- 12.01 Statutory subject-matter – June 2017
- 12.02 Inventions must not be disembodied– June 2017
- 12.03 Excluded subject-matter – June 2017
- 12.03.01 Scientific principles and abstract theorems
- 12.03.02 Methods of medical treatment or surgery
- 12.03.03 Higher life forms
- 12.03.04 Forms of energy
- 12.03.05 Features of solely intellectual or aesthetic significance
- 12.03.06 Printed matter
- 12.03.07 Fine arts
- 12.03.08 Schemes, plans, rules and mental processes
- 12.03.09 Games
- 12.04 Utility – June 2017
- 12.05 Office actions on utility – June 2017
12.01 Statutory subject-matter June 2017
The protection offered by the Patent Act extends to many but not all types of human endeavour; those types to which it applies are called “statutory”.
Section 2 of the Patent Act defines an invention as:
any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.
In order to be considered statutory, the subject-matter for which protection is sought must fall within one of these categories of subject-matter defined in section 2 of the Patent Act. The requirement that an invention be statutory can be framed in terms of asking whether or not the invention is proper “subject-matter” for a patent.
The term “art”, for the purposes of the Patent Act, pertains to the application of knowledge to effect a desired result.Footnote 1 To be statutory, an “art” must be what the courts have termed a “useful art”Footnote 2 and a “manual or productive art.”Footnote 3 An art must be the practical application of knowledge,Footnote 4 and must therefore be defined in a manner that gives practical effect to the knowledge. An art, therefore, is typically claimed as either a use or a method.
A use claim typically sets out a manner or mode of employing something in order to accomplish a particular result without prescribing in detail how the result is to be achieved. For example, a use claim might take the form “Use of a heat source to boil water.” [See Chapter 11 for further guidance on use claims.]
A “method” claim also sets out a mode or manner of accomplishing a certain result but includes particular steps required to achieve the result. For example, a method claim might take the form of “A method of heating water comprising the steps of pouring two cups of water into a stainless steel container, placing the container on a heat source, and heating the water until the water temperature reaches 100 degrees Celcius.”
Whether or not a method is statutory is not determined by whether or not it produces a statutory product.
A “process” implies the application of a method to a material or materials.Footnote 5 A process can be considered to be a mode or method of operation by which a result or effect is produced by physical or chemical action, by the operation or application of some element or power of nature; or of the application of one substance to another. As with methods, whether or not a process is statutory is not determined by whether or not it produces a statutory product.
A “machine” is the mechanical and/or physical embodiment of any function or mode of operation designed to accomplish a particular effect, wherein the parts of the machine cooperate to accomplish the effect. A machine can be considered to be any device that transmits or directs the application of a force, or a device that enables energy from one source to be modified and transmitted as energy in a different form or for a different purpose. A machine may be claimed as a device, as an apparatus, or a system, for example.
A “manufacture” has been broadly defined as “a non-living mechanistic product or process” and as being the process of making (by hand, by machine, industrially, by mass production …) technical articles or material (in modern use on a large scale) by the application of physical labour or mechanical power; or the article or material made by such a process.Footnote 6
12.01.05 Composition of matter
A “composition of matter” refers to a combination of ingredients, whether combined as a chemical union or a physical mixture, and includes chemical compounds, compositions and substances. The term “matter” implies that the ingredients must be perceptible in space and have mechanical mass. In Harvard College v. Canada (Commissioner of Patents), the Supreme Court noted that the scope of this category must be limited in some way, else the categories of "machine" and "manufacture" would be made redundant.Footnote 7
12.02 Inventions must not be disembodied June 2017
An invention is a solution to a practical problem. In order to solve a practical problem, the solution must be in a form that can interact directly with the physical world and, hence, that will itself enable a person skilled in the art to obtain the intended result or benefit. Such a form is referred to herein as a "practical form" or a "practicable form".
