Inventor declaration not related to what is claimed or discussed in the patent would not help the patent to survive from patent eligibility attack in the pleading stage
Sung-Hoon Kim | March 8, 2024
INTERNATIONAL BUSINESS MACHINES CORPORATION v. ZILLOW GROUP, INC., ZILLOW, INC.
Decided: January 9, 2024
Hughes (author), Prost, and Stoll
Summary:
The Federal Circuit affirmed the district court’s decision holding that the claims of two IBM’s patents are directed to patent ineligible subject matter under §101, and properly granting Zillow’s motion to dismiss under FRCP 12(b)(6).
Details:
IBM appealed a decision from the Western District of Washington, where the district court granted Zillow’s motion to dismiss under FRCP 12(b)(6). The district court held that all patent claims asserted against Zillow by IBM were directed to ineligible subject matter under 35 U.S.C. §101.
At issue in this appeal were IBM’s two patents – U.S. Patent Nos. 6,778,193 and 6,785,676.
The ’193 patent
The ’193 patent is directed to a “graphical user interface for a customer self-service system that performs resource search and selection.”
This patent is directed to improving how search results are displayed to a user by providing three visual workspaces: (1) a user begins by entering their search query into a “Context Selection Workspace”; (2) a user can further specify the details of their search in a “Detail Specification Workspace”; and (3) a user can view the results of their search in a “Results Display Workspace.”
Independent claim 1 is a representative claim:
1. A graphical user interface for a customer self service system that performs resource search and selection comprising:
a first visual workspace comprising entry field enabling entry of a query for a resource and, one or more selectable graphical user context elements, each element representing a context associated with the current user state and having context attributes and attribute values associated therewith;
a second visual workspace for visualizing the set of resources that the customer self service system has determined to match the user’s query, said system indicating a degree of fit of said determined resources with said query;
a third visual workspace for enabling said user to select and modify context attribute values to enable increased specificity and accuracy of a query’s search parameters, said third visual workspace further enabling said user to specify resource selection parameters and relevant resource evaluation criteria utilized by a search mechanism in said system, said degree of fit indication based on said user’s context, and said associated resource selection parameters and relevant resource evaluation criteria; and,
a mechanism enabling said user to navigate among said first, second and third visual workspaces to thereby identify and improve selection logic and response sets fitted to said query.
The ’676 patent
The ’676 patent is directed to enhancing how search results are displayed to users by disclosing a four-step process of annotating resource results obtained in a customer self service system that performs resource search and selection.”
Independent claim 14 is a representative claim:
14. A method for annotating resource results obtained in a customer self service system that performs resource search and selection, said method comprising the steps of:
a) receiving a resource response set of results obtained in response to a current user query;
b) receiving a user context vector associated with said current user query, said user context vector comprising data associating an interaction state with said user and including context that is a function of the user;
c) applying an ordering and annotation function for mapping the user context vector with the resource response set to generate an annotated response set having one or more annotations; and,
d) controlling the presentation of the resource response set to the user according to said annotations, wherein the ordering and annotation function is executed interactively at the time of each user query.
The District Court
Initially, IBM sued Zillow in the Western District of Washington for allegedly infringing five patents. The claims for two patents were dismissed, and Zillow filed a motion to dismiss under FRCP 12(b)(6) for the remaining three patents.
As for the ’676 patent, the district court found that the claims were merely directed to offering a user ‘the most beneficial and meaningful way’ to view the results of a query… and not advancing computer capabilities per se.”
The district court noted that four steps could be performed with a pen and paper, and that the claims were merely result-oriented.
Therefore, the district court found the asserted claims of the ’676 patent ineligible under §101.
As for the ’193 patent, the district court found that the claims were directed to the abstract idea of “more precisely tailoring the outcome of a query by guiding users (via icons, pull-down menus, dialogue boxes, and the like) to make choices about specific context variables, rather than requiring them to formulate and enter detailed search criteria.”
The district court did not find user context icons, separate workstations, and iterative navigation to be inventive concepts and held that they were well-understood, routine, or conventional at the time of the invention.
