The second portion of the §112 ¶1 is referred to as the enablement requirement and is typically considered to be made up of two separate requirements. The first part is the “make and use” part and requires that one provide in the specification enough instruction to teach one how to make and use the claimed invention without having to resort to undue experimentation. The second part of the enablement requirement requires that the use taught be credible; this requirement is co-extensive with the utility requirement.
The make and use portion of the enablement requirement means that one of ordinary skill in the art should be able to prepare and practice the claimed invention without having to engage in “undue experimentation” to do so. A patent application is no place to play hide and seek but rather should provide the level of instruction to prepare and practice the invention described in the claims. This does not mean that the applicant needs to understand or explain the theory behind the invention or precisely how the invention works, unless such explanation is required to make the utility of the invention credible (second part of the enablement requirement). Furthermore, an applicant does not need to include every detail already known in the prior art and in fact it is preferred that he does not. As was the case for determining whether the applicant demonstrates possession of the invention, the issue of whether an invention meets the enablement requirement is a mixed question of fact and law. The determination of whether an invention is enabled depends on a number of factors related to the invention and knowledge of the art. A number of these factors were delineated and explained in a case opinion by the CAFC.29 These are the so-called Wands factors and serve as the general template the USPTO examiners use when determining whether a patent application undergoing examination satisfies the enablement requirement. The eight Wands factors are listed and explained briefly in the following paragraphs.
First, one needs to consider the breadth of a claim. Generally, the broader the claim scope, the greater the amount of disclosure required. This is logical from a technical perspective as well as a policy perspective. From the technical perspective,a more broadly claimed invention will capture more embodiments or a wider range of a single embodiment, or a combination of both. A larger number of claimed embodiments will often require more exemplification or a greater level of description because the claim must be enabled throughout its entire scope, meaning each of the claimed embodiments must be enabled. For example, a granted claim to a chemical Markush structure grants its holder the right to exclude others from making, using,or selling compounds falling within its scope. If the patent specification does not teach one of ordinary skill in the art how to make and use the compounds falling within the Markush, then the patent holder has been awarded a broader right to exclude then what he has actually enabled. It is very easy to draw chemical Markush structures on a piece of paper—with the description of just a few broad variables, one can in a few minutes of drafting time define and claim a huge amount of chemical space, thus potentially blocking others from working in that space without providing sufficient working instruction in how to make or use the invention. From a policy standpoint, such a dichotomy between disclosure and enablement upsets the balance of interests between the inventor and public. The right to exclude is a valuable right that needs to be proportionate to the information given to the public in return. Finally,if broad intellectual turf were surrendered so easily, there would be no inducement for inventor’s to actually “do the work.” Allowing structures on paper to substitute for the real thing would simply encourage paper land rushes more than actual research and testing. Clearly the latter is of much more value. Therefore, broader claim scope will generally (and should) require more instruction on how to make and use the claimed invention.
The second factor considers the nature of the invention and the type of disclosure contained in the application. Some inventions by their very nature may be more conceptual in nature, and others require more instruction on how to actually make and use the claimed invention. For example, some mechanical inventions might need nothing more than a blueprint to allow one to make and use the invention.In other words, sometimes little more than a look or inspection of a drawing can allow one to comprehend not only the invention and that it would work but also that it can be made and used without additional comment or instruction from the inventors. The sum total of the disclosure plus the knowledge already available in the art enable the invention. In contrast, many areas of chemistry are more empirical in nature. Absent specific instruction regarding exactly what reagents are used, reaction times required, temperatures employed, etc., a chemical process may fail and/or a composition may not be produced at all or, even if successful, the final result may require a large amount of experimentation to get it to work.
The third Wands factor, the state of the prior art refers essentially to the teachings in the prior art at the time of the invention. Prior art, since it is available as teachings to those of skill in the art, can help fill certain gaps in the disclosure that were left out. By way of hypothetical example, consider a patent application that leaves out an extraction procedure for removing an organic acid impurity from an organic solvent.This might not be a problem, as there exists considerable prior art regarding the extraction of acids from organic solvents using aqueous bases, etc. Such an omission is unlikely to cause one to have to resort to undue experimentation to solve the problem, since such problems are solved as a matter of routine in the prior art.
