Patent Law Weblog
The International Intellectual Property Law Association (IIPLA) will be offering a live webinar by J. Baron Lesperance of Remenick PLLC on "Using Customs to Protect Your Intellectual Property" on October 14, 2021 from 10:00 am to 11:00 am (EST).
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By Kevin E. Noonan —
The International Trade Commission can more readily provide injunctive relief against an adjudged infringer than a district court, under appropriate conditions (i.e., with regard to an infringing product or a product made by infringing a claimed method). In September, the Federal Circuit affirmed an exclusion order by the Commission in Jennewein Biotechnologie GmbH v. International Trade Commission (Glycosyn LLC joined as an Intervenor based on its patent being the basis for the exclusion order), based on importation of a product made by a patented method, which relied in part on an application of the doctrine of equivalents in establishing infringement (something that has become more common of late; see, e.g., Ajinomoto Co. v. International Trade Commission).
The matter arose when Glycosyn filed a complaint before the ITC under 19 U.S.C. § 1337 for importing milk oligosaccharaides (particularly, fucosyllactose or 2'-FL) made using methods claimed in its U.S. Patent No. 9,970,018. Claim 1 is representative of the patented methods:
1. A method for producing a fucosylated oligosaccharide in a bacterium, comprising providing an isolated E. coli bacterium comprising,
(i) a deletion or functional inactivation of an endogenous β-galactosidase gene;
(ii) an exogenous functional β-galactosidase gene comprising a detectable level of β-galactosidase activity that is reduced compared to that of a wildtype E. coli bacterium, wherein the level of β-galactosidase activity comprises between 0.05 and 200 units;
(iii) an inactivating mutation in a colanic acid synthesis gene; and
(iv) an exogenous lactose-accepting fucosyltransferase gene;
culturing said bacterium in the presence of lactose;
and
retrieving a fucosylated oligosaccharide from said bacterium or from a culture supernatant of said bacterium.
Relevant limitations were that the bacterium has an inactivated colonic acid synthase gene and that the endogenous β-galactosidase gene (lacZ) is deleted or inactivated and an exogenous lacZ gene had been added to produce low-level ("between 0.05 and 200 Miller units") β-galactosidase activity; this enzymatic activity would degrade residual lactose that would be difficult and expensive to eliminate in the final product, while being expressed at a level low enough not to "significantly diminish the intracellular lactose pool."
Important cell characteristics resulting from these genetic manipulations included: (1) an increased intracellular guanosine diphosphate (GDP)-fucose pool; (2) an increased intracellular lactose pool; and (3) a fucosyltransferase, resulting in an apparently delicate metabolic balance.
The basis for Glycosyn's ITC complaint was Jennewein's importing 2'-FL made by the process claimed in the '018 patent. Two of the strains express lacZα and lacZΩ, two gene fragments that when expressed together produce active β-galactosidase, with expression of the lacZΩ fragment being under temperature regulatory control (i.e., the gene is expressed at 42°C but not at 30°C).
The ALJ construed the limitations "'β-galactosidase activity comprises between 0.05 and 200 units' to mean 'β-galactosidase activity is measurable at between exactly 0.05 and exactly [200] Miller Units, as defined in Miller'"; "functional β-galactosidase gene" to mean "a functional sequence of DNA that encodes β-galactosidase;" and the term "exogenous" to have its plain and ordinary meaning. The ALJ did not impose any temporal limits on the claimed activity ("the claimed activity need only be met 'at some point in time'"). Under this construction, the ALJ held that the two accused strains that expressed the lacZα and lacZΩ fragments infringed while a third strain (that only expressed the lacZα fragment) and did not use lactose to produce 2'-FL did not have sufficient evidentiary findings to adjudicate whether it infringed or not.
The Commission reviewed the ALJ's findings and concluded that the two strains that expressed lacZα and lacZΩ fragments infringed under the doctrine of equivalents, and that the third, lacZα-expressing strain did not infringe. This appeal followed.
The Federal Circuit affirmed, in an opinion by Judge Chen joined by Judges Lourie and Bryson. The panel expressly rejected Jennewain's three arguments:
(1) [that] Jennewein's [two strains adjudged to infringe did not] satisfy the claim limitation requiring that "the level of β-galactosidase activity comprises between 0.05 and 200 units"; (2) [that] Jennewein's [two strains adjudged to infringe did not] satisfy the "exogenous functional β-galactosidase gene" claim limitation; and (3) that the ITC erred in holding that "the level of β-galactosidase activity comprises between 0.05 and 200 units" claim limitation does not require the β-galactosidase activity to occur "within the claimed range at substantially all times during 2'-FL production and retrieval."
