In most patentlaws, unity of invention is a formal administrative requirement that must be met for a patent application to proceed to grant. An issued patent can claim only one invention or a group of closely related inventions. The purpose of this requirement is administrative as well as financial. The requirement serves to preclude the possibility of filing one patent application for several inventions, while paying only one set of fees (filing fee, search fee, examination fee, renewal fees, and so on). Unity of invention also makes the classification of patent documents easier.
The WIPO and the EPO determine the unity of claims in a patent based on the presence of a common "special technical feature", which is usually equated with inventive step.[1] On the other hand, the USPTO uses for its domestic applications a very different approach ("independent or distinct"), which is based on the fields of use for each claim,[2] justifying this approach by a "burden on the examiner" to search different areas of technology. The patent offices in Japan and China, similarly to the USPTO, also demand splitting patent applications into multiple divisionals as a means of increasing the monetary revenue of the offices.[3]
When a patent application is objected to on the ground of a lack of unity, it may be still considered for patent protection, unlike for example in the case where the invention is found to be lacking novelty. A divisional application can usually be filed for the second invention, and for the further inventions, if any. Alternatively, the applicant may counterargue that there is unity of invention.
Under European patent practice and case law, lack of unity (of invention) can appear either "a priori", before the prior art was examined, or "a posteriori", after the prior art was examined. An a posteriori lack of unity usually results from a lack of novelty or inventive step of the subject-matter of one independent claim.
Patent Cooperation Treaty
Under the Patent Cooperation Treaty (PCT), an international application, which is also called PCT application, "shall relate to one invention only or to a group of inventions so linked as to form a "single general inventive concept".[4] If the requirement of unity of invention is not met, the International Searching Authority (i.e., the patent office in charge of carrying out the international search) "is entitled to request the applicant to pay an additional search fee for each invention beyond the first which is to be searched".[5][6][7]
In reaction to such a request from the International Searching Authority (ISA), the applicant may pay all or some of the requested additional search fees, and the International Searching Authority (ISA) then establishes the international search for all or some of the inventions or groups of inventions, respectively.[5][7] The applicant may also decide not to pay any of the additional search fees, and, in such case, the ISA does not carry out a search for the inventions or groups of inventions for which no search fees have been paid. The international search report (ISR) is then established only for the first claimed invention.[5][7]
If the applicant disagrees with the ISA's finding of lack of unity of invention, the additional fees may be paid under protest.[5][7] In the protest procedure, the applicant files a reasoned statement explaining why it considers that the requirement of unity of invention has been complied with, or that the number of additional fees required is excessive.[5][8][7] After payment of the additional search fees and, if required, of a protest fee,[9] the protest is examined by a review body. If the review body finds the protest justified, it orders the total or partial reimbursement of the additional search fees, and, if applicable, the protest fee, to the applicant.[5][7] When, for instance, the European Patent Office acts as ISA, the review body in charge of examining the protest consists of three members: "the head of a directorate, normally the head of the directorate by which the invitation to pay additional fees was issued, an examiner with special expertise in unity of invention and, normally, the examiner who issued the invitation."[10]
Although U.S. patent law does not use the term "unity of invention", the relevant legislative act (Title 35 of the US Code: 35 U.S.C. §121) specifies the conditions under which the patent examiner may issue a "restriction requirement", i.e. requesting a split:
If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions.[11]
Applications that claim more than one distinct invention may be subject to restriction to a single invention, and the applicant may prosecute the remaining invention(s) by filing divisional applications.[12]