A disembodied idea, concept or discovery that underlies or leads to an invention is not itself patentable; in order to be patentable it must be incorporated in a practical form. A mere idea or intellectual concept, no matter how well it may have been worked out and structured in the mind, is disembodied and is not capable of interacting with the physical world to solve a practical problem. In Shell Oil Co. v. Commissioner of Patents the Supreme Court noted that “a disembodied idea is not per se patentable. But it will be patentable if it has a method of practical application.”Footnote 8 In Riello Canada Inc. v. Lambert, the court cited with approval comments from Reynolds v. Herbert Smith & Co., Ltd., which noted that "the idea that leads to an invention is […] no part of the invention. The idea, or the recognition of the want, stimulates the inventor to do something else. It is the something further which he does which is the invention" and similarly that "discovery adds to the amount of human knowledge, but it does so only by lifting the veil and disclosing something which before had been unseen or dimly seen. Invention also adds to human knowledge, but not merely by disclosing something. Invention necessarily involves also the suggestion of an act to be done, and it must be an act which results in a new product, or a new result, or a new process, or a new combination for producing an old product or an old result".Footnote 9
It is implicit in the definition of “invention” that statutory subject matter must be something with physical existence, or something that manifests a discernible effect or change.Footnote 10
12.03 Excluded subject-matter June 2017
It is apparent from the definition of invention in section 2 of the Patent Act that not everything can be patented. With respect to section 2, the Supreme Court noted in Harvard College v. Canada that “[b]y choosing to define invention in this way, Parliament signaled a clear intention to include certain subject-matter as patentable and to exclude other subject-matter as being outside the confines of the Act.”Footnote 11
The following sections set out various statutory and jurisprudential proscriptions to the scope of patentable subject-matter under section 2 of the Patent Act.
12.03.01 Scientific principles and abstract theorems
Subsection 27(8) of the Patent Act states:
No patent shall be granted for any mere scientific principle or abstract theorem.
This subsection has been interpreted by the courts as excluding from patentability (inter alia) mathematical formulaeFootnote 12, natural phenomena and laws of nature.
The exclusions of this subsection apply when an attempt is made to monopolize the excluded subject-matter in a general sense, but not when a scientific principle, law of nature or mathematical formula is relied upon in operating a practical form of an invention.
The Patent Office considers that mere scientific principles and abstract theorems do not constitute an invention within the meaning of section 2 of the Patent Act. Accordingly, claims that are found to be directed to scientific principles or abstract theorems will be identified as defective under both subsection 27(8) and section 2 of the Patent Act.
12.03.02 Methods of medical treatment or surgery
A method or process of surgery or therapy on living humans or animals is not considered to be within the scope of the meaning of invention as set out in section 2 of the Patent Act.
A detailed consideration of medical and surgical methods can be found in chapter 17.
12.03.03 Higher life forms
The Supreme Court of Canada has determined that higher life forms are excluded from patentability by virtue of their not being either manufactures or compositions of matter within the definition of invention as set out in section 2 of the Patent Act.Footnote 13
A detailed consideration of higher life forms can be found in chapter 17.
12.03.04 Forms of energy
Forms of energy such as regions of the electromagnetic spectrum, electric currents and explosions are not considered to be subject-matter within the scope of the meaning of invention as set out in section 2 of the Patent Act.
Forms of energy are not considered to be manufactures or compositions of matter in the sense intended by the Patent Act. Electromagnetic and acoustic signals are also considered to be forms of energy and do not contain matter even though the signal may be transmitted through a physical medium. Thus, claims to electromagnetic and acoustic signals do not constitute statutory subject-matter within the meaning of section 2 of the Patent Act.
More particularly, an electromagnetic or acoustic signal is not considered to be an art (i.e. not a method or a use per se) nor a process (i.e. not a mode or method of operation by which a result or effect is produced by physical or chemical action; by the operation of application of some element of power of nature; or by the application of one substance to another). Neither is an electromagnetic or acoustic signal a machine, as it is not the mechanical embodiment of any function or mode of operation designed to accomplish a particular effect, nor is it a composition of matter, as it is not a chemical compound, composition or substance. An electromagnetic or acoustic signal is taken not to be itself a material product and is therefore, also not a manufacture.
12.03.05 Features of solely intellectual or aesthetic significance
Features of an invention that have a purely intellectual or aesthetic significance are considered, in a practical sense, not to affect the functioning of the invention. Such features cannot change the manner in which the practical form of an invention operates to solve the problem for which it is the solution.
Where a claim appears to be directed to subject-matter having solely intellectual or aesthetic significance, the claim is defective under section 2 of the Patent Act.Footnote 14
Where an invention requires a practical problem to be solved in order to enable a result or effect having solely intellectual or aesthetic significance, the patentability of the invention is not impacted by the fact its purpose is to produce a non-statutory result or effect.Footnote 15 In such cases, the practical form of the invention does not lie solely in its intellectual or aesthetic significance as the solution to the practical problem gives rise to a new functionality.
