Univ. of S. Fla. Bd. of Trustees v. United States and the Federal Government’s Nonexclusive License under the Bayh-Dole Act

The patent

The patent at issue in Univ. of S. Fla. is now-expired U.S. Patent No. 5,898,094 (the ’094 patent), which was issued on April 27, 1999. The ’094 patent describes and claims doubly transgenic mice with accelerated pathology for Alzheimer’s disease, produced by the mouse’s expression of both a mutant Swedish amyloid precursor protein transgene and a mutant presenilin transgene. The transgenic mouse of the invention develops an identified symptom of Alzheimer’s disease, i.e., amyloid plaque formation, on an accelerated basis, rendering it a highly useful tool in the research of Alzheimer’s and other neurodegenerative disorders.

In Univ. of S. Fla. the parties stipulated to the infringement of Claims 7 and 8 of the patent. Representative Claim 7 recites:

The application that was issued as the ’094 patent was filed on July 30, 1997, and claims priority to a provisional application filed on October 21, 1996. Drs. Karen Duff and John Hardy are the inventors named on the ’094 patent. In October 1996, just before the filing of the provisional application, the two inventors assigned to the USF the patent rights for inventions described in that provisional application.

According to USF, before the patent was issued USF successfully licensed the ‘094 patent to two different types of licensees—large pharmaceutical companies at a uniform price of $400,000 per license and smaller researchers such as universities who paid the cost of the research desired, including the cost of maintenance by USF of the mice in question, to which research cost was added a license fee equaling 12% of the cost of work. ²⁴ USF also states that counterparts of the ‘094 patent were issued “around the world.”

Background

The claimed invention was conceived by Drs. Duff and Hardy while both were professors employed by USF. At USF, Drs. Duff and Hardy worked with Dr. David Morgan and Dr. Marcia Gordon, both of whom were also professors at USF. The latter two scientists conducted the tissue analysis required to determine when in their aging process mice harboring the two recited transgenes developed the recited symptom of Alzheimer’s disease.

The first litter of mice expressing both of the two transgenes at issue—a mutant Swedish amyloid precursor protein transgene and a mutant presenilin transgene—was born at USF on August 21, 1996. But time was needed to determine if those mice would actually develop Alzheimer’s disease pathology at an accelerated rate. During that period of mouse aging, Dr. Hardy changed his employer from USF to Mayo, and Dr. Duff did the same, in December 1996, shortly after Dr. Hardy. The doubly transgenic mice remained at USF after Drs. Duff and Hardy moved to Mayo. While at Mayo, Dr. Duff continued to oversee the doubly transgenic mouse project. The day-to-day work of caring for the mice, however, became the responsibility of Dr. Gordon in Dr. Morgan's laboratory. In addition, Dr. Gordon, at her USF lab, performed immunohistochemistry (i.e., tissue examination) work on the brains of sacrificed doubly transgenic mice to identify whether and when the mice developed Alzheimer’s disease pathology.

An actual reduction to the practice of the claimed invention required the construction of an embodiment and recognition that the embodiment worked for its intended purpose. ²⁵ Here, the first document recording the actual reduction to practice of the doubly transgenic mice—the fact and recognition of the sooner-than-otherwise development of the specified Alzheimer’s disease pathology in those mice—was a facsimile sent on April 25, 1997, by Dr. Duff, then at Mayo, to William Coppola, at USF’s office for technology transfer. It was undisputed that the first actual reduction to practice occurred in April 1997, shortly before that promptly sent communication.

Dr. Duff marked the facsimile “urgent” because “[t]his was the first time we [the researchers] had seen … this pathology developing so rapidly in these mice.” To show the pathology developing, the facsimile included two figures demonstrating that the doubly transgenic mice had amyloid plaques, which play a role in Alzheimer’s disease, at an age lower than the age at which previously identified mice had such plaques. Dr. Duff noted on the figures in the facsimile: “N.B. [nota bene] work performed by D[avid] Morgan at USF, in collaboration.” ²⁶ The tissue analysis (immunohistochemistry testing) that identified the premature development of amyloid plaques was performed within the Morgan-Gordon laboratory at USF. In its brief, USF acknowledged that the mice were raised at USF and that the staining and characterization of the tissues was accomplished by USF personnel in a USF laboratory, but characterized the tissue staining techniques employed as “then-conventional.” The university also asserted that there was no evidence suggesting that anyone at USF did any work of any sort on the mice of the ‘094 Patent after the Grant award in October of 1996, other than the tissue staining.