35 U.S.C. 121 Divisional applications.
If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions. If the other invention is made the subject of a divisional application, which complies with the requirements of section 120, it shall be entitled to the benefit of the filing date of the original application. A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application. The validity of a patent shall not be questioned for failure of the Director to require the application to be restricted to one invention.[11]
However, the Manual of Patent Examining Procedure (MPEP), a document written by the USPTO itself, replaced 'independent and distinct' with 'independent or distinct'.[13][14] The USPTO justified this "and for or" replacement, by stating
The terms "independent" (i.e., unrelated) and "distinct" (i.e. related by patentably distinct) have mutually exclusive meanings and thus are interpreted as alternative requirements. Only one these requirements must be met in order to support a restriction.[15]
Thus, according to MPEP, the claims in a patent application may be properly restricted to (i.e. split into) two or more divisional patent applications, if the claims (i.e. claimed inventions) are either independent (MPEP § 802.01, § 806.06, and § 808.01) or distinct (MPEP § 806.05 - § 806.05(j)).[13]
After this split of the independent and distinct requirements, the MPEP adds a new definition of independent and of distinct, which are based on the field of use – a criterion never mentioned in legislative documents:[14]
Distinctness is proven if the claims to the intermediate and final products do not overlap in scope (i.e., a claim to the final product does not read on the intermediate, and vice versa) and are not obvious variants and it can be shown that the intermediate product is useful other than to make the final product.[16]
There are two criteria for a proper restriction requirement in case of patentably distinct inventions:
(A) The inventions must be independent (see MPEP § 802.01, § 806.06, § 808.01) or distinct as claimed (see MPEP § 806.05 - § 806.05(j)); and
(B) There would be a serious search and/or examination burden on the examiner if restriction is not required (see MPEP § 803.02, § 808, and § 808.02)
The USPTO provides several examples that explained in greater details its current restriction practice based on one-way and two-way distinctions.[15]
Briefly, the two main substantial differences between EPO's/WIPO's unity of invention and the USPTO's restriction requirement is that:
(1) The USPTO's approach to "independent and distinct" inventions is different from the "unity of invention" of the EPO's and WIPO's approach. Whereas the EPO would consider claims as relating to the same invention, if the claims share a "special technical feature" over prior art (e.g. have a common inventive step), the USPTO can find the lack of unity in the same application, if the two alleged inventions can be used not only in combination with each other,[17] or because of several fields of use (purposes) of the invention.
The US "independent and distinct" approach has an advantage, that it can be used before substantial examination, i.e. before an inventive step is identified.[19]
(2) There is no judicial review of the restriction requirement in the US (a petition to the USPTO Director is the only available remedy, which are never granted).[20] This is an unusual situation for a generally litigious US justice system. Many American patent practitioners believe, that the broad discretion given to the USPTO and the lack of judicial review on the issues of unity of invention, allow patent examiners to cynically "issue knee-jerk restriction requirements due to incentives at the USPTO to increase revenue or for examiners to perform less work for the same credit."[3] This policy causes delays in examination and unfairly extends the patent monopoly due to multiple patents (which cover the same invention) with different expiration dates (because each of these divisional patents ends up with a different patent term extension).
On the other hand, the current restriction practice allows the USPTO to raise its revenue with only minuscule increase in its efforts: the patent applicant has to pay to filing, examination, issuance and maintenance of each divisional patent application separately, even though the patent examiner reads exactly the same text in each of the divisionals. In 2003 the Biotechnology Industry Organization urged the USPTO to change its restriction practice because some applicants were forced to spend $500,000 "to fully protect a single invention" due to numerous divisionals.[21] Most of this money goes to lawyers for prosecuting multiple divisionals, and not to the USPTO. Also, in contrast to the USPTO fees,[22] small businesses do not receive any discounts on lawyers' fees, and such excessive amounts prohibit small businesses from getting proper protection of their IP.
More detailed description
The MPEP discusses four situations where an examiner may issue a "restriction requirement", i.e. a split a patent application into two or more divisionals, because even though the inventions are related (i.e. not independent) they are distinct in one or more of the following four cases:[23]
(1) wherein at least one invention is patentable (novel and nonobvious) over the other (though they may each be unpatentable over the prior art)- i.e. the inventions in question have different inventive steps:[24]
(A) Two different combinations, not disclosed as capable of use together, having different modes of operation, different functions and different effects are independent. An article of apparel and a locomotive bearing would be an example. A process of painting a house and a process of boring a well would be a second example.
(B) Where the two inventions are process and apparatus, and the apparatus cannot be used to practice the process or any part thereof, they are independent. A specific process of molding is independent from a molding apparatus that cannot be used to practice the specific process.
Alternatively, "Election of species should not be required between claimed species that are considered clearly unpatentable (obvious) over each other."[25]
This approach is similar to those of WIPO and the European Patent Office (see PCT and EPO sections above). A serious drawback of this approach is that "at the time of restriction (i.e. before the obviousness analysis), whether the inventions are patentably distinct is not known".[3] For this reason this approach is not often used by the USPTO.