12.03.06 Printed matter
Printed matter that has purely intellectual or aesthetic significance, such as a literary work, is excluded from patentability for the reasons outlined in 12.03.05. However, where printed matter provides a new functionality to the substrate on which it is printed, a claim to this subject-matter may be considered statutory. For the printed matter and the substrate to be considered to be a practical form of an invention, they must solve a practical problem related to the use of the printed matter in general, and not be based solely on the intellectual or aesthetic content of the printed matter itself.
By way of example, each of the following has been found by the Commissioner of Patents as being patentable: a textile material bearing markings to enable greater precision during a manufacturing procedure,Footnote 16 a newspaper layout in which white space is left to facilitate reading when the paper is folded, a layout of text on a series of pages to facilitate a bookbinding process, and a layout of text on a ticket which permits the ticket to be divided either horizontally or vertically while ensuring all information will appear on both halves.Footnote 17
In each of the foregoing the printed matter provided a new mechanical functionality to the combination; the actual content of the printed matter was not the basis of the invention. Where printed matter has only intellectual or aesthetic significance, it may conveniently be referred to as “non-functional descriptive matter”.
The term “printed matter” should not be restricted to traditional ink-on-paper printing but may include any means of displaying information.
An application describes a new scratch-off lottery ticket wherein the scratchable areas are arranged in a maze-pattern, wherein the user must scratch one cell at a time to determine if they can move their way to the end of the maze.
- A scratch-off lottery ticket comprising a pattern or a plurality of intersecting pathways that define a maze, said pathways divided into individual cells, each cell including an indicator of direction and each cell being covered by an opaque scratchable material, wherein if the indicators of direction define a path from a first cell of the maze to a final cell of the maze, the lottery ticket is a “winning ticket.”
Person of ordinary skill in the art (POSITA)
The POSITA is considered to be a person who is skilled in the design of scratch-off lottery tickets; the POSITA is also knowledgeable in the field of marketing.
Common General Knowledge (CGK) of the POSITA
The POSITA would consider that substrates on which information is concealed under opaque scratchable material are CGK. The use of such substrates in the art of scratch-off lottery tickets having various game scenarios would also be considered to be CGK.
The POSITA, having read the specification and in light of their CGK, would consider that the problem addressed by the claimed invention was to provide a variation on scratchable lottery tickets.
The solution to the problem is the provision of the pattern or the plurality of intersecting pathways that define a maze.
What are the essential elements?
The essential element (i.e. the element that provides the solution to the problem) is the pattern or the plurality of intersecting pathways that define a maze.
Is the claim statutory?
This essential element provides no new functionality to the substrate on which it is printed; it is merely printed matter that has solely intellectual or aesthetic significance. The claim is directed to non-statutory subject-matter and is therefore non-compliant with section 2 of the Patent Act.
12.03.07 Fine arts
A fine art has been described as “that having intellectual meaning or aesthetic appeal alone”Footnote 18 Fine arts are therefore not patentable subject-matter.Footnote 19 The term is understood to include activities such as exercising, dancing, acting, writing, teaching, hair dressing, cosmetology, flower arranging, painting pictures and playing musical instruments. Generally, any product derived from a fine art will also be non-statutory.
Fine arts and the products thereof are not a practical form of an invention since they do not solve any practical problem. Typically, the features that distinguish a product produced by a fine art will have purely intellectual or aesthetic significance.
The exclusion from patentability of fine arts does not extend to inventive materials and instruments used in practising a fine art. For example, while an artistic method of painting a picture and the resultant picture are non-statutory, an inventive easel for holding a canvas would be patentable. Similarly, the paints, paint-brushes etc., used in conjunction with the fine art - but not derived from the fine art as the picture is - may be considered to be statutory subject-matter.
12.03.08 Schemes, plans, rules, and mental processes
A scheme, plan, or rule for performing an operation, achieving a result or controlling a method,Footnote 20 and a process that is exclusively a series of mental stepsFootnote 21 (e.g., performing calculations; manipulating data or information to produce data or information having a different purely intellectual meaning or aesthetic significance) are disembodied (abstract) and are not a practical form of an invention regardless of reproducibility.
