How Patent Owners Can Disqualify Prior Art References Relied Upon by Petitioner for Unpatentability

By Joshua Javitz
February 23, 2018

How a Patent Owner Can Disqualify Prior Art References Relied Upon by Petitioner for UnpatentabilityTo request cancellation of one or more claims of a patent in an inter partes review (IPR), a petitioner must challenge the claim on the basis that the claim is unpatentable under 35 U.S.C §102 or 103, in view of prior art patents or printed publications. 35 U.S.C. § 311(b).

Two ways a patent owner can disqualify references relied upon by the petitioner for unpatentability are by (i) asserting that the petitioner did not set forth sufficient evidence showing that the reference qualifies as a printed publication, or (ii) antedating the reference to show that the date of invention is prior to the critical date of the reference.

Is the Reference a Prior Art Printed Publication?

Regarding the patent owner’s first option, the statutory phrase “printed publication” is flexibly interpreted to include technological advances for references that are not necessarily physically printed, (e.g., an electronic publication or a video recorded on a CD) but otherwise satisfy the requirements of being a printed publication. In re Wyer, 655 F.2d 221, 226 (CCPA 1981); and Medtronic, Inc. v. Barry, IPR2015-00780, Paper 51 at 9 (PTAB Sept. 7, 2016) (Final Written Decision). A reference qualifies as a printed publication if it was “sufficiently accessible to the public interested in the art” before the critical date of the challenged patent. In re Cronyn, 890 F.2d 24 1158, 1160 (Fed. Cir. 1989). A reference “is ‘publicly accessible’ upon a satisfactory showing that [the reference] 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.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006).

Several factors may support a finding that the reference is accessible to one of ordinary skill in the art. Factors weighing in favor of supporting public accessibility may include “intent to make public, activity in disseminating information, production of a certain number of copies, and production by a method allowing production of a large number of copies.” In re Wyer, 655 F. 2d at 227. Additional factors, establishing an approximate time a reference was public accessible, may include showing competent evidence of routine business practices indicating that the reference was publicly accessible prior to the critical date of the challenged claim. In re Bayer, 568 F.2d 1357 (CCPA 1978); and Seabery North America Inc., v. Lincoln Global, Inc., IPR2016-00840, Paper 60 at 13-17 (PTAB October 2, 2017)(Final Written Decision).

In the Seabery IPR, the reference at issue was a doctoral thesis. The petitioner submitted declaration testimony from an advisor of the student who wrote the thesis to proffer that, based on general routine practices at the advisor’s library, the reference was available to the public well before the critical March 2010 filing date of the challenged patent. Seabery, IPR2016-00840, Paper 60 at 15 and 17. The Board noted several points in the advisor’s testimony that weighed in favor of establishing an approximate time that the thesis was publicly available, for example:

  • According to the rules of the University around the alleged time the reference was publicly accessible, the University required the student to deposit the dissertation at the University’s library for the student to receive his Ph.D. at 15. The advisor testified that the student would not have been able to receive his degree if he did not follow this procedure. Id. at 16. Further, he testified that when the dissertation is formally published, it is assigned an ISBN identifier so that it may be sold. Id. To support his testimony, he showed where an electronic copy of the dissertation is available for sale. Id.
  • The advisor “confirmed the dissertation was deposited and available for retrieval by the public on March 3, 2006.” at 15.
  • He indicated where the work was indexed in the national library system. at 16. As an aside, the Board indicated that “neither cataloging nor indexing is a necessary condition for a reference to be publicly accessible.” Seabery, IPR2016-00840, Paper 60 at 15 quoting In re Lister, 583 F.3d 1307 (Fed. Cir. 2009).
  • He testified “that a reprint of the dissertation [] bears a copyright and publication date and portions and excerpts based on the dissertation were published elsewhere.” Seabery, IPR2016-00840, Paper 60 at 16.
  • Further, he explained why the title in the library shelving record was different from the published book format which included a subtitle, noting that the subtitle relates to the book series from the publisher and not the dissertation.
  • Additionally, the advisor testified that three copies of the thesis are available in the University’s library; “provided a screen shot of the library’s online catalog . . . [showing] the three copies of the thesis and a date of 2006;” and “reviewed the library check-out history and determined one of the copies was first checked out in May 2006.”

