• Dannemann SiemsenDannemann Siemsen will be offering a webinar entitled "Patent System in Brazil: Moving Forward after the Decision on the Constitutional Challenge ADI5529" on June 24, 2021 at 11:00 am (BRT) and 8:00 pm (BRT).  Joaquim Eugenio Goulart, Gustavo de Freitas Morais, Peter Eduardo Siemsen, and Luiz Henrique O. do Amaral will discuss the future scenario of patents in Brazil, following the judgment by the Supreme Federal Court (STF) that deemed unconstitutional the provision of the Industrial Property Law (Law 9,279/1996) which extended the validity of patents in the country.  The panel will address the following topics:

    • What happened at the Brazilian Supreme Court: Patent term calculation?
    • Suggested strategies in order to get a meaningful patent term
    • Initiatives of the IP community to shorten patent prosecution time at the Brazilian PTO
    • Impact of the decision and Brazilian legal and political environment

    Those wishing to register can do so here (11:00 am session) or here (8:00 pm session).

  • IPWatchdogIPWatchdog and CAS and will be offering a webinar entitled "The Nexus of IP and R&D: Building Greater Collaboration to Drive Innovation" on June 23, 2021 at 12:00 pm (ET).  Jerzy Klosin of The Dow Chemical Company; Christine Goddard of Fish & Richardson; Matthew McBride of CAS; and Gene Quinn of IPWatchdog, Inc. will discuss IP, R&D, and facilitating innovation to streamline commercialization.  The panel will share different perspectives about how you can make greater use of IP information to guide R&D. During our webinar the panel will address:

    • Solutions to the challenges facing R&D and IP managers in sharing and using information;
    • How companies are collaborating to improve decision-making with IP insights;
    • Key insights to consider in order to clarify investment directions and mitigate risks; and
    • Most effective strategies for applying IP insights in the R&D process.

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • By Donald Zuhn

    Juneteenth FlagThis afternoon, President Biden signed S. 475, the "Juneteenth National Independence Day Act," into law.  The Act designates Juneteenth National Independence Day as a Federal holiday.

    In a memorandum issued by the U.S. Office of Personal Management shortly after the signing, the OPM noted that when a Federal holiday falls on a non-work day for a full-time Federal employee, an alternative or "in-lieu-of" holiday within the employee's tour of duty is designated based on the rules in 5 U.S.C. § 6103(b) and Executive Order 11582.  Because June 19th falls on a Saturday this year, the "in-lieu-of" holiday for Federal employees with a Monday-through-Friday work schedule will be Friday, June 18.

    The U.S. Patent and Trademark Office posted a notice on its website after the President signed the bill into law, stating that:

    With the declaration of Juneteenth as a federal holiday, the USPTO will be closed Friday, June 18.  Facilities and call centers will be closed and deadlines falling on the holiday will be extended to the next business day (Monday, June 21).  Unless otherwise noted, online events will proceed as scheduled.

    The Office also distributed a USPTO Alert to stakeholders earlier today, noting that:

    The United States Patent and Trademark Office will be closed on Friday, June 18, 2021, in observance of Juneteenth National Independence Day.  Pursuant to 35 U.S.C. 21(b), the USPTO will deem actions or fees due on Friday, June 18, to be timely if taken or paid no later than 11:59 p.m. ET on Monday, June 21, i.e., the next business day the USPTO will be open.

    As a reminder, the remaining Federal holidays in 2021 — which will also result in USPTO closures — include the following:

    • Independence Day — July 4 (for most Federal employees, Monday, July 5, will be treated as a holiday)
    • Labor Day — September 6
    • Columbus Day — October 11
    • Veterans Day — November 11
    • Thanksgiving Day – November 25
    • Christmas Day — December 25 (for most Federal employees, Friday, December 24, will be treated as a holiday)

  • By Kevin E. Noonan

    Late last month, Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") and Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") each filed Motions to Exclude Evidence in Interference No. 106,115.  Now CVC has filed its Opposition to Broad's motion to exclude and Broad has filed its responsive Reply.

    Broad's motion to exclude was specifically directed to testimony from Dr. Phillip Zamore regarding "how a person having ordinary skill in the art ("POSA") allegedly would have understood (1) the March 2011 Deltcheva et al. reference's disclosures regarding tracrRNA, (2) the RNAi, pre-mRNA, and DNA systems he alleges are relevant to Deltcheva et al.'s disclosures, and (3) Dr. Zhang's October 24, 2011 email regarding the role of tracrRNA in the CRISPR-Cas9 cutting complex."  According to Broad, what Dr. Zamore's declaration did not attest to was "(1) whether a 2012 POSA would have had a reasonable expectation of success of using CRISPR-Cas9 in eukaryotic cells; (2) the state of the art after the Jinek 2012 paper; or (3) relevant prokaryotic-based systems, such as Group II introns," all of which were issues upon which CVC Priority Motion relied.  But these issues were attested to not by Dr. Zamore in support of CVC's priority claims but by another witness, who did not opine on them.  Thus, CVC's proffer of Dr. Zamore's testimony on these matters was an attempt, in Broad's view, to "untimely seek[] to obtain expert testimony on these topics via improper re-direct testimony by Dr. Zamore" (i.e., during Broad's cross-examination of CVC's witness).  And Broad asserted that its cross-examination of Dr. Zamore was properly limited to "the actual opinions expressed in Dr. Zamore's declaration and his qualifications," and thus did not "open the door" to the testimony CVC elicited on redirect examination.