A manner of playing a game or sport does not solve a practical problem, and a method for playing a game is therefore non-statutory. This is so whether the claimed method is distinguished on the basis of specific rules governing playFootnote 22 or in terms of actions to be taken to achieve specific game-related results.
Tools made use of in the playing of a game may themselves be patentable (e.g., a specifically designed table or playing piece or a game board with a particular mechanical function, or combination of such that is patentable on its own merits).
12.04 Utility June 2017
Section 2 of the Patent Act requires that an invention be useful. Utility in the sense of the Patent Act can be considered as a requirement for an invention to be operable, controllable and reproducible such that the objectives of the invention are predictably achieved.Footnote 23
Except where utility is the essence of the invention (e.g. new uses for old compounds), an applicant need not expressly set out the utility of the invention in the application;Footnote 24 however if an invention's utility is questioned, utility must be shown to have been demonstrated or soundly predicted (see 12.04.03) as of the application's filing date.Footnote 25 The threshold that must be met to establish utility is generally quite low;Footnote 26 a “mere scintilla” of utility will sufficeFootnote 27. However, where the specification sets out an explicit promise, utility will be measured against that promiseFootnote 28 (see 12.04.02).
Utility is an essential aspect of an invention, but with the exception of new uses for old compounds, utility does not need to be explicitly defined in the claims.Footnote 29 To be directed to a useful embodiment, a claim must define the inventive element or combination of elements necessary to enable the proper operation of the invention for its intended purposes.Footnote 30 A feature that is required to allow the invention to work, the presence of which is understood by the person skilled in the art as being implicit, need not be explicitly defined.Footnote 31
12.04.01 Controllability and reproducibility
To be considered to have utility an invention must be controllable and be reliably reproducible;Footnote 32 the desired result must inevitably follow when the invention is put into practice and may not be left up to chance. It is to be noted that the idea that “the desired result must inevitably follow” can refer to an accepted degree of success of a particular repetitive mass production method. For example, if a method is known and well recognized in a particular art as having a particular ratio of success or a certain percentage of rejects, the desired result inevitably follows if the method's ratio of success is inside such generally accepted parameters or if the method produces a percentage of rejects that is within these known parameters.
Inventions which are arrived at by chance and which cannot be reliably reproduced lack utility.Footnote 33 An invention that relies upon the judgment or reasoning of an operator is considered to lack reproducibility and thus, lacks utility.Footnote 34 Certain mental steps involving the ascertaining and sensing facilities have precise and predictable results, and do not of themselves cause the art or process that relies on them to lack utility. Whenever a person is called upon to perform a subjective judgement, however, the result will invariably be subject to factors such as intuition, creativity, conjecture and approximation, and the result will not be objectively controllable or reproducible. This lack of control and reproducibility is amplified if the subjective judgement calls into play a person's system of values, beliefs, interests or preferences.
12.04.02 Promised utility of the invention
A lack of utility exists if “the invention will not work, either in the sense that it will not work at all, or more broadly, that it will not do what the specification promises that it will do”Footnote 35; “[i]f and when used in accordance with the directions contained in the specification, the promised results are obtained, the invention is useful in the sense in which that term is used in the patent law.”Footnote 36
As discussed in 12.04, in most cases an applicant is not required to set out an invention's utility. However if an applicant indicates that an invention will provide a particular advantage (e.g. will do something better or more efficiently or will be useful for a previously unrecognized purpose) and this advantage is determined to be an explicitly promised utility, it is this utility that the invention must in fact have. The promise doctrine represents an exception to the “scintilla of utility” threshold. Recognizing that when utility is the essence of the invention (e.g. new uses for old compounds) it does have to be set out in the specification, in cases where an applicant need not describe any particular utility for an invention but nevertheless explicitly promises a specific result, the applicant will be held to that promise; “when called upon to prove utility […] that the invention may well have satisfied the scintilla threshold is of no assistance in establishing utility where a promise, if it be made, cannot be met.”Footnote 37
The specification must be read keeping in mind that “not all statements of advantage in a patent rise to the level of a promise. A goal is not necessarily a promise.”Footnote 38 “The promise doctrine will hold an inventor to an elevated standard only where a clear and unambiguous promise has been made.”Footnote 39 It is not enough to merely label a promise as “explicit” if it can only be supported on the basis of equivocal inferences and ambiguous indications.Footnote 40 A promise of utility is not to be inferred from the language of the specification. Instead it must be clearly and unequivocally found in the express language of the specification.Footnote 41 “[A] utility not expressed in the claim portion of the specification […] should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility.”Footnote 42
