# United States **Court of Appeals**  **for the Federal Circuit**

______________________
JAZZ PHARMACEUTICALS , INC., Appellant

v.

AMNEAL PHARMACEUTICA LS, LLC, Appellee

______________________

2017

- 1671, 2017

- 1673, 2017

- 1674, 2017

- 1675, 2017

- 1676, 2017

- 1677, 2017

- 2075

______________________ Appeals from the United States Patent and Trad emark Office, Patent Trial and Appeal Board in No s

. IPR2015

- 00545, IPR2015

- 00546, IPR2015

- 00547, IPR2015

- 00548 , IPR2015

- 00551, IPR2015

- 00554, IPR2015

- 01903.

______________________

Decided: July 13, 2018

______________________

K ATHLEEN M. S ULLIVAN , Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY, argued for appellant. Also represented by F. D OMINIC C ERRITO , G ABRIEL P. B RIER , F RANK C HARLES C ALVOSA , E VANGELINE S HIH , E RIC C. S TOPS ; D AVID B. C OCHRAN , Jones Day, Cleveland, OH.

S TEVEN A RTHUR M ADDOX , Maddox Edwards, PLLC, Washington, DC, argued for appellee Also represented by M ATTHEW C. R UEDY

.J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 2

______________________

Before N EWMAN , L OURIE , and R EYNA , Circuit Judges.

L OURIE , Circuit Judge

. Jazz Pharmaceuticals, Inc. (“Jazz”) appeals from six inter partes review (“IPR”) decisions of the United States Patent and Trademark Office Patent Trial and Ap peal Board ( the “Board”). 1 Collectively, the decisions held certain claims of Jazz’s U.S. Patents 7,668,730 (“’730 patent”) , 7,765,106, 7,765,107, 7,895,059, 8,589,182, 8,457,988 (“’988 patent”)

, and 8,731,963 (“’963 patent”) (together, the “patents in suit”) invalid as obvious. Because the Board did not err in its conclusions of obviou sness , we affirm.

B ACKGROUND

T he patents in suit are members of a family of patents owned by Jazz relating to a drug distribution system for tracking prescriptions of a “sensitive drug .” ’730 patent

1 Amneal Pharm., LLC v. Jazz Pharm., Inc. , No. IPR2015

- 01903, 2017 WL 1096638 (P.T.A.B. Mar. 22, 2017) (“ ’963 Decision ”); Amneal Pharm.

, LLC v. Jazz Pharm., Inc. , No. IPR2015

- 00545, 2016 WL 7985452 (P.T.A.B. Dec. 22, 2016); Par Pharm., Inc. v. Jazz Pharm.

, Inc. , No. IPR2015

- 00546, 2016 WL 7985429 (P.T.A.B. Dec. 22, 2016); Pa r Pharm., Inc. v. Jazz Pharm., Inc. , No. IPR2015

- 00547, 2016 WL 7985454 (P.T.A.B. Dec. 22, 2016); Par Pharm., Inc. v. Jazz Pharm., Inc. , No. IPR2015

- 00548, 2016 WL 7985430 (P.T.A.B. Dec. 22, 2016); Par Pharm., Inc. v. Jazz Pharm., Inc. , Nos. IPR2015

- 00551, IPR2015

- 00554, 2016 WL 7985458 (P.T.A.B. July 27, 2016) (“ ’ 730/’988 Decision ”).J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 3

Abstract. 2 “A sensitive drug is one which can be abused, or has addiction properties or other properties that render the dru g sensitive.” ’730 patent col. 3 ll. 14

– 16. One such sensitive drug is Xyrem ®

. Jazz exclusively markets Xyrem ®

, which the U.S. Food and Drug Admi nistration (“FDA”) has approved to treat symptoms assoc iated with narcolepsy. However, t he active ingredient in Xyrem ®

, gamma

- hydroxybutyrate (“GHB”) , m ay also be illicitly used as a “ date

- rape drug

. ” See Hillory J. Farias and Samantha Reid Date

- Rape Drug Prohibition Act of 2000, Pub. L. No. 106

- 172, 114 Stat. 7 (2000). Accordin gly, under the Controlled Substances Act any approved drug product containing GHB i s classified as a Schedule III depressant

. 21 C.F.R. § 1308.13

. Because of its pote ntial for abuse, the FDA approved Xyrem ® under “restric ted distribution regulations contained in [ 21 C .F.R

. § 314.500 ] (Subpart H) to assure safe use of the product.” J.A. 11055; see 21 C.F.R. § 314.520. During the regulatory review process for Xyrem ® , the FDA scheduled a n advisory committee meeting for June 6, 2001

. The meeting was announced in a May 14, 2001 Federal Register Notice, which stated that the meeting was open to the public and that “[a] main focus of the deliberations will be on risk management issues” assoc iated with Xyrem ®

. Meeting Notice, 66 Fed. Reg. 24
, 391 (May 14, 2001) (“Notice”)

. The N otice also provided a hyperlink to an FDA website where background material would be posted before the meeting

, and the meeting minutes, transcript, and slides would be posted after the meeting. Id. Collec tively, the Board referred to the background materials and the meeting minutes, tra nscript, and slides on the FDA website as the Advisory

2 As the patents in suit share a substantially ide ntical specification, for ease of reference we cite only the ’730 patent.J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 4

Committee Art (“ACA materials ”). Each of the Board’s obviousness determinations relied on the ACA materials

as prior art

. Th e primary issue on appeal is whether the ACA materials were sufficiently accessible to the public to constitute prior art.

