Patent Docs

Conference & CLE Calendar

February 11, 2018

February 13, 2018 – "Patent Drafting for Machine Learning: Structural Claim Limitations, Avoiding §101 or §112 Rejections" (Strafford) – 1:00 to 2:30 pm (EST)

February 13, 2018 - "eMod Update: Patent Center and Structured Text" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

February 14, 2018 – "Sect. 112 Indefiniteness in Chemical and Biotech Patent Claims — Drafting and Prosecuting Patent Claims That Will Hold Up Under Any Definiteness Standard" (Strafford) – 1:00 to 2:30 pm (EST)

February 14, 2018 – "Tech Transfer for Medical Advances: Challenges and Opportunities in Commercializing Academic Biomedical Research" (Keystone Symposia on Molecular and Cellular Biology) – 12:00 to 1:30 pm (ET) on

February 17, 2018 – "Patent Post-Grant Practice" (John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 9:00 am to 4:30 pm, Chicago, IL

February 20, 2018 – "Patent-Eligibility in 2018: Current Status and Best Practices" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

February 21-22, 2018 – Advanced Summit on Life Sciences Patents (American Conference Institute) – New York, NY

February 22, 2018 – "Managing Patent Infringement Risk in Product Development" (Strafford) – 1:00 to 2:30 pm (EST)

February 26, 2018 – "Chinese Patent Developments" (Practising Law Institute) – 4:00 to 5:00 pm (Eastern)

March 3, 2018 – "Patent Post-Grant Practice" (John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 9:00 am to 4:30 pm, Chicago, IL

March 5-6, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Houston, TX

March 8-9, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

March 14, 2018 – Patent Litigation Seminar (New Jersey Intellectual Property Law Association) – 12:00 to 5:00 pm, Iselin, NJ
NJIPLA Patent Litigation Seminar

February 10, 2018

The New Jersey Intellectual Property Law Association (NJIPLA) will be holding a Patent Litigation Seminar from 12:00 to 5:00 pm on March 14, 2018 in Iselin, NJ. The seminar will offer presentations on the following topics:

• Life Technologies Corp. v. Promega Corp.
• Impression Products, Inc. v. Lexmark International, Inc.
• Oil States Energy Services, LLC v. Greene's Energy Group, LLC
• The Inequitable Conduct Doctrine: A Look Back and Forward (ethics session)
• Litigating Written Description

Additional information regarding the seminar, including a complete agenda and list of speakers, can be found here. The registration fee for the seminar is $225 (general), $125 (corporate/government employee), or $50 (students). Those interested in registering for the seminar can do so here.
Webcast on Chinese Patent Developments

February 10, 2018

Practising Law Institute (PLI) will be offering a one-hour webcast on "Chinese Patent Developments" on February 26, 2018 beginning at 4:00 pm (Eastern). Elizabeth Chien-Hale of the Institute for Intellectual Property in Asia will discuss the latest and future changes planned by China's State Intellectual Property Office, both structurally (local IP bureaus, satellite offices) and legally (changes to Patent Examination Guidelines and the Patent Law). Attendees will also receive point‑by‑point comparisons between several areas of patent law that were much discussed in the U.S. system in recent years, and their counterparts in the Chinese system. The webcast will use examples and cases to illustrate the changes in Chinese patent system in the following three areas:

• Quality and Scope: accelerated examination, expanded protection for software and business method patents, and proposed changes to the Fourth Amendments to the Patent Law;
• Protection: increasing efforts on administrative enforcement, reducing burden on evidence collection, increasing damage awards; and
• Commercialization: innovation-based entrepreneurship.

The registration fee for this webcast is $299. Those interested in registering for the webcast, can do so here.
Webinar on Managing Patent Infringement Risk

February 10, 2018

Strafford will be offering a webinar entitled "Managing Patent Infringement Risk in Product Development" on February 22, 2018 from 1:00 to 2:30 pm (EST). Gregory M. Ansems, Assistant General Counsel, Intellectual Property, Honeywell International; Thomas Hipkins of Fredrikson & Byron; and Jeffrey C. Totten of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on identifying and addressing patent infringement risk in the product development process. The panel will examine how the courts have applied Halo and offer strategies for minimizing patent infringement risk. The webinar will review the following issues:

• What are best practices for patent counsel when analyzing infringement risk issues in the product development process?
• When should counsel seek opinions to protect new research and products from infringement claims?
• How are courts ruling on enhanced damages since the Halo decision?