The fourth factor requires an ascertainment of the level of ordinary skill in the art. Where the level of skill in the art is high, the ordinary practitioner is assumed to be able to practice a complex invention with less likelihood of requiring undue experimentation, as she is presumably more skilled in getting experiments to work in her particular field of endeavor. In contrast, some inventions might be aimed at alay person audience, (i.e., the general public). In such an example, one would assume less competence for any technical subject matter required by the invention; therefore,more detailed instruction on how to make and use the invention would be required. For example, the patent drafter could reasonably assume the general public would know how to screw off the top of a screw-top bottle but probably would need instruction on how to put the threads into one. In typical patent prosecution or chemical and pharmaceutical patent litigation where a finding on this topic must be made, the level of ordinary skill in the art is often determined to be very high. The generic skill level for a given art is considered to be a combination of education and working experience.
It is not uncommon for a federal court to find the level of ordinary skill in the chemicalor pharmaceutical arts to be at least a bachelor’s degree in the discipline together with several years of working experience. With a high level of ordinary skill in the art,less basic instruction needs to be provided. As a practical matter, this might mean that a chemical worker with ordinary problem-solving skills probably would not need specific instruction on how to make a solution of standard concentration, pH, etc.The fifth Wands factor is the level of predictability in the art. If an art is generally unpredictable, then the amount of disclosure will need to be higher than that required for a more predictable art. This is true because one of ordinary skill in the art would not be able to extrapolate easily from a single example or limited disclosure and thus more instruction might be required. As was already mentioned, chemistry is often very unpredictable and highly empirical; small changes in chemical structure or composition can often lead to large changes in chemical or biological properties.
Accordingly, this consideration generally supports the requirement that chemical or pharmaceutical patents provide a greater level of detail. Remember that ennoblement that we teach how to make and use the invention throughout the claimed scope of the invention. If one thinks of the specification like a map, then the map will need more detail when the terrain is rougher and more unpredictable.
The sixth Wandsfactor relates specifically to the direction actually provided by the inventor in the patent application. Where the inventor has provided a lot of direction on how to make and use the invention, it is less likely that undue experimentation will be required to practice the invention.
The seventh Wands factor relates to whether there are working examples of the invention—these are usually helpful to one who wishes to make and use the invention.This should not be a surprise, especially when the working examples fall within the claim scope (and they actually work!) because one essentially should have to simply repeat the examples to produce the invention, or at least the part of it the example represents. The presence of working examples is typical in chemical composition cases and thus, for example, a patent claiming a genus of compounds that provides several examples of the preparation of compounds having utility within the genus will be considered to have working examples of the invention. If an invention claimed a method of using the compound to treat a disease in a mammal, then a working example of that method might be demonstration of the compound being tested in are levant mammalian model or a prophetic example explaining how such a treatment could be carried out. As a general matter, applications directed toward compound shaving utility as drugs typically contain a section describing how the compounds may be formulated, dosed, and delivered to humans. Although these experiments have often not been done as of the date of the filing of the application, they can be written prophetically to help provide the necessary guidance.33
This last consideration from the Wands factors directly assesses the amount of experimentation required to make or use the invention in view of the direction provided in the disclosure. At first blush, this might appear to be the final determination masquerading as the eighth factor, but it’s not. The ultimate determination of whether the invention is enabled or not is not whether significant experimentation is required but whether the experimentation required to make and use the invention is an unreasonable or undue amount. Some experimentation may still be required after reading the disclosure but it is not per se unreasonable if the experimentation is routine or if the disclosure provides considerable guidance as to the direction the experimentation should proceed.
The question of whether a disclosure is enabling is a broad inquiry that is fact intensive. While certain factors are outside of the applicant’s control when the application is drafted (such as Wands factors 2–5), for those within the applicant’s (and/or her representative’s) control, one should keep these factors in mind. For example,if one wishes to claim broadly, then one might be advised to provide representative description commensurate with the claim scope. Likewise, if one is making a broad claim, the provision of several working examples within and representative of the scope of the claim is helpful. In contrast, if one were claiming a single species or specific composition per se, then possibly just a single working example demonstrating how the compound is prepared might be sufficient (together with a credible assertion of utility).