Therefore, the district court similarly found the asserted claims of the ’193 patent ineligible under §101.
The CAFC
The CAFC reviewed de novo.
As for the ’193 patent, the CAFC agreed with the district court that the claims do nothing more than improving a user’s experience while using a computer application.
Here, the CAFC noted that IBM failed to explain how the claims do anything more than identify, analyze, and present certain data to a user and that the claims did not disclose any technical improvement to how computer applications are used.
Furthermore, the CAFC agreed with the district court that IBM’s allegations of inventiveness “do[] not . . . concern the computer’s or graphical user interface’s capability or functionality, [but] relate[] merely to the user’s experience and satisfaction with the search process and results.”
Finally, the CAFC noted that the inventor declaration (“one of the key innovative aspects of the invention of the ’193 patent was not just the multiple visual workspaces alone, but how these various visual workspaces build upon each other and interact with each other,” as well as “the use of one visual workspace to affect the others in a closed-loop feedback system.”) did not cite the patent at all, and that neither the claims nor the specification include any such information. Therefore, the CAFC held that simply including allegations of inventiveness in a complaint with the inventor declaration did not make the complaint survive at the pleading stage.
Accordingly, the CAFC affirmed the district court’s decision holding that the ’193 patent is directed to ineligible subject matter under §101 and granting Zillow’s motion to dismiss as to the ’193 patent.
As for the ’676 patent, the CAFC agreed with the district court that the claims are directed to an abstract idea of displaying and organizing information because the representative claims use results-oriented language without mentioning any specific mechanism to perform the claimed steps.
In addition, the CAFC agreed with the district court that IBM failed to plausibly allege any inventive concept that would render the abstract claims patent-eligible.
IBM argued that the district court erred by failing to consider a supposed claim construction dispute regarding the term “user context vector”.
However, the CAFC noted that Zillow adapted IBM’s construction and did not propose an alternate construction. Therefore, the CAFC found that there was no claim construction dispute for the district court to resolve.
Accordingly, the CAFC affirmed the district court’s decision holding that the ’676 patent claimed ineligible subject matter under §101 and granting Zillow’s motion to dismiss as to the ’676 patent.
Dissenting opinion by Stoll
Stoll would vacate the district court’s holding of ineligibility of the claims of the ’676 patent because the majority, like the district court, did not meaningfully address IBM’s proposed construction of “user context vector.”
Takeaway:
- Conclusionary allegations of inventiveness in the inventor declaration would not help the patent to survive from patent eligibility attack in the pleading stage.
- The inventor declaration should be closely tied to the claims and the specification to help the patent to survive from patent eligibility attack.
Tags: 35 U.S.C. § 101 > declaration > Motion to Dismiss > patent eligible subject matter
The Twists and Turns of Claim Construction Issues in an IPR
John Kong | February 2, 2024
Parkervision v. Vidal
Decided: December 20, 2023
Summary:
Although patent owner ParkerVision’s claim construction was adopted in multiple district court litigations, it was not adopted by the PTAB in the IPR of the same patent. The Federal Circuit, reviewing claim construction de novo, affirmed the Board’s final decision. ParkerVision introduced the claim construction issue in its patent owner response, arguing that the claimed “storage element” should be construed as “an element of an energy transfer system that stores non-negligible amounts of energy from an input EM signal” and that the cited prior art did not teach the claimed “storage element” because its allegedly corresponding capacitors were not part of any energy transfer system. Intel filed a reply asserting that the interpretation of a “storage element” does not require it to be part of an energy transfer system. The Board and the Federal Circuit agreed. ParkerVision did not further argue in its patent owner response that the cited prior art’s capacitors failed the requirement that it store “non-negligible” amounts of energy from the input EM signal. ParkerVision included in its sur-reply that the cited prior art’s capacitors stored only a negligible amount of energy because “non-negligible” must be measured relative to the available energy of the input EM signal. The Board granted Intel’s motion to strike this part of ParkerVision’s sur-reply. The court affirmed, noting that there was no abuse of discretion when the Board refused to consider a new theory of patentability raised for the first time in a sur-reply.