The registration fee for the webcast is $297. Those interested in registering for the webinar, can do so here.
JMLS CLE Course on Patent Post-Grant Practice

February 10, 2018

The John Marshall Law School Center for Intellectual Property, Information & Privacy Law will be hosting Russell Cass of Clark Hill PLC, who will be presenting a CLE course entitled "Patent Post-Grant Practice" from 9:00 am to 4:30 pm on February 17, 2018 and March 3, 2018 at the John Marshall Law School in Chicago, IL. The course will review the purpose and history of post-grant proceedings (i.e., Inter Partes Reviews (IPRs), Post-Grant Review (PGRs), and Covered Business Method Proceedings (CBMs)), the statutory framework, and how these proceedings fit into the overall patent landscape. The course will then cover the various phases of the proceedings, including the petition, response and reply, discovery, evidentiary issues, use of experts, oral hearing, and appeal to the Federal Circuit. The interplay between PTAB contested proceedings and district court litigation will also be explored.

Tuition for the course is $1,565. Those interested in registering for the conference can do so here.
Keystone Symposium on Tech Transfer for Medical Advances

February 10, 2018

Keystone Symposia on Molecular and Cellular Biology will be offering a virtual symposium entitled "Tech Transfer for Medical Advances: Challenges and Opportunities in Commercializing Academic Biomedical Research" on from 12:00 to 1:30 pm (ET) on February 14, 2018. Juan Carlos López of Haystack Science will moderate a panel consisting of Lita Nelsen, former Director of the MIT Technology Licensing Office; Curtis Keith of Harvard University; Katherine Bowdish of Sunrise Ventures Sanofi; and Avi D. Spier of Novartis Institutes of Biomedical Research. The panel will discuss issues such as the key considerations when deciding what project to commercialize, how academic institutions can learn more about what investors or pharma look for when they scout for projects. what the biggest obstacles are for investors when interacting with academic institutions, and other related questions.

Additional information about the symposium can be found here. Those interested in registering for the symposium can do so here. To determine whether your system is compatible, a system checker can be accessed here.
Berkheimer v. HP Inc. (Fed. Cir. 2018)

February 8, 2018

By Michael Borella —

This first five or so weeks of 2018 have been busy for Federal Circuit 35 U.S.C. § 101 jurisprudence. At last count, four substantive decisions have come down so far (including this one, but not including Rule 36 judgments without opinion). Out of these, two have found the claims at issue to be patent-eligible, and one has found the claims to be ineligible. This case splits the baby, finding some claims ineligible and others in need of further review.

But the impact of today's decision may be further-reaching than the other three. At the very least, it provides a degree of clarity as to the evidentiary standard applicable to a § 101 challenge on summary judgment. This may result in the USPTO having to update its § 101 guidance for examiners and the PTAB.

Steven E. Berkheimer brought an action against HP in the Northern District of Illinois, alleging infringement of U.S. Patent No. 7,447,713. After a Markman hearing in which the judge construed several claim terms, HP moved for summary judgment under § 101. The District Court granted the motion and Berkheimer appealed.

The '713 patent is directed to "digitally processing and archiving files in a digital asset management system." This system "parses files into multiple objects and tags the objects to create relationships between them," then compares these objects to "to archived objects to determine whether variations exist based on predetermined standards and rules." Doing so "eliminates redundant storage of common text and graphical elements, which improves system operating efficiency and reduces storage costs."

Claims 1 and 4 of the '713 patent recite:

1. A method of archiving an item comprising in a computer processing system:
    presenting the item to a parser;
    parsing the item into a plurality of multi-part object structures wherein portions of the structures have searchable information tags associated therewith;
    evaluating the object structures in accordance with object structures previously stored in an archive;
    presenting an evaluated object structure for manual reconciliation at least where there is a predetermined variance between the object and at least one of a predetermined standard and a user defined rule.

4. The method as in claim 1 which includes storing a reconciled object structure in the archive without substantial redundancy.

The Supreme Court's Alice Corp. v. CLS Bank Int'l case set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101. One must first decide whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion. But generic computer implementation of an otherwise abstract process does not qualify as "significantly more." On the other hand, a claimed improvement to a computer or technological process is typically patent-eligible.

The Federal Circuit began by addressing whether Berkheimer waived his ability to separately argue for the eligibility of the independent and dependent claims. Notably, a court will usually conduct a § 101 analysis only on a small number of claims (e.g., one) for purpose of judicial economy. According to the Federal Circuit, "[c]ourts may treat a claim as representative in certain situations, such as if the patentee does not present any meaningful argument for the distinctive significance of any claim limitations not found in the representative claim or if the parties agree to treat a claim as representative."

HP asserted that claim 1 was representative. But Berkheimer never agreed to this notion, and in fact separately argued claim 5 in an opposition to HP's summary judgment motion. In the opposition, Berkheimer also argued for the eligibility of other features that only appear in claims 4-7. The Court observed that an independent claim is not automatically a representative claim just because it is independent. Also, since Berkheimer "advanced meaningful arguments regarding limitations found only in the dependent claims," these separate arguments were not waived.