In January 1998, Dr. Duff, along with Dr. Hardy, Dr. Morgan, Dr. Gordon, and others, published an article in the journal Nature Medicine describing the doubly transgenic mice and their accelerated development of the Alzheimer’s disease-related phenotype. ²⁷ The article notes that “[t]his work was supported by the Mayo/USF Program Project on the presenilins,” citing, though with a typographical error, the government grant described below.

The NIH grant

In September 1995, Dr. Hardy, while still employed by USF, submitted a grant application to the National Institute of Aging, one of the institutes within the NIH. The application, titled “The Role of the Presenilins in Alzheimer's Disease,” proposed five related projects aimed at elucidating the role of the presenilins in Alzheimer’s disease. The grant application identified Dr. Hardy, Dr. Duff, Dr. Morgan, and Dr. Gordon, then all employed by USF, as key personnel on the project. The proposed period of government support ran from July 1, 1996, to June 30, 2001.

The scientists’ already-begun research continued during the year that consideration of the grant application was underway. Just as the 1996 fiscal year was ending, NIH awarded the applied-for grant, which had a project start date of September 30, 1996. The Federal Circuit concluded that the project covered by the grant included the specific doubly transgenic mice that were the subject of what was to become the ’094 patent. Just before the award was made, the grantee designated in the application was changed from USF to Mayo, to which Dr. Hardy was in the process of switching his employment. The grant, therefore, was made to Mayo, and funds from the NIH grant were available to Mayo as of October 1, 1996.

Because Mayo was the grantee, but some grant-covered work was to take place at USF, government policies implementing the Bayh-Dole Act, as set forth in NIH Guidelines, required that Mayo and USF would in due course enter into a subcontract with each other in order for grant money received by Mayo to be paid to USF for the grant-covered work of individuals remaining there, such as Drs. Morgan and Gordon. ²⁸ In November 1997, more than a year after the NIH grant was awarded, Mayo and USF executed a written subcontract, i.e., a “Consortium Agreement,” which states that the agreement was executed to comply with the NIH guidelines, The November 1997 agreement states that the start of its “effective period”—when its obligations took effect—was September 1, 1997. It expressly provides for the treatment of patents and inventions in accordance with the Bayh-Dole Act [and implementing regulations, 45C.F.R. chs. VI, VIII (1997)], thus supplying USF's agreement to the Act’s § 201(c) government-license provision.

The lawsuit

Shortly after the issuance of the ‘094 patent in 1999, The Jackson Laboratory (“Jackson”), with the support of the Government, began making and selling mice encompassed by Claims 7 and 8 of the ‘094 patent. ²⁹ Although the government characterizes Jackson as a “nonprofit biomedical research facility located in Bar Harbor, Maine,” in its brief USF characterizes Jackson as a “private company.” According to the government’s brief, the Jackson research facility includes a mouse and services business with a little over 13,000 strains of mice that Jackson makes available to the biomedical community. Jackson also participates in the Mutant Mouse Resource and Research Center (MMRRC) established by the NIH in 1999. The MMRRC is a consortium of nonprofit entities created to facilitate the availability of their mice to the entire nonprofit research community.

In June 2011, NIH granted a retroactive “authorization and consent” in a letter to Jackson based on Government contracts in favor of Jackson dating back to 1993, pursuant to 28 U.S.C. § 1498(a). The letter authorized and consented to Jackson’s practice of the patented invention, for the purposes of its activities in breeding and distributing certain strains of mice useful in Alzheimer’s research through the MMRRC.

In 2015, USF sued the United States in the Court of Federal Claims (the “Claims Court”) under 28 U.S.C. § 1498(a), alleging that the United States was liable for infringement of the ’094 patent because Jackson, with the government’s authorization and consent, had been producing and using mice covered by the patent. As a defense, the government argued that the United States had a license under § 202(c)(4) to have Jackson practice the patent by creating and using patent-covered mice (with the two transgenes and accelerated plaque development required by the ’094 patent). It was undisputed that Jackson was practicing the patent, and it was doing so for the government and with the government’s authorization and consent. After summary-judgment proceedings and a trial, the Claims Court agreed with the government and entered a final judgment of noninfringement. ³⁰

