidic antigens”, as in the Prevenar vaccine), supported by expert testimony, rendered claims 1-6, 10, 11, 14, 17 19 and 20 obvious. In its analysis, the PTAB explained that “an inherent property in an obviousness challenge must be subjected to consideration of whether such property would have been unexpected” (Honeywell, FC 2017) and that MSD’s “inherency argument” regarding the “siliconized container” limitation “is not based upon probabilities or possibilities” but is instead “the natural result of the combination of elements described in the prior art” (PAR Pharm., FC 2014 (“[t]he mere fact that a certain thing may result…is not sufficient [to establish inherency]”)). As in the ‘378 IPR, the PTAB concluded that MSD did not show by a preponderance of the evidence that claim 18 is invalid for obviousness.

In the ‘390 IPR, the PTAB explained that Wyeth did not challenge MSD’s allegations that “Chiron teaches or suggests the additional limitations set forth in dependent claims 7-9 and 12” but disputed “whether the combined prior art teaches or suggests (a) placing Chiron’s formulation in a ‘siliconized container means,’ and (b) the formulation ‘inhibits aggregation induced by the siliconized container means.” The PTAB concluded, again based in part on expert testimony, that the combined prior art did teach these limitations (e.g., “As the parties acknowledge, Chiron disclosed placing the formulations in vials and storing them for at least one month”, “[t]here is no dispute that a person of ordinary skill in the art would have had a reason to use a rubber stopper with such storage vials”, and “Chiron’s formulation contains a surfactane, such as polysorbate/Tween® 80” (in re O’Farrell, FC 1988 (“reasonable expectations”)). Claims 13, 15 and 16, requiring a histidine buffer, saline solution buffered by sodium chloride, and aluminum phosphate, were also determined to have been shown by MSD to be invalid for obviousness by a preponderance of the evidence (e.g., by Chiron’s formulation comprising a histidine buffer at pH 5.8” (ClearValue, FC 2012 (invalidity where “no allegation of criticality…across the range”)). The PTAB also agreed with MSD regarding the obviousness of claims 21 and 22 (requiring 5 mM succinate buffer). As in the ‘380 IPR, the PTAB also agreed with MSD’s obviousness arguments regarding claims 7-9, 12, 13, 15, 16, 21 and 22 over Prevenar and Chiron (e.g., Wyeth “resorts again to the inadequately supported testimony of one of its declarants”). The validity of claims 13 and 16 in view of Merck and the ‘787 patent was not addressed as it was previously “removed from the proceeding”.

Claim status following IPR decisions:

1. (Invalid, ‘378 IPR) A formulation comprising (i) a pH buffered saline solution, wherein the buffer has a pKa of about 3.5 to about 7.5, (ii) an aluminum salt and (iii) one or more polysaccharide-protein conjugates, wherein the formulation is comprised in a siliconized container means and inhibits aggregation induced by the siliconized container means.
2. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the formulation further comprises polysorbate 80, and wherein the final concentration of the polysorbate 80 in the formulation is at least 0.001% to 10% polysorbate 80 weight/volume of the formulation.
3. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the polysaccharide-protein conjugate comprises one or more pneumococcal polysaccharides.
4. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the formulation further comprises one or more meningococcal polysaccharides, one or more meningococcal antigenic proteins, or a combination thereof.
5. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the formulation further comprises one or more streptococcal polysaccharides, one or more streptococcal antigenic proteins, or a combination thereof.
6. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the formulation further comprises an adjuvant.
7. (Invalid, ‘390 IPR) The formulation of claim 1, wherein the pH buffered saline solution has a pH of 5.5 to 7.5.
8. (Invalid, ‘390 IPR) The formulation claim 1, wherein the buffer is phosphate, succinate, histidine or citrate.
9. (Invalid, ‘390 IPR) The formulation of claim 1, wherein the salt in the pH buffered saline solution comprises magnesium chloride, potassium chloride, sodium chloride or a combination thereof.
10. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the aluminum salt is aluminum hydroxide, aluminum phosphate or aluminum sulfate.
11. (Invalid, ‘378 IPR) The formulation of claim 10, wherein the aluminum salt is aluminum phosphate.
12. (Invalid, ‘390 IPR) The formulation of claim 1, wherein the buffer is histidine, the salt in the pH buffered saline solution is sodium chloride and the aluminum salt is aluminum phosphate.
13. (Invalid, ‘390 IPR) The formulation of claim 1, wherein the buffer is histidine at pH 5.8, the salt in the pH buffered saline solution is sodium chloride and the aluminum salt is aluminum phosphate.
14. (Invalid, ‘378 IPR) The formulation claim 1, wherein the formulation further comprises a surfactant selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, polysorbate 85, nonylphenoxypolyethoxethanol, octylphenoxypolyethoxethanol, oxtoxynol 40, nonoxynol-9, triethanolamine, triethanolamine polypeptide oleate, polyoxyethylene-660 hydroxystearate, polyoxyethylene-35ricinoleate, soy lecithin and a poloxamer.
15. (Invalid, ‘390 IPR) The formulation of claim 1, wherein the one or more polysaccharide-protein conjugate comprises one or more pneumococcal polysaccharides, the buffer is histidine, the salt in the pH buffered saline solution is sodium chloride and the aluminum salt is aluminum phosphate.
16. (Invalid, ‘390 IPR) The formulation of claim 1, wherein the one or more polysaccharide-protein conjugate comprises one or more pneumococcal polysaccharides, the buffer is histidine at pH 5.8, the salt in the pH buffered saline solution is sodium chloride and the aluminum salt is aluminum phosphate.
17. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the one or more polysaccharide-protein conjugate comprises an S. pneumoniae serotype 4 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6B polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 9V polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 14 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 18C polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 19F polysaccharide conjugated to a CRM197 polypeptide, and an S. pneumoniae serotype 23F polysaccharide conjugated to a CRM197.
18. (Not unpatentable, ‘378 and ‘380 IPRs) The formulation of claim 1, wherein the one or more polysaccharide-protein conjugate comprises an S. pneumoniae serotype 4 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6B polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 9V polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 14 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 18C polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 19F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 23F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 1 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 3 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 5 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6A polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 7F polysaccharide conjugated to a CRM197 polypeptide and an S. pneumoniae serotype 19A polysaccharide conjugated to a CRM197 polypeptide.
19. (Invalid, ‘378 IPR) The formulation of claim 1, wherein the siliconized container means is selected from the group consisting of a vial, a syringe, a flask, a fermentor, a bioreactor, tubing, a pipe, a bag, a jar, an ampoule, a cartridge and a disposable pen.
20. (Invalid, ‘378 IPR) The formulation of claim 19, wherein siliconized container means is a syringe.
21. (Invalid, ‘390 IPR) The formulation of claim 8, wherein the buffer is succinate at a final concentration of 1 mM to 10 mM and pH 5.8 to 6.0.
22. (Invalid, ‘390 IPR) The formulation of claim 21, wherein the succinate buffer is at a final concentration of 5 mM.