I

T he claimed invention of the patents in suit involves tracking prescriptions of a sensitive drug through a database

. ’730 patent Abstract. Claim 1 of the ’730 patent is illustrative, and recites: 1. A computerized method of distributing a pr escription drug under exclusive control of an excl usive central pharmacy, the method comprising:
receiving in a computer processor all p rescription requests, for any and all patients being prescribed the prescription drug, only at the exclusive central pharmacy from any and all medical doctors a llowed to prescribe the prescription drug, the pr escription requests containing information iden tifying patients, the prescription drug, and various credentials of the any and all medical do ctors ; requiring entering of the information into an e xclusive computer database associated with the e xclusive central pharmacy for analysis of potential abuse si tuations, such that all prescriptions for the prescription drug are processed only by the exclusive central pharmacy using only the excl usive computer database;
checking with the computer processor the crede ntials of the any and all doctors to determine th e eligibility of the doctors to prescribe the prescri ption drug;J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 5

confirming with a patient that educational mat erial has been read prior to shipping the prescri ption drug; checking the exclusive computer database for p otential abuse of the prescription dru g; mailing the prescription drug to the patient only if no potential abuse is found by the patient to whom the prescription drug is prescribed and the doctor prescribing the prescription drug; confirming receipt by the patient of the prescri ption drug; and
generating with the computer processor periodic reports via the exclusive computer database to evaluate potential diversion patterns

. Id. col. 8 l. 37

– col. 9 l. 3 (emphases added).
Of particular relevance to this appeal are the “excl usive computer databas e,” “information identifying,” and “periodic reports” terms , italicized above

. The specific ation describes an “exclusive central database” as including all data relevant to distribution of a sensitive drug, “i ncluding patient, physician and prescription i nformation.” Id. col. 2 ll. 10

– 12

. Several types of such information are listed i n the description of figure 2. “The prescriber information contains standard contact information as well as license number, DEA number and physician specialty. Patient and prescription information includes name, social security number, date of birth, gender, contact information, drug identification, patient’s appropriate dosage, and number of refills allowed .

. . .” Id. col. 4 ll. 18

– 23.
Reports may be run against info rmation in the dat abase to “reveal potential abuse of the sensitive drug, such as early refills.” Id. col. 2 ll. 14

– 15. An e arly refill re port is made when a specific event occurs: a patient requests aJ AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 6

prescription refill prior to the scheduled refill date. Id. col. 6 ll. 36

– 42. If the physician does not approve the early refill, the patient must wait until the next scheduled refill date. Id. col. 6 ll. 43

– 44. Other types of reports are created at set time points, for example, at “a predete rmined nu mber of days or product remaining.” Id. col. 6 ll. 12

– 13. Likewise, the specification discusses “sample reports” that have “an associated frequency or freque ncies.” Id. col. 8 ll. 22

– 29. While claim 1 refers to “periodic reports,” that specific term does not appear elsewhere in the written description.

II Amneal Pharmaceuticals, LLC (“Amneal”) petitioned for IPR of the seven patents in suit. 3 The Board institu ted review of all petitioned claims for each patent except for the ’963 patent , where the Boar d partially instituted review of a subset of the petitioned claims, see Amneal Pharm., LLC v. Jazz Pharm., Inc. , IPR2015

- 01903, slip op. at 2 (P.T.A.B. Mar. 25, 2016), Paper No. 10. Also, in several of its institution decisions, the Board instituted revie w on fewer than all grounds raised in the petition. E.g.

, Amneal Pharm., LLC v. Jazz Pharm., Inc. , IPR2015

- 00551, IPR2015

- 00554, slip op. at 42 (P.T.A.B. July 28, 2015), Paper No. 20.

3 Amneal filed several of its petitions for IPR jointly with Par Pharmaceutical, Inc. (“Par”). Jazz and Par reached a settlement during the pendency of this appeal, and accordingly Par is no longer a party

. See Jazz Pharm., Inc. v. Amneal Pharm., LLC , No. 17

- 1671 (Fed. Cir. Jan. 19, 2018), ECF No. 51 . In discussing the pr oceedings before the Board, we refer to the petitioners collectively as “Amneal.”J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 7

The Board issued six final written decisions regarding the patents in suit. 4 T he parties’ current dispute centers on the Board’s determination that the ACA materials

were publicly accessible

. The ACA materials con sist of four documents associated with the public meeting held by the Xyrem ® advisory committee : (1) the FDA advisory committee meeting transcript and slides; (2) an FDA preliminary clinical safety review of Xyrem ® ; (3) a Xyrem ® briefing booklet; and (4) a video and transcript regarding a proposed distribution system for Xyrem ®

. ’ 730/’98 8 Decision

, 2016 WL 7985458, at *2; Appellant Br. 9. The Board determined that the ACA materials were publicly accessible on an FDA website listed in the Notice no later than October 4, 2001, over two months prior to the critical date of December 17, 2001

. ’ 730/’988 Decision , 2016 WL 7985458, at *11, *14.
Next, the Board turned to whether a person of ord inary skill exercising reasonable diligence would have been able to locate the ACA materials. Id. at *14

– 16. It found that a person of ordinary sk ill in the art was a pharmacist or computer scientist having familiarity with computerized drug distribution procedures

. Id. at *4

– 5. Furthermore, the Board agreed with Amneal that a person of ordinary skill “ would have been familiar with the Federal Regist er a nd motivated to look for notices related to drug distribution, safety, or abuse prevention,” and that a skilled artisan would have known that Xyrem ® contained an active ingredient susceptible to abuse. Id. ; see also id. at *15. According to the Board

, this provided a person of ordinary skill with “sufficient motivation to have located the Federal Register Notice and FDA we b-

4 For simplicity, unless otherwise noted we cite only the Board’s final written decision concerning the ’730 and ’988 patent s , which is representativ e of the other dec isions on appeal. See Appellant Br. 9 n.5.J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 8

site for Xyrem.” Id. at * 15. Given that motivation, the Board found that a person of ordinary skill would have been capable of locating the Notice, as the Notice expres sly stated that a “main focus of the deliberations will be on risk management issues” related to Xyrem ® , and the basic purpose of the Federal Register is to provide “notice to interested individuals of the actions of federal agen cies. ” Id. (internal quotation marks omitted).