As for Jennewein's first argument, the Federal Circuit assessed the Commission's decision under the substantial evidence standard appropriate for questions of fact such as infringement. The panel held that the evidence presented to the Commission was sufficient under this standard to withstand Jennewein's appeal, and in particular that no negative control strain was needed when performing the Miller assay to determine β-galactosidase activity. There was no evidence of "background" lactose being produced in these cells or that any other enzymatic pathway produced this sugar other than the combination of the lacZα and lacZΩ fragments to produce functional (albeit barely) β-galactosidase (and thus that there was nothing to control for), according to the Court. The panel agreed that any β-galactosidase activity detected at the lower temperature (30°C) was due to "leakage" in the temperature control of lacZΩ fragment expression, according to unrebutted expert (Glycosyn's)) testimony as well as other controls performed as part of the Miller assay.
The Court also was not convinced by Jennewein's quantitative arguments that showed the two negative control strains having higher Miller values than the accused strains. Because the negative control strains should only have "background" β-galactosidase activity levels these results were anomalous for the panel, leading them to conclude that these strains were "not valid" as negative controls. That the two control strains had different Miller levels also suggested to the Court that there was something amiss. (There were also communications between Jennewein and a third party hired to assess infringement that undercut Jennenwein's arguments in this regard, to the effect that the control strains were "not suitable.")
The Federal Circuit found that Jennewein's strains satisfied the "exogenous functional β-galactosidase gene limitations" under the substantial evidence standard, at least under the doctrine of equivalents. Jennewein based its arguments on the endogenous nature of the lacZα β-galactosidase gene fragment but the Federal Circuit agreed with the Commission (supported by substantial evidence) that the (barely) functional β-galactosidase gene was exogenous because the lacZΩ fragment was exogenous. (The lacZΩ fragment itself is exogenous to the E. coli genome, having originated according to the opinion in a prophage.)
Finally, the panel agreed with the Commission that there was no temporal aspect recited in the claims and rejected Jennewein's argument that the Commission erred by not requiring Glycosan to establish that "the modified bacterium's level of β-galactosidase activity be 'within the claimed range substantially throughout 2'-FL production and retrieval'" based on the Commission's claim construction. In reaching this conclusion, the Federal Circuit reviewed the Commission's claim construction de novo because the Commission had relied solely on intrinsic evidence, using the rubrics set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), finding no error.
Jennewein Biotechnologie GmbH v. International Trade Commission (Fed. Cir. 2021)
Panel: Circuit Judges Lourie, Bryson, and Chen
Opinion by Circuit Judge Chen
By Michael Borella —
CosmoKey asserted U.S. Patent No. 9,246,903 against Duo in the U.S. District Court for the District of Delaware, alleging infringement. The District Court found the patent's claims to be ineligible under 35 U.S.C. § 101 because they were directed to an abstract idea and lacked an inventive concept. On review, the Federal Circuit reversed, and provided a small glimmer of clarity illuminating the ever-elusive contours of the "inventive concept."
The Claimed Invention
Two-factor authentication is the current state-of-the-art when it comes to providing secure remote access to information and software applications. In short, a user first registers their mobile device with an authentication entity. When the user remotely logs on to a secure site (e.g., with a userid and password), the authentication entity transmits a challenge to the registered mobile device. The user then either responds to this challenge (e.g., with a second password or some other form of identity verification), or provides information from the challenge (e.g., a numeric code) into the secure site. If the provided credentials are correct, the user gains access to the site. Doing so allows the authentication entity and the secure site to verify the user's identity in two ways — based on what they know (the userid and password) and the devices to which they have physical access.
The '903 patent purports to improve on these procedures by having the secure site maintain an authentication function that is normally inactive. When a user attempts to log in, the authentication function is activated for a short period of time. During this period of time, the user must cause their mobile device to transmit a message to the authentication entity. Advantageously, this does not require the user to enter credentials.
According to the '903 patent, this "provides an authentication method that is easy to handle and can be carried out with mobile devices of low complexity [and] it is a particular advantage of the invention that the mobile device does not have to have any specific hardware for capturing or outputting information."
Claim 1 of the '903 patent recites:
A method of authenticating a user to a transaction at a terminal, comprising the steps of:
transmitting a user identification from the terminal to a transaction partner via a first communication channel,
providing an authentication step in which an authentication device uses a second communication channel for checking an authentication function that is implemented in a mobile device of the user,
as a criterion for deciding whether the authentication to the transaction shall be granted or denied, having the authentication device check whether a predetermined time relation exists between the transmission of the user identification and a response from the second communication channel,
ensuring that the authentication function is normally inactive and is activated by the user only preliminarily for the transaction,
ensuring that said response from the second communication channel includes information that the authentication function is active, and
thereafter ensuring that the authentication function is automatically deactivated.