Examiners must therefore carefully evaluate the specification before deciding that the applicant has made an explicit promise of utility and must keep in mind that not every patent contains an explicit promise of a specific result.Footnote 43 However when a result or advantage is asserted in a patent's claims, it will generally be seen as a promise of utility.Footnote 44
Where such an explicit promise is found, the effect of an explicit promise must be carefully evaluated for each of the claims. “It is now settled law that some promises can be construed to impose utility requirements across each of a patent's claims, while other promises may touch only a subset of the claims. In every case it is a question of proper construction of the relevant claims.”Footnote 45
Although an invention need only have one use in order to be patentable, where several uses are explicitly promised the applicant must have established the utility of each by demonstration or sound prediction as of the filing date. For example, if a composition is explicitly promised to be useful as a drug, the applicant must have shown that it is useful in the therapy of at least one disease as of the filing date. If, however, it is explicitly promised to be useful as a drug for treating many diseases, the applicant must have established its utility in treating each of the diseases as of the filing date.
12.04.03 Demonstration or sound prediction
The utility of an invention must be established as of the filing date of the patent, either by demonstration or sound prediction.Footnote 46 Where an examiner reviewing an application has reasonable grounds to believe that the application does not comply with the utility requirement of section 2 of the Patent Act and in response the applicant provides data to demonstrate utility, the data must show that the utility of the invention was demonstrated as of the filing date. “Unless the inventor is in a position to establish utility as of the time the patent is applied for, on the basis of either demonstration or sound prediction, the Commissioner is “by law” required to refuse the patent.”Footnote 47 “Utility and sound prediction are questions of fact and must obviously be supported by evidence.”Footnote 48
Demonstrated utility pertains to embodiments of the invention that have been specifically shown to actually work for the ends promised by the applicant. Where the utility of an invention is to be established by demonstration, the demonstration must have occurred as of the filing date but need not have been included in the description.Footnote 49 Information establishing the demonstrated utility as of the filing date may be provided after the filing date by the applicant by way of affidavit.
Where an applicant is called upon to establish utility and proposes to demonstrate that their invention had utility as of the filing date, this demonstrated utility should be established by experimentation and testing of all embodiments of the invention or of all members of a genus claimed, for example, and cannot rely on literal assertions that the claimed invention has utility.
When an applicant is not in a position to demonstrate the utility of the invention, a sound prediction must be relied upon to establish utility. Soundly predicted utility pertains to embodiments of the invention that have not been demonstrated to have utility, but for which an appropriate factual basis exists upon which this utility, across the full scope of the claimed invention, can be predicted. That is, the utility need not have been demonstrated at the time of filing the patent, but the scientific rationale underlying the utility must have been established through a sound prediction at the time of filing.
It bears mentioning that the doctrine of sound prediction is of general applicability in every field for which patent protection may be sought and has, for example been applied in the mechanical arts. Footnote 50
12.04.04 Requirements for sound prediction
In order for a prediction to be considered “sound”, it must meet the following test:
- there must be a factual basis for the prediction;
- the inventor must have at the date of the patent application an articulable and “sound” line of reasoning from which the desired result can be inferred from the factual basis; and
- there must be proper disclosure.Footnote 51
The factual basis generally comprises the facts regarding the invention that are provided by the applicant in the description and drawings, relevant scientific principles, and information pulled from the common general knowledge of the person skilled in the art. The sound line of reasoning can be thought of as the analysis that sets out how the applicant logically bridges the gap between the factual basis and the purported utility of the invention.
The relevant date for determining whether the prediction is “sound” is the filing date of the application.Footnote 52 Where an applicant is claiming priority, this claim is valid only insofar as the document or documents upon which it is based are sufficient to establish the utility of the invention. Although an applicant is entitled to add matter not included in the priority document(s) to the application as filed, where this matter is necessary to establish the utility of any embodiments of the invention those embodiments do not benefit from the priority date.