In some instances, the issue of inoperable embodiments within a claim arises.Strictly speaking, one could plausibly argue that a claim containing one or more inoperable embodiments was not enabled throughout the claim scope since a person could not be expected to be able to make and use an inoperable embodiment of the claim. However, if we examine the inoperable embodiment issue in view of the overarching requirement that one can make and use the claimed invention without undue experimentation, then it can be appreciated that the issue is not whether there is an inoperable embodiment in the claim but whether the operable embodiments of the claim can be discerned without undue experimentation. This does not mean to imply that attempting to knowingly claimable amount of inoperable subject matter is recommended, it’s not. It means simply that the presence of one or more inoperable embodiments of a claimed invention is not always a harbinger of nonenablement.
The enablement requirement is difficult to understand and apply because it requires that we not only understand what the patent application actually teaches, but we also need to ascertain how that knowledge in combination with what is already known in the art would be applied by one of ordinary skill in the art to determine if the practice of the claimed invention requires undue experimentation. To further compound the challenge, there is very little enablement federal case law in the chemical and pharmaceutical arts to light our way.
Fortunately for us, however, the chemists at Miracles in a Bottle have been extra busy of late since their management has imposed a new time deadline for their stated goal of curing the world’s Alzheimer disease epidemic. Unfortunately for the employees, it seems that “Discovering yesterday’s drugs, tomorrow . . . maybe” is no longer soon enough. To properly motivate the employees, management has determined that patent applications must be filed immediately to cover all recently completed as well as ongoing work. The chemists in the Alzheimer disease research group have been working on small peptide-aldehyde inhibitors of the _-amyloid
secretase enzyme (BACE), which they hope can function to prevent the accumulation of the neurotoxic peptide fragment, _-amyloid fragment 1-42 (A_1-42). Upon hearing of their new directive, the chemists promptly stop all ongoing research activities in order to write up their records of invention, including the experimental description of how they made the peptides of interest and tested them for inhibition of BACE activity. In particular, they have prepared the six modified peptides shown in Figure below.
In their record of invention, the chemists explain that they have discovered a novel series of hexapeptides bearing an aldehyde at the C-terminal end. While they have not had the opportunity to fully characterize the activity through extensive structure–activity investigations as is their usual preference, they have done some
FIGURE :Amino acid sequence of modified peptides prepared by chemists at Miracle sin a Bottle pharmaceutical company.
molecular modeling and preliminary co-crystallization studies with the BACE enzyme and the six peptide aldehydes. The chemists observed a general unpredictability in regard to which peptides function as inhibitors and which are inactive, although there was a trend where hydrophobic amino acids at the one to three-positions anda polar amino acid at the six-position were preferred. In addition, an as partic acid at the four-position and a glutamic acid at the five-position were preferred for optimal activity. The chemists believed the necessary pharmacophore for inhibition at the BACE active site is likely be a pretty narrow set because, as they say, “that BACE enzyme is one picky eater.” Unfortunately, they were not able to test any of the compounds in vivo using their mouse _-amyloid model because they did not have the required time with management on their backs. Just 2 weeks after the chemists presented their record of invention and discussed their results with the suddenly very busy patent attorney, a patent application was drafted and submitted to the USPTO.
