Federal Circuit Affirms Alice Nix of Poll-Based Networking System
John Kong | August 10, 2023
Trinity Info Media v Covalent, Inc.
Decided: July 14, 2023
Before Stoll, Bryson and Cunningham.
Summary:
The Federal Circuit affirmed patent ineligibility of the Trinity’s poll-based networking system under Alice. The claims are directed to the abstract idea of matching based on questioning, something that a human can do. The additional features of a data processing system, computer system, web server, processor(s), memory, hand-held device, mobile phone, etc. are all generic components providing a technical environment for performing the abstract idea and do not detract from the focus of the claims being on the abstract idea. The specification also does not support a finding that the claims are directed to a technological improvement in computers, mobile phones, computer systems, etc.
Procedural History:
Trinity sued Covalent for infringing US Patent Nos. 9,087,321 and 10,936,685 in 2021. The district court granted Covalent’s 12(b)(6) motion to dismiss, concluding that the asserted claims are not patent eligible subject matter under 35 USC §101. Trinity appealed.
Decision:
Representative claim 1 from the ‘321 patent is as follows:
A poll-based networking system, comprising:
a data processing system having one or more processors and a memory, the memory being specifically encoded with instructions such that when executed, the instructions cause the one or more processors to perform operations of:
receiving user information from a user to generate a unique user profile for the user;
providing the user a first polling question, the first polling question having a finite set of answers and a unique identification;
receiving and storing a selected answer for the first polling question;
comparing the selected answer against the selected answers of other users, based on the unique identification, to generate a likelihood of match between the user and each of the other users; and
displaying to the user the user profiles of other users that have a likelihood of match within a predetermined threshold.
Representative claim 2 from the ‘685 patent is as follows:
A computer-implemented method for creating a poll-based network, the method comprising an act of causing one or more processors having an associated memory specifically encoded with computer executable instruction means to execute the instruction means to cause the one or more processors to collectively perform operations of:
receiving user information from a user to generate a unique user profile for the user;
providing the user one or more polling questions, the one or more polling ques-tions having a finite set of answers and a unique identification;
receiving and storing a selected answer for the one or more polling questions;
comparing the selected answer against the selected answers of other users, based on the unique identification, to generate a likelihood of match between the user and each of the other users;
causing to be displayed to the user other users, that have a likelihood of match within a predetermined threshold;
wherein one or more of the operations are carried out on a hand-held device; and
wherein two or more results based on the likelihood of match are displayed in a list reviewable by swiping from one result to another.
Looking at the claims first, the claimed functions of (1) receiving user information; (2) providing a polling question; (3) receiving and storing an answer; (4) comparing that answer to generate a “likelihood of match” with other users; and (5) displaying certain user profiles based on that likelihood are all merely collecting information, analyzing it, and displaying certain results which fall in the “familiar class of claims ‘directed to’ a patent ineligible concept,” which a human mind could perform. The court agreed with the district court’s finding that these claims are directed to an abstract idea of matching based on questioning.
The ‘685 patent adds the further function of reviewing matches using swiping and a handheld device. These features did not alter the court’s decision. The dependent claims also added other functional variations, such as performing matching based on gender, varying the number of questions asked, displaying other users’ answers, etc. These are all trivial variations that are themselves abstract ideas. The further recitation of the hand-held device, processors, web servers, database, and a “match aggregator” did not change the “focus” of the asserted claims. Instead, such generic computer components were merely limitations to a particular environment, which did not make the claims any less abstract for the Alice/Mayo Step 1.
With regard to software-based inventions, the Alice/Mayo Step 1 inquiry “often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool.” In addressing this, the court looks at the specification’s description of the “problem facing the inventor.” Here, the specification framed the inventor’s problem as how to improve existing polling systems, not how to improve computer technology. As such, the specification confirms that the invention is not directed to specific technological solutions, but rather, is directed to how to perform the abstract idea of matching based on progressive polling.
Under Alice/Mayo Step 2, the claimed use of general-purpose processors, match servers, unique identifications and/or a match aggregator is merely to implement the underlying abstract idea. The specification describes use of “conventional” processors, web servers, the Internet, etc. The court has “ruled many times” that “invocations of computers and networks that are not even arguably inventive are insufficient to pass the test of an inventive concept in the application of an abstract idea.” And, no inventive concept is found where claims merely recite “generic features” or “routine functions” to implement an underlying abstract idea.