It is important to keep in mind that a “sound prediction” by its very definition does not imply certainty; however a sound prediction is not to be diluted to a lucky guess or mere speculation.Footnote 53 Consequently, in assessing whether or not utility has been established via a sound prediction the emphasis is appropriately placed on the term “sound”, and the question at hand is whether a prediction is “sound” or “speculative”. In Monsanto Co. v. Commissioner of Patents, Pigeon J. adopted the following terms to express this lack of certainty: "[i]f it is possible for the patentee to make a sound prediction and to frame a claim which does not go beyond the limits within which the prediction remains sound, then he is entitled to do so. Of course, in so doing he takes the risk that a defendant may be able to show that his prediction is unsound or that some bodies falling within the words he has used have no utility or […] that some promise he has made in his specification is false in a material respect".Footnote 54
12.04.04a Factual basis
Evaluating what will be a sufficient factual basis for a sound prediction must be conducted on a case-by case basis and will depend on such factors as:
- the scope of the claims;
- the state of the art;
- the nature of the invention and its predictability; and
- the extent to which the applicant has explored the area claimed, for example by conducting experiments which provide a factual basis for the purported utility.
A factual basis does not by necessity mean experimental dataFootnote 55 and though it may be provided by way of examples there is no absolute requirement that this be so. The factual basis could be found in scientifically accepted laws or principles, in data forming part of the state of the art and referred to in the description, or in information that is considered to be common general knowledge of the person skilled in the art.
The term “factual basis” implies support and proof. As mentioned in 12.04.03, “[u]tility and sound prediction are questions of fact and must obviously be supported by evidence”.Footnote 56 Simple, unsubstantiated statements in the description suggesting that the invention will work are not considered to be factual. Similarly, while an applicant can include “prophetic examples” in their application, they have no value in providing a factual basis for a sound prediction. A prophetic example is by definition a statement of what might be, rather than what is, and therefore is not factual.
12.04.04b Sound line of reasoning
The sound line of reasoning connects the factual basis to the purported utility of the invention. The person skilled in the art must be able to understand how the sound line of reasoning links the factual basis to the purported utility of the invention.
12.04.04c Proper disclosure of the sound prediction
For there to be a proper disclosure of the sound prediction, the description must provide sufficient information such that a skilled person in the art, in light of their CGK, would understand the basis of the sound prediction and be able to predict that the entire scope of the claimed invention would work once reduced to practice.Footnote 57
With respect to what needs to be disclosed to meet the third requirement of the test for sound prediction, it is the factual basis and the sound line of reasoning that must be disclosed.Footnote 58 The extent to which the factual basis and sound line of reasoning must be described in the original description must be evaluated on a case-by-case basis. Elements of either the factual basis or the sound line of reasoning that can be found in scientifically accepted laws or principles, or which would be self-evident to a person of skill in the art in view of the common general knowledge will not, as a general rule, need to be disclosed in the specification. Information that forms part of the state of the art could, depending on the specific circumstances, be properly disclosed merely by referring to the document in which it is set out. Where such documents are referred to they must be properly identified.Footnote 59
Where a sound prediction relies on additional information that is not publicly available, such information must be included in the descriptionFootnote 60 at the time of filing. In contrast with evidence that demonstrates utility, an applicant cannot provide evidence after the filing date to properly disclose a sound prediction, even if the evidence was generated before the filing date. Explanations provided during prosecution as to the nature of the sound line of reasoning can only be considered to the extent that they explain why a person skilled in the art would have appreciated the sound line of reasoning on the basis of the description as filed and their common general knowledge.
Since the disclosure is directed to a person skilled in the art, the disclosure must allow that person to make a sound prediction. It is not enough for the description to disclose information that allows for a sound prediction only when interpreted in view of information not available to the public (e.g. proprietary knowledge possessed by the applicants only), or only when interpreted by an expert having a level of knowledge beyond that expected of the person skilled in the art.
Although an applicant is generally not required to provide a theory of how an invention works, if the utility of the invention is predicated on a sound prediction, and the line of reasoning depends on an understanding of the theory as to why the invention works, it may not be possible to properly express the line of reasoning unless this theory is disclosed.
It is important to note that the disclosure requirement within the test for sound prediction and the sufficiency of disclosure requirement are distinct and separable requirements.Footnote 61 The disclosure requirement within the test for sound prediction is tied to the requirement that an invention have utility as set out in section 2 of the Patent Act; it does not pertain to the sufficiency of disclosure requirement set out in subsection 27(3) of the Patent Act. [See chapter 9 for a discussion of sufficiency.]