The patent application as drafted contains a description of how to make the specifically disclosed peptides as well as additional description explaining that it was “well within the purview of one of ordinary skill in the art to make hexapeptideamino acid sequences by standard synthesis, solid phase peptide synthesis or synthesis by recombinant techniques.” The patent application also described the in vitro BACE inhibition assay and the data generated from it. The application further explains:
Despite the challenges associated with discovering potent BACE inhibitors due to thievery particular active site of BACE and the general unpredictability of designing specific inhibitors for this enzyme, the examples contained herein all demonstrate an IC50 of inhibition for BACE in the low micro molar range. Accordingly, the peptides of this invention are useful for the treatment of Alzheimer’s disease. Furthermore, one of ordinary skill in the art appreciates that one could take the peptides of this invention,optionally combine them with excipients and compress them into tablets suitable for oral delivery to patients in need thereof. The dosages may vary from 1 mg to 500 mg,depending upon the patient’s weight and need. In addition to these uses, the peptides of this invention may be used to ascertain the activity of BACE enzyme preparations .Incubation of an active enzyme preparation with a compound of this invention and measurement of a changed substrate turnover rate indicates that the enzyme preparation has specific BACE activity. The peptides of this invention may be prepared according to the methods described herein but may also be prepared by other standard peptide synthes is methods well-known to those of ordinary skill in the art.
FIGURE :Claims to anti-amyloidogenic peptides and their uses.
The claims to the patent application are shown in Figure(Claims to anti-amyloidogenic peptides and their uses). After some time, the first substantive response to the patent application is received by the Miracles ina Bottle patent attorney. Before opening the USPTO response, the patent attorneydecides to break for lunch thinking, “I’d better eat lunch now before I open this thing,otherwise I might lose my appetite.”
Back from lunch and after a very brief time for quiet reflection (i.e., nap), the attorney screws up his courage and takes the envelope from his assistant’s desk when his assistant is not looking. He then quickly ducks back into his office, pulling the door shut behind him. “After that last fiasco, I think I better keep these USPTO letters to myself from now on,” he thinks. Inhaling deeply, he opens the correspondence from the USPTO and reads the relevant portions:
Claims 1–4 are pending in the instant application. Claims 1 and 4 are rejected for failure to satisfy 35 U.S.C. §112 ¶1. Claims 2 and 3 are objected to as being improperly dependent from a rejected claim. They will be allowed if rewritten in proper form.
The USPTO examiner further explained his reasoning:
At the outset, we note that claim 1 is drawn to an extremely broad set of hexapeptide C-terminal aldehyde sequences. Claim 1 requires only that amino acids 1-3 and 6 be a naturally occurring l-amino acid.Aclaim must be enabled such that one of ordinary skill in the art can make and use the claimed invention throughout its entire scope without resorting to undue experimentation. Even if an invention can be made, a credible utility must still be taught and moreover, that use must be credible throughout the scope of the claim as well. The primary inquiry the USPTO undertakes when examining claims for compliance with 35 U.S.C. §112 ¶1 is not whether one of ordinary skill in the art would have to engage in any experimentation to make and use the claimed invention but whether that experimentation is undue (In re Wands, 858 F.2d 731, 737 (CAFC 1988).
Whether experimentation is “undue” can be ascertained by considering the eight Wands factors:
Breadth of the claims;
Nature of the invention;
State of the prior art;
Level of ordinary skill in the art;
Predictability of the art;
Amount of direction provided in the specification;
Any working examples; and
Quantity of experimentation needed relative to the disclosure.
Before applying the Wand’s factors to claim1, we stipulate at the outset that the peptides of claim1can be made without undue experimentation. It is accepted that the state of the art with regard to peptide synthesis coupled with the applicants’ teaching are sufficient to satisfy this aspect of 35 U.S.C. §112 ¶1. In contrast, however, a credible utility is not established throughout the claimed scope. The Wand’s factors have been applied as follows:
The breadth of the invention. The applicants have claimed an extraordinarily broad array of peptide sequences in claim 1. Using just the standard 20 natural amino acids in claim 1 covers 160,000 peptide sequences. It is axiomatic that a broader invention requires broader enablement.
The nature of the invention. The present invention is directed towards peptide inhibitors of the BACE enzyme. The binding and inhibition prerequisites for active peptide inhibitors of this enzyme are not adequately understood nor explained in such a way that one can extrapolate from a very limited set of examples to a very broad set of claimed compounds.
The state of the prior art. Numerous studies with small molecule inhibitors of BACE have been published and some studies with peptide inhibitors have also been disclosed. However, with regard to peptide aldehyde inhibitors of BACE, very little is known. Accordingly, the state of the prior art with regard to claims 1 is relatively undeveloped.