Trinity’s Argument 1
Claim construction and fact discovery was necessary, but not done, before analyzing the asserted claims under §101.
Federal Circuit’s Response 1
“A patentee must do more than invoke a generic need for claim construction or discovery to avoid grant of a motion to dismiss under § 101. Instead, the patentee must propose a specific claim construction or identify specific facts that need development and explain why those circumstances must be resolved before the scope of the claims can be understood for § 101 purposes.”
Trinity’s Argument 2
Under Alice/Mayo Step One, the claims included an “advance over the prior art” because the prior art did not carry out matching on mobile phones, did not employ “multiple match servers” and did not employ “match aggregators.”
Federal Circuit’s Response 2
A claim to a “new” abstract idea is still an abstract idea.
Trinity’s Argument 3
Humans cannot mentally engage in the claimed process because humans could not perform “nanosecond comparisons” and aggregate “result values with huge numbers of polls and members” nor could humans select criteria using “servers, storage, identifiers, and/or thresholds.”
Federal Circuit’s Response 3
The asserted claims do not require “nanosecond comparisons” nor “huge numbers of polls and members.”
Trinity’s claims can be directed to an abstract idea even if the claims require generic computer components or require operations that a human cannot perform as quickly as a computer. Compare, for example, with Electric Power Group, where the court held the claims to be directed to an abstract idea even though a human could not detect events on an interconnected electric power grid in real time over a wide area and automatically analyze the events on that grid. Likewise, in ChargePoint (electric car charging network system), claims directed to enabling “communication over a network” were abstract ideas even though a human could not communicate over a computer network without the use of a computer.
Trinity’s Argument 4
Claims are eligible inventions directed to improvements to the functionality of a computer or to a network platform itself.
Federal Circuit’s Response 4
As described in the specification, mere generic computer components, e.g., a conventional computer system, server, web server, data processing system, processors, memory, mobile phones, mobile apps, are used. Such generic computer components merely provide a generic technical environment for performing an abstract idea. The specification does not describe the invention of swiping or improving on mobile phones. Indeed, the ‘685 patent describes the “advent of the internet and mobile phones” as allowing the establishment of a “plethora” or “mobile apps.” As such, “the specification does not support a finding that the claims are directed to a technological improvement in computer or mobile phone functionality.”
Trinity’s Argument 5
The district court failed to properly consider the comparison of selected answers against other uses “based on the unique identification” which was a “non-traditional design” that allowed for “rapid comparison and aggregation of result values even with large numbers of polls and members.”
Federal Circuit’s Response 5
Use of a “unique identifier” does not render an abstract idea any less abstract.
On the other hand, the “non-traditional design” appears to be based on use of an “in-memory, two-dimensional array” that “provides for linear speed across multiple match servers” and permits “an immediate comparison to determine if the user had the same answer to that of another user.” However, the asserted claims do not require any such in-memory, two-dimensional array.
Trinity’s Argument 6
The district court failed to properly consider the generation of a likelihood of a match “within a predetermined threshold.” Without this consideration, “there would be no limit or logic associated with the volume or type of results a user would receive.”
Federal Circuit’s Response 6
This merely addresses the kind of data analysis that the abstract idea of matching would include, namely how many answers should be the same before declaring a match. This does not change the focus of the claimed invention from the abstract idea of matching based on questioning.
Trinity’s Argument 7
There is an inventive concept under Alice/Mayo Step 2 because the claims recite steps performed in a “non-traditional system” that can “rapidly connect multiple users using progressive polling that compare[s] answers in real time based on their unique identification (ID) (and in the case of the ’685 patent employ swiping)” which “represents a significant advance over the art.”
Federal Circuit’s Response 7
These conclusory assertions are insufficient to demonstrate an inventive concept. “We disregard conclusory statements when evaluating a complaint under Rule 12(b)(6).”
Takeaways:
The evisceration of software-related inventions as abstract ideas continues. Although the court looks at the “claimed advance over the prior art” in assessing the “directed to” inquiry under Alice Step 1, conclusory assertions of advances over the prior art are insufficient to demonstrate inventive concept under Alice Step 2, at least for a 12(b)(6) motion to dismiss. It remains to be seen what type of description of an “advance over the prior art” would not be “conclusory” and satisfy the “significantly more” inquiry to be an inventive concept under Alice Step 2.