Procedural History:
Intel petitioned for inter partes review (IPR) of claim 3 of Parkervision’s USP 7,110,444 (the ‘444 patent). There are related district court litigations involving the ‘444 patent and other related patents, which adopted a claim construction of a “storage element” aligned with Parkervision’s proposed claim construction. The Patent Trial and Appeal Board (the Board) adopted Intel’s claim construction of a “storage element” and issued a final decision that the ‘444 patent was obvious over cited prior art. Parkervision appealed. In issuing its final decision, the Board recognized that several district court cases involving the ‘444 patent adopted claim constructions inconsistent with Intel’s proposed construction. See, ParkerVision, Inc. v. Intel Corp., Nos. 6:20-cv-108-ADA, 6:20-cv-562-ADA (W.D. Tex.); ParkerVision, Inc. v. Hisense Co., Nos. 6:20-cv-870-ADA, 6:21-cv-562-ADA (W.D. Tex.); ParkerVision, Inc. v. TCL Indus. Holdings Co., No. 6:20-cv-945-ADA (W.D. Tex.); ParkerVision, Inc. v. LG Elecs. Inc., No. 6:21-cv-520-ADA (W.D. Tex.).
Decision:
Claim 3 of the ‘444 patent is as follows:
A wireless modem apparatus, comprising:
a receiver for frequency down-converting an input signal including,
a first frequency down-conversion module to down-convert the input signal, wherein said first frequency down-conversion module down-converts said input signal according to a first control signal and outputs a first down-converted signal;
a second frequency down-conversion module to down-convert said input signal, wherein said second frequency down-conversion module down-converts said input signal according to a second control signal and outputs a second down-converted signal; and
a subtractor module that subtracts said second down-converted signal from said first down-con-verted signal and outputs a down-converted signal;
wherein said first and said second frequency down-conversion modules each comprise a switch and a storage element.
The ‘444 patent relates to wireless local area networks (WLANs) that use frequency translation technology. In a two-device network using frequency translation, the first device receives a low-frequency baseband signal (audible voice signal) and up-converts it to a high-frequency electromagnetic (EM) signal before wireless transmission to the second device. The second device receives the EM signal, down-converts it back to a low-frequency baseband signal, and outputs an audible signal. The ‘444 patent is directed to down-converting EM signals using down-converter modules that include a switch and a storage element (also called a storage module).
The main issue in this case is the claim construction for a “storage element.”
ParkerVision contends that a “storage element” is an element of an energy transfer system that stores non-negligible amounts of energy from an input EM signal. A magistrate judge’s claim construction order in ParkerVision v. LG and a special master’s recommendation in ParkerVision v. Hisense and in ParkerVision v. TCL adopted ParkerVision’s proposed claim construction.
Intel contends that a “storage element” is “an element of a system that stores non-negligible amounts of energy from an input EM signal” – which does not require that the element be part of an energy transfer system. The Board adopted Intel’s claim construction. The Federal Circuit agreed. This is dispositive in the obviousness holding because ParkerVision’s patent owner response in the IPR focused exclusively on the prior art’s lack of an energy transfer system.
The ‘444 patent incorporated by reference USP 6,061,551 (the ‘551 patent) which provided the following disclosure critical to the meaning of a “storage element”:
1 FIG. 82A illustrates an exemplary energy transfer system 8202 for down-converting an input EM signal 8204. 2 The energy transfer system 8202 includes a switching module 8206 and a storage module illustrated as a storage capacitance 8208. 3 The terms storage module and storage capacitance, as used herein, are distinguishable from the terms holding module and holding capacitance, respectively. 4 Holding modules and holding capacitances, as used above, identify systems that store negligible amounts of energy from an under-sampled input EM signal with the intent of “holding” a voltage value. 5 Storage modules and storage capacitances, on the other hand, refer to systems that store non-negligible amounts of energy from an input EM signal.