    University of California-BerkleyCVC opposes Broad's motion to exclude on the grounds that Dr. Zamore's testimony on redirect was within the scope of Broad's cross-examination and was proffered to "clarify facts that were not made sufficiently clear by either cross examination or direct examination" and that Broad's assertion of prejudice is unfounded.  Moreover, CVC asserts that it is "'entirely appropriate' to admit testimony elicited on redirect even where that testimony extends beyond the scope of cross-examination," citing Taskett v. Dentlinger, 344 F.3d 1337, 1339 (Fed. Cir. 2003).  And CVC resorts to 37 C.F.R. § 1.671(b) and Fed. R. Evid. 611(b) for the rule that redirect testimony in proceedings before the PTAB were permissible where such testimony "clarify[ies] facts that were not made sufficiently clear by . . . cross examination."  Because Broad's motion does not address these standards nor assert a basis in view of them for CVC's purported transgression thereof, CVC's Opposition maintains that Broad fails to provide the Board with any basis for granting their motion.  CVC further argues that Broad has failed to establish any prejudice to itself, because Broad has had a "full and fair opportunity to re-cross Dr. Zamore" under 37 C.F.R. § 42.53(c)(2), but "chose not to do so."

    CVC's Opposition sets forth in detail, point by point under interference rules, its basis for contending that Broad did not establish a basis for the Board to grant their motion to exclude.  CVC alleges that Broad has mischaracterized Dr. Zamore's redirect testimony, which was directed (in CVC's view) to a question that "has been discussed in nearly every filing throughout the course of this Interference": whether a person of skill in the art "would have understood the sgRNA CRISPR-Cas9 system to work in eukaryotes without needing any special instructions or conditions, based on the skilled artisan's experience with comparable prior art systems."  CVC's brief sets forth the dynamics of the testimony elicited from this witness by Broad during its cross-examination and CVC's questions on redirect examination, supporting its assertion that the testimony Broad seeks to exclude is properly within the scope of Broad's cross-examination.  CVC asserts accordingly that to the extent that Dr. Zamore's testimony was "expanded," the Board can consider it "provided such testimony provides the PTAB valuable clarity and context for his previous answers, many of which answered questions from Broad's counsel that were confusing or misleading in the absence of an understanding of the broader implications of the discussion," citing Taskett.  These relationships between Broad's questioning on cross-examination and CVC's redirect are set forth in this table:

    2021-06-17 Table
    The Opposition brief further exemplifies CVC's argument specifically as relates to its inquiry on Dr. Zamore's redirect testimony regarding comparisons (elicited on Broad's cross-examination) between CRISPR-Cas9 and other RNA-based regimes ("[r]ibozymes, Group II introns, and riboswitches").  CVC contends these are not the most compatible prior art systems, as Dr. Zamore explained for the Board's benefit on re-direct (testifying that "ZFNs and TALENs are far more comparable than any of these RNA systems").  In view of the clarifying nature of this testimony, CVC argues that there no basis to exclude it under Taskett or other Federal Circuit precedent.

    CVC further contends that there is no prejudice to Broad, because the topics that were the subject of Dr. Zamore's redirect testimony were "not news" and that "[n]othing in Dr. Zamore's redirect testimony raised any issues that Broad and its experts have not already briefed extensively," noting that Broad had proffered Dr. Breaker's expert witness testimony on these issues.

    Finally, CVC argues that Broad had the opportunity under 37 C.F.R. § 42.53(c)(2) to recross Dr. Zamore but did not do so.

    Broad InstituteBroad's Reply repeats the arguments already made in Broad's Motion to Exclude, here calling CVC's Opposition arguments "a transparent attempt to circumvent the rule against submitting reply declarations without leave."  Broad ties these efforts to the Board's earlier denial of CVC's request for leave to file reply declarations with regard to CVC Reply 2 (see "CVC Files Reply to Broad's Opposition to CVC's Priority Motion").  Broad's Reply discusses in detail the scope of Dr. Zamore's testimony on cross-examination and on re-direct, arguing that his cross-examination testimony was far less expansive than CVC contends.  The Reply notes that Dr. Zamore's declaration was filed in support of CVC's Opposition to Broad's priority motion and that nothing in either the Opposition nor the declaration was directed to questions of whether the skilled worker would have had a reasonable expectation of success at operable CRISPR-Cas9 in eukaryotic cell nor comparisons to other prior art systems.  Broad points out that these considerations apply to CVC's Priority Motion (fairly, because Broad itself has put these issues into question) and that CVC's expert asserted in support of CVC's priority motion did not address these issues.

    Broad supports its argument that the Board should exclude this evidence as CVC overreach by noting that CVC has not cited anything (not "a single page") in Dr. Zamore's declaration that supports its argument that the Board should not exclude this testimony.  Moreover, Broad argues that:

    Dr. Zamore's declaration does not contain any discussion of the obstacles and difficulties presented when adapting a prokaryotic system, such as CRISPR-Cas9, for use in a eukaryotic cell, nor any discussion of prior art systems such as Group II Introns or ZFNs/TALENs—indeed, Dr. Zamore's declaration does not contain a single mention of those systems.  These topics and systems have long been live issues here, and there is no excuse for CVC to have neglected addressing them in the declarations served with its Priority Motion.