The one glimmer of hope for the patentee might have been the use of an “in-memory, two-dimensional array” that “provides for linear speed across multiple match servers.” An example of patent eligibility based on use of such logical structures can be found in Enfish. However, if the specification does not describe this use of an in-memory two-dimensional array and the “technological” improvement resulting therefrom to be the “focus” of the invention, even this feature might not be enough to survive § 101.
Claim Construction Should be Well-Grounded in Intrinsic Evidence
Bo Xiao | August 3, 2023
MEDYTOX, INC. v. GALDERMA S.A.
Decided: June 27, 2023
Before DYK, REYNA, and STARK, Circuit Judges.
Summary
The CAFC upheld a decision by the PTAB in a post-grant review involving a patent for a botulinum toxin treatment. The patent owner attempted to replace original claims with substitute claims was rejected by the Board, leading to the cancellation of the original claims and the finding that the substitute claims were unpatentable. The court affirmed the Board’s decision, emphasizing the challenges of amending claims in post-grant proceedings.
Background
Medytox owns U.S. Patent No. 10,143,728 (‘728 patent), issued in December 2018, which is directed to a method that uses an animal-protein-free botulinum toxin composition for cosmetic and non-cosmetic applications. Galderma filed a petition for post-grant review (PGR) proceedings at the PTAB to challenge the validity of ‘728 patent claims.
During the PGR proceedings, Medytox attempted to modify all 10 claims of its ‘728 patent and obtained initial feedback on proposed substitute claims under the PTAB’s amendment motion pilot program. The PTAB’s preliminary guidance revealed that Medytox did not meet the statutory requirements for submitting an amendment motion. However, the board acknowledged that the new phrase claiming “a responder rate at 16 weeks after the first treatment of 50% or greater” neither introduced new matter nor suggested a range of responder rates. Despite this, Galderma opposed Medytox’s substitute claims, arguing that the ‘728 patent’s specification only revealed responder rates up to 62% in clinical trials, whereas Medytox’s claim language encompassed a range of responder rates from 50% to 100%.
Contrary to its initial guidance, the PTAB issued a final written decision in the PGR proceedings, ruling that the substitute claims introduced new matter regarding to the responder rate limitation. Medytox asserted that the 50% responder rate was claimed as a minimum threshold and not a range. Nevertheless, the PTAB found the substitute claim language to be invalid for indefiniteness after reviewing the complete record, as “a skilled artisan would not have been able to achieve higher responder rates under the guidance provided in the specification without undue experimentation.” Ultimately, the Board cancelled the original claims 1-5 and 7-10 and also found that the substitute claims to be unpatentable.
Below, substitute claim 19 is provided as a representative of the substitute claims.
19. A method for treating glabellar lines
a conditionin a patient in need thereof, comprising:locally administering a first treatment of
therapeutically effective amount ofa botulinum toxin composition comprising a serotype A botulinum toxin in an amount pre-sent in about 20 units of MT10109L, a first stabilizer comprising a polysorbate, and at least one additional stabilizer, and that does not comprise an animal-derived product or recombinant human albumin;locally administering a second treatment of the botulinum toxin composition at a time interval after the first treatment;
wherein said time interval is the length of effect of the serotype A botulinum toxin composition as determined by physician’s live assessment at maximum frown;
wherein said botulinum toxin composition has a greater length of effect compared to about 20 units of BOTOX®, when
whereby the botulinum toxin composition exhibits a longer lasting effect in the patient when com-pared to treatment of the same condition with a botulinum toxin composition that contains an animal-derived product or recombinant human albumin dosed at a comparable amount andadministered in the same manner for the treatment of glabellar linesand to the same locations(s)as that of the botulinum toxin composition; andwherein said greater length of effect is determined by physician’s live assessment at maximum frown and requires a responder rate at 16 weeks after the first treatment of 50% or greater.
that does not comprise an animal-derived product or recombinant human albumin, wherein the condition is selected from the group consisting of glabellar lines, marionette lines, brow furrows, lateral canthal lines, and any combination thereof.
Discussion
The key issues in the case were the responder rate limitation and whether the substitute claims contained new matter not found in the patent specification. The responder rate limitation referred to the proportion of patients who responded favorably to the treatment with Medytox’s animal-protein-free botulinum toxin composition. In the appeal, Medytox contested the Board’s findings on claim construction, new matter, written description, and enablement, as well as the Board’s Pilot Program on amending practice and procedure under the Administrative Procedure Act.