In explaining its conclusion, the Claims Court pointed to documents indicating that USF set up internal accounts associated with the NIH grant project and expected money from that grant to partially fund at least Dr. Gordon’s salary. Relatedly, the Claims Court recited testimony from Dr. Morgan and Dr. Gordon about when USF actually received grant money, which included testimony about the difficulty of recalling precisely what occurred two decades earlier and testimony about the system of USF underwriting salary and other expenses and getting reimbursed for the advance once grant money covering the earlier work eventually arrived. ³¹

Critically, the Claims Court found that Mayo paid for the work done by Dr. Gordon at USF with the NIH grant funds, including the April 1997 immunohistochemistry work whereby the invention was actually reduced to practice, though not necessarily at the time of the work or, before Mayo and USF entering into the formal contract later that year.

The Claims Court’s based its decision on an implied-in-fact contract, concluding that “beginning in October 1996, [USF] operated [in the relevant work on the invention] pursuant to an implied contract with the Mayo Clinic for grant funds under the” NIH grant. The Claims Court found that the evidence established an implied-in-fact contract (a meeting of the minds inferred from the surrounding circumstances), stating: “Regardless of whether [USF] underwrote those funds for a time before money flowed from the Mayo Clinic, it is clear in the record that [USF] had a ‘tacit understanding’ with Mayo that the funds would eventually arrive.”

Based on its findings, the Claims Court determined that USF was a “contractor” having an implied-in-fact subcontract that constituted a “funding agreement”; the invention was an “invention of the contractor,” given the assignment to USF; and the invention was a “subject invention” in that it was “first actually reduced to practice” in April 1997 “in the performance of” the funding agreement. The government therefore had a license under § 202(c)(4) to practice the ’094 patent, or have the patent practiced for or on behalf of it by Jackson.

On appeal, USF identified the following issues for review by the Federal Circuit:

Whether the CFC erred in finding: (1) that any money from Mayo’s Grant was paid to USF at any time for any purpose before November 8, 1997—well after the reduction to practice of the invention of the ‘094 patent; and (2) that any money from Mayo’s grant was paid for any purpose connected to or in support of any work related to the ‘094 patent.

On appeal, the Federal Circuit sidestepped USF’s Issues 2 and 3 by concluding that it was not necessary to establish the existence of an implied-in-fact agreement and that the express agreement the government and Jackson entered into in November 1997 sufficed. As to Issue 1, the court found that (1) the timing of the payment to USF did not control, and (2) the work that was paid for with Mayo’s grant was used in actually reducing the invention to practice.

On appeal, the Federal Circuit treated the following as established facts: (1) the April 1997 work that first actually reduced the ’094 patent invention to practice was covered by the NIH grant; (2) Mayo and USF entered into an express subcontract in November 1997 whereby Mayo would pay USF money received from NIH under the grant for work covered by the grant; and (3) USF in fact accepted payment from Mayo, using funds from the NIH grant, for the April 1997 work at issue.

USF argued that USF did not receive such payment from Mayo at the time of the April 1997 work, or at any time before Mayo and USF entered into the express subcontract in November 1997. The government disputed this, but the Federal Circuit concluded that it was unnecessary to resolve the dispute, and accepted, for purposes of this appeal, USF’s assertion that it had received NIH money from Mayo—including money for the April 1997 work—when the November 1997 express subcontract was in place and not earlier.

The Federal Circuit explained that USF’s argument for reversal of the Claims Court’s judgment relied on two necessary premises: (1) that any “funding agreement” adequate to trigger § 202(c)(4) must be in place at the time of the relevant work (here, a first actual reduction to practice in April 1997), so that the November 1997 subcontract (whose execution and effective date were later than April 1997) did not trigger § 202(c)(4); and (2) that there was no legally adequate implied agreement at the time of the April 1997 work (indeed, at all), and the Claims Court’s contrary determination must be reversed.