The Patent-Eligibility Test
In Alice Corp. v. CLS Bank Int'l, the Supreme Court 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 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 part two of Alice 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 qualities — 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.
District Court Proceedings
In the District Court, Duo moved for judgment on the pleadings under Rule 12(c), alleging that "the claims are directed to the abstract idea of authentication and do not recite any patent-eligible inventive concept." The District Court granted the motion.
Applying part one of the Alice test, the District Court agreed with Duo, finding the claims focused on "the verification of identity to permit access to transactions." Based on Federal Circuit precedent, the District Court concluded that authentication, in and of itself, was an abstract idea.
Applying part two, the District Court found that the claims and the specification merely taught generic computer functionality to carry out this abstract idea. Particularly, the District Court wrote that "the detection of an authentication function's activity and the activation by users of an authentication function within a pre-determined time relation were well-understood and routine, conventional activities previously known in the authentication technology field."
Federal Circuit Majority Opinion
The Federal Circuit acknowledged that it had previously found claims directed to authentication to be abstract. But the Court also noted that it had "held claims directed to specific verification methods that depart from earlier approaches and improve computer technology eligible under § 101."
Considering the District Court's part one analysis, the Federal Circuit disagreed with that body's characterization of the invention. Instead, the Court opined that "the claims and written description suggest that the focus of the claimed advance is activation of the authentication function, communication of the activation within a predetermined time, and automatic deactivation of the authentication function, such that the invention provides enhanced security and low complexity with minimal user input." However, the Court further noted that it need not resolve the tension between its view of the claims and that of the District Court, because the claims met the requirements of part two.
The Court centered its attention on the purported technical advance — that the invention provides authentication using low-complexity processes and devices. In view of this, the claims "recite a specific improvement to authentication that increases security, prevents unauthorized access by a third party, is easily implemented, and can advantageously be carried out with mobile devices of low complexity." Moreover, the Court found that the invention solved a technical problem in the field of computer networks using steps that were not conventional — notably, the last four steps of claim 1.
Thus, given the posture of the case — a 12(c) motion for which all reasonable inferences are to be drawn in favor of CosmoKey — the Court ruled that the claims as interpreted through the specification recite an inventive concept that goes beyond any alleged abstract idea therein. Consequently, the Federal Circuit reversed the District Court's § 101 ruling.
Judge Reyna's Concurrence
Judge Reyna concurred with the majority's decision to reverse the District Court, but took issue with how the majority focused on part two of the Alice test without completing part one. He believes that doing so violates the premises set forth in Alice. In detail, he wrote:
Step two is rendered superfluous and unworkable without step one. Without the benefit of a step-one analysis, we are hobbled at step two in reasonably determining whether additional elements transform the nature of the claim into a patent-eligible application of the abstract idea. And by skipping step one, we create a risk that claims that are not directed to an abstract idea might be deemed to "fail" at step two.
This disagreement over whether step one is necessary or otherwise guides the exercise of step two is somewhat surprising. As we have noted in a previous analysis, the Court actually looks for the same factors in both step one and step two — novelty, specificity, and a technical character. Thus, the Alice test is better thought of as a one-part affair with these three factors than having two distinct components. In view of this, and in contrast to Judge Reyna's position, whether the eligibility evaluation takes place under part one or part two does not matter — the outcome should be the same.
Judge Reyna's own Court is responsible for any confusion in the application of Alice. It has had over seven years to interpret and set forth a clear set of guidelines for the § 101 inquiry. But it has not. Until this changes, arguments over what questions should be asked in each part of Alice are likely to continue.
In the mean time, this case reiterates the notion that a clearly established and specifically claimed technical improvement over the prior art is an inventive concept.
CosmoKey Solutions GmbH v. Duo Security LLC (Fed. Cir. 2021)
Panel: Circuit Judges O'Malley, Reyna, and Stoll
Opinion by Circuit Judge Stoll; concurring opinion by Circuit Judge Reyna
By Kevin E. Noonan —
On May 20th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Preliminary Motion No. 3 in Interference No. 106,127 (which names ToolGen as Senior Party), asking the Patent Trial and Appeal Board to add claims in ToolGen's U.S. Patent No. 10,851,380* to this interference, pursuant to 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) and Standing Order ¶ 208.3.2. On July 5th ToolGen filed its Opposition. On August 27th, CVC filed its Reply.
In its Motion No. 3, CVC argued that the only difference between the language of the Count and the claims in the '380 patent is that those claims require the addition of two guanine residues ("GG") positioned before the crRNA portion of the sgRNA sequence. CVC argued that these species of sgRNA (the fusion of crRNA and tracrRNA) recited in the '380 patent claims were solely a consequence of using the T7 phage RNA polymerase to produce sgRNA, and that in vitro RNA production using T7 RNAP promoters was well-known in the art ("for decades"; emphasis in brief) at the priority date of the '380 patent; these arguments are supported by testimony from CVC's expert, Dr. Scott Bailey and this method of producing sgRNA and relevant prior art disclosing the use of T7 RNAP and promoters recognized by the polymerase was set forth in the brief.