The Board’s interpretation of the responder rate limitation as a range was the first issue addressed. Medytox argued that the responder rate limitation should be viewed as a binary (“yes-or-no”) inquiry, serving as a “threshold” for determining whether the animal protein-free composition has a more extended effect than BOTOX®.
According to Galderma, Medytox failed to cite intrinsic evidence supporting its suggested claim construction. Galderma also asserts that Medytox did not propose its “minimum threshold” interpretation of the responder rate limitation until after the Preliminary Guidance was released. Medytox did not substantively counter Galderma’s claim but instead insisted that extrinsic evidence supports their claim construction.
The court upheld the Board’s decision and noted that it is typically considered that intrinsic evidence, such as the specification and the prosecution history, is the most crucial consideration in a claim construction analysis. The court cited the U.S. Supreme Court’s recent landmark decision in Amgen v. Sanofi (2023) when nixing Medytox’s challenge to the PTAB’s lack of enablement determination. Under Amgen, “[t]he more one claims, the more one must enable,” and the court noted that data tables included with the ‘728 patent’s specification only disclosed responder rates of 52%, 61% and 62%. While the parties do not substantially dispute the responder rate limitation as a “threshold” or “range,” the Board’s construction of the responder rate limitation as a range in the substitute claims was ultimately affirmed.
Furthermore, the court concluded that the Board’s change in claim construction between its Preliminary Guidance and final written decision was not arbitrary and capricious and did not violate due process or the Administrative Procedure Act (APA). The court emphasized that the Board’s Preliminary Guidance, as indicated in its statement, is “initial, preliminary, [and] non-binding”, and only provides initial views on whether the patent owner has demonstrated a reasonable likelihood of meeting the requirements for filing an amendment motion. The court cited previous rulings which state that the Board must reevaluate matters based on the full record, especially when the standard changes, and that it is encouraged to modify its viewpoint if further development of the record necessitates such a change. Therefore, the Board’s decision to alter its claim construction for the responder rate limitation was not deemed arbitrary and capricious.
Takeaway
- The evolution of the record over the course of a proceeding can significantly impact the outcome, necessitating adjustments in views and decisions as the evidence develops.
- Arguments related to claim construction should be well-grounded in the intrinsic evidence, which includes the specification and the prosecution history, as these are typically the most important considerations in claim construction.
- Claims should be well-grounded in the specification.
UNEXPECTED RESULTS VERSUS UNEXPECTED MECHANISM
Stephen G. Adrian | July 28, 2023
In Re: John L Couvaras
Decided June 14, 2023
Before Lourie, Dyk and Stoll.
Summary
This precedential decision serves as a good lesson on what is necessary to overcome an obviousness rejection based on unexpected results. The applicant in this decision, however, failed to overcome the rejection due to arguing an unexpected mechanism instead of unexpected results.
Background
The applicant appeals a decision from the Patent Trial and Appeal Board (PTAB) affirming the Examiner’s rejection of the pending claims as obvious over prior art. Representative claim 11 recites:
11. A method of increasing prostacyclin release in systemic blood vessels of a human individual with essential hypertension to improve vasodilation, the method comprising the steps of:
providing a human individual expressing GABA-a receptors in systemic blood vessels due to essential hypertension;
providing a composition of a dosage of a GABA-a agonist and a dosage of an ARB combined into a deliverable form, the ARB being an Angiotensin II, type 1 receptor antagonist;
delivering the composition to the human individual’s circulatory system by co-administering the dosage of a GABA-a agonist and the dosage of the ARB to the human individual orally or via IV;
synergistically promoting increased release of prostacyclin by blockading angiotensin II in the human individual through the action of the dosage of the ARB to reduce GABA-a receptor inhibition due to angiotensin II presence during a period of time, and
activating the uninhibited GABA-a receptors through the action of the GABA-a agonist during the period of time; and
relaxing smooth muscle of the systemic blood vessels as a result of increased prostacyclin release. (emphasis added).
The applicant had conceded during prosecution that GABA-a agonists and ARBs had been known as essential hypertension treatments for many decades. The Examiner agreed and found that the claimed results (increased release of prostacyclin; activating the uninhibited GABA-a receptors; relaxing smooth muscle of the systemic blood vessels) were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.
On appeal to the PTAB, the applicant asserted that the prostacyclin increase was unexpected and that objective indicia had overcome any existing prima facie case of obviousness. The PTAB affirmed the rejection, holding that the claimed result of an increased prostacyclin release was inherent, and that the objective indicia arguments did not overcome the rejection because no evidence existed to support a finding of objective indicium.