    Even if this were not the case, Broad argues that CVC cannot be permitted to "grossly expand the scope of his declaration via re-direct to systems not even mentioned in the declaration" (specifically Group II Introns and ZFNs/TALENs)(emphasis in Reply).  Broad asserts that its cross-examination was limited to the opinions he expressed in his declaration and what CVC attempts to introduce in testimony Broad opposes because it goes beyond this testimony and unfairly prevents Broad from cross-examining Dr. Zamore on these issues (despite any culpability Broad may have for failing to re-cross Dr. Zamore during his deposition).

    Broad also reiterates its argument in its Motion to Exclude that the testimony it asks the Board to exclude was "a clearly prepared Q&A with CVC's counsel on re-direct on all three systems," i.e., Group II Introns, ZFNs and TALENs.  Broad set forth with specificity its challenges to the portions of Dr. Zamore's cross-examination testimony CVC cites in support of its arguments against the Board excluding this evidence, contending that these portions do not support the scope of the redirect testimony CVC attempts to include and nor does the authority CVC cites as favoring its position (including Taskett and Chrimar Holding Co., LLC v. ALE USA Inc., 732 F.App'x 876 (Fed. Cir. 2018)).

    In response to CVC's assertion that Broad squandered its opportunity to re-cross examine Dr. Zamore on his redirect testimony Broad argues that:

    [A]ll this does is highlight the unfairness and prejudice of CVC's canned re-direct.  There was no surprise to CVC that it needed to address [reasonable expectation of success] and prior art systems with a declaration in support of its opening Priority Motion.  CVC decided not to do so, and then ambushed Broad by eliciting it on Dr. Zamore's re-direct.  Broad did not have an opportunity to submit a rebuttal declaration and evidence or prepare a considered cross-examination of a properly disclosed opinion from Dr. Zamore.  To contend Broad should have cross-examined Dr. Zamore on his undisclosed and improperly elicited "re-direct" confirms that prejudicing Broad was CVC's goal—not merely a byproduct of its improper re-direct.

    The Board will decide whether to exclude this or any other testimony included in the Parties' Motions prior to Oral Hearing, for which the Board has not set a date.

  • By Kevin E. Noonan

    Late last month, Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") and Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") each filed Motions to Exclude Evidence in Interference No. 106,115.  Now Broad has filed its Opposition to CVC's motion and CVC has filed its responsive Reply.

    CVC's motion was directed to testimonial declarations of several Broad witnesses, including Benjamin Davies, Mark Kay, Alan Lambowith, Paul Simons, Erez Lieberman Aidan, Greg Hannon, Mark Isalan, Caixao Gao, Adam Bogdanove, Thierry VandenDriessche, Bryan Cullen, Paula Cannon, and Ronald Breaker, as well as documentary evidence.  CVC's basis for its motion was that this witness testimony had not been subject to cross-examination, based on the Federal Rules of Evidence, Standing Order (SO) ¶ 157.3, 37 C.F.R. § 42.51(c), and precedent including Rose v. Frazer, Praxair Distrib., Inc. v. INO Therapeutics LLC, and Mexichem Amanco Holdings S.A. de C.V. v. Honeywell Int'l, Inc.  CVC also asserted that certain testimony, particularly that of Dr. Breaker, was hearsay.  CVC raised similar hearsay objections to Broad's proffer of two books about CRISPR, by Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race) and Kenneth (sic) Davies (Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing).

    Broad InstituteBroad's opposition to this motion asserts existentially that CVC is attempting to avoid contemporaneous evidence regarding the inventors' appreciation that they had (or through the exercise of routine practice could) reduce eukaryotic embodiments to practice during the time from CVC's alleged conception date (March 3, 2012) to the constructive reduction to practice date, the filing of CVC's earliest priority document U.S. provisional application no. 61/757,640, filed January 28, 2013.  Reciting an argument made throughout this interference (and, indeed, in the earlier interference between the parties, No. 106,048), Broad asserts that the evidence it has adduced in this regard is admissible at least as an admission against interest.  And, Broad argues, its witness Dr. Breaker was entitled therefore to rely on them in support of his opinion that CVC has not shown that it was in possession of eukaryotic CRISPR earlier than Broad's dates of conception and actual reduction to practice.

    In addition, Broad argues that much of the evidence objected to by CVC involves opinions from scientists regarding whether the person of ordinary skill would have considered eukaryotic embodiments of CRISPR to involve nothing more than the exercise of ordinary skill and to have been reasonably expected to succeed in view of CVC's evidence regarding in vitro experiments.

    Broad's opposition also specifically addresses particular evidentiary items (e.g., Exhibit 3681, Issacson's Codebreaker) (conceding that should the Board consider CVC's objection to have any merit the issue is one of weight not admissibility).  Broad makes the equitable point that CVC should not "be allowed to tell science writers and the public about the difficulties and obstacles of their eukaryotic work so they can seek public acclaim" and then have the PTAB "ignore that those statements contradict CVC's arguments here, where CVC contends the same work actually required only 'routine techniques' and 'ordinary skill.'"  Broad then cites examples of inconsistencies between the statements CVC has made in this interference and what was said in the Exhibit regarding whether reducing eukaryotic CRISPR to practice was difficult or routine.