T he parties also dispute two of the Board’s claim co nstructions and its obviousness analysis

. First, the Board construed “periodic reports” to “refer to reports th at are generated at regu lar intervals or intermittently, ” id. at *8, rejecting Jazz’s argument that the term only included reports g enerated at regular frequencies, id. at *7. Se cond, the Board construed “information identifying p atients” as “information identifying a patient,” and not limited to the information listed in the specification or requiring all listed types of information. Id. at *8. Sim ilarly, the Board construed “information identifying .

. . various credentials of the any and all medical d octors” as “information identifying various credentials, i.e., at least two different types of credentials, of the prescribing doctor,” and not limited to the information listed in the specification or requiring all listed types of information. Id. at *9.
Applying the above constructions, the Board held all instituted claims of the patents in suit unpatentable as obvious over the ACA materials alone or in combination with Robert R. Korfhage, Information Storage and R etrieval (1997) (“Korfhage”)

. The Boar d found that a person of ordinary skill would have been motivated to combine the ACA materials, id. at *16, and that the ACA materials collectively taught or suggested all limitations of the claims

, e.g. , id. at *22 , except for claims 2 and 10 of the ’988 patent and claims 24, 26, and 27 of the ’963 patent

. The Board held those latter five claims obviousJ AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 9

over the ACA materials and Korfhage. Id. at *25; ’963 Decision , 2017 WL 1096638, at *12, *14.

Claim s 2 and 10 of the ’988 patent depend from ind epende nt claim s 1 and 9

, respectively, and recite an excl usive central database “distributed over multiple computers , and wherein a query operates over all data in all the distributed databases relating to the prescriptions, the doctors, and the narcoleptic pati ents .” ’988 patent col. 9 ll. 14

– 16. The Board found that Korfhage disclosed a database that can be distributed over multiple computers for cost and efficiency reasons, and that a person of ord inary skill “would have been motivated to modify the [ACA] di stribution system to include multiple computers in a distributed database system for reasons of cost, efficiency, and the anticipated volume of prescription

related information to be received, entered, and queried.”

’ 730/’988 Decision , 2016 WL 7985458, at *24. The Board credited Amneal’s expert ’s testimony that distributed systems “were well

- known in the art and that information systems were being driven toward distributed databases.” Id. Accordingly, the Board held claims 2 and 10 u npatentable as obvious because implementing a database system on multiple computers “would have been a pr edictable use of a known distributed data system according to its established function.” Id. at * 25 (citing KSR Int’l Co. v. Teleflex Inc. , 550 U.S. 398, 417 (2007) )

. The Board conducted a similar obviousness analysis with respect to claims 24, 26, and 27 of the ’963 patent. These claims also recite a “central computer database being distributed over multiple computers.” ’963 patent col. 11 ll. 19

– 20; id. col. 12 ll. 23

– 24. Again, the Board found that a person of ordinary skill “ would have been motivated to distribute the ACA’s single, centralized computer database over multiple computers, for reasons of cost, efficiency, and the anticipated volume of prescri ption- rel ated information to be received, entered, and queried.” ’963 Decision , 2017 WL 1096638, at *9. TheJ AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 10

Board later noted that the ACA materials disclose “a single, centralized database for controlling distribution of Xyrem.” Id. at *12. It did so in the co ntext of rejecting Jazz’s argument that Korfhage emphasized systems having multiple databases. Crediting Amneal’s expert, the Board explained that Korfhage also disclosed single database systems, consistent with the ACA system. Id. As with the other ins tituted claims of the patents in suit, the Board held claims 24, 26, and 27 unpatentable as obvious. Id. at *12, *14.
Jazz appealed, challenging the Board’ s holding that the ACA materials are prior art and its claim constru ctions and obviousness analysis. We consider each issue in
turn.

D ISCUSSION

I. Jurisdiction

We must first address whether we have jurisdiction over the entirety of Jazz’s appeal. The Supreme Court recently decided that 35 U.S.C. § 318(a) prohibits the Board from insti tuting IPR of fewer than all claims cha llenged in a petition

. SAS Inst

. , Inc. v. Iancu , 138 S. Ct. 1348 , 1353 (2018) (“The agency cannot curate the claims at issue but must decide them all.”) . However, following its pre

- SAS regulation, see 37 C.F.R. § 42.108(a)

, the Board here did partially institute IPR

. For the ’963 patent, the Board instituted review of fewer than all claims challenged in the petition. And for several of the other patents, the Board did not institute review of each ground asserted in the petition

. See PGS Geophysical AS v. Iancu , 891 F.3d 1354, 1360 (Fed. Cir. 2018) (“Equal treatment of claims and grounds for institution purposes has pervasive support in SAS .”). Nonetheless, on appeal neither party has requested a remand for the Board to conside r non

- instituted claims or grounds, or any other SAS

- based relief.J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 11

We recently addressed a similar scenario in PGS

. In PGS , the Board had instituted IPR of only some of the claims and grounds raised by the petitioner. Id. at 1358

. But n either party on appeal “ask[ed] for any SAS

- based action.” Id. at 1359

. Despite the Board’s partial instit ution, we held that : ( 1) “the combination of the non

institution decisions and the final written decisions on the instituted claims and grounds ‘terminated the IPR pr oceeding[s]’” so as to satisfy the finality requirement that this court has read to be incorporated in 28 U.S.C. § 1295(a)(4)(A), id. at 1361 (alteration in original) (quo ting Arthrex, Inc. v. Smith & Nephew, Inc. , 880 F.3d 1345, 1348 (Fed. Cir. 2018)); and (2) any error committed by the Board under the Administrative Procedure Act in partia lly instituting IPR was waivable, so we could decide the appeal from the Board’s final written decision absent a request by a party for SAS