Several IPRs regarding US 9,492,559B2 (also relating to PREVNAR® but specifically claiming serotype 22F which is not claimed in the ‘999 patent) are also pending (IPR2017-02131, -02132, -02136, -02138; IPR2018-00187, -00188).

Posted in Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

Stone Basket Innovations, LLC v. Cook Medical LLC


Docket No. 2017-2330

PROST, WALLACH, TARANTO
June 11, 2018

Brief summary: DC finding of no exceptionality and denial of attorney’s fees under § 285 affirmed since, e.g., “Stone’s litigating position did not ‘stand[] out from others.’”

Summary: Cook appealed DC denial of attorney’s fees under § 285 regarding litigation of Stone’s US 6,551,327. The FC panel considered whether the DC “erred in its assessment of: (1) the substantive strength of Stone’s litigating position, and (2) the alleged pattern of vexatious litigation by Stone.” The FC panel opinion explained that under Octane Fitness (US 2014), DCs “may determine whether a case is ‘exceptional’ in the case-by-case exercise of their discretion, considering the totality of the circumstances” and such decision are reviewed “for abuse of discretion” (Highmark, US 2014; Rothschild, FC 2017 (“erroneous view of the law or on a clearly erroneous assessment of the evidence”)). Regarding the “substantive strength” analysis, Cook argued the DC “disregarded both the law and the facts showing the weakness of [Stone’s] patent claims” (e.g., in a deposition, “the ‘327 patent inventor stated, regarding the additional of the ‘sheath movement element’ in claim 1 to overcome an examiner’s rejection, ‘I realize there is nothing novel about it’” and “Stone filed a motion requesting adverse judgment in the IPR proceeding” which was granted and resulted in cancellation of all of the ‘327 patent’s claims). But the FC panel found the DC “did not err in finding Stone lacked any type of ‘clear notice’ of the ‘327 patent’s invalidity by service of Cook’s invalidity contentions” (e.g., those “fall short of notifying how Leslie renders the ‘327 patent obvious” and since the reference “is listed on the face” of the ‘327 patent, “the examiner is presumed to have considered it” (Shire, FC 2015); PowerOasis, FC 2008 (“where a party only relies on prior art considered by an examiner in its invalidity contentions, that party has the burden to ‘overcome the deference that is due” to the PTO); SFA, FC 2015 (“a strong or even correct litigating position is not the standard by which we assess exceptionality”); “[a] post-issuance statement regarding a single element of a claimed invention does not establish invalidity” (Graham, US 1996 ([w]e must consider the subject matter sought to be patented taken as a whole”)) and “concluding that Stone’s litigating position did not ‘stand[] out from others.’” And regarding some of Cook’s behavior throughout the litigation (e.g., “Cook could not explain why it did not make its assertion of frivolousness of the claims known to Stoner sooner”), the FC panel explained that “a party cannot simply hide under a rock, quietly documenting all the ways it’s been wronged, so that it can march out its ‘parade of horribles’ after all is said and done” (citing C.D. Cal., Mar. 20, 2018). The FC panel also noted that its “holding with respect to this factor does not disturb the rule that ‘a party cannot assert baseless infringement claims and must continually assess the soundness of pending infringement claims” (Taurus IP, FC 2013; Medtronic, FC 2010). The FC panel also found no error with the DC’s finding a lack of evidence that Stone had sued Cook or “other defendants, ‘for the sole purpose of forcing settlements, without any intention of testing the merits of its claim” (Eon-Net, FC 2011). Thus, the DC finding of no exceptionality and denial of attorney’s fees under § 285 was affirmed.

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