Turning to part one of the § 101 analysis, the District Court had ruled that claim 1 was directed to "the abstract idea of 'using a generic computer to collect, organize, compare, and present data for reconciliation prior to archiving.'" Addressing the claims separately, the Federal Circuit held that "claims 1-3 and 9 are directed to the abstract idea of parsing and comparing data; claim 4 is directed to the abstract idea of parsing, comparing, and storing data; and claims 5-7 are directed to the abstract idea of parsing, comparing, storing, and editing data."

To justify this position, the Court found analogies between Berkheimer's claims and those of In re TLI Commc'ns LLC Patent Litig. and Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass'n. In both of those prior cases, claims directed to obtaining, processing, and storing data were found to be abstract. Berkheimer argued that the claims were not abstract because "the 'parsing' limitation roots the claims in technology and transforms the data structure from source code to object code." But the Court rejected this notion, stating "[t]hat the parser transforms data from source to object code does not demonstrate non-abstractness without evidence that this transformation improves computer functionality in some way." In support, the Court pointed out that Berkheimer had admitted that parsers existed well before the priority date of the '713 patent.

Then the Court turned to step two of the § 101 inquiry. This is where things get interesting.

The Court reiterated that "[t]he second step of the Alice test is satisfied when the claim limitations involve more than performance of well-understood, routine, and conventional activities previously known to the industry." The Court went on to flesh out this concept:

The question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact. Any fact, such as this one, that is pertinent to the invalidity conclusion must be proven by clear and convincing evidence. Like indefiniteness, enablement, or obviousness, whether a claim recites patent eligible subject matter is a question of law which may contain underlying facts [emphasis added].

In support of this statement, the Court cited to similar language in its Accenture Global Servs., GmbH v. Guidewire Software, Inc. case, as well as Justice Breyer's statement from Mayo v. Prometheus that the § 101 inquiry may overlap with fact-sensitive inquiries such as novelty under § 102.

Nonetheless, some § 101 disputes may be resolved as a matter of law when there is no material issue of fact regarding whether one or more claim elements or combination thereof is well-understood, routine, or conventional to a person of ordinary skill in the art. In this case, however, Berkheimer argued that "summary judgment is improper because whether the claimed invention is well-understood, routine, and conventional is an underlying fact question for which HP offered no evidence."

The Court went on:

While patent eligibility is ultimately a question of law, the district court erred in concluding there are no underlying factual questions to the § 101 inquiry. Whether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination. Whether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art. The mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.

Thus, the Court is distinguishing between whether a technology is "known" in the sense of § 102 (e.g., publically available) and whether one of ordinary skill would find this technology to be well-understood, routine, and conventional (e.g., something that this person of ordinary skill would consider to be textbook knowledge or part of his or her ordinary course of activities).

The specification of the '713 patent states that, at the time of the invention, existing digital asset management systems included "numerous documents containing multiple instances of redundant document elements" which resulted in "inefficiencies and increased costs." The specification continued on to explain that the claimed invention "increases efficiency and computer functionality over the prior art systems." Thus, according to the Court, "[t]he improvements in the specification, to the extent they are captured in the claims, create a factual dispute regarding whether the invention describes well-understood, routine, and conventional activities, so we must analyze the asserted claims and determine whether they capture these improvements."

Ultimately, the Court concluded that claim 1 does not provide an inventive concept beyond that of the abstract idea therein. Particularly, claim 1 "does not include limitations which incorporate eliminating redundancy of stored object structures or effecting a one-to-many change of linked documents within an archive." Furthermore, claim 1 "does not even require the storage of data after it is presented for manual reconciliation." On the other hand, claim 4 and claims 5-7 that depend therefrom recite "limitations directed to the arguably unconventional inventive concept described in the specification [, that] storing object structures in the archive without substantial redundancy improves system operating efficiency and reduces storage costs."

Accordingly, the Court concluded that "there is at least a genuine issue of material fact in light of the specification regarding whether claims 4-7 archive documents in an inventive manner that improves these aspects of the disclosed archival system." Thus, "[w]hether claims 4-7 perform well-understood, routine, and conventional activities to a skilled artisan is a genuine issue of material fact making summary judgment inappropriate with respect to these claims." This does not mean that claims 4-7 are patent-eligible, only that the District Court's summary judgment ruling was improper for these claims. So, the case was remanded back to that court to make such a determination.

This holding and the supportive reasoning appears to be the first time that the Federal Circuit has explicitly required that a district court make findings of fact in order to justify a § 101 decision. Previously, § 101 determinations have been addressed purely as a matter of law. Nonetheless, many such decisions compared the claimed subject matter to prior art, and even used the term "prior art" when doing so.

Since Alice, a challenger has been able to make conclusory statements that claim elements are well-understood, routine, and conventional. When a patentee would rebut these statements as unsupported, a court could rule that, as a matter of law, there was no need for the challenger to provide supporting evidence. Similarly, in the USPTO, examiners routinely make § 101 rejections that are conclusory in a similar fashion, and decline to consider evidence to the contrary.