(bracketed numbers identifying referenced sentences)
This is deemed “lexicographic” because “as used herein” in sentence #3 refers to the use of these terms (contained throughout the drawings and specification) in general, and not to specific embodiments, and “refer to” in sentence #5 links “storage modules” (parties agreed this is synonymous with “storage element”) to “systems that store non-negligible amounts of energy from an input EM signal.”
ParkerVision’s argued that the ‘551 paragraph was addressing examples in which storage modules are used in energy transfer systems in which holding modules, by contrast, are used in under-sampling systems. The court dismissed this because the comparative nature of the paragraph does not prevent it from being definitional. And, the court refused to incorporate an entire “energy transfer system” into the claim just because a single component (storage element) can be a part of such a system. The court also stated that the district court claim constructions by the magistrate judge and special masters do not alter its conclusion that the Board arrived at the correct construction.
Another, procedural, issue on appeal is whether (1) the Board erred in relying on Intel’s reply (raising this claim construction issue that “storage element” is not limited to being part of an “energy transfer system”) and (2) the Board erred in striking parts of ParkerVision’s sur-reply.
First, ParkerVision asserted that the Board erred in relying on Intel’s arguments allegedly raised for the first time in Intel’s reply. The presumed contention is that the Board deprived ParkerVision of its procedural rights under the Administrative Procedure Act (APA) and failed to comply with the USPTO’s rule that a reply “may only respond to arguments raised in the … patent owner response…” 37 C.F.R. § 42.23(b). The court reviews the Board’s compliance with the APA de novo, and the Board’s determination that a party violated USPTO rules for abuse of discretion. Under the APA, the Board must:
“timely inform[]” the patent owner of “the matters of fact and law asserted,” 5 U.S.C. § 554(b)(3), must provide “all interested parties opportunity for the submission and consideration of facts [and] arguments . . . [and] hearing and decision on notice,” id. § 554(c), and must allow “a party . . . to submit rebuttal evidence . . . as may be required for a full and true disclosure of the facts,” id. § 556(d).
Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1301 (Fed. Cir. 2016).
Neither petitioner nor patent owner expressly proposed any pre-institution claim construction. Post-institution, ParkerVision first proposed a new claim construction position in its patent owner response wherein “storage element” was construed as “an element of an energy transfer system that stores non-negligible amounts of energy from an input electromagnetic signal.” The APA required the Board to give Intel “adequate notice and an opportunity to respond under the new construction” proffered in ParkerVision’s patent owner response. As in Axonics, Inc. v. Medtronic, Inc., 75 F.4th 1374 (Fed. Cir. 2023), the court held that “where a patent owner in an IPR first proposes a claim construction in a patent owner response, a petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness under the new construction….” Id. at 1384. Intel did just that. Intel’s reply countered that ParkerVision’s non-obviousness position that the cited prior art did not disclose the claimed “storage element” because it was not in an energy transfer system is misplaced because that term is not restricted to be an element of an energy transfer system.
Pursuant to the APA, the Board may not change theories mid-stream without giving the parties reasonable notice of its change. The Board’s adopting of Intel’s claim construction did not “change theories midstream without giving the parties reasonable notice of its change.” “Once ParkerVision introduced a claim construction argument into the proceeding through its patent owner response, Intel was entitled in its reply to respond to that argument and explain why that construction should not be adopted.” And, ParkerVision had an opportunity to respond to Intel’s proposed construction by filing its sur-reply, which continued to press for its own claim construction.
However, with regard to patentability (non-obviousness), ParkerVision added in its sur-reply, for the first time, that the cited prior art’s capacitors stored only a negligible amount of energy because “non-negligible” must be measured relative to the available energy of the input EM signal. This part of ParkerVision’s sur-reply was stricken by the Board. ParkerVision’s patent owner response asserted that the cited prior art capacitors must store non-negligible amounts of energy, but did not assert that the reference failed to meet that requirement (instead, merely arguing the capacitors are not part of an energy transfer system). Accordingly, its sur-reply offered a new theory of patentability. There is no abuse of discretion in declining to consider a new theory of patentability raised for the first time in sur-reply.