An application describes the use of a solution comprising cells and a biocompatible, cross-linkable hydrogel-forming polymer to produce, when injected into a patient, a tissue-equivalent (which comprises a three-dimensional open-lattice hydrogel with cells dispersed therein). The description states that any biocompatible, cross-linkable hydrogel-forming polymer is suitable to create the tissue-equivalent. Also disclosed is detailed information concerning the preferred types of biocompatible, cross-linkable hydrogel-forming polymers that can be used and the specific structural features of each of these types of polymers that make them suitable for use. In particular, the description demonstrates that a tissue-equivalent is successfully formed using a calcium alginate polymer and osteoblast cells.
A use of a cell-polymeric solution for injecting a cell suspension into an animal under conditions which cross-link the cell-polymeric solution within the animal to form a three-dimensional open-lattice structure having cells dispersed therein, the solution comprising a biocompatible hydrogel-forming biopolymer which can be cross-linked via covalent, ionic, or hydrogen bonds to create a three-dimensional open-lattice hydrogel which entraps water molecules to form a gel, mixed with osteoblast cells.
The use of claim 1 wherein the biocompatible hydrogel-forming biopolymer is calcium alginate.
Analysis: claim 1 encompasses the use of any biocompatible cross-linkable hydrogel-forming biopolymer to create a three-dimensional open-lattice hydrogel for the delivery of osteoblast cells into a patient, while claim 2 is limited to the use of calcium alginate as the biopolymer. Where the utility of an invention is called into question, the applicant must be in a position to show that they had either demonstrated or soundly predicted the utility of the invention as of the filing date. In this case, the examiner questions the utility of the invention and notes that the description demonstrates that calcium alginate is a suitable biopolymer for the creation of the desired open-lattice hydrogel. As such, the utility of claim 2 is considered to be established by demonstration and is compliant with section 2 of the Patent Act. What is not demonstrated with respect to claim 1, however, is the use of other suitable polymers, other than alginate. In view of this, it is apparent that the utility over the full scope of claim 1 has not been demonstrated and must, therefore, be established on the basis of a sound prediction.
In order for the prediction to be “sound”, there must be a factual basis for the prediction, an articulable and sound line of reasoning from which the desired result can be inferred from the factual basis, and there must be a proper disclosure of the factual basis and sound line of reasoning.
The factual basis disclosed in the description includes the fact that alginate, which is a biocompatible polymer that can be cross-linked to form a 3D open-lattice hydrogel, was successfully used to achieve the desired result (i.e., creating a tissue equivalent). Further, in this case it is part of the common general knowledge of a person skilled in the art that the open-lattice hydrogel-forming ability is not unique to the alginate polymer as it is a property shared by many other known biopolymers that are capable of cross-linking through covalent, ionic, or hydrogen bonds.
The line of reasoning is articulated to be that the presence of specific structural features relating to biocompatibility and cross-linkability are required in a polymer in order to produce a 3D open-lattice hydrogel. Given the fact that alginate has these structural features and forms the tissue-equivalent, the applicant states that other polymers having the same specific structural features would also produce a 3D open-lattice hydrogel and deliver the same result. In view of the factual basis, the line of reasoning is considered to be sound and both the first and second requirements of the test for sound prediction have been satisfied. Given that elements of both the factual basis and the sound line of reasoning that were not CGK to the POSITA were disclosed in the description at the time of filing, the requirement for proper disclosure is also met. Therefore, claim 1 satisfies the utility requirement of section 2 of the Patent Act.
An application describes a method of controlling weeds in a wheat field wherein wheat plants comprising a mutated acetohydroxyacid synthase (AHAS) gene have increased tolerance to imazapyr, an imidazolinone herbicide. The description subsequently states that any mutation in Domain A of the AHAS gene in wheat will confer imazapyr resistance to the wheat. This mutation in wheat allows for weeds to be selectively targeted when the imazapyr herbicide is applied to a field containing both weeds and the mutant wheat plants. Both the wild-type AHAS gene (SEQ ID NO:1) and a mutant AHAS gene having a single nucleotide substitution in Domain A (SEQ ID NO: 2) are disclosed. The description demonstrates that wheat plants comprising the mutant gene of SEQ ID NO:2 are resistant to the imazapyr herbicide, while the wheat plants comprising the unmodified wild-type AHAS gene (SEQ ID NO:1) show susceptibility to the herbicide. The application makes no mention of any other mutations in Domain A of the AHAS gene, nor does it include any information regarding why the applicant believes that any such mutation would lead to the increased tolerance to the imazapyr herbicide.