Has this case changed § 101 procedures to the point where patentee or applicant has an opportunity to rebut such presumptive techniques? With the requirement that the challenger provide clear and convincing evidence of ineligibility, it seems so. If nothing else, it is now apparent that facts matter in the § 101 analysis. This may make it more difficult to invalidate patents on the pleadings, as well as at the summary judgment stage.

Berkheimer v. HP Inc. (Fed. Cir. 2018)
Panel: Circuit Judges Moore, Taranto, and Stoll
Opinion by Circuit Judge Moore
Science Application International Corp. v. United States (Fed. Cl. 2018)

February 7, 2018

U.S. Government Fails in Attempt to Invalidate U.S. Patents under § 101

By Joseph Herndon —

In a bit of an ironic outcome, the U.S. government was unsuccessful in invalidating U.S. patents under § 101. It seems odd that the government issued the patents on the one hand, and later, tried to invalidate them.

Plaintiff, Science Applications International Corp. ("SAIC"), claimed that the U.S. government infringed four patents by entering into contracts with plaintiff's competitors for the procurement of specialized heads up displays ("HUD") and night vision goggles that allegedly use SAIC's patented technology. Defendant, the United States, moved to dismiss for failure to state a claim under Rule 12(b)(6), contending that Plaintiff's patents claim ineligible subject matter under 35 U.S.C. § 101.

The patents at issue here are U.S. Patent Nos. 7,787,012; 8,817,103; 9,229,230; and 9,618,752. The four patents form two patent families due to the interrelatedness of the applications.

The first patent family (the '012 and '103 Patents) are directed to video image registration in a HUD. The '012 Patent describes methods for displaying images on a HUD. The '012 Patent describes that the prior art placed one image on top of another, using a beam combiner, but it could not dynamically compare, adjust, or reposition an image using orientation data such that the narrower field of vision was displayed accurately in the transparent display. The prior technique superimposed by simply placing the narrower field of vision within the broader field of vision. Although a user could view both fields, the user ran the risk of mismatched boundaries, repetitive or obscure images, and the inability to recalculate with movement. The patent claims purport to solve these problems in the process of registering two independently moveable fields of vision. Claim 1 of the '012 Patent is set forth below.

1. A method of registering video images with an underlying visual field comprising the steps of:
    (1) determining a source orientation of a video source providing a video feed containing data for a series of video images representing portions of a visual field;
    (2) determining a display orientation of a transparent display overlaying the visual field, wherein the video source and the transparent display are independently movable about multiple axes; and
    (3) displaying the video images in positions on the transparent display that overlay portions of the visual field represented by the displayed video images,
    wherein boundaries of the displayed video images are in registration with boundaries of portions of the visual field represented by the displayed video images.

The '103 Patent is a division of the '012 Patent and has corresponding system claims.

The second patent family (the '230 and '752 Patents) is directed to video image registration and providing supplemental data in a HUD.

The '230 Patent describes that the identification and comparison system dynamically places images within the transparent display such that matching images appear despite movement of either the display or the second video source and without obscuring relevant portions of the scene with mismatched images. The '230 Patent purports to offer an advance over the requirement for manual recalibration found in prior approaches. The patent claims minimize the manual recalibration by using the location comparison data to adjust how subsequent sensor-based locations are determined. The claims thus build on the previous techniques for superimposition by increasing accuracy and decreasing the need for manual adjustments. Claim 15 of the '230 Patent is set forth below.

15. A method, comprising:
    (a) receiving video images from a first video source and from a second video source representing portions of an external environment;
    (b) receiving motion data indicative of motion of the first and second video sources;
    (c) identifying, based on the received motion data, a part of a first video source image that potentially represents a portion of the external environment represented in a part of a second video source image;
    (d) evaluating, based on a comparison of data from the first and second video source images, the identification performed in step(c); and
    (e) displaying at least a portion of the first video source image and at least a portion of the second video source image such that the second video source image portion overlays a corresponding region of the first video source image portion, wherein the corresponding region represents a portion of the external environment represented in the second video source portion.

The '752 Patent is a continuation of the '230 Patent and has claims of generally the same scope.

The Court followed the two-part Alice/Mayo test for determining whether a patent claims ineligible subject matter. First, a court must determine whether the patent is directed to a patent-ineligible concept, such as an abstract idea. If so, the second step is to determine, considering the claims both individually and as an ordered combination, whether the patent claims sufficiently transform the ineligible subject matter with an inventive concept.

The government's arguments regarding the first and second patent family can be set out together. The government contended that SAIC's patents claim the abstract idea of superimposing a video image in a location on a display, thereby preempting future innovation in how images can be manipulated to appear in the same field of vision.