Discussion
The PTAB’s legal determination is reviewed de novo, and the factual findings are reviewed for substantial evidence.
Couvaras asserts that (1) the Board erred in affirming that motivation to combine the art applied by the Examiner, (2) that the claimed mechanism of action was unexpected in that the Board erred in discounting its patentable weight by deeming it inherent, and (3) that the Board erred in weighing objective indicia of nonobviousness.
1. Motivation to Combine
As explained by the Examiner and affirmed by the Board, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” Couvaras asserted that the Board’s reasoning was too generic. However, it is undisputed that the antihypertensive agents recited in the claims existed and were known to treat hypertension.
Couvaras also asserted that even if there had been a motivation to combine, such motivation would fail to identify a finite number of identified, predicted solutions. The CAFC dismissed this argument because (1) it was made in a footnote and thus waived, (2) there was no evidence presented regarding a “substantial number of hypertension treatment agent classes”, and (3) the Board’s conclusion was supported by substantial evidence.
Regarding a reasonable expectation of success, Couvaras did not present any arguments against the Examiner’s findings when the rejection was appealed.
2. Unexpected Mechanism of Action
Couvaras contends that because the increased prostacyclin release was unexpected, it cannot be dismissed as having no patentable weight due to inherency, citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A.,865 F.3d 1348, 1355 (FED. Cir. 2017). This decision, however, held that unexpected properties may cause what may appear to be an obvious composition to be nonobvious, not that the unexpected mechanisms of action must be found to make the known use of known compounds nonobvious. As stated in the opinion:
We have previously held that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) (citation omitted); see also In re Huai-Hung Kao, 639 F.3d 1057, 1070–71 (Fed. Cir. 2011) (holding that a “food effect” was obvious because the effect was an inherent property of the composition). While mechanisms of action may not always meet the most rigid standards for inherency, they are still simply results that naturally flow from the administration of a given compound or mixture of compounds. Reciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected.”
3. Weighing objective indicia of nonobviousness
To establish unexpected results, Couvaras needed to show that the co-administration of a GABA-a agonist and an ARB provided an unexpected benefit, such as, e.g., better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages. The CAFC agreed with the Board that no such benefits have been shown, and therefore no evidence of unexpected results exists.
Takeaways
- Evidence needs to be presented to rebut a prima facie rejection. It seems that the applicant was attempting to assert that the combined use of the 2 agents provided unexpected results (better than what would be expected) based on synergy. As set forth in MPEP 716.02, greater than expected results are evidence of nonobviousness.
MPEP 716.02(a)
Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating “synergism”). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).
It seems that no evidence was presented to support the applicant’s argument of synergy. In reviewing the prosecution history, there were two interviews with the primary Examiner, one of which also included the Supervisory Examiner (SPE)[1]. In the interview summary, the Examiners indicated that the claims were too broad in that there were no amounts recited, no dose regime and/or no specific agents recited. It seems that a successful outcome could have been possible if evidence had been presented which was commensurate in scope with the claims.
- Once an Examiner establishes a prima facie rejection, the burden shifts to the applicant to prove otherwise.
[1] It is never a good idea to call on the SPE to attend an interview with a Primary Examiner. This not only angers a Primary Examiner but also the SPE.
THE MORE YOU CLAIM, THE MORE YOU MUST ENABLE
Andrew Melick | July 12, 2023
Amgen Inc. v. Sanofi
Decided: May 18, 2023
Supreme Court of the United States. Opinion by Justice Gorsuch
Summary:
Amgen owns patents covering antibodies that help reduce levels of low-density lipoprotein (LDL) cholesterol. Amgen sued Sanofi for infringement of its patents in district court. Sanofi raised the defense of invalidity for lack of enablement because while Amgen provided amino acid sequences for 26 antibodies, the claims cover potentially millions more undisclosed antibodies. The district court granted a motion for JMOL for invalidity due to lack of enablement, the CAFC affirmed, and the Supreme Court affirmed.