ParkerVision further asserted that its sur-reply arguments addressed allegedly new arguments in Intel’s reply. But, the Board noted:
[I]f [ParkerVision] believed [Intel’s] Reply raised an issue that was inappropriate for a reply brief or that [ParkerVision] needed a greater opportunity to respond beyond that provided by our Rules (e.g., to include new argument and evidence in its Sur-reply), it was incumbent upon [ParkerVision] to contact [the Board] and request authorization for an exception to the Rules. [ParkerVision] did not do so. [ParkerVision] did not request that its Sur-reply be permitted to include arguments and evidence that would otherwise be impermissible in a sur-reply.
The court faulted ParkerVision for not availing itself of the available procedural mechanisms. For these reasons, the court found no abuse of discretion in the Board’s exclusion of part of ParkerVision’s sur-reply.
Takeaways:
The existence of district court claim construction positions do not guarantee the same claim constructions being adopted by the Board. And, the Federal Circuit reviews claim construction issues de novo.
For the patent owner’s sur-reply, be wary of potentially “new” patentability positions being advanced that were not originally raised in the patent owner response. If any such “new” patentability positions are taken, be cognizant of the procedural mechanism to contact the Board and request authorization for an exception to the Rules to include arguments and/or evidence that may otherwise be impermissible in a sur-reply.
Claim Construction Should Be Well-Grounded in Both Intrinsic and Extrinsic Evidence
Bo Xiao | January 15, 2024
ACTELION PHARMACEUTICALS LTD v. MYLAN PHARMACEUTICALS INC.
Decided: November 6, 2023
Before REYNA, STOLL, and STARK, Circuit Judges.
Summary
The Federal Circuit ruled that the patent claim term “a pH of 13 or higher” could not be interpreted solely based on the patent’s intrinsic evidence. The court remanded the case to the district court, instructing it to consider extrinsic evidence to determine the proper construction of this claim limitation.
Background
The case of Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc. involves a dispute over patent infringement related to epoprostenol, a drug used for treating hypertension. Actelion Pharmaceuticals, the patent holder, owns two patents of the drug: U.S. Patent Nos. 8318802 and 8598227. These patents disclose a pharmaceutical breakthrough in stabilizing epoprostenol using a high pH solution, which is otherwise unstable and difficult to handle in medical applications.
Mylan Pharmaceuticals, aiming to enter the market with a generic version of epoprostenol, filed an Abbreviated New Drug Application (ANDA). In this process, Mylan certified under Paragraph IV that the patents held by Actelion were either invalid or would not be infringed by Mylan’s manufacture, use, or sale of the generic drug. In response, Actelion asserted these patents against Mylan, claiming infringement.
The key issue in the dispute revolves around the interpretation of the phrase “a pH of 13 or higher” in the patent claims. This particular claim is crucial because the stability of epoprostenol is significantly impacted by the pH level of its solution. Actelion’s patents suggest that the epoprostenol bulk solutions should preferably have a pH adjusted to about 12.5 to 13.5 to achieve the desired stability. However, in the claims, Actelion’s patents only set the limitation as “a pH 13 or higher” as shown in claim 11 of the ’802 patent, a representative of the asserted claims:
11. A lyophilisate formed from a bulk solution comprising:
(a) epoprostenol or a salt thereof;
(b) arginine;
(c) sodium hydroxide; and
(d) water,
wherein the bulk solution has a pH of 13 or higher, and wherein said lyophilisate is capable of being reconstituted for intravenous administration with an intravenous fluid.
The dispute centered on the interpretation of the pH value specified in the patent claims. Actelion contended that the claim should encompass pH values that effectively round up to 13, including values like 12.5. Conversely, Mylan argued for a narrower interpretation, asserting that the claim should only cover pH values strictly at 13 or higher, thus excluding anything below this threshold, such as 12.5.
This interpretation was critical in determining whether Mylan’s generic version of epoprostenol would infringe upon Actelion’s patents. The district court initially adopted Actelion’s interpretation, which led to a stipulated judgment of infringement against Mylan.