SAIC responded that none of the claims are directed to the underlying idea of superimposing images. Rather, SAIC contended that its patents focus on solving a problem in the technology available for registering images by combining orientation sensors and data, inertial sensors and motion data, boundary registration, and independently movable components.

The Court noted that, at a high level, all four claims undoubtedly involve the idea of superimposition of images. But the Federal Circuit has admonished that just because the claims involve an abstract idea does not mean that they are directed to an abstract idea. The Court framed the question as whether the claims are directed to the idea of superimposing one image on another or whether the claims "recite more than a mere result."

The Court gave heavy weight to the claims being similar to patent claims previously found to satisfy § 101 in Thales Visionix, in which claims offered an improvement to accuracy when "measuring relative position and orientation of a moving object on a moving reference frame." Using a comparative analysis, it seems for this reason alone, the Court found the patent claims at issue here to also satisfy § 101.

In addition, the Court found that the '012 method claim and the '103 system claim are directed to improving prior processes by using known components in an unconventional way to register images within accurate boundaries. The Court also found that the '752 and '230 method claims further describe how to combine known components, including inertial sensors, to communicate motion data such that the images can be accurately aligned and the calibration process can be tied to the collected location data. The claims, therefore, recited more than a mere result by including details for carrying out the claimed invention.

The Court strictly followed the Alice/Mayo test for section 101, and noted that this test is not concerned with whether an artisan skilled in the art can perform the method claimed by the patent nor whether the claim language is sufficiently definite, novel, or non-obvious, but rather whether the character of a claim as a whole is directed to a patent-ineligible subject matter. Taken on the face of the claims and the specification, the Court found that SAIC's patents combine existing computer technology, sensors, and calculations in an unconventional way in order to reach a solution to the problem of alignment and consistently accurate display. Because SAIC did not stop at the concept of superimposition (in the abstract) but instead provided a solution for achieving accuracy and consistency in image registration, SAIC's claims are not directed to an abstract idea.

The Court thus denied defendant's motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6) since the claims satisfied step 1 of the Alice/Mayo test (and therefore, it was unnecessary to progress to Alice/Mayo step 2).

Science Application International Corp. v. United States (Fed. Cl. 2018)
Order by Senior Judge Eric G. Bruggink
Arthrex, Inc. v. Smith & Nephew, Inc. (Fed. Cir. 2018)

February 6, 2018

By Kevin E. Noonan –

Although having built up a track record for several years and several thousand petitions and "trials," inter partes review proceedings under the Leahy-Smith America Invents Act are still relatively new. As a statute administered by an administrative agency having the power (and duty) to promulgate rules effecting implementation of that statute, IPRs, like many administrative proceedings, have in due course generated controversies on how the statute has been implemented. A fair number of these controversies have been reviewed by the Federal Circuit (see "Redline Detection, LLC v. Star Envirotech, Inc. (Fed. Cir. 2015)"; "Aqua Products, Inc. v. Matal (Fed. Cir. 2017)"; "Wi-Fi One, LLC v. Broadcom Corp. (Fed. Cir. 2018) (en banc)") and the Supreme Court (see "Cuozzo Speed Technologies LLC v. Lee (2016)"), and indeed even the constitutionality of the proceedings has put in question (see "Oil States Energy Services, LLC v. Greene's Energy Group, LLC"). This week, the Federal Circuit ruled on the proper interpretation of another PTAB Rule, entry of adverse judgment under 37 C.F.R. § 42.73(b) in Arthrex, Inc. v. Smith & Nephew, Inc., affirming the PTAB's interpretation of the rule.

The case arose in an IPR against Arthrex's U.S. Patent No. 8,821,541; claims 1-9 were challenged (remaining claims 10 and 11 were not) and claim 1 is representative:

1. A suture anchor comprising: an anchor body having a longitudinal axis, a proximal end, a distal end, a central passage, a first suture opening, and a second suture opening, wherein the central passage extends along the longitudinal axis, the central passage extends from the first suture opening which is located at the proximal end of the anchor body and through a portion of a length of the anchor body, the first suture opening is encircled by a perimeter of the anchor body, and the second suture opening extends through a portion of the anchor body; a rigid support fixed to the anchor body, wherein the rigid support extends across the central passage and has a first portion and a second portion spaced from the first portion, the first portion branching from a first wall portion of the anchor body and the second portion branching from a second wall portion of the anchor body, the rigid support spaced axially away from the first suture opening along the longitudinal axis of the anchor body, and the second suture opening is disposed near the rigid support; and at least one suture strand threaded into the central passage, wherein the at least one suture strand is supported by the rigid support and threaded through the first suture opening and the second suture opening of the anchor body.