However, in certain situations, the availability of a reference does not automatically mean the ordinarily skilled artisan would be able to locate the reference in order to be considered a prior art printed publication. Medtronic, IPR2015-00780, Paper 51 at 9.

For instance, to support an argument of public accessibility, the petitioner may be required to submit additional evidence to corroborate that a date printed on a reference is in fact the date the reference was publicly accessible. Sandoz Inc. v. Abbvie Biotechnology LTD., IPR2017-01824, Paper 14 at 7 and 8 (PTAB February 9, 2018) (Decision, Denying Institution of Inter Partes Review). In Sandoz, the petitioner asserted that the FDA gave regulatory approval for a drug product on December 20, 2002; this date was displayed on the drug package insert; and the package insert qualified as a printed publication as of this date. Id. at 6 and 7. To disqualify the insert from being used in the IPR, the patent owner asserted that the petitioner did not set forth sufficient evidence to establish that the insert was publicly accessible on the alleged date, where the Board quickly agreed and noted several deficiencies with the petitioner’s argument. Id. at 7.

In light of the petitioner’s mere assertions, the Board indicated that the petitioner did “not direct [the Board] to any source-identifying information from the FDA (e.g., a copy of the insert on the FDA’s website), a publication date, or other indicia indicating when the relied upon Humira Package Insert, or the information contained therein, became publicly available.” Id. Further, the Board noted that the language of the regulatory approval letter indicated that the “drug product ‘will be marketed in . . .’ vials and syringes . . . , [and therefore, the] drug product was not yet marketed or available to the public [on December 20, 2012].”  Id. at 8.

Other factors may depend on the type of reference being used by the petitioner.

For instance, in Electronic Frontier Foundation, the Board determined that when a reference was only temporarily publicly available via a URL but no longer exists at that URL, the petitioner must show that the reference can be found through another source not including the URL. Electronic Frontier Foundation v. Personal Audio, LLC, IPR2014-00070, Paper 21 at 22 (PTAB Apr. 18, 2014) (Decision, Institution of Inter Partes Review).

In another example, the Board determined that confidential submissions later published by the FDA are publicly accessible not on the date the patent pertaining to the submission was filed, but rather, on the date the FDA published the submission. Medtronic, Inc. v. NuVasive, Inc., IPR2014-00074, Paper 15 at 13 (PTAB Apr. 8, 2014) (Decision, Institution of Inter Partes Review).

Further, a reference can be disqualified as a printed publication if the petitioner is unable to prove that the reference is a true and accurate copy as it appeared when published. C&D Zodiac, Inc. v. B/E Aerospace, Inc., IPR2014-00727, Paper 65 at 26-30 (PTAB Oct. 26, 2015) (Final Written Decision). In C&D Zodiac, the petitioner submitted a reference that was a three-ringed binder of loose-leaf pages; however, the patent owner argued that the pages in this binder can be inserted and removed to update the reference. IPR2014-00727, Paper 65 at 27. Additionally, the petitioner’s witness, who testified that the reference was a true and accurate copy of the reference as it appeared at the alleged publication date, subsequently admitted that he lacked personal knowledge of whether the [reference] submitted . . . was actually published” at the alleged date. Id.

Can the Reference be Antedated?

Turning to the patent owner’s second option, a patent owner may disqualify a reference as being prior art if the patent owner can produce evidence antedating the reference. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015).