- based relief, id. at 1362

– 63

. Confronted with indistinguishable partially instituted IPR s and a lack of any request by either party for SAS

based action , we conclude that PGS controls this case. Under PGS , we have jurisdiction over Jazz’s appeal under 28 U.S.C. § 1295(a)(4)(A) and are not obliged to reopen

non

- instituted claims or grounds. Id. at 1362

. And we likewise see no reason to exercise any discretion to r emand the non

- instituted claims or grounds sua sponte

. See id. at 1362

– 63

. II. Public Accessibility of the ACA Materials
Having concluded that we have jurisdiction over Jazz’s appeal, we turn to the merits. We review the Board’s legal determinations de novo

, In re Elsner , 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the Board’s factual findings underlying those determinations for substantial evidence, In re Gartside , 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by substa ntial evidence if a reasonab le mind might accept the ev i-J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 12

dence as adequate to support the finding. Consol. Edison Co. v. NLRB , 305 U.S. 197, 229 (193 8).
Jazz principally argues on appeal that the ACA mat erials are not prior art , so all of the Board’s decisions relying on the ACA mate rials should be reversed

. According to Jazz, the Board erred in concluding otherwise “by equating the constructive notice provided by the Federal Register with the law governing public accessibility of prior art.” Appellant Br. 17. Emphasizing the substa ntial length of the annual Federal Register, Jazz asserts that the Board failed to make the requisite finding that a person of ordinary skill exercising reasonable diligence could have located the ACA materials. Id. Nor could the Board have made su ch a finding, Jazz contends

, as under the facts of this case “searchability or indexing [is] required to conclude that the ACA [m]aterials are prior art,” Reply Br. 10, and Amneal failed to submit any evidence of searchability or indexing

. Amneal respo nds that the ACA materials were widely disseminated, and that substantial evidence supports the Board’s finding that a person of ordinary skill would have been motivated to find the ACA materials. Amneal further argues that neither indexing nor searchabil ity is required under relevant case law.
This court and its predecessor have interpreted the “printed publication” provision of 35 U.S.C. § 102(b) (2006) 5 in light of its purpose “to prevent withdrawal by an inventor .

. . of that which was already in the posse ssion of the public.” Medtronic, Inc. v. Barry

, 891 F.3d

5 Because the applications for each of the patents in suit were filed before March 16, 2013, the pre

- Leahy

Smith America Invents Act version of § 102 applies. See Pub L. No. 112

- 29, 125 Stat. 284 (2011); 35 U.S.C. § 102 (2006).J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 13

1368
, 1380 (Fed. Cir. 2018) (alteration in original) (quo ting In re Wyer , 655 F.2d 221, 226 (CCPA 1981))

. “Because there are many ways in which a reference may be disse minated to the interested public, ‘public accessibility ’ has been called the touchstone in determining whether a reference con stitutes a ‘printed publication ’ . . . . ” In re Hall , 781 F.2d 897, 89 8–9 9 (Fed. Cir. 1986)

. A reference is considered publicly accessible “upo n a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or
art
, exercising reasonable diligence, can locate it.” Wyer

, 665 F.2d at 226

. “If accessibility is proved, there is no requirement to show that particular members of the public actually received the information.” Constant v. Advanced Micro

- Devices, Inc. , 84 8 F.2d 1560, 1569 (Fed. Cir. 1988).

Whether a reference qualifies as a “p rinted public ation” under § 102(b) is a legal conclusion based on unde rlying factual findings. E.g.

, Suffolk Techs., LLC v. AOL Inc. , 752 F.3d 1358, 1364 (Fed. Cir. 2014). As relevant to this issue, Jazz appeals only from the Board’s underlying determina tion that the ACA materials were publicly accessible. Public accessibility is a question of fact that we review for substantial evidence. In re NTP, Inc. , 654 F. 3d 1279, 1296 (Fed. Cir. 2011). A s the IPR petitioner, Amneal had the burden to prove that a particular refe rence is a printed publication. Medtronic

, 891 F.3d at 1380

. We agree with Amneal that substantial evidence su pports the Board’s finding that the ACA materials were publicly accessible. At the outset, we not e that whether a reference is a “printed publication” is a “case

- by

- case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein , 380 F.3d 1345, 1350 (Fed. Cir. 2004). We thus review t he pertinent facts here

.J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 14

On May 14, 2001, the FDA announced a meeting of the Peripheral and Central Nervous System Drugs Adv isory Committee through the Notice in the Federal Regi ster. Notice, 66 Fed. Reg. 24,391 (May 14, 2001) . The Notice stated that t he meeting would be about “the safety and efficacy of .

. . Xyrem,” and that “[a] main focus of the deliberations will be on risk management issues.” Id. The meeting would be “ open to the public, ” and permit interested persons to “present data, information, or views, orally or in writing, on issues pending before the commi ttee.” Id.
The Notice also included a hyperlink to an FDA we bsite where background material from the drug sponsor and the FDA would be posted before the meeting, and the meeting minute s, transcript, and slides would be posted after the meeting. Id. Furthermore, the Notice provided specific instructions on how to access the meeting mater ials on the FDA website: “Click on the year 2001 and scroll down to the Peripheral and Central Nerv ous Sy stems Drugs meetings.” Id. Consistent with the guidance provided in the Notice, t he Board found that the ACA materials were accessible on the hyperlinked public FDA website no later than October 4, 2001

, over two months prior to the critical date of the patents in suit. ’ 730/’988 Decision , 2016 WL 7985458, at *9, *11, *14. Jazz does not challenge that finding on appeal.