Prior to institution of the IPR, Arthrex disclaimed claims 1-9 under 37 C.F.R. § 42.107(e) and filed their preliminary response to the petition, arguing that the Board should dismiss the petition because Rule 107(e) precludes instituting an IPR on disclaimed claims. Arthrex also asserted in its petition that it was not requesting that the Board enter an adverse judgment, rather Arthrex argued that the Board's rule precluded the Board from instituting the IPR because all the challenged claims had been disclaimed. Nevertheless, the Board entered an adverse judgment, based on its interpretation of another rule, under 37 C.F.R. § 42.73(b), which states:

A party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include:
    (1) Disclaimer of the involved application or patent;
    (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial;
    (3) Concession of unpatentability or derivation of the contested subject matter; and
    (4) Abandonment of the contest.

(emphasis in opinion). The significance of entering judgment is that the estoppel provisions of 37 C.F.R. § 42.73(d)(3)(i) attached; these provisions prevent a patent owner from "taking action inconsistent with the adverse judgment, including obtaining in any patent . . . [a] claim that is not patentably distinct from a finally refused or canceled claim." This rule materially affected the scope of claims Arthrex could pursue in two pending continuation and a third more recently filed applications. Arthrex appealed; as part of that appeal the Federal Circuit denied Smith & Nephew's motion that Arthrex was precluded from appealing this decision under 35 U.S.C. § 319 because the Board had not entered a Final Written Decision.

The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Judge O'Malley (who filed a concurring opinion) over a dissent by Judge Newman. The panel first held that the Board's decision was appealable, not falling within the proscriptions of 35 U.S.C. § 314(d) regarding institution decisions. The panel majority started from the presumption that PTAB decisions were appealable as for any other final administrative agency action. 5 U.S.C. §§ 701,704. The panel also found support in 28 U.S.C. § 1295(a)(4)(A), which provides for judicial review of final agency action absent statutory provisions precluding review. The Board did not find the Court's decision in St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014), to be to the contrary, based on the different procedural posture in that case (which considered whether § 1295(a)(4)(A) permitted appeal of the PTAB's decision not to institute, which is precluded by § 314(d)).

Next the panel held that, Arthrex having disclaimed any argument regarding whether the PTAB had exceeded its statutory authority to promulgate the rules, the PTAB properly applied its rules under these circumstances. The panel rejected the argument that Arthrex had immunized itself from adverse judgment by specifically asserting that it was not requesting adverse judgment by disclaiming claims 1-9; the panel stated that if this was the rule then any patentee disclaiming any claims in an IPR would make the same representation; this would "render the rule a nullity," according to the Court. Moreover, the panel majority believed that the language of the rule centered around how the Board construed the disclaimer and was not dependent on representations from a patentee. The panel also rejected Arthrex's argument that an adverse judgment should be entered only if claims are disclaimed after an IPR is instituted; the panel backed the Board's interpretation that "an adverse judgment may be entered after a petition has been filed, but before an IPR proceeding has been instituted." The Board interpreted the rule to mean that there is no remaining claim "ready for trial," whether the IPR has been instituted or not. Accordingly, the panel majority stated that

The purpose of the estoppel provision is to "provide[ ] estoppel against claims that are patentably indistinct from those claims that were lost." For this purpose, there seems to be no meaningful distinction between claims that are cancelled before an IPR proceeding is instituted and claims that are cancelled after an IPR proceeding is instituted [citations omitted].

In Judge O'Malley's concurrence, the Judge agrees with the outcome under the present rule but has "doubts about whether the Director had the authority under 35 U.S.C. § 316 (or any other statutory provision) to issue that regulation or whether, if so, the regulation was properly promulgated." Specifically, the Judge finds a contradiction with the result here and the result in Facebook, Inc. v. Skky, LLC, No. CBM2016-00091, 2017 WL 4349404, at *3 (P.T.A.B. Sept. 28, 2017), where the Court held that covered business method patent review cannot be instituted on disclaimed claims. She cites the Board's position in that case as "our case law requires that statutorily disclaimed claims must be treated as if they never existed and therefore those claims cannot support institution of CBM review." If that is the case, then for Judge O'Malley it should also apply here and "if the Board lacks the authority to institute review based on statutorily disclaimed claims, as § 42.107(e) and Facebook seem to indicate, it is unclear to me why the Board would have the authority to take any other action—particularly prior to institution—with respect to disclaimed claims."

Judge O'Malley also disagreed with the Board's position that the word "proceeding" as used in Rule 73(b) includes both the time before and after institution, i.e., the entire time period from when the petition is filed until a Final Written Decision is issued. But under Shaw Industries Group, Inc. v. Automated Creel Systems, Inc., 817 F.3d 1293, 1300 (Fed. Cir. 2016), however, "[t]he IPR does not begin until it is instituted." Entering an adverse judgment in this case seems to the Judge to be a contradiction of this controlling Federal Circuit precedent. And nowhere in the AIA provisions regarding IPRs can Judge O'Malley find the authority for the Board to enter an adverse judgment in an IPR.