The level of ordinary skill in the art. The level of ordinary skill in the chemical and pharmaceutical arts is high.
The level of predictability in the art. Medicinal chemistry is generally an unpredictable and largely empirical science. Small changes in a molecule’s structure often lead to large and unpredictable changes in its activity. Despite significant advance sin structure-based design, the make-and-try approach is often still the rule of the day. But these are generalities and a lower or higher level of predictability against certain targets with certain scaffolds is sometimes known or can be demonstrated. In such instances, the more specific information can be used to make a finding in place of the more general assumption. In the instant case, the applicants themselves have described both the difficulty of finding active site inhibitors of the BACE enzyme as well as a lack of predictability for making BACE inhibitory molecules. The general lack of predictability in the medicinal chemistry arena coupled with the applicants’own statements support a finding of a high level of unpredictability for the identified utility (i.e. inhibition of the BACE enzyme).
The level of direction provided. The applicants have provided sufficient direction for making the explicit examples of the invention and it is stipulated that one of ordinary skill in the art could make the claimed peptides. However, the applicant shave not provided a clear path or direction towards understanding which of the more than one hundred thousand peptides covered by claim will actually have the desired activity.
The presence of working examples. The applicants have provided six working examples of the invention. The examples have been demonstrated to have inhibitory activity against in vitro BACE preparations. Determining whether this utility for these compounds is sufficient to demonstrate in vivo activity against Alzheimer’s disease is not necessary to the present inquiry. The applicants have posited that the compounds of this invention are also useful for measuring the specific BACE enzyme activity of a preparation and this is sufficient to establish that working examples are present in the application.
The amount of experimentation required to make or use the invention in view of the direction provided in the disclosure. The direction provided in the disclosure is sufficient for the production of the compounds of the invention.
No single Wand’s factor should be considered by itself but rather the collective effect of the total should be balanced carefully in the final determination. Claim 1 fails to satisfy the enablement requirement primarily because the breathtaking scope of the claim coupled with the highly unpredictable nature of the underlying science is clearly insufficient. The disclosure of little more than a handful of active compounds pales next to the un climbed mountain of peptides remaining to be made but yet still claimed.
While the level of skill in the art is high, it is not high enough to traverse this towering obstacle without undue experimentation and accordingly, claim 1 is rejected. It should be noted that claim 2 does not suffer the same fatal defect because the claim scope is considerably attenuated and moreover, a reasonable correlation between the disclosed active compounds and the claimed compounds has been established—the claim scope is commensurate to what is taught in the application.
Claim 4 is drawn to a method of treating Alzheimer’s disease in a patient in need there of. The treatment of Alzheimer’s disease is highly speculative even under the best of circumstances, but here the applicants are claiming a method of treating this CNS disease by the oral administration of a peptide. The difficulty in achieving systemic delivery of peptides after oral administration is well known The rapid gut metabolism of peptides coupled with generally poor intestinal absorption pose very significant hurdles.
(see, e.g. Foye’s Principles of Medicinal Chemistry, Lippincott Williams & Wilkins;Sixth Edition edition (September 1, 2007)). Further compounding this challenge is the presumed requirement that these synthetic peptides effectively cross the blood brain barrier where the BACE inhibition needs to take place. Despite these significant challenges, the applicants have provided limited in vitro data only. The in vitro data indicate that micro molar concentrations of the drug are required for inhibition of the enzyme. While these concentrations might be achievable in a test tube and therefore suitable for laboratory diagnostic work, it is simply not credible to think that such concentrations could be reached after oral administration of the peptides of the invention
In order to achieve the method of claim 4, one of ordinary skill in the art would have to engage in undue experimentation and even then any chance of success would be remote.There fore, claim 4 is also rejected for lack of enablement.After reading the entire office action, the patent attorney leans back in his chair and breathes a heavy sigh of relief, “Two claims out of four, that’s 50%. That was a passing grade for me in law school and so I’ll take it as a passing grade now. This calls for a celebration!”
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