    Broad's legal basis for its opposition to CVC's motion to exclude is that a party admission is not hearsay under Fed. R. Evid. 801(d)(2) and Rawlings v. Kentucky, 448 U.S. 98 (1980).  Even if not falling under this hearsay exception, Broad argues, Dr. Breaker as an expert is permitted to rely on these statements under Fed. R. Evid. 703.  As for reliability, Broad argues that the statements at issue are ones the PTAB relied upon in Decisions on Motions in this interference and the '048 Interference.  Broad argues "[t]hese statements are relevant and admissible as directly contradicting the inventors' present testimony" and Dr. Breaker was able to consider them in forming his opinions.  And the status of the statements in Issacson's book as "double hearsay"  under Fed. R. Evid. 805 is not to the contrary to Dr. Breaker's ability to consider and rely on them under Rule 703 and In re Biogen '755 6 Patent Litig., No. CV102734, 2018 WL 3613162, at *10 (D.N.J. July 26, 2018).

    The Broad also argues that Dr. Breaker permissibly relied on admissible, contemporaneous, factual accounts of scientists' opinion regarding whether eukaryotic CRISPR would be reasonably expected to succeed in view of the in vitro experiments disclosed in the Jinek 2012 reference.  Broad bases these arguments on (what it characterizes as) both parties (and their experts) having relied on public statements from scientists in the field to assert evidence on "the state of the art, how POSAs reacted to historical research and developments in the gene editing and CRISPR fields, and how various scientists reacted to the disclosure of Jinek 2012's in vitro experiments," as well as the Board's reliance on this evidence.  This argument sets forth in parallel the equivalence of CVC's expert's reliance on such evidence and Broad's as well as correspondence between this evidence and publicly available records of these and other scientists' comments on the expectation of the skilled worker on reducing eukaryotic CRISPR to practice.

    The opposition (under PTAB rules in interferences) then sets forth a line-by-line rebuttal of the legal bases of the assertions in CVC's motion to exclude.  And Broad addresses what it describes as "similar but slightly different issues" regarding CVC's objections to the Lambowith declaration specifically related to "trying (and failing to adapt Group II introns for use in eukaryotic cells."

    Finally, Broad sets forth its rebuttal to CVC's objections to specific Exhibits comprising figures relied upon by Dr. Breaker in his expert testimony.

    University of California-BerkleyCVC in its Reply sets forth its grounds for the Board to grant its motion.  Most of these arguments reiterate arguments made in its motion, focusing on the statements by the authors (Issacson and Davies) as "double hearsay" in violation of Fed. R. Evid. 805 and re-emphasizing violation of the rule set forth in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 593-94 (1993) (an argument Broad does not address in their Opposition).  CVC disputes Broad's assertions that as publicly available statements much of what CVC has objected to should be allowed (saying that Broad has cited no authority for this proposition), characterizing Broad's use of this hearsay as "unapologetic" and that Broad should not be permitted to "cure its defiance of the Rules [of Evidence] through further defiance."  CVC also emphasizes Broad's failure to provide CVC with an opportunity to challenge these witnesses over this evidence (which even though being a practical impossibility might not excuse it).  CVC makes a distinction between relying on "scholarly journal articles, written by scientists for the scientific community and subject to rigorous peer-review" with what they characterize as "statements prepared for advocacy purposes during adversarial proceedings or ex parte prosecution, and not subject to any review (by cross-examination or otherwise)."

    Next, CVC argues that Broad's purpose for submitting this evidence can be distinguished from the purpose to which CVC and the Board have relied upon public statements.  That distinction is that the Board and CVC have cited such statements "as examples of information on which a hypothetical person of ordinary skill in the art might base his or her expectations of success—something that does not turn on whether the statements are true or reliable."  In contrast, CVC argues, Broad is submitting these statements for the truth of the matter asserted (as an example, "whether the witness believed the CVC inventor's CRISPR-Cas9 system would work in eukaryotes, and what obstacles they expected to encounter"), where "[m]ost of these witnesses do not appear to have sworn any oath, nor have any of them been offered for cross-examination in any forum."  Asserting that "[i]f ever there were a model situation to exclude declaration testimony, this is it," CVC asks the Board to exclude the specific Exhibits set forth in its Motion to Exclude.

    CVC's Reply then turns to portions of Dr. Breaker's Declaration.  These portions are merely an attempt for Broad to "backdoor so-called 'factual accounts'" and deny CVC the opportunity for cross-examination, CVC argues.  In addition, CVC notes that Dr. Breaker is being advanced as a scientific expert and "witness declarations from adversarial proceedings are not the type of documents that experts in Dr. Breaker's field reasonably rely upon to draw scientific conclusions," citing United States v. Tran Trong Cuong, 18 F.3d 1132, 1143 (4th Cir. 1994), authority supported by similar statements by the Federal Circuit (see Wi-Lan Inc., v. Sharp Electronics Corp., 992 F.3d 1366 (Fed. Cir. 2021)).  Accordingly, CVC argues that Broad has "not met its burden of establishing that these declarations fall within the scope of Rule 703," that these portions of Dr. Breaker's declaration violate Daubert and the Standing Order, and that the Board should grant CVC's Motion that this portion of his testimony is inadmissible.