CVC argued that the distinction of including two guanine residues in crRNA and sgRNA comprised thereof is not enough to distinguish the claims of the '380 patent from the Count in this interference (to which CVC argues these claims correspond) because "including a 5'-GG would have been obvious over Count 1 in view of [CVC's] Jinek 2012" reference as illustrated above, which reliance is permitted under Desjardins v Wax, Interference No. 105,915, Paper 127, 17-20 (P.T.A.B. Jan. 21, 2014). Regarding motivation to combine the teachings of the Jinek reference in this regard with the more general teachings of producing an sgRNA for eukaryotic CRISPR, CVC argued that such motivation is supported by the method's "low cost, efficiency, and accuracy," and because "Jinek 2012 had already used the method to generate RNAs that effectively cleave eukaryotic DNA sequences (e.g., GFP) in CRISPR-Cas9 systems (i.e., ToolGen knew the method would be successful in eukaryotic CRISPR). This success also would have provided the requisite reasonable expectation of success to complete a prima facie case of obviousness and hence for the '380 claims to properly be determined to correspond to the Count in this interference.
ToolGen argued in its opposition that the claims of the '380 patent do not correspond to Count 1 of this interference and that CVC's motion did not comply with the requirements of 37 C.F.R. §§ 41.202 and 41.203. With regard to the substantive question, ToolGen's brief focused on whether the Count would render those claims obvious (because the lack of the two guanine residues positioned before the crRNA portion of the sgRNA sequence in the Count precludes anticipation, i.e., each and every limitation in the claim is not found therein). And, ToolGen contended, Count 1 alone cannot render the '380 patent claims obvious (and CVC did not so argue). Thus, the issue was whether the combination of the language of the Count and the disclosure of the Jinek 2012 reference raises a prima facie obviousness case, which ToolGen maintained it does not. ToolGen's reasoning was that, at the priority date of the '380 patent (October 23, 2012), "(1) a POSA would not have been motivated to combine Count 1 and Jinek; (2) a POSA would not have had an expectation of success in implementing the CRISPR/Cas9 system of independent claim 1 in eukaryotic cells; and (3) the claims of the '380 patent exhibit superior properties and advantages that a POSA would have found surprising or unexpected." ToolGen's reasoning reiterated in part the argument raised in its opposition to CVC's Preliminary Motion No.2, that Jinek describes uses of prokaryotic CRISPR-Cas9 in a "non-cellular, experimental environment," citing the Board's decision in Interference No. 105,048 and the Federal Circuit's affirmance thereof. Further, ToolGen argued that the Jinek 2012 reference does not describe any experiments using CRISPR in eukaryotic cells nor introduction of CRISPR complexes into such cells. Finally, ToolGen cited the PTO's determination during prosecution of the '380 patent that Claim 1 of the '380 patent was non-obvious over the Jinek 2012 reference which is binding here they contended, citing Harris Corp. v. Fed. Exp. Corp., 502 F. App'x 957, 968 (Fed. Cir. 2013), and Glaxo Grp. Ltd. v. Apotex, Inc., 376 F.3d 1339, 1348 (Fed. Cir. 2004).
ToolGen also challenged CVC's contention that the skilled worker would have been motivated to combine the teachings of the Jinek 2012 reference with the subject matter of Count 1 in support of a prima facie obviousness case. The basis for this argument was that "nothing in the prior art—cited by CVC or otherwise—'suggest[s] the desirability' of RNA transfection—a method necessitated by Jinek—as a method of introducing sgRNA (or 'guide RNA') into eukaryotic cells as of the priority date" (emphasis in brief), citing In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004), and Forest Labs., LLC v. Sigmapharm Labs., LLC, 918 F.3d 928, 22 934 (Fed. Cir. 2019). This argument was based on the limitation recited in Count 1 to a method for "introducing into [a] eukaryotic cell" a CRISPR-Cas9 complex comprising an sgRNA. Jinek's disclosure in limited to a method for preparing RNA by in vitro transcription (emphasis in brief) and this RNA would be understood by the skilled worker to be introduced into eukaryotic cells using RNA transfection techniques, ToolGen asserts, which were not routinely employed in the art. And ToolGen argued the Jinek 2012 reference provided no disclosure (being "entirely silent" on the question) regarding RNA transfection that would overcome these limitations in the prior art (this argument being supported by copious citations to that art).