This is not the first time we have considered whether materials disclosed in association with meetings or co nferences were “p rinted publications.” In Massachusetts Institute of Technology v. AB Fortia ( “ MIT ” )

, the reference at issue was a paper orally presented at a scientific co nference attended by between 50 and 500 cell culturists. 774 F.2d 1104, 1108 (Fed. Cir. 1985). A c opy of the paper was given to the head of the conference and to no more than six other persons , without restrictions

, who reques ted the paper. Id. at 1108

– 09. We held that the paper was prior art because “between 50 and 500 persons interestedJ AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 15

and of ordinary skill in the subject matter were actually told of the existence of the paper and informed of its contents by the oral presentation, and the document itself was actually disseminated without restriction to at least six persons.” Id. at 1109.

Similarl y, in Klopfenstein , several researchers pr esented slides at two scientific meetings for a total of approximately three days. 380 F.3d at 1347, 1350. At the meetings “[t]he reference was shown to a wide variety of viewers, a large subsection of whom possessed ordinary skill in the art.” Id. at 1350. As in MIT , the slides were presented “with no stated expectation that the info rmation would not be copi ed or reproduced by those vie wing it.” Id. After considering multiple factors, including the length of the display, the expertise of the intended audience, whether the presenters had a reasonable expe ctation that the materials would not be copied, and th e ease or simplicity of copying the materials, we held that the slide presentation was sufficiently publicly accessible to count as a printed publication. Id. at 1350

– 52. We so held even though the slides were never distributed to the public and never indexed. Id. at 1350.

In Cordis Corp. v. Boston Scientific Corp. , a medical resident presented a scientific monograph to several physicians and other colleagues, and gave copies of the paper to approximately six of his teachers. 561 F.3d 1319, 1333 (Fed. Cir. 2009). Unlike in MIT and Klopfenstein

, “[t]he record

. . . contain[ed] clear evidence that .

. . ac ademic norms gave rise to an expectation that disclosures will remain confidential.” Id. at 1334. Accordingly, in the context of a “distribution to a limited number of entities,” we held that the resident’s distribution of his monograph to academic and researc h colleagues did not make the monograph a prior art printed publication. Id.
Most recently, in Medtronic we considered whether distribution o f a video and slides at several scientificJ AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 16

meetings on spinal surgery were prior art printed public ations. Medtronic

, 891 F.3d at 1379

. A CD containing the video was distributed at three meeting s , and the slides at two of those meetings. Id. As in Klopfenstein

, t here was no evidence that either the video or the slides were stored for public access after the meetings. Id. at 1381

. The first meeting was limited to members of a certain professional organization, but the second and third meetings were open to other surgeons. Id. at 1379

. Roughly 20 and 55 surgeons attended the second and third meetings, respe ctively. Id. The Board had held that the video and slides were not prior art, but neither distinguished the limited from the open meetings

, no r addressed whether the video and slides were distributed with a reasonable expectation that they would remain confidential

. Id. at 1382 . As “the size and nature of the meetings [,] .

. . whether they are open to people interested in the subject matter [,] ” and “whether there is an expectation of confidentiality b etween the distributor and the recipients of the materials” are important factors in assessing public accessibility , we vacated the Board’s finding that the video and slides were not prior art and remanded for further considerations. Id.
at 1382

– 83

. Comparing the facts of this case to those in MIT

, Klopfenstein , and Medtronic confirms that the ACA mat erials were disseminated more broadly and for a longer duration to persons of ordinary skill than the materials disclosed at individual meetings in those cases. In add ition, unlike in Cordis

, disclosure through public domain sources such as the Federal Register and a public federal agency website plainly indicates that there was no re asonable exp ectation that the ACA materials would remain confidential. As we explain below, each of these factors supports the Board’s finding that the ACA materials were publicly accessible printed publications.
First, the breadth of the dissemination here to pe rsons of ordinary skill is significant. “[A] printed public a-J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 17

tion need not be easily searchable after publication if it was sufficiently disseminated at the time of its public ation.” Suffolk , 752 F.3d at 1365

. Un like meetings of at most several hundred p ersons as in the cases above

, 6 the Notice in the Federal Register widely disseminated the ACA materials through a hyperlink to a public FDA website where the ACA materials could be accessed

. T he Notice explained what materials were located on the FDA website, approximately when they would be available, and how to navigate to them.

Whether the disseminated material is addressed to or of interest to persons of ordinary skill is also relevant to the public accessibility inquiry. See, e.g.

, Klopfenstein

, 380 F.3d at 1351 ( considering whether the reference “goes direct to those whose interests make them likely to o bserve and remember whatever it may contain that is new and useful ”) (internal quota tion marks omitted) ). T he Board found, unchal lenged on appeal, that a person of ordinary skill “ would have been familiar with the Federal Register and motivated to look for notices related to drug distribution, safety, or abuse prevention.” ’ 730/’988 Dec ision , 2016 WL 7985458

, at *4– 5; see also id. at * 15. In making that finding, the Board credited Amneal’ s expert, id. at *5, *15, and found that Jazz’s expert ’s testimony was not to the contrary under the proper standard for a person of ordinary skill in the art

, i d. at

6 The record in this case lacks any details regarding the FDA meeting itself

— who attended and whether they were persons of ordinary skill, how long the meeting lasted, and whether copies of the ACA materials were distri buted. Consequently, the Board did not address whether any potential distribution of the ACA materials at the meeting alone satisfied the “public accessibility” standard, and we do not address that possibility here in the first instance.J AZZ P HARM ., INC