    Finally, turning to the Issacson book, CVC characterizes this as "media coverage" which is inadmissible "to prove sequences of events or an inventor's mental state," citing New England Mut. Life Ins. Co., v. Anderson, 888 F.2d 646, 650 (10th Cir. 1989), and Horta v. Sullivan, 4 F.3d 2, 8 (1st Cir. 1993).  In addition, CVC's Reply makes a distinction between the Board's citation of a book written by one of the inventors and this book written by a third party, reiterating its allegations that this evidence is inadmissible double hearsay.  (CVC also notes that Broad did not oppose CVC's motion to exclude Exhibits 6107 and 6116.)

    CVC's Opposition to Broad's Motion to Exclude portions of its evidence and Broad's Reply will be the subject of a later post.

  • By Michael Borella

    Federal Circuit SealWhen the Supreme Court began poking around into the law of patent eligibility just over a decade ago, the invention topics that it considered under the abstract idea exception were limited to types of financial transactions.  The invention of Bilski v. Kappos was directed to hedging and that of Alice v. CLS Bank was directed to escrow.  While both inventions were ostensibly computer implemented, they involved software being applied to just one rather narrow field of endeavor.

    The Court's findings of invalidity in both cases are open to criticism both on procedural and substantive grounds, and these decisions could have been held to the facts of their cases or those of cases similar thereto.  But that did not happen.  We have seen a continuous expansion of the scope of what is considered to be "abstract" occur in a way that would make 19th-century imperialists jealous.

    Since Bilski and Alice, the Federal Circuit has grown the exception to encompass business methods in general, software in general, and more recently mechanical devices and processes involving such devices.  Notably, an electric car charger was deemed abstract in ChargePoint v. SemaConnect, as was a garage door opener in Chamberlain Group v. Techtronic Industries.  More recently, the controversial decision in American Axle v. Neapco found that a method for tuning driveshaft liners that improved damping capabilities was directed to nothing more than a law of nature and therefore ineligible.  American Axle is up for Supreme Court review, but no one expects that the justices will admit that their subject matter eligibility jurisprudence is a Gordian Knot that requires reformulation by way of a sword.

    Which brings us to last week's eligibility decision that came down from the Federal Circuit, this one involving a camera.  Yanbin Yu and Zhongxuan Zhang sued Apple and Samsung for alleged infringement of U.S. Patent No. 6,611,289.  Claim 1 of the '289 patent, which was considered representative of all asserted claims, recites:

    1.  An improved digital camera comprising:
        a first and a second image sensor closely positioned with respect to a common plane, said second image sensor sensitive to a full region of visible color spectrum;
        two lenses, each being mounted in front of one of said two image sensors;
        said first image sensor producing a first image and said second image sensor producing a second image;
        an analog-to-digital converting circuitry coupled to said first and said second image sensor and digitizing said first and said second intensity images to produce correspondingly a first digital image and a second digital image;
        an image memory, coupled to said analog-to-digital converting circuitry, for storing said first digital image and said second digital image; and
        a digital image processor, coupled to said image memory and receiving said first digital image and said second digital image, producing a resultant digital image from said first digital image enhanced with said second digital image.

    The camera of claim 1 has some fairly specific hardware requirements, such as a pair of closely positioned image sensors, lenses, A-D circuitry, memory, and a digital image processor.  Also, the camera is configured to carry out a fairly broad set of tasks, such as producing a first image and a second image, producing a resultant digital image from said first digital image enhanced with said second digital image.  It is the latter functionality that was the focus of the majority opinion from Judges Prost and Taranto, and the perceived nature of this functionality ultimately doomed the claims.

    In Alice, the Supreme Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under 35 U.S.C. § 101.  One must first decide whether the claim at hand involves 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 elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle.  While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

    Last year, the Federal Circuit provided a major clue as to how to think about patent eligibility in practice.  In Dropbox Inc. v. Synchronoss Techs. Inc. the Court wrote that "an inventive concept exists when a claim recites a specific, discrete implementation of the abstract idea where the particular arrangement of elements is a technical improvement over the prior art."  This suggests that in order for a claim that is otherwise directed to an abstract idea to be successful under § 101, it should have three qualities: specificity, a technical solution that it provides, and some degree of novelty.  More particularly, there should be a nexus between these three factors — specificity, technical character, and novelty should appear in the same claim element or at least be explicitly linked in some fashion in the recitation of the claim.

    On a Rule 12(b)(6) motion, the District Court found that claim 1 was invalid under § 101 because the claim was directed to the abstract idea of "taking two pictures and using those pictures to enhance each other in some way."  The District Court also opined that there was a "complete absence of any facts showing that the claimed elements were not well-known, routine, and conventional."  Yu appealed.

    Applying part one of the Alice test, the Federal Circuit quickly agreed with the District Court.  The majority noted that this process involves "asking what the patent asserts to be the focus of the claimed advance over the prior art."  On review of the language of claim 1 and Yu's specification, the majority found that the claim is "directed to a result or effect that itself is the abstract idea and merely invokes generic processes and machinery rather than a specific means or method that improves the relevant technology."

    It was undisputed in the District Court that "the idea and practice of using multiple pictures to enhance each other has been known by photographers for over a century."  The majority then took this as given and concluded that the hardware aspects of the claimed camera were generic and conventional.

    Yu argued that the specification described the technical advance provided by the claimed hardware configuration.  But the majority was unconvinced, finding that the specification described the benefits and advantages of a more specific hardware configuration (a "four-lens, four-image-sensor configuration in which three of the sensors are color-specific while the fourth is a black-and-white sensor") than what was claimed.  According to the majority, "the mismatch between the specification statements that Yu points to and the breadth of claim 1 underscores that the focus of the claimed advance is the abstract idea and not the particular configuration discussed in the specification that allegedly departs from the prior art."