Details:
Amgen’s patents are to PCSK9 inhibitors. PCSK9 is a naturally occurring protein that binds to and degrades LDL receptors. PCSK9 causes problems due to degradation of LDL receptors because LDL receptors extract LDL cholesterol from the bloodstream. A method used to inhibit PCSK9 is to create antibodies that bind to a particular region of PCSK9 referred to as the “sweet spot” which is a sequence of 15 amino acids out of PCSK9’s 692 total amino acids. An antibody that binds to the sweet spot can prevent PCSK9 from binding to and degrading LDL receptors. Amgen developed a drug named REPATHA and Sanofi developed a drug named PRALUENT, both of which provide a distinct antibody with its own unique amino acid sequence. In 2011, Amgen and Sanofi received patents covering the antibody used in their respective drugs.
The patents at issue are U.S. Patent Nos. 8,829,165 and 8,859,741 issued in 2014 which relate back to Amgen’s 2011 patent. These patents are different from the 2011 patents in that they claim the entire genus of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to LDL receptors.” The relevant claims are provided:
Claims of the ‘165 patent:
1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
19. The isolated monoclonal antibody of claim 1 wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3.
29. A pharmaceutical composition comprising an isolated monoclonal antibody, wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO: 3 and blocks the binding of PCSK9 to LDLR by at least 80%.
Claims of the ‘741 patent:
1. An isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
2. The isolated monoclonal antibody of claim 1, wherein the isolated monoclonal antibody is a neutralizing antibody.
7. The isolated monoclonal antibody of claim 2, wherein the epitope is a functional epitope.
In its application, Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. Amgen provided two methods to make other antibodies that perform the described binding and blocking functions. Amgen refers to the first method as the “roadmap,” which provides instructions to:
(1) generate a range of antibodies in the lab; (2) test those antibodies to determine whether any bind to PCSK9; (3) test those antibodies that bind to PCSK9 to determine whether any bind to the sweet spot as described in the claims; and (4) test those antibodies that bind to the sweet spot as described in the claims to determine whether any block PCSK9 from binding to LDL receptors.
Amgen refers to the second method as “conservative substitution” which provides instructions to:
(1) start with an antibody known to perform the described functions; (2) replace select amino acids in the antibody with other amino acids known to have similar properties; and (3) test the resulting antibody to see if it also performs the described functions.
Amgen sued Sanofi for infringement of claims 19 and 29 of the ‘165 patent and claim 7 of the ‘741 patent. Sanofi raised the defense of invalidity because Amgen had not enabled a person skilled in the art to make and use all of the antibodies that perform the two functions Amgen described in the claims. Sanofi argued that Amgen’s claims cover potentially millions more undisclosed antibodies that perform the same two functions than the 26 antibodies identified in the patent.
The court provided an explanation of the law and policy regarding the enablement requirement. 35 U.S.C. § 112 requires that a specification include “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art … to make and use the same.” The court stated:
the law secures for the public its benefit of the patent bargain by ensuring that, upon the expiration of [the patent], the knowledge of the invention [i]nures to the people, who are thus enabled without restriction to practice it.
The court stated that “the specification must enable the full scope of the invention as defined by its claims.” Specifically, the court stated:
If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.
The court emphasized that the enablement requirement does not always require a description of how to make and use every single embodiment within a claimed class. A few examples may suffice if the specification also provides “some general quality … running through” the class. A specification may also not be inadequate just because it leaves a skilled artisan to engage in some measure of adaptation or testing, i.e., a specification may call for a reasonable amount of experimentation to make and use a patented invention. “What is reasonable in any case will depend on the nature of the invention and the underlying art.”
Regarding this case, the court stated that while the 26 exemplary antibodies provided by Amgen are enabled by the specification, the claims are much broader than the specific 26 antibodies. And even allowing for a reasonable degree of experimentation, Amgen has failed to enable the full scope of the claims.
The court stated that Amgen seeks to monopolize an entire class of things defined by their function and that this class includes a vast number of antibodies in addition to the 26 that Amgen has described by their amino acid sequences. “[T]he more a party claims, the broader the monopoly it demands, the more it must enable.”
Amgen argued that the claims are enabled because scientists can make and use every undisclosed but functional antibody if they simply follow Amgen’s “roadmap” or its proposal for “conservative substitution.” The court stated that these instructions amount to two research assignments and that they leave scientists “forced to engage in painstaking experimentation to see what works.” The court referred to Amgent’s two methods as “a hunting license.”
Comments
The key takeaway from this case is that the broader your claims are, the more your specification must enable. If it is difficult to show enablement for every embodiment claimed, then make sure your specification describes some general quality throughout the class or genus. A reasonable amount of experimentation is permissible for enablement, but reasonableness will depend on the nature of the invention and the underlying art.
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