ToolGen also argued that the prior art, including the Jinek 2012 reference, did not disclose any reason to introduce two guanine residues before the crRNA portion of the sgRNA sequence, asserting that it was the '380 patent inventors who first discovered that doing so resulted in greater specificity. Accordingly, ToolGen stated, "as of the priority date, a POSA would have understood the Jinek method as having inherent limitations, i.e., the requirement of one or more guanines at the 5' end, without any known benefit." Indeed, ToolGen made the case that the state of the prior art would have preferred using eukaryotic promoters, such as the U6 promoter, as part of a DNA plasmid encoding sgRNA as the preferred method for producing (rather than introducing using RNA transfection methods fraught with known difficulties) sgRNA in a eukaryotic cell for achieving CRISPR in such a cell. (After all, ToolGen noted that CVC's own application, filed three months after the '380 patent's priority date, utilized plasmids encoding sgRNA expressed using a eukaryotic promoter to produce RNA in a eukaryotic cell.)
ToolGen next turned to CVC's argument that the skilled worker would have had a reasonable expectation of success in combining the Jinek 2012 reference with the limitations of Count 1 to achieve CRISPR in a eukaryotic cell. ToolGen bluntly asserts such a POSA would not have had such a reasonable expectation of success because it had been established by the Board, and affirmed by the Federal Circuit, "that as of 5 December 2012—two months after the priority date—a POSA 'would not have reasonably expected success' in implementing CRISPR/Cas9 in eukaryotic cells" by any means. ToolGen refers to "a similar argument" made by CVC in Interference No. 106,115 (against Broad) and CVC's reliance on the Board distinguishing its decision in the '048 interference as meaning that "[e]xpectation of success in eukaryotes would not be in doubt" as of the priority date. CVC is incorrect, ToolGen argued, because it ignored the distinctions regarding the limitations in Count 1 (which under 37 C.F.R §41.207(b) is considered prior art) and the "problematic nature of RNA transfection as of the priority date" arising in the context of this interference. Under the prior art presumption regarding the Count, ToolGen argued, "to interpret §41.207(b) as providing for an assumption of a reasonable expectation of success—as CVC suggests—would be inconsistent with the plain language of the rule and Board precedent" and "such an interpretation would effectively nullify the requisite obviousness analysis of §41.207(b)." Nor does the routine nature of producing RNA in vitro using T7 promoter and polymerase support a reasonable expectation of using such RNA to achieve CRISPR in eukaryotic cells as CVC argues in its Motion No. 3, ToolGen asserted.
Finally, in this regard ToolGen contended that the invention claimed in Claim 1 of the '380 patent "exhibits superior properties and advantages that a POSA would have found surprising and unexpected as of the priority date." Specifically, these include that having two guanine residues positioned before the crRNA portion of the sgRNA "discriminated off-target sites effectively," an improvement over a recognized drawback. ToolGen relied on the non-obviousness of Claim 1 of the '380 patent in support of its contention that Claims 2-10 are also non-obvious when considered in view of the Jinek 2012 reference in combination with the limitations recited in Count 1 and thus the Board should deny CVC's motion to designate them as corresponding to the Count and including them in this interference.
In its Reply, CVC argues legal and evidentiary errors by ToolGen in reiterating the arguments made in CVC's Preliminary Motion No. 3. Ironically, CVC relies extensively on the Board's decision in the '115 Interference (Regents of the Univ. of Cal. v. The Broad Inst., Inc., Interference No. 106,115, 13 Paper 877, 66 (P.T.A.B. Sept. 10, 2020)) in support of its arguments that the '380 patent claims would have been obvious over the combination of the Jinek reference and Count 1. Further, CVC argues that ToolGen improperly ignored (or at least did not rebut) its argument that direct methods for introducing CRISPR into eukaryotic cells (microinjection and RNA transfection) were known in the art and consistent with in vitro production of sgRNA by T7 RNA polymerase, which produces the added GG dinucleotides characteristic of ToolGen's methods claimed in the '380 patent. CVC's arguments depend at their core on the legal fiction that the Count is in the prior art under Rule 207(b)2), because under those circumstances the issue is one CVC contends is no different from the factual predicate the Board applied in the '115 interference. Under these circumstances CVC reiterates earlier arguments in its Motion that the combined teachings of Jinek and the Count would render obvious ToolGen's '380 patent claims because synthesizing sgRNA using T7 polymerase (and thus having the resulting sgRNA comprise the GG dinucleotide at its 5' end) and using microinjection or RNA transfection were known in the art and would have created a reasonable expectation of success.