    Holding claim 1 abstract under part one of Alice, the majority moved on to part two.  Here, it reiterated the points made above regarding the well-understood, routine, conventional nature of the hardware configuration.  Yu argued that this configuration was actually unconventional because the claim was allowed by the USPTO "over multiple prior art references."  The majority was unpersuaded, however, and stated that "even if claim 1 recites novel subject matter, that fact is insufficient by itself to confer eligibility."

    As an aside, this reasoning illustrates the logical contortions that the current application of § 101 forces one to go through.  Claim 1 was considered to be abstract because some of its features were in the prior art and therefore lacked novelty.  But Yu's argument that the claim as a whole was novel has no weight in the § 101 realm.  This type of Kafkaesque reckoning from the Federal Circuit is not new and dates back to 2014's Ultramercial v. Hulu.

    In any event, there is no evidence in this opinion that the majority properly considered the combination of elements in claim 1 as required by Alice.  Consequently, the majority ruled that Yu's claims failed the § 101 requirements and were invalid.

    Writing in dissent, Judge Newman kicked off by stating that "[t]his camera is a mechanical and electronic device of defined structure and mechanism; it is not an abstract idea."  Put another way, if you can drop it on your foot, it is not an abstract idea.

    Judge Newman criticized the majority for departing from the language of claim 1 when considering its eligibility.  She wrote:

    I repeat: claim 1 is for a digital camera having a designated structure and mechanism that perform specified functions; claim 1 is not for the general idea of enhancing camera images.  The camera of the '289 patent may or may not ultimately satisfy all the substantive requirements of patentability, for this is an active field of technology.  However, that does not convert a mechanical/electronic device into an abstract idea.

    Judge Newman also took a dim view of the majority's consideration of prior art under § 101.  In her opinion, Diamond v. Diehr and the legislative history of the 1952 Patent Act make it abundantly clear that there is an "explicit distinction" between §§ 101 and 102, and that the majority's wedging of § 102 factors into a § 101 analysis is improper.  She observed that "[s]ection 101 ineligibility does not arise simply because a device embodies minor and predictable differences from the prior art, as the majority holds."[1]

    Instead, Judge Newman found that there is historical support for considering claim specificity in the § 101 inquiry.  She wrote:

    [T]his reasoning has solidified the foundations of eligibility, drawing on the fundamental distinction between breadth of general scientific principle, and its embodiment in practical application.  This distinction between a general concept and its specific application is implemented in the Patent Act.

    So, it appears that she is willing to consider some incorporation of § 112 considerations into § 101.  This is perhaps in contrast to her colleague, Judge Moore, who coined the term "enablement on steroids" to describe how some panels of the Federal Circuit require that the claims (and not just the specification) enable one to practice the invention.

    Judge Newman concluded her dissent with a few pointed thoughts on novelty and non-obviousness being part of the eligibility calculus:

    In the current state of Section 101 jurisprudence, inconsistency and unpredictability of adjudication have destabilized technologic development in important fields of commerce.  Although today's Section 101 uncertainties have arisen primarily in the biological and computer-implemented technologies, all fields are affected.  The case before us enlarges this instability in all fields, for the court holds that the question of whether the components of a new device are well-known and conventional affects Section 101 eligibility, without reaching the patentability criteria of novelty and nonobviousness.

    The digital camera described and claimed in the '289 patent is a mechanical/electronic device that easily fits the standard subject matter eligibility criteria.  Neither the panel majority nor the district court decided patentability under Section 102 or Section 103, having eliminated the claims under Section 101.  The '289 claims warrant review under the substantive criteria of patentability—a review that they have never received.

    The fresh uncertainties engendered by the majority's revision of Section 101 are contrary to the statute and the weight of precedent, and contrary to the public's interest in a stable and effective patent incentive.

    Yu v. Apple (Fed. Cir. 2021)
    Panel:  Circuit Judges Newman, Prost, and Taranto
    Opinion by Circuit Judge Prost; dissenting opinion by Circuit Judge Newman

    [1] While Judge Newman's interpretation of the law is logical and arguably how it should be interpreted, it is fair to note that Justice Breyer wrote in Mayo v. Prometheus that "the §101 patent-eligibility inquiry and, say, the §102 novelty inquiry might sometimes overlap."  But he did not specify or discuss any further the nature of this overlap.  The blame for the current incursion of prior art concerns into questions of eligibility falls largely on the Federal Circuit.

  • CalendarJune 15, 2021 – "Federal Circuit Update on Claim Construction: Evolving Standards" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    June 15, 2021 – "Saving the World with Patents: Is the TRIPS Waiver Helping or Hurting Innovation?" (IPWatchdog and LexisNexis) – 11:00 am (ET)

    June 15-16, 2021 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office)

    June 22-22, 2021 – Summit on Biosimilars & Innovator Biologics: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace (American Conference Institute)

  • MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Federal Circuit Update on Claim Construction: Evolving Standards" on June 15, 2021 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorney Bradley J. Hulbert will provide a current update of Federal Circuit case law, as the Court continues to refine its approach toward determining the scope of patent claims.  The webinar will also provide a description of:

    • A framework for understanding how the Federal Circuit determines the "ordinary and customary" meaning of claim terms.
    • The Court's most significant, recent instructions for resolving "the distinction between using the specification to interpret the meaning of a claim and importing limitations from the specification into the claim."
    • How the Court now determines a patent applicant has disavowed claimed subject matter.
    • The Court's refinements in interpreting preambles, coined terms, and "wherein clauses."
    • Indicators as to when a narrowing amendment is "merely tangential," such that an amended claim still covers insubstantially different devices or methods.
    • Further constraints on when a claim limitation would be improperly vitiated if construed to cover an accused device or method.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • IPWatchdogIPWatchdog and LexisNexis and will be offering a webinar entitled "Saving the World with Patents: Is the TRIPS Waiver Helping or Hurting Innovation?" on June 15, 2021 at 11:00 am (ET).  Brian Arthur Pomper of Akin Gump; Melissa Brand, Assistant General Counsel, IP, Biotechnology Innovation Organization (BIO); Sarbani Chattopadhyay of LexisNexis; and Gene Quinn of IPWatchdog will discuss the petition by South Africa and India at the World Trade Organization (WTO) to waive most of the protections in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, and whether this is helping or hurting innovation.  The panel will also address the following topics:

    • The R&D regarding vaccination has been an ongoing process — you can see the correlation in patent filing statistics with the different virus outbreaks of previous years.
    • How patent analytics can provide insight into where a company is focusing their innovations even before they announce the innovations.
    • The patent data shows that prior to the Covid-19 outbreak, patents related to SARS and MERS vaccines, mRNA vaccines, and spike protein-based vaccines were already being developed.
    • The TRIPS Waiver pros and cons, is it more helpful or harmful to innovation?

    LexisNexisThere is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • By Kevin E. Noonan

    Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") and Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") each filed Motions to Exclude Evidence and Requests for Oral Hearing in Interference No. 106,115.

    University of California-BerkleyCVC's motion to exclude is directed to "declarations of Benjamin Davies (Ex. 3435), Mark Kay (Ex. 3436), Alan Lambowith (Ex. 3437); Paul Simons (Exs. 3438 and 3440); Erez Lieberman Aidan (Ex. 3439), Greg Hannon (Ex. 3441 and 3442), Mark Isalan (Ex. 3443), Caixao Gao (Ex. 3446); Adam Bogdanove (Ex. 3449), Thierry VandenDriessche (Ex. 3450), Bryan Cullen (Ex. 3451), Paula Cannon (Ex. 3452), portions of the Third Declaration of Ronald Breaker (Ex. 3448)," and certain documentary exhibits.  The legal basis for the motion is that these exhibits and testimony "seeks to exclude violates the Federal Rules of Evidence, the Standing Order (Paper 2), and the Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 593-94 (1993)."

    With regard to CVC's arguments based on the Rules of Evidence, CVC objects to Broad being permitted to rely on testimony proffered in support of its motion that has not been offered for witness cross-examination by CVC.  This is prejudicial to CVC, the motion explains, because "it had no opportunity to confront and challenge these witnesses on their statements, including their purported recollections, proffered opinions, and potential biases."  This testimony is particularly relevant because Broad has relied on it to show whether a person of ordinary skill in the art would have expected CRISPR-Cas9 to work in eukaryotic cells in early 2012; this testimony thus involves "disputed facts at the heart of [Broad's] opposition" to CVC's priority position.  In addition, because "[m]any of these witness statements were submitted in foreign patent office proceedings" they were not sworn to under oath and also constitute hearsay and thus should not be entered into evidence.

    In addition to CVC's objections based on the Federal Rules of Evidence, the motion asserts that this evidence is contrary to Standing Order (SO) ¶ 157.3, which provides that testimony not subject to cross-examination can be excluded.  Permitting Broad to rely on such unchallenged testimony is also contrary to relevant precedent, including Rose v. Frazer, Inf. No. 104,733 Paper 73 at 4 (B.P.A.I. Mar. 29, 2002); Praxair Distrib., Inc. v. INO Therapeutics LLC, IPR2015-00529, Paper 33 at 2 (PTAB Dec. 22, 2015); and Mexichem Amanco Holdings S.A. de C.V. v. Honeywell Int'l, Inc., Case IPR2013-00576, Paper 36 at 3 (PTAB Sept. 5, 2014), as well as 37 C.F.R. § 42.51(c).  This precedent stands against Broad's arguments that cross-examination is unnecessary because the statements contained therein are part of the "public record" according to CVC.

    CVC points out for particular objection portions of Dr. Breaker's declaration as hearsay for relying on declarations of others he stated show that others in the field shared his opinions with regarding to eukaryotic CRISPR embodiments; to do so would contravene Federal Circuit precedent according to CVC, citing Wi-Lan Inc., v. Sharp Electronics Corp., 992 F.3d 1366 (Fed. Cir. 2021).  In addition to striking the specified portions of Dr. Breaker's testimony, CVC asks the Board to give no weight to citations of Dr. Breaker's opinion in Broad's priority motions, oppositions, and replies.  And because Dr. Breaker's reliance on unchallenged opinions of others is accordingly unreliable, those portions violate Daubert as well, according to CVC's brief.  To an anticipated response by Broad that an expert is entitled to rely on hearsay in forming their opinions, CVC argues that while true an expert cannot be used as a "conduit" for bringing hearsay to the factfinder for the truth of the matter asserted, citing the Federal Circuit's reliance on Marvel Characters, Inc. v. Kirby, 726 F.3d 119 (2d Cir. 2013), in its Wi-Lan Inc., v. Sharp Electronics Corp. decision.