(2) the inventions as claimed are not connected in at least one of design, operation, or effect (e.g., can be made by, or used in, a materially different process) - i.e. alternative uses/methods. The term "distinct inventions" means here that related (i.e. not "independent") concepts (such as apparatus for charging the disclosed battery, an apparatus for discharging the battery, a material to make an electrode for the battery) would be considered "distinct inventions" if they can be used not only in a combination with each other.[26]
An example of such restriction requirement is: the inventions as claimed are not connected in at least one of design, operation, or effect (e.g., can be made by, or used in, a materially different process) - i.e. alternative uses/methods. The term "distinct inventions" means here that related (i.e. not "independent") concepts (such as apparatus for charging the disclosed battery, an apparatus for discharging the battery, a material to make an electrode for the battery) would be considered "distinct inventions" if they can be used not only in a combination with each other. An example of such restriction requirement is:
The examiner noted that Inventions I and II are related as a method and apparatus for its practice, respectively. The examiner further noted that Invention I and Invention II are distinct, if either:
The method (Invention II) as claimed can be practiced by another and materially different apparatus or by hand, or
The apparatus (Invention I) as claimed can be used to practice another and materially different method or by hand.[27]
The "independent inventions" approach, as shown in the previous paragraph, implies that both the field of use and the inventive step of the two inventions are different. However, as explained below, in the USPTO's current practice either the field of use or the inventive step of the two inventions suffice to be different to find the lack of unity.
Nevertheless, the MPEP provides an exception similar to the EPO/WIPO approach: "If there is an express admission that the claimed inventions would have been obvious over each other within the meaning of 35 U.S.C. 103 restriction should not be required."[28]
In a pharmaceutical context, restriction requirement is usually issued to divide claims directed to the drug as a composition-of-matter, claims directed to methods of preparing the drug, and claims directed to a method for using the drug in treatment.[19] In biotech, US examiners often divide claims on a DNA gene, on mRNA, on complementary DNA, on a method of using the gene and on a corresponding protein into separate divisional applications.[29]
(3) if two claimed species are mutually exclusive (i.e. if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first). "The claims must not overlap in scope."[24]
(4) finally, an examiner can present an "undue burden" argument to justify her restriction requirement: "there would be a serious search burden as evidenced by separate classification, status, or field of search and/or a serious examination burden as evidenced by non-prior art issues relevant to one invention that are not relevant to the other invention."[30] A serious search burden can be evidenced by separate classification, status, or field of search. A serious examination burden can be evidenced by, for example, non-prior art issues relevant to one invention that are not relevant to the other invention.
Similar arguments apply to the analysis of whether combination and subcombination (see MPEP § 806.05 (combination and subcombination) and § 806.05(j) (related products or related processes)) are distinct:
The inventions are distinct if it can be shown that a combination as claimed:
(A) does not require the particulars of the subcombination as claimed for patentability (to show novelty and non-obviousness), and
(B) the subcombination can be shown to have utility either by itself or in another materially different combination.[30]
(5) notably, the USPTO allows more generous grouping of species in Markush claim: i.e. "(a) the members of the Markush group share a "single structural similarity," and (b) the members share a common use,"[28] than it does for different types of claims (i.e. process, apparatus and product) in the same patent.
A restriction requirement can be appealed to a USPTO Division Director, but not to a judge.[31][32] In practise, the Director never reverses the restriction requirement. It is also advised that inventors/applicants do not split their applications themselves, but rather always wait for an examiner to issue a "restriction".[33] Such restriction, issued by an examiner, provides a safe harbor provision of 5 U.S.C. §121 against future accusations of double patenting.[34] Otherwise, the applicant can be accused of double patenting later, and have her patents revoked.[35] The problem of using two different standards for obviousness-type double patenting (i.e."independent and distinct" at the USPTO and "patentably distinct" in the courts) was mostly rectified by the Safe Harbor provision of the Patent Act of 1952.