CVC cites (undoubtedly with ironic satisfaction) the PTAB's refutation of similar arguments by Senior Party Broad in the '115 Interference that relied on the Board's decision in the '048 Interference: "We are not persuaded by Broad's argument because the issue in the prior ['048] interference was whether a CRISPR-Cas9 system would have been expected to work in a eukaryotic cell. That issue is assumed under the framework of 37 C.F.R. § 41.207(b)(2), wherein Count 1 is presumed to be prior art to the Broad claims" (emphasis in brief). And the fact that ToolGen overcame citation of the Jinek 2012 reference during ex parte prosecution is irrelevant, CVC argues, because those arguments did not concern obviousness in view of the recitations in Count 1 being considered part of the prior art. Accordingly, CVC contends that "the PTAB should reject ToolGen's argument because it is fundamentally no different than Broad's failed argument in the '115 Interference."
CVC rebuts ToolGen's arguments regarding whether the skilled worker would have used plasmid-based methods for producing sgRNA in a eukaryotic cell by citing Apple Inc. v. Samsung 10 Electronics Co., Ltd., 816 F.3d 788, 801-802 (Fed. Cir. 2016), for the rubric that "a motivation to use the teachings of a particular prior art reference need not be supported by a finding that that feature be the 'preferred, or the most desirable.'" CVC also argues that ToolGen's reference to which method of producing sgRNA and introducing CRISPR-Cas9 into a eukaryotic cell were more advantageous is also irrelevant in view of the teaching in the Jinek 2012 reference that "production and introduction of in vitro-transcribed RNA as described in Jinek 2012 was well-established, quick, cost-effective, and accurate." Moreover, CVC cites expert testimony (from their own experts and, perhaps grudgingly, from ToolGen's expert) that introducing RNA into a eukaryotic cell by RNA transfection or microinjection were "routine" and "fairly standard" methods (supported, CVC notes, by "the pre-2012 availability of various commercial transfection reagents advertised as being appropriate for RNA transfection").
CVC also contradicts ToolGen's arguments regarding unexpected results on the basis that "there can be no unexpectedly superior results for a claimed species when a previously-disclosed genus to which the species 1belong demonstrates those same results," citing AbbVie, Inc. v. Mathilda and Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1380 (Fed. Cir. 2014).
Finally, CVC argues that its Motion was procedurally proper under 37 C.F.R. §§ 41.202 and 41.203 and that ToolGen's arguments to the contrary improperly apply the law with regard to having a new interference declared rather than having a claim of another patent designated as corresponding to the Interference Count (citing several Board decisions in other interferences having that effect). But just in case the Board agrees with ToolGen's argument that CVC's priority showing was deficient, CVC asks the Board to use its discretion under Rule 41.104(b) in this case to waive any such requirement based on the priority case CVC has asserted in its other pleading which apply in this instance as well.
* '830 Patent Claims CVC Asserts Correspond to the Count in the '127 Interference
1. A method of introducing a site-specific, double-stranded break at a target nucleic acid sequence in a eukaryotic cell, the method comprising introducing into the eukaryotic cell a Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/Cas system, wherein the CRISPR/Cas system comprises: a) a nucleic acid encoding a Cas9 polypeptide comprising a nuclear localization signal, wherein the nucleic acid is codon-optimized for expression in eukaryotic cells, and b) a guide RNA that hybridizes to the target nucleic acid, wherein the guide RNA is a chimeric guide RNA comprising a CRISPR RNA (crRNA) portion fused to a trans activating crRNA (tracrRNA) portion, wherein the guide RNA comprises two guanines at its 5' end, and there are no additional nucleic acid residues between the two guanines at the 5' end and the crRNA portion of the guide RNA; whereby a site-specific, double stranded break at the target nucleic acid sequence is introduced.
2. The method of claim 1, wherein the nuclear localization signal is located at the C terminus of the Cas9 polypeptide.
3. The method of claim 1, wherein the eukaryotic cell is a mammalian cell.
4. The method of claim 3, wherein the mammalian cell is a human cell.
5. The method of claim 1, wherein the nucleic acid encoding the Cas 9 polypeptide is codon-optimized for expression in mammalian cells.
6. The method of claim 1, wherein the target nucleic acid sequence is a genomic sequence located at its endogenous site in the genome of the eukaryotic cell.
7. The method of claim 1, wherein the nucleic acid encoding the Cas9 polypeptide is a vector.
8. The method of claim 1, wherein the Cas9 polypeptide is a Streptococcus pyogenesCas9 polypeptide.
9. The method of claim 1, wherein the nucleic acid encoding the Cas9 polypeptide is introduced into the eukaryotic cell before introducing the guide RNA into the eukaryotic cell.
10. The method of claim 1, wherein the Cas9 polypeptide is a StreptococcusCas9 polypeptide.
October 5, 2021 – "Celebrate Hispanic Heritage Month" (Intellectual Property Owners Association Education Foundation) – 5:00 pm to 6:00 pm (ET).