In an IPR, the petitioner bears the burden of establishing a reference as being prior art under 35 U.S.C §102 or 103. However, if a patent owner chooses to remove the petitioner’s reference by antedating the reference, the patent owner bears the burden of production showing that (a) the inventor of the challenged claim(s) reduced the invention to practice before the critical date of the reference (Green Cross Corp., v. Shire Human Genetic Therapies, Inc., IPR 2016-00258, Paper No. 89 at 11 (PTAB March 22, 2017) (Final Written Decision); or (b) the inventor conceived the idea for the invention before the critical date of the reference and exercised reasonably continuous diligence following conception to reduce the invention to practice (See REG Synthetic Fuels v. Neste Oil OYJ, Appeal No. 2015-1773 at 13-14 (Fed. Cir. Nov. 8, 2016), and Perfect Surgical Technical, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009 (Fed.Cir. 2016)).

The Board will “review the record as a whole and determine the sufficiency of a patent owner’s antedating effort after evaluating all relevant admissible evidence and argument.” Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 7 (PTAB May 1, 2014) (Final Written Decision). Once the patent owner shows either (a) or (b), the burden shifts to the petitioner to show that the reference is entitled to an earlier date than the date the invention was reduced to practice or to show that the challenged claims were not actually reduced to practice at the alleged date. Green Cross Corp., at 11. The remainder of this article focuses on reduction to practice.

A patent owner may establish reduction to practice either by showing “constructive” reduction to practice, which occurs when a patent application is filed, or by showing “actual” reduction to practice. ABB Inc. v. Roy-G-BIV Corp., IPR 2013-00062, Paper 84 (PTAB Apr. 11, 2014) (Final Written Decision). “In order to establish an inventor’s actual reduction to practice, Patent Owner must show: (1) construction of an embodiment meeting all limitations of the challenged claims; (2) that the invention would work for its intended purpose, and (3) sufficient evidence to corroborate the inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006).” Green Cross Corp., at 11. Supporting a finding of sufficient evidence to corroborate the inventor’s testimony is determined using a rule of reason analysis by examining the evidence as a whole and is based on the facts of each case. Id. at 11-12.

In Green Cross Corp., the challenged claim related to a composition of a purified recombinant I2S protein having a specific amino acid sequence and having less than a certain amount of a host cell protein. Id. at 5. To support the burden of production in antedating the challenged reference, the patent owner submitted evidence of several laboratory tests with different dates before the critical date of the reference and declarations from the inventor and co-workers of the inventor to corroborate the inventor’s testimony. Id. at 12, 16, and 19-21. The Board determined that these tests were “within the scope of the invention to show that the reduction to practice of the claimed invention was ‘consistent and reliable.'” Id., see footnote 11. Subsequent to shifting the burden of persuasion back to the petitioner, the petitioner was unable to persuade the Board that the patent owner’s evidence was insufficient in showing that the purported embodiments met all the limitations of the challenged claim. Id.  at 13 and 21.

The above discussion demonstrates the wide range of factual matters considered by the Board in assessing whether a patent owner has successfully disqualified a prior art publication relied upon by the petitioner.  Patent owners seeking to defeat a challenge to its claims in this manner would be well-advised to question both the sufficiency and admissibility of the petitioner’s reference as a viable basis for an inter partes challenge.  Conversely, if patent owner seeks to antedate petitioner’s reference, it must make sure that its own evidence is sufficient in its weight and properly corroborated.

The Author

Joshua Javitz

Joshua Javitz is an Associate at Sughrue Mion in the firm's Electrical/Mechanical Practice Group. His practice focuses on Patent Office practice, including drafting and prosecuting patent applications in a broad range of technological areas related to electrical, computer, and mechanical arts. Joshua is also a contributor to "The Essential Case Law Guide to PTAB Trials," a compendium of PTAB decisions on procedural, evidentiary, and substantive issues encountered in IPRs, PGRs, and CBMs (Release date, April 2018).