Discussion
The Federal Circuit’s analysis began with a de novo review of the district court’s decision. The central question was whether the district court’s adoption of Actelion’s interpretation, which included pH values that could round up to 13 (such as 12.5), was appropriate. This broader interpretation affected the scope of the patent and the potential infringement by Mylan’s generic version of the drug. In scientific and technical contexts, the practice of rounding pH levels, such as rounding 12.5 to 13, depends on the specific requirements of the situation and the level of precision needed. pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution, and even small changes can represent significant differences in acidity or basicity.
Mylan Pharmaceuticals argued for a narrower interpretation of the term. They insisted that “a pH of 13” sets a definitive lower limit, suggesting that any pH value below 13, even those marginally lower like 12.995, would not fall within the scope of the patent. Mylan suggested that if a margin of error was considered necessary for a pH of 13, it should be minimal, encompassing a range only from 12.995 to 13.004. This interpretation was grounded in the belief that precision was implicit in the claim term, as the absence of approximation language like “about” in the claim suggested an exact value.
In contrast, Actelion Pharmaceuticals argued for a broader interpretation. They argued that the term should include values that round up to 13, thus potentially including values such as 12.5. Actelion’s argument was based on the principle that a numerical value in a patent claim includes rounding, dictated by the inventor’s selection of significant figures, unless the intrinsic record explicitly indicates a different intention. Actelion maintained that rounding was a common practice in scientific measurements and that the absence of specific approximation language did not necessarily dictate a precise value.
One of the key findings of the Federal Circuit was the inadequacy of intrinsic evidence to resolve the dispute conclusively. Intrinsic evidence, which includes the original patent claim language, specification, and prosecution history, is generally the primary resource for interpreting patent claims. However, in this case, these sources did not clearly define the precision of the pH value in question. The specification stated that, “the pH of the bulk solution is preferably adjusted to about 12.5-13.5, most preferably 13.” This language suggested that while the inventor recognized a preferred range (about 12.5-13.5), they specifically highlighted a most preferred value (13). The Federal Circuit also noted that the specification uses both “13” and “13.0” and various degrees of precision for pH values generally throughout the specification. Moreover, the prosecution history shows that the Examiner drew a distinction between the stability of a composition with a pH of 13 and that of 12. However, such distinction does not clarify the narrower issue of whether a pH of 13 could encompass values that round to 13, in particular 12.5.
The specifications and prosecution history left ambiguous whether the term referred exclusively to a pH of 13.0 or could include values that round up to 13. Recognizing this ambiguity, the Federal Circuit emphasized the need for extrinsic evidence to properly interpret the term. This approach is aligned with the Supreme Court’s guidance in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., which acknowledged the importance of considering such evidence in certain contexts of patent claim interpretation. The Federal Circuit decided to vacate the district court’s ruling and remand the case for further consideration of extrinsic evidence.
Takeaway
- Precise and specific wording in patent claims is crucial, especially in technical fields, as it defines the scope and protection of the invention.
- Although intrinsic evidence (claim language, specifications, and prosecution history) is primary in patent interpretation, it may not always be sufficient. In cases where intrinsic evidence is ambiguous or lacks clarity, extrinsic evidence such as expert testimonies, scientific literature, and other technical documents becomes crucial for a comprehensive understanding of the claim.
FUNCTIONAL CLAIMS REQUIRE MORE THAN JUST TRIAL-AND-ERROR INSTRUCTIONS FOR SATISFYING THE ENABLEMENT REQUIREMENT
Andrew Melick | January 5, 2024
Baxalta Inc. v. Genentech, Inc.
Decided: September 20, 2023
Moore, Clevenger and Chen. Opinion by Moore
Summary:
Baxalta sued Genentech alleging that Genentech’s Hemlibra product infringes US Patent No. 7,033,590 (the ‘590 patent). Genentech moved for summary judgment of invalidity of the claims for lack of enablement. The district court granted summary judgment of invalidity. Upon appeal to the CAFC, the CAFC affirmed invalidity for lack of enablement citing the recent Supreme Court case Amgen v. Sanofi.