October 5-21, 2021 – Hatch-Waxman and BPCIA Virtual Proficiency Series (American Conference Institute)
October 7, 2021 – "Green Technologies – Patenting Trends and Technology Development" (J A Kemp) – 16:00 BST (British Summer Time)
October 8, 2021 – "International IP Practice" (Center for Intellectual Property, Information & Privacy Law at the University of Illinois Chicago School of Law, the World Intellectual Property Organization, and Kuhnen & Wacker) – 7:15 am to 3:15 pm (CDT) on
November 9-10, 2021 – Paragraph IV Disputes Conference (American Conference Institute) – 8:00 am until 6:00 pm (EST) on November 9 and 7:50 am until 5:15 pm (EST) on November 10, 2021
The Intellectual Property Owners Association (IPO) Education Foundation will offer a webinar in the Behind the IDEA series to "Celebrate Hispanic Heritage Month," on October 5, 2021 from 5:00 pm to 6:00 pm (ET). The webinar, which is sponsored by IBM, will highlight Hispanic professionals who will share how their culture has impacted their career in innovation, STEM, or IP. Natalie Gonzales of Baker Botts will moderate a panel consisting of Victor Garcia of NVIDIA, Natalia Russi-Vigoya of IBM Corp., and Augusto Vega of IBM Corp.
There is no registration fee for the webinar. However, those interested in attending the webinar should register here.
J A Kemp will be offering a webinar entitled "Green Technologies – Patenting Trends and Technology Development" on October 7, 2021 at 16:00 BST (British Summer Time). Henry Hunt-Grubbe and Hermione Thompson of J A Kemp will look into the patenting trends in greentech, discuss examples of how technology developments have been made and patented, and discuss procedural aspects of greentech patenting. The webinar will address the following topics:
• An overview of what greentech is and patenting trends in greentech.
• Discuss examples of challenges faced with greentech development.
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By Kevin E. Noonan —
On June 11th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Responsive Preliminary Motion No. 1 in Interference No. 106,127 to be accorded benefit of priority to U.S. Patent Application No. 13/842,859, filed March 15, 2013, or in the alternative U.S. Patent Application No. 14/685,504, filed April 7, 2015, or U.S. Patent Application No. 15/138,604, filed April 26, 2016, pursuant to 37 C.F.R. §§ 41.121(a)(2) and 41.208(a)(3) and Standing Order ¶ 208.4.1. CVC filed this motion contingent on the Board granting Senior Party ToolGen's Substantive Preliminary Motion No. 2 to deny CVC priority benefit to U.S. Provisional Application No. 16/757,640, filed January 28, 2013 ("P3"). On July 15th, Toolgen filed its Opposition, and on August 27th CVC filed its Reply.
ToolGen's Substantive Preliminary Motion No. 2 challenged CVC's entitlement to priority benefit to the P3 provisional in this interference on the grounds that it did not disclose "successful cleavage of DNA within eukaryotic cells, nor does it otherwise show a constructive reduction to practice of an embodiment within Count 1." In its Responsive Motion, CVC sought to establish its entitlement to later-filed applications, to retain its best priority position against ToolGen (CVC itself has filed its Preliminary Motion No. 2 to deny ToolGen of the priority benefit to its earliest application, U.S. Provisional Application No. 16/717,324, filed October 23, 2012). In its Responsive Motion, CVC argued entitlement to the '859 application as a matter of law because it is the earliest application having an identical specification to CVC's applications-in-interference and CVC argues that it therefore is entitled to a presumption that this application provides a constructive reduction to practice thereby, citing Transco Prod. Inc. v. Performance Contracting, Inc., 38 F.3d 551, 556–57 (Fed. Cir. 1994). CVC's alternative priority claims were based on the common specification shared by all these applications, comprising "a string of continuation applications [that] thus provide[s] the same disclosure as the involved applications." CVC provided the following table of comparison evidence of what is disclosed in the specification of the '859 application with each element of the Count:
Specifically, CVC argued that Examples 4, 5, and 7 set forth a constructive reduction to practice of an embodiment falling within the scope of the Interference Count.