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*15. As relevant here, wide dissemination of a reference through a publication like the Federal Register that those of ordinary skill would be motivated to examine is a factor strongly favoring public acc essibility. See Suffolk , 752 F.3d at 1365 ; Cordis , 561 F.3d at 1333 (distinguishing case from situations involving “widespread distribution so that the public could easily obtain copies of the public ation” ); see also Klopfenstein

, 380 F.3d at 1348 (“[A] p ublic billboard targeted to those of ordinary skill in the art that describes all of the limitations of an invention and that is on display for the public for months may be neither ‘di stributed’ nor ‘indexed’

— but it most surely is ‘sufficiently accessible to the public interested in the art’ and therefore

. . . a ‘printed publication.’ ”).
Second, the ACA materials were available online for a substantial time before the critical date of the patents in suit. “[T]he longer a reference is displayed, the more likely it is to be considered a ‘printed publication.’” Klopfenstein , 380 F.3d at 1351. In Klopfenstein

, three days of slide presentations between two scientific mee tings were enough

. I d. at 1351

– 52 . H ere, the ACA mat erials were available on a public FDA website for at least two months before the critical date of the patents in suit. As with the breadth of dissemination, the length of time the ACA materials were available supports the Board’s public accessibility finding.

Third

, the ACA m aterials were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied

. We have consistently emphasized the importance of such expectations in determining whether a reference is publi cly accessible. See Medtronic

, 891 F.3d at 1382 ; Cordis

, 561 F.3d at 1333

– 34; Klopfenstein , 380 F.3d at 1351; MIT

, 774 F.2d at 1108

– 09. There can be no dispute that mat erials disclosed in the Federal Register and available online on a public FDA website have no expectation of confidentiality. T his case bears no resemblance to Cordis

,J AZZ P HARM ., INC

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where “academic norms gave rise to an expectation that disclosures will remain confidential.” 561 F.3d at 1334. Like the factors considered above, the FDA’s and drug sponsor’s lack of any reasonable expectations of confide ntiality support the Board’s finding of public accessibility.
In sum, a fter considering the relevant factors ident ified in our public accessibility cases, the record here demonstrates that the ACA materials were widely di sseminated to persons of ordinary skill for a substantial time with no reasonable expectation of confidentiality. They were “in the possession of the public,” Wyer , 655 F.2d at 226, and cannot be withdrawn from it.

Jazz asserts t hat the Board’s finding of public access ibility must be reversed because evidence of “ searchability or indexing [is] required to conclude that the ACA [m]aterials are prior art,” Reply Br. 10, and Amneal did
not submit such evidence

. Because neither index ing nor searchability was required, we reject Jazz’s argument.
We have consistently held that indexing or searchabi lity is unnecessary for a reference to be a printed publi c ation under § 102(b). Medtronic

, 891 F.3d at 1381 (“We have stated that a printed publication ‘need not be easily searchable after publication if it was sufficiently dissem inated at the time of its publication.’” (quoting Suffolk , 752 F.3d at 1365)); Klopfenstein

, 380 F.3d at 1350 (“[D]istribution and indexing are not the only factors t o be considered in a § 102(b) ‘printed publication’ inquiry.”); accord MIT , 774 F.2d at 1108

– 09 (holding paper distri buted at conference publicly accessible without considering indexing). Jazz has presented no persuasive argument for

us to impose an index ing or searchability requirement here. Following our precedent , we decline to do so.
Moreover, even a ssuming that indexing is relevant to this case

, the Federal Register was meaningfully i n-J AZZ P HARM ., INC

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dexed. 7 The Notice was published on May 14, 2001

, in issue 93 of the 66th annual volume of the Federal Regi ster

. 66 Fed. Reg.

, No. 93 (May 14, 2001)

. Consistent with its governing regulation

, 1 C.F.R. § 6.1 (“Each daily issue of the Federal Register shall be appropriately indexed.”), issue 93 included a five

- pa ge table of contents organized alphabetically by agency; each agency’s rules, proposed rules, and notices are then listed in that order. Table of Contents, 66 Fed. Reg.

, No. 93, at III (May 14, 2001)

. FDA notices appear on the third page, with three entr ies in total

. Id. at V. The last entry refers to the Notic e at issue in this case. It includes the title of the Notice, “Meetings: Peripheral and Central Nervous Systems Drugs Advisory Committee,” and provides the page nu mber. Id.
Accepting the Board’s unchallenged finding s that a person of ordinary skill has a degree in either pharmacy or computer science, “was interested in drug distribution, safety, and abuse,” and “would have had reason to look to the Federal Register and FDA Advisory Co mmittee mee ting notices,” ’ 730/’988 Decision

, 2016 WL 7985458, at *4

– 5, *15, we are unpersuaded by Jazz ’s argument that the 2001 Federal Register “could be reviewed only page

- by

page in paper fo rmat,” Reply Br. 12 , because the Federal Register was indexed with a table of contents organizing notices by agency. Thus, considering the multiple factors discussed above favoring public accessibility, Jazz’s emphasis that the annual edition of the 2001 Federal Register was a lengthy 67, 702 pages does not demonstra te the Board erred in finding that the ACA materials were publicly accessible

. Jazz also argues that the Board erred by “equating the constructive notice provided by the Federal Register

7 “The contents of the Federal Register shall be j udicially noticed .

. . .” 44 U.S.C. § 1507 (2012).J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 21

with the legal standard for prior art.” Appellant Br. 21. We disagree. In response to Jazz’s argument that a person of ordinary skill would have been incapable of finding the Notice, t he Board observed that “[t]he Federal Register provides notice to interested individuals of the actions of fed eral agencies, ” and that a skilled artisan would have been motivated to seek out FDA meeting notices regarding drug abuse. ’ 730/’988 Decision , 2016 WL 7985458, at *15 (citing Aris Gloves, Inc

. v. United States , 154 F. Supp. 203, 209 (Cust. Ct. 1957) (“[C] ongress, by statutory enactment, has designated the ‘Federal Register’ as the official publication in which notices by departments of the Federal Government shall

appear .