The court then concluded that the first of USF's premises was legally incorrect because in fact the November 1997 subcontract was adequate to give the government a § 202(c)(4) license. In particular, the April 1997 work, i.e., the first actual reduction to practice, was “in the performance of work under a funding agreement,” i.e., a subcontract between Mayo and USF to the NIH grant (the latter a funding agreement of NIH with Mayo)

The Federal Circuit held that the relevant terms of the Bayh-Dole Act were broad enough to cover the facts of this case. In particular, the court found that the November 1997 agreement between Mayo and USF was a “funding agreement” pursuant to § 201(b), which defines a funding agreement as “any contract, grant, or cooperative agreement entered into between any Federal agency … and any contractor for the performance of experimental, developmental, or research work funded in whole or in part by the Federal Government. Such term includes any … subcontract of any type.” ³² The original NIH grant awarded to Mayo was itself a funding agreement because it was a grant entered into between NIH and Mayo for the performance of experimental, developmental, or research work funded in whole or in part by the federal government. The November 1997 agreement, then, was also a funding agreement because it was an express “subcontract” entered into for the performance of experimental, developmental, or research work under the 1996 NIH grant.

The court found that the work of tissue analysis (a necessary component of the first actual reduction to practice in April 1997) was covered by the 1996 NIH grant. The November 1997 agreement signed by USF and Mayo did not limit the scope of the NIH grant, and the April 1997 work was in the performance of work under both of those funding agreements since both provided money to pay for it.

USF argued that the November 1997 agreement is legally insufficient, even if it provided funds to pay for the pre-agreement, April 1997 work, because it was entered into in November 1997 and had an effective date in September 1997, after the April 1997 work. But the court rejected this purported temporal limitation on the scope of the relevant Bayh-Dole Act language, pointing out that under the language of § 201(b) a “funding agreement” includes “any … subcontract of any type” for the performance of work under a funding agreement. The court found that this “breadth-indicating language” supported inclusion within the provision of a subcontract that provides for, among other things, payment for work already performed before the subcontract is executed or its “effective” date. The court found it to be well-established that a contract may provide for payment for work previously done at least where, as here, the contract also pays for work yet to be done. ³³ The court further found that Mayo could not properly pay for that work with the NIH grant funds outside a subcontract, as Mayo was obligated under the statute, as implemented by NIH guidelines, to enter into subcontracts for funded work with its consortium partners.

The November 1997 agreement states that the “effective period of this Agreement shall be from September 1, 1997, through August 31, 1998, unless otherwise provided for by modification in this Agreement.” The court found that the start of the “effective period” on September 1, 1997—for a one-year period to align with NIH's designation of the second year of the NIH grant—did not exclude the April 1997 work from being under the formal agreement, in that it was part of what Mayo undertook to pay for, and did pay for with the NIH grant funds through the formal contract.

The court states that its interpretation of the language of the Bayh-Dole Act, which embraces such past-work funding, fits the statutory context. For one thing, it respects, rather than overrides, the patent owner's choice as to whether to enter into a subcontract and on what terms, including what work will be paid for under it. It also reflects the stated statutory policy to “ensure that the Government obtains sufficient rights in federally supported inventions,” ³⁴ when the patent owner accepts federal funds under an agreement that invokes the Act.

The court went on to find that its interpretation of the statute was strongly bolstered by the record in this case, which suggests that what occurred in this case was not uncommon in government-funded research conducted in part by non-grantee members of a consortium called for in a government grant. Specifically, subcontracts are commonly not executed until sometime after the grant is awarded, yet the grant-covered work proceeds without waiting for the formal signing of a subcontract. The court opined that if USF’s time-restrictive view of Bayh-Dole were adopted, one or more policies of the Act might be impaired—e.g., by the government insisting, in order to protect its rights, that research by a consortium member be postponed until a subcontract was executed. The court’s interpretation of the statute avoids such impairment by focusing on the facts of agreement, coverage, and actual funding, whether forward-looking or backward-looking.

The court further noted that several witnesses had testified, without contradiction, that it was common for there to be a delay in subcontracting after the award of a government grant. Other aspects of the record—e.g., the absence in the record of any written subcontract for more than a year after the NIH grant award, Dr. Morgan’s own uncertainty about when money actually flowed from Mayo to USF, the evident expectation by USF that it would receive grant funds—tended to confirm that, in practice, grantees and their consortium institutions often do not place high priority on speedily getting a formal subcontract executed after a grant is awarded.