- A method of controlling weeds in a field, the method comprising:
- a) growing in a field a wheat plant having increased tolerance to imazapyr herbicide and;
- b) contacting the wheat plant and weeds in the field with an effective amount of the imazapyr herbicide; wherein the wheat plant comprises an AHAS gene which comprises a mutation in Domain A.
Analysis: the application claims that a method of controlling weeds in a wheat field using the imazapyr herbicide will be effective where wheat plants in the treated field comprise any mutation in Domain A of the AHAS gene. The description demonstrates that one particular mutation in Domain A of the gene, as depicted in SEQ ID NO:2, successfully provides resistance to wheat plants when exposed to imazapyr. What has not been demonstrated, but which is covered in the claim, is that any and all possible mutations in Domain A of AHAS would result in the utility of imazapyr herbicide resistance. In view of this, it is apparent that the utility has not been demonstrated over the full scope of the claim and since the examiner questions the utility, it must be established on the basis of a sound prediction.
The factual basis disclosed is that the AHAS gene is associated with the imazapyr herbicide and that a specific Domain A mutation, as defined in SEQ ID NO:2, confers increased tolerance to said herbicide. These facts alone, however, are not enough to soundly predict the utility of all possible Domain A mutations. The person skilled in the art, in light of their CGK and the information provided in the description, would recognize the complexity and unpredictability of gene expression, and as such, would not be led to extrapolate that the specific Domain A mutation of SEQ ID NO:2 is a reasonable predictor that all possible mutations in Domain A would confer a similar tolerance. As such, the application fails to disclose an articulable and sound line of reasoning.
Therefore, in the absence of an articulate sound line of reasoning, the skilled person could not soundly predict that any and all mutations in Domain A of the AHAS gene would have the disclosed utility. As such, the claim is defective under section 2 of the Patent Act because the utility has not been established on the basis of either demonstration or sound prediction over the full scope of the claim.
Moreover and independent of the section 2 defect, the specification, insofar as it relates to claims defining any and all mutations in Domain A of the AHAS gene (other than the mutation depicted in SEQ ID NO:2), and uses thereof for imazapyr herbicide resistance in wheat plants, does not comply with subsection 27(3) of the Patent Act because it does not correctly and fully describe the alleged invention and its operation or use, so as to enable any person skilled in the art to practice the alleged invention over the entire scope of the claims. It would require undue experimentation from the skilled person to identify any and all mutations that would lead to a wheat plant having increased tolerance to the imazapyr herbicide.
12.05 Office actions on utility June 2017
Where there is evidence of inutility in respect of the subject-matter claimed, or where an examiner questions the purported utility and determines that the applicant has not established that utility, either through demonstration or sound prediction, a defect will be identified under section 2 of the Patent Act. A defect may also be identified when the description fails to demonstrate or soundly predict the utility over the entire scope of a claim.
Where an examiner determines that utility is not established by a sound prediction, the examiner must include supporting arguments which detail how the defect is related to the three step test of sound prediction as set out in section 12.04.04.
It should be noted that evidence of inutility can be provided at any time and there is no requirement that such evidence existed at the time the application was filed for.
As mentioned above, care must be taken to ensure that the disclosure requirement of sound prediction is not confused with the sufficiency requirement under subsection 27(3) of the Patent Act. An examiner may determine that there is a separate and independent defect under subsection 27(3) of the Patent Act if the description fails to sufficiently disclose the invention, or if the person skilled in the art could not put it into practice without undue experimentation or without exercising inventive skill. Where both defects are presented in an examiner's report the report must clearly identify both defects and provide separate supporting arguments for each.
On occasion, an examiner may be presented with an alleged invention that is contrary to known scientific principles. Unless the proper operation of such an invention can be established by demonstration (and the applicant can show that it was, in fact, demonstrated at the time of filing), the claims defining it are identified as defective under section 2 of the Patent Act.