For more information or to contact Mr. Javitz, please visit his Firm Profile Page.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 10 Comments comments.

  1. Tesia Thomas February 23, 2018 10:41 am

    If only people had enough money to IPR and invalidate all patents in existence except the absolute first patent in an art…
    That is legally possible under AIA but not possible with inventor pocketbooks.

  2. Paul Morgan February 24, 2018 9:47 am

    Nice to see useful advice on how to defend against IPRs rather than rants.

  3. Paul Morgan February 24, 2018 11:49 am

    On another FAILED scheme to avoid adverse IPRs, the PTAB rendered its decision against stopping IPRs with tribal immunity allegations on Friday. The details of the so-called “assignment” and exclusive-license-back with the tribe are particularly revealing.
    This PTAB decision is so thoroughly researched and well written that it could [but probably will not] get a per curium affirmance by the Fed. Cir.

  4. Ron Katznelson February 24, 2018 3:47 pm

    So, Paul @3, is there a particular reason why you leave the readers guessing by not providing specific identifying information on the case and/or a link to the PTAB decision? You must have read it somewhere?

  5. Paul Morgan February 24, 2018 6:46 pm

    Ron, I downloaded the decision indirectly to read from a hotlink in a non-patent news report. [It should be all over the P-webs by Monday, but if the suspense is killing you just post your email address here and I will send you a copy, as I did Dennis.] The PTAB case title is:
    “MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA, INC., and AKORN INC. Petitioners, v. SAINT REGIS MOHAWK TRIBE”

    P.S. The PTAB did NOT put an appropriate name on this Mylan “assignment,” unlike the Fed. Cir. judge that was handling their D.C. case in E.D. TX.

  6. Joachim Martillo February 25, 2018 12:15 pm

    I think this document is the decision to which Paul Morgan referred.

    Order-130-Decision_Denying_The_Tribe_Motion_to_Terminate.pdf

    I read through the document. It is better than run-of-the-mill PTAB crap, but it has some severe problems not least of which includes failing to distinguish at critical points between Indians, who are US citizens, and Indian tribes, which are dependent sovereigns.

    I am fairly certain that any of the lawyers with whom I work could pick it apart in an afternoon.

    The Legal Background section says it all, and this particular case should be deferred until Congress makes a decision.

    Indian tribes are “domestic dependent nations” that exercise “inherent sovereign authority.” Michigan v. Bay Mills Indian Cmty., 134 S. Ct. 2024, 2030 (2014) (“Bay Mills”) (quoting Oklahoma Tax Comm’n v. Citizen Band Potawatomi Tribe of Okla., 498 U.S. 505, 509 (1991)). “As a matter of federal law, an Indian tribe is subject to suit only where Congress has authorized the suit or the tribe has waived its immunity.” Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751, 754 (1998). A tribe’s sovereignty, however, “is of a unique and limited character.” United States v. Wheeler, 435 U.S. 313, 323 (1978). “It exists only at the sufferance of Congress and is subject to complete defeasance.” Id.

    The point would be obvious to any except apparently USPTO crooks and clowns, who dominate the PTAB in matters of post-grant review proceedings and who are destroying the US political and economic system by stealing IP and putting it in the public domain.

    Just ask the following question. What if Congress decided tomorrow that tribal sovereign immunity is absolute and unpierceable by an Administrative Agency with respect to disputes over the validity of patents?

    SCOTUS has already stated that Congress could make such a decision and that SCOTUS would accept it.

    And guess what? The petitioner would still have recourse to the Article III courts, in which the St. Regis tribe has already affirmed willingness to plead its case.

  7. Paul Morgan February 25, 2018 12:26 pm

    J.M., re your comment “the St. Regis tribe has already affirmed willingness to plead ‘its’ case,” did you read the details of the Mylan exclusive license and control provisions, especially with regard to the requirements in both IPRs and district courts to identify “the real party in interest?”