Judge Newman's dissent is based on her opinion that Arthrex had disclaimed all claims challenged in the petition prior to the Board's decision whether to institute an IPR, and accordingly under 37 C.F.R. § 42.107(e) there were no claims against which an adverse judgment could be entered. For Judge Newman, the relevant language of 37 C.F.R. § 42.73(b) in subparagraph (2) is that "[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial" (emphasis in opinion), because under the factual circumstances at bar there was no trial and thus entering an adverse judgment was contrary to the express language of the rule. Judge Newman believes that the PTAB has exceeded its statutory authority, and it is "[t]he judicial obligation is to assure agency compliance with its legislated authority," citing Nat'l Broad. Co. v. United States, 319 U.S. 190, 224 (1943). For Judge Newman, "[s]ubsection (b)(2) on its face is directed to disclaimer or cancellation 'in the trial.' It is not disputed that 'in the trial' can occur only after institution." Thus, because claims 1-9 were disclaimed before the IPR was instituted, it is a misapplication of the rule for the Board to have entered an adverse judgment. Any other interpretation is for Judge Newman an explicit change in the rule, which requires rulemaking procedures specified under the APA (35 U.S.C. § 2(b)(2)(B)).

Arthrex, Inc. v. Smith & Nephew, Inc. (Fed. Cir. 2018)
Panel: Circuit Judges Newman, Dyk, and O'Malley
Opinion by Circuit Judge Dyk; concurring opinion by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Newman
PTAB Life Sciences Report

February 5, 2018

By John Cravero —

About the PTAB Life Sciences Report: periodically, we will report on developments at the PTAB involving life sciences patents.

Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH

PTAB Petition: IPR2017-01526; filed June 5, 2017.

Institution of Inter Partes Review; entered December 13, 2017.

Patent at Issue: U.S. Patent No. 7,476,652 ("Acidic insulin preparations having improved stability," issued January 13, 2009) claims a pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from polysorbate 20 and polysorbate 80; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

Petitioners Mylan N.V., Biocon Research Ltd., and Biocon Ltd. are challenging the '652 patent on six grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Erica A. Franklin, Robert A. Pollock, and Michelle N. Ankenbrand (author) issued a decision instituting inter partes review of whether claims 1–25 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Lougheed; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and FASS; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Grau; claims 1–25 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Lougheed; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and FASS; and claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Grau.

Related Matters: According to the petition, the '652 patent is not involved in any related proceedings. However, the Patent Owner identified that the '652 patent is involved in the following civil litigations: Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A. No. 1-16- cv-00812-RGA (D. Del.); Sanofi-Aventis v. Merck Sharp & Dohme Corp., C.A. No. 2-17-cv-05914 (D.N.J.). Patent Owner also identified the following concluded litigations involving the '652 patent: Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00113-RGA (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00884-RGA (D. Del.). Patent Owner also identified a related inter partes review that Petitioner filed challenging U.S. Patent No. 7,713,930, which issued from a continuation application to the application that issued as the '652 patent (IPR201-01528; filed 06/05/2017; instituted 12/13/2017; pending).

Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH

PTAB Petition: IPR2017-01528; filed June 5, 2017.

Institution of Inter Partes Review; entered December 13, 2017.

Patent at Issue: U.S. Patent No. 7,713,930 ("Acidic insulin preparations having improved stability," issued May 11, 2010) claims a pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from esters and ethers of polyhydric alcohols; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

Petitioners Mylan N.V., Biocon Research Ltd., and Biocon Ltd. are challenging the '930 patent on eight grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Erica A. Franklin, Robert A. Pollock, and Michelle N. Ankenbrand (author) issued a decision instituting inter partes review of whether claims 1–20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Lougheed; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and FASS; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Grau; claim 19 of the '930 patent is unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label, FASS or Grau, and Lougheed; claims 1–20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Lougheed; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and FASS; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Grau; and claim 19 of the '930 patent is unpatentable under 35 U.S.C. § 103 over the combination of Owens, FASS or Grau, and Lougheed.

Related Matters: According to the petition, the '930 patent is not involved in any related proceedings. However, the Patent Owner identified that the '930 patent is involved in the following civil litigations: Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A. No. 1-16- cv-00812-RGA (D. Del.); Sanofi-Aventis v. Merck Sharp & Dohme Corp., C.A. No. 2-17-cv-05914 (D.N.J.). Patent Owner also identified the following concluded litigations involving the '930 patent: Sanofi-Avent0s U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00113-RGA (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00884-RGA (D. Del.). Patent Owner also identified related inter partes review that Petitioner filed challenging U.S. Patent No. 7,476,652, which issued from a parent application to the application that issued as the '930 patent (IPR201-01526; filed 06/05/2017; instituted 12/13/2017; pending).

Pfizer, Inc. v. Biogen, Inc.