International (Patent Cooperation Treaty) applications in the US
The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis). This difference was confirmed in 1986 by a US Federal Court, which found that when the USPTO acts as an International Searching Authority (ISA), the USPTO is required to use the PCT rules rather than US domestic rules.[36]
If the USPTO issues a divisional restriction while serving as an International Searching Authority (ISA) under the Patent Cooperation Treaty, this restriction would not shield the applicant's US patents from double-patenting accusation later in the national stage of the PCT. Only restrictions issued by the USPTO in a national stage provide immunity from double-patenting.[37]
Noteworthy, the current (2023) USPTO guidelines require patent examiners to apply the PCT-style unity of invention requirement to the PCT applications that enter the National stage in the US, rather than the "independent or distinct" requirement.[38] Thus, the PCT route is recommended for applicants who are concerned with the cost of numerous divisionals and with potential double patenting accusations in the future.[39]
Related Research Articles
Prior art is a concept in patent law used to determine the patentability of an invention, in particular whether an invention meets the novelty and the inventive step or non-obviousness criteria for patentability. In most systems of patent law, prior art is generally defined as anything that is made available, or disclosed, to the public that might be relevant to a patent's claim before the effective filing date of a patent application for an invention. However, notable differences exist in how prior art is specifically defined under different national, regional, and international patent systems.
In a patent or patent application, the claims define in technical terms the extent, i.e. the scope, of the protection conferred by a patent, or the protection sought in a patent application. In other words, the purpose of the claims is to define which subject-matter is protected by the patent. This is termed as the "notice function" of a patent claim—to warn others of what they must not do if they are to avoid infringement liability. The claims are of paramount importance in both prosecution and litigation.
A patent examiner is an employee, usually a civil servant with a scientific or engineering background, working at a patent office.
Under United States patent law, a continuing patent application is a patent application that follows, and claims priority to, an earlier-filed patent application. A continuing patent application may be one of three types: a continuation, divisional, or continuation-in-part. Although continuation and continuation-in-part applications are generally available in the U.S. only, divisional patent applications are also available in other countries, as such availability is required under Article 4G of the Paris Convention.
Patent prosecution is the interaction between applicants and a patent office with regard to a patent application or a patent.
Under United States patent law, a provisional application is a legal document filed in the United States Patent and Trademark Office (USPTO), that establishes an early filing date, but does not mature into an issued patent unless the applicant files a regular non-provisional patent application within one year. There is no such thing as a "provisional patent".
Sufficiency of disclosure or enablement is a patent law requirement that a patent application disclose a claimed invention in sufficient detail so that the person skilled in the art could carry out that claimed invention. The requirement is fundamental to patent law: a monopoly is granted for a given period of time in exchange for a disclosure to the public how to make or practice the invention.
In patent law, an inventor is the person, or persons in United States patent law, who contribute to the claims of a patentable invention. In some patent law frameworks, however, such as in the European Patent Convention (EPC) and its case law, no explicit, accurate definition of who exactly is an inventor is provided. The definition may slightly vary from one European country to another. Inventorship is generally not considered to be a patentability criterion under European patent law.
Maintenance fees or renewal fees are fees paid to maintain a granted patent in force. Some patent laws require the payment of maintenance fees for pending patent applications. Not all patent laws require the payment of maintenance fees and different laws provide different regulations concerning not only the amount payable but also the regularity of the payments. In countries where maintenance fees are to be paid annually, they are sometimes called patent annuities.
The Manual of Patent Examining Procedure (MPEP) is published by the United States Patent and Trademark Office (USPTO) for use by patent attorneys and agents and patent examiners. It describes all of the laws and regulations that must be followed in the examination of U.S. patent applications, and articulates their application to an enormous variety of different situations. The MPEP is based on Title 37 of the Code of Federal Regulations, which derives its authority from Title 35 of the United States Code, as well as on case law arising under those titles. The origins of the Manual date back to a 1920 Patent and Trademark Office Society publication known as the "Wolcott Manual". "One of the most fruitful endeavors of the [Patent and Trademark Office] Society in the area of education was the publication of the first Manual of Patent Office Procedure. The first Manual was written by two employees of the Office and was published in 1920 by the Society. This Manual, with its eight revisions, often referred to as Wolcott's Manual, was the only procedural manual available until 1949 when the Patent Office assumed the publication of the Manual of Patent Examining Procedure."