ToolGen disagreed, arguing in its Opposition that CVC failed to carry its burden of showing the constructive reduction to practice it alleged. As an initial matter, ToolGen cited CVC's argument that the disclosure in the three non-provisional applications here has been continuously disclosed in earlier provisional applications (U.S. Provisional Application No. 61/652,086, filed May 25, 2012 ("P1"), U.S. Provisional Application No. 61/716,256, filed October 19, 2012, ("P2"), and U.S. Provisional Application No. 61/757,640, filed January 28, 2013 ("P3"), priority to which CVC asked the Board to accord benefit in its Substantive Preliminary Motion No. 1 (opposed by ToolGen separately). ToolGen understandably repeated (in brief) its principal argument in that Opposition, that CVC had not shown that CRISPR-mediated DNA cleavage in eukaryotic cells would have been a matter of routine and predictable experimentation, based inter alia on the Board's decisions in Interference No 105,048 (and Federal Circuit affirmance thereof; Regents of Univ. of California v. Broad Inst., Inc., 903 F.3d 1286, 1291–92 (Fed. Cir. 2018)) and Interference No. 106,115 to the contrary. And ToolGen, as it has done in its own Preliminary Motion No. 2 to deny priority benefit, argued that the Board erred in granted CVC priority benefit to its P3 provisional application (U.S. Provisional Application No. 61/757,640, filed January 28, 2013) in the '115 Interference because it did not consider ToolGen's arguments that CVC had not satisfied the constructive reduction to practice requirement for this provisional (again, briefly recounting their earlier arguments here). ToolGen thus made its first argument on the backs of its earlier arguments with regard to the P1, P2, and P3 priority documents, because if CVC was not entitled to priority to them then the Board should not grant CVC priority benefit to the three non-provisional applications at issue here in the face of CVC's representations that the disclosure in Examples 4, 5, and 7 was the same in these non-provisional applications and the earlier-filed provisional applications. ToolGen supported these arguments by applying them to each of these Examples to illustrate what it considered to be their flaws that precluded CVC from entitlement to priority benefit.
CVC's Reply focuses on having the Board grant priority to the '859 application even if its claims for priority benefit to all the earlier applications have been denied. The basis for this claim is that the '859 application contains disclosures regarding eukaryotic CRISPR embodiments that appear in all the other, later-filed applications in this interference and thus CVC is entitled to priority benefit under 35 U.S.C. § 120 and precedent, citing Transco Prods. 6 Inc. v. Performance Contracting, Inc., 38 F.3d 551, 556 (Fed. Cir. 1994). CVC bootstraps ToolGen's failure to challenge specification support in later-filed applications (inter alia, its involved Application No. 15/981,807) as an admission that the disclosure in the '859 application is similarly sufficient, based on its assertion that the disclosures (at least with respect to Examples 4, 5, and 7) are the same, citing Dreyfus v. Lilienfeld, 49 F.2d 1062, 1064 (C.C.P.A. 1931), and Renz v. Jacob, 326 F.2d 792, 799 (C.C.P.A. 1964).
On the merits, CVC sets forth its case regarding what is disclosed in the '859 application as the basis for its priority claim. In doing so, CVC distinguishes the Board's basis for denying priority to earlier applications (specifically in the '048 and '115 Interferences) because it asserts that "the evidence supporting this motion involves additional disclosures, including at least the '859 application's Examples 4, 5, and 7, which were not at issue in the '048 or '115 interferences, as well as different expert testimony and a later state of the art, March 15, 2013—by which time numerous peer-reviewed publications had reported using sgRNA CRISPR-Cas9 in eukaryotic cells." CVC characterizes ToolGen's arguments are requiring actual (as opposed to constructive) reduction to practice, which is generally not required, citing Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006). Regardless, CVC argues that ToolGen is wrong in asserting any deficiencies in its disclosure of eukaryotic CRISPR falling within the scope of Count 1, which errors it then explicates in its brief.
Specifically, CVC argues that ToolGen is wrong at least with regard the human cell experiments set forth in Example 4 (and alleging that ToolGen's expert Dr. Tuchi agreed), enumerating the eight specific elements of the Count and where in the Example they were satisfied. CVC's brief faults ToolGen for applying an incorrect legal theory, specifically that the '859 application would need to provide "definitive evidence that CRISPR-Cas9 modulates transcription of at least one gene encoded by the target DNA molecule in eukaryotic cells" (emphasis in brief). CVC cites Faulkner and In re Borkowski, 422 F.2d 904, 908 (C.C.P.A. 1970), for the principle that there is no need to show specific working examples to satisfy constructive reduction to practice. CVC's brief faults ToolGen's expert witness for a variety of blunders in his analyses and consideration of the prior art (including positions CVC contends are contradicted by the '859 application), and accordingly urges that his testimony be given no weight. And CVC argues that reassertion of arguments regarding its P1-P3 provisional applications here against the '859 application are mere illustrations of the consistency of ToolGen's errors it makes in supporting its Opposition.
The focus of the parties' arguments is at the nexus of where a constructive reduction to practice in an unpredictable art meets the requirement that a skilled artisan would recognize by that disclosure that an inventor has possession of the disclosed invention, described in such a way that a person of ordinary skill in the art would be able to practice a claim throughout its full scope without undue experimentation. In an interference context these principles apply to an application receiving priority benefit adequately discloses at least one embodiment of an invention falling within the scope of the interference Count, which ultimately is what the Board will need to decide in determining the priority question regarding the '859 application.
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