. . .”)). We do not interpret the Board’s decision

as applying a per se rule that e very notice in the Federal Register satisfies the requirements for prior art, nor do we endorse such a rule that would supplant the case

- by

case inquiry consistently applied throughout our case law. Nor do we discern any error in the Board’s sensible obse rvation that the purpose of the Federal Register is to provide notice of government action such as the advisory committee meeting here.
However, we do reiterate that “[i] f accessibility is proved, there is no requirement to show that particular members o f the public actually received the information.” Constant v. Advanced Micro

- Devices, Inc. , 84 8 F.2d 1560, 1569 (Fed. Cir. 1988) ; see also In re Lister , 583 F.3d 1307, 1313

– 14 (Fed. Cir. 2009) (“[O]nce accessibility is shown, it is unnecessary to show that anyone actually inspected the reference.”). As we have explained, the ACA materials were publicly accessible because they were broadly di sseminated to interested persons of ordinary skill for a subst antial time with no expectations of confidentiality. The Board did not need to find that specific persons actually received or examined the materials. For the foregoing reasons, we hold that substantial evidence supports the Board’s finding that the ACAJ AZZ P HARM ., INC

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materials were publicly accessible to persons of ordinary skill exercising reasonable diligence before the critical date of the patents in suit. Hence, they qualify as printed publications under § 102(b).

III. Claim Construction

We now turn to Jazz’s claim construction arguments

. Claim construction is a question of law that may involve underlying factual inquiries. Teva Pharm. USA, Inc. v. Sandoz, Inc. , 135 S. Ct. 831, 841 (2015). We review the Board’s claim construction based solely on intrinsic ev idence de novo , while we review subsidiary factual findings regarding extrinsic evidence for substantial evidence

. HTC Corp. v. Cellular Commc’ns Equip., LLC , 877 F.3d 1361, 1367 (Fed. Cir. 2017). The Board construed the claims on appeal according to the ir “broadest reasonable interpretation in light of the patent specification.” E.g.

, ’730/’988 Decision , 2016 WL 2985458, at *5 (citing Cuozzo Speed Techs., LLC v. Lee , 136 S. Ct. 2131, 2144

– 46 (2016) ).
A. “periodic reports”

Jazz asserts that the Board erred in construing “per iodic reports ,” as recited in claim 1 of the ’730 patent, among others. According to Jazz, “periodic” as used in the claims means at regular frequencies, Appellant Br. 18, and the Board’s construction renders the word sup erfl uous. Amneal responds that the Board properly construed “periodic reports ” as including reports generated at irre gular frequencies, and Jazz ’s proposed construction i mproperly adds limitations without support in the intrinsic or extrinsic evidence

. We agree with Amneal that the Board did not err in construing “periodic reports ” to encompass reports gene rated at both regular and irregular intervals. ’ 730/’988 Decision , 2016 WL 7985458, at *8. We begin with th eJ AZZ P HARM ., INC

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language of the claim itself

. The cla im does not define the word “periodic,” nor does the written description ever use it. The Board considered dictionar y definitions , some of which indicated “periodic” required regular intervals, while others suggested broader meanings of “repeated,” “inter mittent,” or “occurring repeatedly from time to time.” Id. at *7. While not decisive, the ordinary mea ning of “periodic reports” is consistent with reports gene rated at irregular intervals. And although the meaning of “periodic” is broad, the word is not superfluous; a report that by its nature could only be generated once would not be “periodic.”
We also look to the specification in interpret ing the claims. The disclosure of the patents in suit further

suppor ts the Board’s construction. The specif ication discloses two types of reports: reports made in response to a specific event that may occur at irregular intervals

, such as early refill requests, ’730 patent fig. 4B; id. col. 2 ll. 14

– 15; id. col. 6 ll. 33

– 37, and reports generated at regular fr equencies

, id. col. 6 ll. 12

– 13

. Jazz argues that “periodic reports” refers only to the latter, and that the former reports are unclaimed embodiments. Appellant Br. 34

. But Jazz provides no persuasive support in either the plain meaning of “periodic” or in the written descri ption to exclude an embodiment repeatedly highlighted in the specifica tion.
In addition, the prosecution history supports the Board’s construction. During prosecution, the patent applicant pointed to several parts of the specification as providing written description support for the claim limit ation “generating periodic reports via the exclusive co mputer database to evaluate potentia l diversion patterns.” J.A. 14 966. The cited disclosures referred specifically to early refill reports, J.A. 14 993, and to the procedure for early refill requests, J.A. 15000, but not to reports gene rated at regular intervals. By indicating that the specific ation’s disclosure of early refill reports provides writtenJ AZZ P HARM ., INC

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description support for the “periodic reports” term, the prosecution history lends further support to the Board’s construction that does not exclude reports generated at irregular frequencies from the scope of the claims.

Because the totality of the evidence supports the Board’s construction of “periodic reports” but not Jazz’s, we affirm the Board’s construction. B. “information identifying”
Jazz also argues that the Board erred in construing the various terms reciting “information identifying” patients and physicians, as recit ed in claim 1 of the ’730 patent, among others

. Contrary to the Board’s constru ction

, Jazz contends that the specification identified exa mples of such information, and those examples set forth the minimum content needed to satisfy the “information identif ying” term because the specification uses the words “contains” and “includes .” Appellant Br. 43.
Amneal responds that the Board properly construed the “information identifying” claim terms as potentially including the types of information listed in the specific ation, but not limited to those types of information and not requiring all types of that information. Again, Amneal argues that Jazz’s construction improperly imports lim itations from the specification into the claims.
We agree with Amneal that th e Board did not err in rejecting Jazz’s request to read into the claims a min imum set of identifying information. The claim language simply refers to “prescription requests containing info rmation identifying patients, the prescription drug, and various credentials of the any and all medical doctors.” E.g. , ’730 patent col. 8 ll. 45

– 48 (emphasis added). It recites no specific types of identifying information

. The specification does list various kinds of identifying info rmation in discussing figure 2, id. col. 4 ll. 18

– 25, but

never indicate s that such information must be included inJ AZZ P HARM ., INC

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the claimed “information identi fying” a patient or phys ician

. We decline to read such limitations into the broad claim language based on the specification’s use of the word “contains” or “includes” in the context of describing a certain embodiment. Jazz cites no authority persuading us to do so. Thus, we affirm the Board’s constructions of the claim terms reciting “information identifying.”