    With regard to certain exhibits, CVC objects as hearsay to recent books about CVC inventors including Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race) and Kenneth (sic) Davies (Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing) that CVC contends the Broad proffered as "purported evidence of the timing, difficulty, challenges, and the role different people played in the events leading up to the CVC inventors' fame and accolades."  Rather than providing admissible evidence, CVC contends that these books are the authors' words and interpretations of information they gathered and that the authors are without personal knowledge of the events they describe.  Nor have these authors submitted declarations under oath nor been made available for deposition.  And as "hearsay within hearsay" (as being the authors' hearsay statements regarding what others have said to them) these exhibits are inadmissible under FRE 805.  As stated by CVC in its motion, "[t]here is no hearsay exception for a published book, even a popular one."

    Broad InstituteBroad's motion to exclude is more limited, being specifically directed to testimony from Dr. Phillip Zamore regarding "how a person having ordinary skill in the art ("POSA") allegedly would have understood (1) the March 2011 Deltcheva et al. reference's disclosures regarding tracrRNA, (2) the RNAi, pre-mRNA, and DNA systems he alleges are relevant to Deltcheva et al.'s disclosures, and (3) Dr. Zhang's October 24, 2011 email regarding the role of tracrRNA in the CRISPR-Cas9 cutting complex."  According to Broad, what Dr. Zamore's declaration did not attest to was "(1) whether a 2012 POSA would have had a reasonable expectation of success of using CRISPR-Cas9 in eukaryotic cells; (2) the state of the art after the Jinek 2012 paper; or (3) relevant prokaryotic-based systems, such as Group II introns," all of which were issues upon which CVC Priority Motion.  But these issues were attested to not by Dr. Zamore in support of CVC's priority claims but by another witness, who did not opine on them.  Thus, CVC's proffer of Dr. Zamore's testimony on these matters is an attempt, in Broad's view, to "untimely seek[] to obtain expert testimony on these topics via improper re-direct testimony by Dr. Zamore" (i.e., during Broad's cross-examination of CVC's witness).  And Broad asserts that its cross-examination of Dr. Zamore was properly limited to "the actual opinions expressed in Dr. Zamore's declaration and his qualifications," and thus did not "open the door" to the testimony CVC elicited on redirect examination.

    The brief recites specific portions of Dr. Zamore's redirect testimony to illustrate that Broad terms "an obviously rehearsed question and answer session that attempted to add to the record new testimony regarding reasonable expectation of success."  Broad's brief sets forth with specificity the testimony Broad asks the Board to exclude:

    Table
    Broad's basis for this relief is that the Board "allowing the challenged po1tions of Dr. Zamore's testimony into evidence here would prejudice Broad" because "Broad was denied a fair opportunity to prepare a full rebuttal to Dr. Zamore on topics such as prior art systems and reasonable expectation of success given such opinions were not in Dr. Zamore's declaration and only proffered for the first time on a purported re-direct, after Broad's opposition was filed."

    Both Broad and CVC request oral hearing and present a list of issues for the Board to resolve.  For Broad, these issues include Broad's Motion No. 5 for judgment of priority, as well as CVC's Opposition Motion and Broad's Reply; Broad's motion No. 9 to exclude evidence (as well as any opposition by CVC and reply by Broad); CVC's Motion No. 2 for priority judgment, as well as Broad's Opposition and CVC's Reply; CVC's Motion No. 3 for misjoinder of inventorship, Broad's Opposition, and CVC's Reply; and Broad's Contingent Motion No. 6, CVC's Opposition, and Broad's Reply for Correction of Inventorship if the Board grants CVC's Motion No. 3 on misjoinder.  Broad also lists for the Board any motions to exclude by CVC and "any other issues that the PTAB would like Senior Party to address."

    For CVC the issues on which CVC asks the Board to hear oral argument include CVC's Motion No. 2 for priority judgment, as well as Broad's Opposition and CVC's Reply; CVC's Motion No. 3 for misjoinder of inventorship, Broad's Opposition, and CVC's Reply; CVC's Motion No. 7 to exclude evidence, as well as any Broad Opposition and CVC Reply; Broad's Motion No. 5 for judgment of priority, as well as CVC's Opposition Motion and Broad's Reply; and Broad's Contingent Motion No. 6, CVC's Opposition, and Broad's Reply for Correction of Inventorship if the Board grants CVC's Motion No. 3 on misjoinder.  CVC also includes any other issues "raised by Broad during oral argument or issues the PTAB would like CVC to address."

    The Board in its discretion will decide whether to grant these requests for oral hearing and set a hearing date in due course.

    Finally, Broad has filed an unopposed Miscellaneous Motion (No. 8) pursuant to Standing Order ¶¶ 121 and 123 to seal redacted material under the protective order contained in portions of the deposition transcripts of two CVC witnesses, Erik Joseph Sontheimer (Ex. 6214) and Rodolphe Barrangou (Ex. 6212).  This testimony relates to financial disclosures and licensing information that, if disclosed, would "compromise privacy interests and competitively sensitive information about licensing held by non-parties to this proceeding."  Broad makes the case that the redactions are "narrowly tailored" to minimize negative impact on the public, and that the redacted information is not necessary for the public to understand the context or substantive merits in the interference.