PTAB Petition: IPR2018-00285; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 8,329,172 ("Combination therapies for B-cell lymphomas comprising administration of anti-CD20 antibody," issued February 14, 2017) claims a method of treating low grade B-cell non-Hodgkin's lymphoma in a human patient comprising administering to the patient chemotherapy consisting of CVP therapy to which the patient responds, followed by rituximab maintenance therapy, wherein the maintenance therapy comprises four weekly administrations of rituximab at a dose of 375 mg/m.sup.2 every 6 months, and wherein the maintenance therapy is provided for 2 years.

Petitioner Pfizer, Inc. is challenging the '172 patent on 2 grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, Petitioners previously filed an inter partes review petition on the '172 patent (IPR2017-01166; filed 04/21/2017; institution denied 11/13/2017; request for rehearing submitted 12/12/2017). Petitioners also identified the following additional inter partes review challenges to the '172 patent: IPR2015-00418 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 12/15/2014; institution denied 07/13/2015) and IPR2017-01093 (Celltrion Inc.; filed 03/15/2017; institution denied 10/06/2017).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2018-00300; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '392 patent is involved in the following civil litigation: Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.). Additionally, the '392 patent is involved in the following ITC proceeding: Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC). Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00301 and IPR2018-00302; filed 12/14/2017; pending).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2018-00301; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '392 patent is involved in the following civil litigation: Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.). Additionally, the '392 patent is involved in the following ITC proceeding: Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC). Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00300 and IPR2018-00302; filed 12/14/2017; pending).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2018-00302; filed December 14, 2017.

Patent at Issue: U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '392 patent is involved in the following civil litigation: Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.). Additionally, the '392 patent is involved in the following ITC proceeding: Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC). Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00300 and IPR2018-00301; filed 12/14/2017; pending).

Becton, Dickinson and Company v. B. Braun Melsungen AG

PTAB Petition: IPR2017-01586; filed June 16, 2017.

Institution of Inter Partes Review; entered December 15, 2017.

Patent at Issue: U.S. Patent No. 8,328,762 ("Catheter insertion device," issued December 11, 2012) claims a embodiments of a catheter insertion device.

Petitioner Becton, Dickinson and Company is challenging the '762 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Scott A. Daniels (author), Michael L. Woods, and Robert L. Kinder issued a decision instituting inter partes review of whether claims 18 and 22 are unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten; whether claim 25 is unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten and Lynn; and whether claim 22 is unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten and Tauschinski.

Related Matters: According to the petition, the '762 patent is the subject of the following civil litigation: B. Braun Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D. Del.). Petitioner also filed petitions for inter partes review in related U.S. Patent Nos. 9,149,626 (IPR2017-01587; filed 06/16/2017; instituted 12/15/2017; pending); 8,333,735 (IPR2017-01583; filed 06/16/2017; institution denied 11/29/2017); 8,337,463 (IPR2017-01585; filed 06/16/2017; institution denied 12/15/2017); 8,540,728 (IPR2017-01584; filed 06/16/2017; institution denied 11/29/2017); 8,597,249 (IPR2017-01589; filed 06/16/2017; instituted 01/12/2018; pending); 8,460,247 (IPR2017-01588; filed 06/16/2017; instituted 12/21/2017; pending); and 9,370,641 (IPR2017-01590; filed 06/16/2017; instituted 01/11/2018; pending).

Becton, Dickinson and Company v. B. Braun Melsungen AG

PTAB Petition: IPR2017-01587; filed June 16, 2017.

Institution of Inter Partes Review; entered December 15, 2017.

Patent at Issue: U.S. Patent No. 9,149,626 ("Catheter insertion device," issued October 6, 2015) claims a embodiments of a catheter insertion device.

Petitioner Becton, Dickinson and Company is challenging the '626 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Scott A. Daniels, Michael L. Woods, and Robert L. Kinder (author) issued a decision instituting inter partes review of whether claims 11 and 20 are unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten.

Related Matters: According to the petition, the '626 patent is the subject of the following civil litigation: B. Braun Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D. Del.). Petitioner also filed petitions for inter partes review in related U.S. Patent Nos. 8,328,762 (IPR2017-01586; filed 06/16/2017; instituted 12/15/2017; pending); 8,333,735 (IPR2017-01583; filed 06/16/2017; institution denied 11/29/2017); 8,337,463 (IPR2017-01585; filed 06/16/2017; institution denied 12/15/2017); 8,540,728 (IPR2017-01584; filed 06/16/2017; institution denied 11/29/2017); 8,597,249 (IPR2017-01589; filed 06/16/2017; instituted 01/12/2018; pending); 8,460,247 (IPR2017-01588; filed 06/16/2017; instituted 12/21/2017; pending); and 9,370,641 (IPR2017-01590; filed 06/16/2017; instituted 01/11/2018; pending).

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