Expanding upon the policy considerations at play, the court found it to be of great significance for the advancement of useful knowledge that research continue without interruption, suggesting that all persons concerned, including the government, would expect the grant-covered work to proceed immediately upon award of the grant, without awaiting a formal subcontract. Notably, in this particular case, it was clear from the outset of the NIH grant project that the USF work that was part of it would have to proceed without delay. The first litter of the doubly transgenic mice was born in August 1996, just before the late-September NIH award. The responsibility for the colony remained at USF, even after Dr. Duff moved to Mayo in December. The court noted that Dr. Gordon and her USF colleagues could not have waited to complete the work of caring for the mice, and the immunohistochemistry work on the brains of sacrificed mice in the colony to identify the development of Alzheimer’s disease pathology was highly time sensitive. A core objective of the work was to determine the timing of such development, and the immunohistochemistry testing therefore had to begin, and it did begin, no more than a few months after the birth of the mice. Such immediate performance of the work, beyond being necessary as a scientific matter, was also important for grant administration, as NIH had to decide each year whether to renew the funding of the grant, requiring an evaluation of progress in the project.

Actual reduction to practice

The outcome in this case was dictated in part by the courts’ conclusion that an actual reduction of practice occurred when the immunohistochemistry work was done at USF, and the inventors were informed of the results, and appreciated their significance, in April 1987. This is because the nonexclusive license to the government mandated by Bayh-Dole is triggered by either of two events, conception of the invention or its actual reduction to practice. If the birth of the first litter of mice expressing both of the two transgenes recited in the claims in August 2016 was deemed to constitute actual reduction practice, it would not have triggered the nonexclusive license, assuming that the work leading up to this event was not paid for by Mayo using money from the grant. The same would apply with respect to the conception of the invention, which must have occurred before August 2016.

Of course, it seems quite possible that the conception of the invention and the creation of the transgenic mice (as opposed to the immunohistochemistry work confirming the phenotype) was paid for, at least in part, with an NIH grant or some other form of federal funding, which would have presumably served as an independent basis for the nonexclusive government license. The inventors were professors at USF at the time, and it seems unlikely their work was not being funded by the federal government. However, that issue did not appear to come up in this litigation and was unnecessary to arrive at the ultimate conclusion that Jackson’s use of the patented technology was covered by the government’s nonexclusive license.

In its brief to the Federal Circuit, USF concedes that actual reduction to practice occurred in April 1997, but characterized the immunohistochemistry work as “conventional” or “then-conventional,” and thus not requiring any “inventive work from USF’s (Morgan’s) laboratory.” ³⁵ But to my knowledge, while the use of conventional technology in an invention can be relevant in the context of obviousness and patent eligibility, it does not have any bearing on the question of actual reduction to practice, and the court does not address the issue. The issue here is whether the tissue staining was necessary to confirm that the invention worked for its intended purpose, not whether the technology used in the confirmation is conventional.

Before the America Invents Act of 2011(AIA), the term “reduction to practice” appeared in Section 102(g) of the Patent Act, and the concept played an important role in the context of priority and patentability. The AIA shifted away from the pre-AIA’s focus on the date of invention in the determination of priority and patentability, and the AIA version of the Patent Act appears to only use the term once, in Section 201(g), where it is used in defining the term “made” for purposes of the Bayh-Dole Act.

As illustrated by the case at hand, the concept of actual reduction to practice will remain relevant post-AIA. Contracts, employment relations law, and other statutes may make ownership of an invention depend on when it was made, which, in turn, may depend on reduction to practice as a completion of an invention. Furthermore, Section AIA 102 retains the “public use” and “on sale” bars, and in Pfaff the Supreme Court identified reduction to practice as an indicator that an invention is “ready for patenting” and thus complete enough to trigger an “on sale” bar if it is combined with a commercial offer. ³⁶

The precedent has clearly established that actual reduction to practice occurs when the inventor (1) constructs a product or performs a process that is within the scope of the patent claims, and (2) demonstrates the capacity of the invention to achieve its intended purpose. ³⁷ Although testing is not always necessary, particularly when the operability of the invention is apparent upon its construction, the Federal Circuit has held that “when testing is necessary to establish utility, there must be recognition and appreciation that the tests were successful for reduction to practice to occur.” ³⁸ In some cases, a noninventor’s recognition of the utility of an invention can inure to the benefit of the inventor. ³⁹ Whether an invention has been reduced to practice is a question of law based on underlying facts, which the Federal Circuit reviews de novo. ⁴⁰

In his treatise, Professor Chisum observes:

Given the AIA’s elimination of priority contests, i.e., patent interferences, implicit in Professor Chisum’s observation is a suggestion that perhaps the requirement that the inventor establish that an invention works for its intended purpose rests on shaky policy grounds, and should be revisited, particularly given that utility can be established by testing after constructive reduction to practice, i.e., a patent application has been filed.