  8. Paul Morgan February 25, 2018 1:03 pm

    Sorry, Allergan is the patent-controlling “real party in interest” [and “essential” party in D.C. suits] on the subject patents, not Mylan [Mylan is a petitioner].

  9. Joachim Martillo February 26, 2018 7:24 am

    A long time ago I consulted for the State Department with respect to the international telecommunications legal regime, which was defined by the CCITT-ITU back then. The CCITT-ITU seems to have been renamed ITU-T. The telecommunications and telegraphy standards constitute treaties between sovereigns even though only AT&T had real interest in the case of the USA before the breakup. Thus the US State Department consulted with AT&T to obtain advice on a given issue. In the event of a genuine dispute between sovereigns, the parties would agree to adjudication by the ICJ or in rare cases by ITLOS. I think now a trade related telecommunications case might go before the Appellate Body of the WTO, but WTO adjudication of this sort post-dates my time, and I would have to review the rules and regulations with respect to international telecommunications. Before the breakup, the USA would be a party in such a proceeding, which would be directed by the State Department. AT&T would provide consultation.

    While the decision is more coherent than the typical PTAB final written decision, it seems casuistical and to a large extent irrelevant. (IANAL. An expert on sovereign immunity in US law should comment.)

    As I understand, a sovereign is immune to civil and criminal proceedings unless the sovereign agrees (or — in cases of tribal sovereign immunity — until Congress defines tribal sovereign immunity to be defeasible in a specific situation).

    All the discussion of real party in interest or essential party seem irrelevant to the Doctrine of Sovereign Immunity. The agreement is not a sham legally, and action by the PTAB might deprive a tribal sovereign of a revenue stream and thus constitutes a civil action to which a tribal sovereign is supposed to be immune unless Congress says the tribal sovereign is not immune.

    I understand that the anti-patent mafia is already attempting to tear the heart of the US legal, political, and social fabric. Thus from the standpoint of the USPTO capos and button men, trying to claim a power heretofore reserved only to Congress makes perfect sense, but it is just one more stab to the heart of the USA.

    I also must point out that the decision would not apply if Dubai (or the UAE) had made the deal with Allergan. The UAE and Dubai are full independent sovereigns. Dubai has announced it will encourage local tech startups, many of which might seek US patents. It would make perfect sense for Dubai to purchase IP from its startups on the model of the St. Regis sale. If one full sovereign evaded the post-grant review proceedings today, they all will tomorrow.

    Then many foreign startups would be immune to the PTAB con scam, and post-grant review proceedings become an open gate through which foreigners storm and seize the US tech markets that depend on IP.

    This logic makes it clear that the anti-patent mafia constitutes an anti-American seditious conspiracy, which is killing American hi-tech in a despicable un-American effort to eliminate new disruptive local competitors.

    If Trump can fling the accusation of “treason” at Democrats, who they don’t applaud him, patent system advocates have much more reason to fling the accusation of treason at the anti-patent mafia.

  10. Anon February 26, 2018 12:51 pm

    Mr. Morgan’s glee and extremely high level of delight are easy to see.

    The decision starts out solidly enough – detailing many aspects that might lead to the formal declaration that the deal was a sham deal.

    Sadly, both the PTAB and Mr. Morgan fall short. The decision becomes a muddled mess, and on at least one point (the immunity point) is contrary to controlling law (whether or not this is an item of “first impression WITHIN the PTAB does not dictate that the PTAB can do whatever it feels like.

    As I predicted back when the PTAB appeared to want to make some offers of an Olive Branch when Oil States was hot and heavy in the headlines, the Office has (once again) reverted back to its true colors of being a rogue entity.

    Maybe reprinting James Madison’s letters addressing the danger of an uncontrolled court would be appropriate (here, in this case, the uncontrolled court is not even situated with the Article III branch of the government).

Our website uses cookies to provide you with a better experience. Read our privacy policy for more information.Accept and Close