IV

. Obviousness We finally cons ider Jazz’s challenge to the Board’s o bviousness analysis. Obviousness is a question of law with underlying factual issues, including the scope and content of the prior art, differences between the prior art and the claims at issue, the level of ordinary skill, and relevant evidence of secondary considerations. Graham v. John Deere Co. , 383 U.S. 1, 17

– 18 (1966). Whether a skilled artisan would have been motivated to combine references is a question of fact. Apple Inc. v. Samsung Elecs. Co.

, 839 F.3d 103 4, 1051 (Fed. Cir. 2016) (en banc). Jazz argues that the Board’s finding that a person of ordinary skill would have been motivated to modify the ACA materials with the distributed system disclosed in Korfhage lacks substantial evidence with respect to cl aims 2 and 10 of the ’988 patent and claims 24, 26, and 27 of the ’963 patent

. First, Jazz argues that the Board’s decisions regarding the ’963 and ’988 patents are contr adictory, so both cannot be right. Appellant Br. 47

– 48. Second, Jazz asserts that t he Supreme Court’s decision in KSR International Co. v. Teleflex Inc. , 550 U.S. 398 (2007) , requires that every finding of a motivation to combine be premised on subsidiary findings of “(1) whet her there was a problem to be solved; and (2) whether there

we re a finite universe of possible options.” Appellant Br. 49. Jazz contends that the Board failed to make such findings, so its decisions must be reversed.
Amneal responds that the Board’s decisions are not contradictory, and that Jazz’s reading of KSR wouldJ AZZ P HARM ., INC

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impose “the exact sort of ‘rigid preventative [rule] that [denies] factfinders recourse to common sense’ the Court rejected.” Appellee Br. 41 (alteration in original) (quoting KSR , 550 U.S. at 421).
We agree with Amneal that the Board’s decisions are consistent

. The Board made the same esse ntial finding in both decisions that a person of ordinary skill would have been motivated to run the ACA materials’ distribution system over multiple computers, as taught in Korfhage

. Compare ’ 730/’988 Decision

, 2016 WL 7985458 , at *24 ( “[O]ne of ordinary skill would have been motivated to modify the [ACA materials’] distribution system to i nclude multiple computers in a distributed database sy stem for reasons of cost, efficiency, and the anticipated volume of prescription

- related information to be received, entered, and queried.”), with ’963 Decision , 2017 WL 1096638, at *9 (“[A] [person of ordinary skill] would have been motivated to distribute the ACA’ s single, centralized computer database over multiple computers, for reasons of cost, efficiency, and the anticipated volume of prescri ption- related information to be received, entered, and queried. ”). When the Board discussed a “distributed database system” or “ distributed databases,” we unde rstand it to have referred to a database implemented over multiple computers, consistent with the ’988 patent itself,

see ’988 patent col. 10 ll. 29

– 34 (reciting “an exclusive central database .

. . distributed over multiple computers,” then referr ing to that system as “distributed databases”).
We also agree with Amneal that Jazz misinterprets both the Supreme Court’s decision in KSR and this court’s obviousness precedent

. KSR did not impose a rigid r equirement to identify both a problem to be solved in the art and a finite universe of potential options. Rather, the Supreme Court rejected the teaching, suggestion, or motivation test, because the Court considered that the
test was a “[r]igid, preventative rule[] that den[ies] fac tfinders recourse to common sense.” KSR , 550 U.S. at 421.J AZZ P HARM ., INC

. v. AMNEAL P HARM ., LLC 27

Furthermore

, the Supreme Court also rejected the “a ssumption that a person of ordinary skill attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem.” Id. at 420. W e have similarly recognized that persons of ordinary skill have diverse motivations, including “[t] he normal desire

. . . to improve upon what is already generally known.” In re Ethicon, Inc. , 844 F .3d 1344, 1351 (Fed. Cir. 2017) ; see also Otsuka Pharm. Co. v. Sandoz, Inc. , 678 F.3d 1280, 1291 (Fed. Cir. 2012) (“New compounds may be created from theoretical considerations rather than from attempts to improve on prior art compounds.”)

. KSR did state that “[w]hen there is a design n eed or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known o ptions within his or her technical grasp.” KSR , 550 U.S. at 421. But it did not set forth such factors as part of a mandatory formula. To treat them as such would be inconsistent with KSR ’s holding and our own case law. Thus

, the Board did not err in concluding that implemen ting the ACA materials’ centralized database system on mult iple computers “would have been a predictable use of a known distributed data system according to its esta blished function.” ’730/’988 Decision

, 2016 WL 7985458 , at *25 (citing KSR , 550 U.S. at 417). As Jazz has presented no other arguments challenging the Board’s finding of a motivation to modify, we affirm its holdings with respect to claims 2 and 10 of the ’988 patent and claims 24, 26, and 27 of the ’963 patent.

C ONCLUSION We have considered Jazz’s remaining arguments, and find them unpersuasive . Fo r the foregoing reasons, we affirm the Board’s decisions.

AFFIRMED