A patent application is a request pending at a patent office for the grant of a patent for an invention described in the patent specification and a set of one or more claims stated in a formal document, including necessary official forms and related correspondence. It is the combination of the document and its processing within the administrative and legal framework of the patent office.
This is a list of legal terms relating to patents and patent law. A patent is not a right to practice or use the invention claimed therein, but a territorial right to exclude others from commercially exploiting the invention, granted to an inventor or their successor in rights in exchange to a public disclosure of the invention.
In the United States, an Office action is a document written by an examiner in a patent or trademark examination procedure and mailed to an applicant for a patent or trademark. The expression is used in many jurisdictions.
An information disclosure statement refers to a submission of relevant background art or information to the United States Patent and Trademark Office (USPTO) by an applicant for a patent during the patent prosecution process. There is a duty on all patent applicants to disclose relevant art or background information that the applicant is aware of and that may be relevant to the patentability of the applicant's invention, as established by the United States Code title 35 and related sections of 37 CFR and the Manual of Patent Examining Procedure (MPEP). If a patent applicant, with deceptive intent for art known to the applicant, fails to submit material prior art to the USPTO, then any patent that later issues from the patent application may be declared unenforceable because of inequitable conduct. Furthermore, the duty to submit such relevant information to the USPTO lies not only on the applicant or inventor, but also on any patent attorney or other legal staff employed by the applicant.
Double patenting is the granting of two patents for a single invention, to the same proprietor and in the same country or countries. According to the European Patent Office, it is an accepted principle in most patent systems that two patents cannot be granted to the same applicant for one invention. However, the threshold for double patenting varies from jurisdiction to jurisdiction.
Title 35 of the United States Code is a title of United States Code regarding patent law. The sections of Title 35 govern all aspects of patent law in the United States. There are currently 37 chapters, which include 376 sections, in Title 35.
The grant procedure before the European Patent Office (EPO) is an ex parte, administrative procedure, which includes the filing of a European patent application, the examination of formalities, the establishment of a search report, the publication of the application, its substantive examination, and the grant of a patent, or the refusal of the application, in accordance with the legal provisions of the European Patent Convention (EPC). The grant procedure is carried out by the EPO under the supervision of the Administrative Council of the European Patent Organisation. The patents granted in accordance with the EPC are called European patents.
Under Article 82 EPC, a European patent application must "...relate to one invention only or to a group of inventions so linked as to form a single general inventive concept." This legal provision is the application, within the European Patent Convention, of the requirement of unity of invention, which also applies also in other jurisdictions.
Although not clearly defined, the backlog of unexamined patent applications consists, at one point in time, of all the patent applications that have been filed and still remain to be examined. The backlog was said to be 4.2 million worldwide in 2007, and in 2009 it reportedly continued to grow. The United States Patent and Trademark Office (USPTO) alone had a backlog of ca. 700,000 patent applications in 2009. By May 22, 2024 this number grew to 783,134 applications.
During the grant procedure before the European Patent Office (EPO), divisional applications can be filed under Article 76 EPC out of pending earlier European patent applications. A divisional application, sometimes called European divisional application, is a new patent application which is separate and independent from the earlier application, unless specific provisions in the European Patent Convention (EPC) require something different. A divisional application, which is divided from an earlier application, cannot be broader than the earlier application, neither in terms of subject-matter nor in terms of geographical cover.
1 2 Hildreth, Heather. Rampant Restrictions and Improper Divisionals: The Gap between" Independent or Distinct" at the USPTO and" Patentably Distinct" in the Federal Circuit and Why We Should Encourage Examiners to Keep Similar Claim Sets Together. 2021. J Pat & Trademark Off Soc'y. 102/364.
↑ "MPEP". mpep.uspto.gov. Retrieved June 18, 2023.
↑ 802.01 Meaning of "Independent" and "Distinct" [R-08.2012]
↑ Taylor, J. and M. Inman (2020). "Looking at Patent Law: Patenting a Unitized Regenerative Fuel Cell System for Space Energy Storage Applications-A Case Study." Electrochemical Society Interface 29(1): 37-42; 10.1149/2.F04201if
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