Details:
Baxalta’s patent is to a treatment for Hemophilia A. Blood clots are formed by a series of enzymatic activations known as the coagulation cascade. In a step of the cascade, enzyme activated Factor VIII (Factor VIIIa) complexes with enzyme activated Factor IX (Factor IXa) to activate Factor X. Hemophilia A causes the activity of Factor VIII to be functionally absent which impedes the coagulation cascade and the body’s ability to form blood clots. Traditional treatment includes administering Factor VIII intravenously. But this treatment does not work for about 20-30% of patients.
The ‘590 patent provides an alternative treatment. The treatment includes antibodies that bind to Factor IX/IXa to increase the procoagulant activity of Factor IXa which allows Factor IXa to activate Factor X in the absence of Factor VIII/VIIIa. Claim 1 of the ‘590 patent is provided:
1. An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.
The ‘590 patent describes that the inventors performed four hybridoma fusion experiments using a prior art method. And using routine techniques, the inventors screened the candidate antibodies from the four fusion experiments to determine whether the antibodies bind to Factor IX/IXa and increase procoagulant activity as claimed. Only 1.6% of the thousands of screened antibodies increased the procoagulant activity of Factor IXa. The ‘590 patent discloses the amino acid sequences of eleven antibodies that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa.
Citing Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the CAFC stated that “the specification must enable the full scope of the invention as defined by its claims, allowing for a reasonable amount of experimentation. Citing additional cases, the CAFC stated “in other words, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.”
Baxalta argued that one of ordinary skill in the art can obtain the full scope of the claimed antibodies without undue experimentation because the patent describes the routine hybridoma-and-screening process. However, the CAFC stated that the facts of this case are indistinguishable from the Amgen case in which the patent at issue provided two methods for determining antibodies within the scope of the claims. In Amgen, the Supreme Court stated that the two disclosed methods were “little more than two research assignments,” and thus, the claims fail the enablement requirement.
The CAFC described the claims in this case as covering all antibodies that (1) bind to Factor IX/IXa; and (2) increase the procoagulant activity of Factor IXa, and that “there are millions of potential candidate antibodies.” The specification only discloses amino acid sequences for eleven antibodies within the scope of the claims. Regarding the method for obtaining the claimed antibodies, the specification describes the following steps:
(1) immunize mice with human Factor IX/IXa;
(2) form hybridomas from the antibody-secreting spleen cells of those mice;
(3) test those antibodies to determine whether they bind to Factor IX/IXa; and
(4) test those antibodies that bind to Factor IX/IXa to determine whether any increase procoagulant activity.
The CAFC stated that similar to Amgen, this process “simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the eleven antibodies they elected to disclose.”
The Supreme Court in Amgen also stated that the methods for determining antibodies within the scope of the claims might be sufficient to enable the claims if the specification discloses “a quality common to every functional embodiment.” However, no such common quality was found in the ‘590 patent that would allow a skilled artisan to predict which antibodies will perform the claimed functions. Thus, the CAFC concluded that the disclosed instructions for obtaining claimed antibodies, without more, “is not enough to enable the broad functional genus claims at issue here.”
Baxalta further argued that its process disclosed in the ‘590 patent does not require trial-and-error because the process predictably and reliably generates new claimed antibodies every time it is performed. The CAFC stated that even if a skilled artisan will generate at least one claimed antibody each time they follow the disclosed process, “this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen.” “Under Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).”
Baxalta also argued that the district court’s enablement determination is inconsistent with In re Wands. The CAFC disagreed stating that the facts of this case are more analogous to the facts in Amgen, and the Amgen case did not disturb prior enablement case law including In re Wands and its factors.
Comments
When claiming a product functionally, make sure your specification includes something more than just trial-and-error instructions. The CAFC suggested in this case that the enablement requirement may be satisfied if the patent discloses a common structural or other feature delineating products that satisfy the claims from products that will not. The CAFC also suggested that a description about why the actual disclosed products perform the claimed functions or why other products do not perform the claimed function would be helpful for satisfying the enablement requirement.
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