Note that the utility that must be demonstrated in order to satisfy the requirement for actual reduction to practice is dictated by the “intended purpose” of the claimed invention. In the case at hand, it was assumed that the intended purpose of the invention was to provide not only a mouse expressing the two transgenes but also showing the phenotype of amyloid plaque deposition associated with Alzheimer’s disease. Indeed, the patent claims at issue (Claims 7 and 8) explicitly recite “wherein the mouse expresses the transgenes such that the accelerated pathology develop accelerated deposition of Aβ in its brain as compared to non-transgenic mice or mice expressing either transgene.” However, this begs the question of whether USF could have avoided including this limitation in the claims, in which case the claims would simply recite transgenic mice comprising the two recited transgenes. If the claim served to define the intended purpose of the invention, then actual reduction to practice could have occurred as early as August 2016 with the birth of the first litter of mice expressing the two transgenes. It would seem that the presence and expression of the transgenes in the mice could have been shown as soon as the mice were born, rather than having to wait months until amyloid plaque formation was apparent. Moreover, if the actual reduction to practice had occurred in August 2016, as mentioned above, it would not appear to have been funded by the granted issue in the case, although it might have been the case that the work was funded by another federal grant.

There are examples of patent claims that have been issued that recite a transgenic mous, useful for Alzheimer’s research, without explicitly reciting a phenotype indicative of the disease. For example, Claim 1 of U.S. Patent No. 8,283,517 recites:

Claim 1 of U.S. Patent No. 9,462,793 recites:

But it is not unusual for patent claims in this area to recite an Alzheimer’s associated phenotype:

For example, Claim 1 of U.S. Patent No. 9,161,520 recites:

Claim 1 of U.S. Patent No. 7,745,688 recites:

In a 2019 Federal Circuit decision, Barry v. Medtronic, Inc., ⁴² a majority and dissent expressed conflicting views regarding the relationship between an invention’s “intended purpose” and the patent claims and specification. In particular, the majority held that the intended purpose need not be explicitly expressed in the claims or specifications. The dissent, on the other hand, argued that the majority had legally erred by looking beyond the claims and the specification to define the intended purpose.

In Barry, the patent claims at issue recite a surgical “method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions,” which involves using a device to “derotate” a patient’s spine. Before the pre-AIA §102(b) critical date, the sole inventor (a surgeon) performed three surgeries using the method later claimed in the patent. The inventor conducted a “follow-up” appointment with each patient three months after the surgery when the patient was again able to walk. The last of these occurred just after the critical date.

In an infringement suit, an accused infringer challenged the patent as invalid under pre-AIA §102(b) because it was allegedly “in public use” or “on sale” more than one year before the filing date. The inventor admitted that he had determined that the surgeries had effected correction (“amelioration”) of the curvatures immediately upon completion of the surgeries. but testified that he was not satisfied that the invention would work for its intended purpose until he confirmed this three months later in the course of the final follow-up examinations. A jury found no invalidity, and on appeal, a divided Federal Circuit panel affirmed the jury’s verdict.

In particular, the majority held that the invention had not been actually reduced to practice, or otherwise “ready for patenting,” ⁴³ before the last of the three follow-up examinations, and that the jury could credit the inventor’s testimony that the follow-ups, including the third one after the critical date, “were reasonably necessary for a prudent determination that his technique worked for its intended purpose.” As such, there was no reduction in practice until after the critical date.

The dissent argued that the “intended purpose” was defined by the patent as the “amelioration” of the “aberrant” condition (curvature). The inventor admitted that the surgeries achieved amelioration, and neither the claims nor the specification identified follow-up time as an element of the invention’s intended purpose. Furthermore, even assuming a follow-up appointment was necessary, the dissent argued that the two follow-up appointments that preceded the critical date sufficed because the patent required only that the method work on “a” condition or “conditions.” She argued that “intended purpose” for reduction to practice (and therefore for the invention to be ready for patenting) was controlled by a patent’s claims and specification, not the inventor’s subjective intent, and cited case law purported to support this proposition. ⁴⁴

The majority rejected the dissent’s position, noting that “the “intended purpose” need not be stated in claim limitations that define the claim scope, and distinguishing the case law upon which the dissent relied, stating: