Article 26 of Patent Law, para.4 provides: Patent claims must be supported by the written description, pointing out in clear and concise terms the subject matter sought to be patented. Article 59, para. 1 provides: The scope of protection for invention or a utility model patents shall be limited to the claims; the written description and the drawings may be used for claim construction.

The scope of patent protection is the core of patent examination and protection, but how to deter mine the scope of patent protection defined by functional limitations remains an often-debated question. Currently the Guidelines for Patent Examination relied on by Chinese examiners and Interpretations of the Supreme People's Court on Certain Issues Concerning the Application of Law in the Trial of Patent Infringement Cases adopt clearly different rules in the determination, giving rise to uncertainties and questions. As an examiner for the field of A61L inventions in the substantive examination, the author draws on her experience and shares her views on the aforesaid questions on the basis of specific cases.

Zhao Li

I. What is a functional limitation?

1. The basics of functional limitation

Generally, a product claim should be drafted in terms of structural or compositional limitations, and a process claim, of steps or methods of completing the process; if, however, the subject matter in a claim is defined by the effect, function, or result of component, rather than by structural or procedural terms, such a defining limitation is called a functional limitation.

As long as one of the limitations in a product claim is drafted at least in part in terms of the purported function rather than of its structures or composition, it may be deemed "functional," and such a claim may also be called a "claim that contains functional limitations," or for short a "claim with functional limitations."

Of these, a claim is called a "purely functional claim" if it is defined by the purported purpose or effect only, without any reference to a technical solution to achieve such purpose or effect.

2. The requirement in pertinent part for claims with functional limitations in Guidelines for Patent Examination

A product claim should generally avoid limitations by function or effect whenever possible, which are permissible only when a limitation cannot be defined in terms of structure, or when limitation by structure is not as appropriate as by function or effect; moreover, such a limitation may be permissible only when the function or effect has been proven by the test result indicated in the written description, or is directly and positively verifiable by conventional method used in the pertinent technical field.

The technical feature in a functional limitation of a claim should be construed to embrace all the means that are capable of performing the function. A claim containing a functional limitation should be examined against whether the limitation is supported by the written description. Such a functional limitation in a claim may not be sustained if the function, embodied by the particular mode recited in the written description, may be performed by substitutive modes which a person skilled in the art could not perceive beyond the written description, or the person has reason to doubt the capability in one or more modes under the functional limitation of solving the technical problem intended by the invention or utility model to achieve the same technical effect, as the functional limitation may not embrace the aforesaid substitutive means or the means incapable of solving the technical problems.

Moreover, if the written description merely states in vague terms that substitutive modes may also exist, but a person of ordinary skill in the art cannot understand what they might be or how they might be used, then the functional limitation in the claim is not permitted. In addition, a pure functional claim cannot be supported by the written description, and therefore is not permitted.

II. Chinese approaches in the substantive examination

In specific substantive examinations, the following three approaches are generally adopted to handle "functional limitations in claims": whether a claim has been supported by the written description and clearly described according to the 4th paragraph of Article 26 of Patent Law; whether a claim lacks necessary technical features according to the 2nd paragraph of Article 22 of the Implementing Regulations of Patent Law; and whether a claim is novel and/or creative according to Article 22 of Patent Law. A patent protects a subject matter composed of technical features, not just the function or effect. From the practice of substantive examinations, it is not easy to search and examine all the technical features capable of performing said function or effect, and create an effective reference document within a reasonable and effective time limit. In addition, it is not easy to determine the extent to which functional limitations are permitted. So far no consensus has been reached as to whether a feature defined by function in a claim should be interpreted to be confined to specific means performing the said function set forth in the description, or interpreted to encompass all the means capable of performing the said function. Therefore, as regards the examination of a "claim defined by function," the author opines that primary consideration should go to determination of novelty and/or creativity in substantive examinations, enabling applicants to further limit their claims through amendments and/or observations, and limit the feature defined by function to specific means capable of performing the said function, so that the examination procedure will be effectively simplified.

1. Case 1

Claim: A composition of matter used in mammals for spraying and lubricating.

In the claim, "for spraying and lubricating" is a functional limitation. The written description discloses a composition under the invention which is any composition having the property of being sprayed and lubricating, and the lubricating property is realized when the composition is sprayed or otherwise applied to a surface; further limits personal lubricating composition under the invention to at least 8 within a time range of 100-900 seconds, preferably more than 8 within a time range between 100-900 seconds, and indicates said composition comprises at least one water-soluble polyols and water-soluble polymer, and points out that the composition may be: benzoic acid, potassium sorbate, sodium benzoate, propylparaben, sodium bisulfite, sassafras oil, sodium metabisulfite, sorbic acid, merthiolate, maleic acid and propyl gallate. The compound may also contain organic acids, such as benzoic acid, citric acid, linoleic acid, oxalic acid, ketoglutaric acid, tannic acid, humic acid, glycolic acid, gallic acid and malic acid, said water constituting rest of the composition for providing appropriate consistency, viscosity, sprayability and lubricity.

In the substantive examination, the examiner located a reference document which disclosed a sprayable skin care composition having technical features of: skin care composites, such as mica and/or talc (equivalent to the lubricating limitation of the claim); the composition being "sprayable," meaning it is liquid at 20℃, and capable of being applied on the skin by a common hand-held pump sprayer under normal finger pressure (equivalent to the spraying limitation); the composition being applicable to humans (equivalent to the mammal limitation), to evaluate the novelty of the claim.

During the substantive examination process, the examiner found that the technical features of the claim had a broad scope of protection. If the examination first goes to the determination of whether the features can be supported by the written description, then doubt will arise as to whether the features have covered all the means capable of performing the said function. There are numerous options to satisfy the single requirement of "the composition is lubricious" alone. If a doubt is raised, strong evidence to the contrary should be furnished, which would be time-consuming. Therefore, in line with the principle of simplifying the procedure, the examiner chose to prioritize determination of the novelty and/or creativity. Mica and talc are commonly used lubricating materials, and the claim does not contain mica and/or talc in the options of the said product, therefore, the examiner started with a search, got a reference document describing a product in full compliance with descriptions of the relevant product in the said claim. Therefore, given that the claim is apparently not novel, the applicant is certain to consider setting specific limitations on elements and/or parameters, so that the protection scope will be expressly defined to overcome the too broad protection scope arising from the definition by function.

2. Case 2

Claim: A system for delivering volatile material, said system comprising at least one volatile material containing one or more fragrant ingredients, said system providing a continuous maintenance level emission of at least one volatile material and/or a temporary boost level emission of at least one volatile material, said system being free of heat, pneumatic, or electrical sources, said at least one volatile material being delivered by means other than aerosol mechanically, and said fragrant ingredient making up at least about 40% by weight having a Kovat's Index of 1500 or more.

In the claim, "said delivery system provides a continuous maintenance level emission of at least one volatile material and/or a temporary boost level emission of at least one volatile material" is the technical feature defined by function. In the description, the maintenance level emission of volatile materials may exhibit a uniform intensity until substantially all the volatile materials are exhausted and human interaction is needed to deliver the said boost level emission. When the boost level emission mode is activated, the delivery system can automatically return to delivering volatile material(s) in the maintenance level emission mode without further human interaction and the boost level emission exhibits an emission intensity greater than or equal to the maintenance level emission.

In the substantive examination, the examiner provided a reference document disclosing a perfume polymeric particle with the following technical features: the particle can be used as a delivery system for the perfume raw materials ("PRMs"); such perfume polymeric particle, once deposited onto a substrate, provide a controlled, sustained release (equivalent to the continuous maintenance level emission) of PRMs, especially the volatile top notes, the most volatile PRMs (equivalent to the volatile substance in the claim), over an extended period of time; such particle can also optionally combine an adjunct ingredient in such a manner as to increase or enhance the deposition of PRMs onto a substrate and/or the release of PRMs from a substrate at any time point after said substrate has been exposed to said benefit agent delivery system (equivalent to the temporary boost level emission in the claim); herein the perfume is absorbed in, adsorbed on, or otherwise associated with the polymeric particle after the polymeric particle has been formed, and the association between the perfume and the polymeric particle excludes encapsulation (equivalent to that the said delivery system is free of a source of heat, gas, or electrical current, and wherein said at least one volatile material is not mechanically delivered by an aerosol in the claim); the perfume comprising one or more PRMs having a Kovats Index value of from about 1000 to about 1400 or having a Kovats Index value of greater than about 1700 (the value falls within the range of the technical features in the claim, namely, a Kovat's Index of 1500 or more). It is easy for the person having ordinary skill in the art to choose the appropriate content of volatile perfume on the basis of the intensity of the aroma, namely, it is the customary choice of technology, in a bid to rule against the creativity of the claim. The application will be deemed to have been withdrawn if the applicant fails to make amendments and/or observations within a specified period of time.

In the substantive examination, the examiner found that the technical feature in the application, namely, "said delivery system provides a continuous maintenance level emission of at least one volatile material and/or a temporary boost level emission of at least one volatile material", also has a broad scope of protection. If the examination first goes to the determination of whether the features can be supported by the description, then doubt will arise as to whether the features have covered all the means capable of performing the said function. If a doubt is raised, strong evidence to the contrary should be furnished, which will be time consuming. Besides, the description has further limited the "boost level emission" to activation by human interaction. Therefore, in line with the principle of simplifying procedure, the examiner chose to prioritize determination of the novelty and/or creativity. In the area where volatile substances are used as perfume, how to control emission of perfume has been a common problem and similar application of the delivery system will be a better solution. Furthermore, the claim does not contain a similar delivery system in the options; therefore, the examiner started with a search, created a reference document, ruled against the creativity, and urged the applicant to set limitations, so that the protection scope would be expressly defined to overcome the too broad protection scope arising from the definition by function.

Ⅲ.Conclusion

Currently there has been no consensus over the determination of a "functional limitation in claims" and judicial interpretation fails to offer any inconsistency with the examination guidelines. Given that, in substantive examinations, an examiner should adhere to the relevant provisions set forth in the Guidelines for Patent Examination, strictly examine functional limitations and raise objections resolutely, particularly when only a single embodiment is given in the written description by requiring the applicant delineate further limitations in the claim.

In the substantive examination, the examiner should strictly examine whether the "functional limitation" is supported by the written description, but priority can be given to the determination of its novelty and/or creativity in a bid to further limit the applicant's claim and clearly determine the protection scope of the claim.

In identifying a reference document, breakthrough may be made by analyzing the feature of function or effect in a claim, analyzing how the technical solutions in the claim accomplish the said technical function or effect on the basis of the written description and the cur rent technologies, and analyzing the role of the feature in the technical solutions to determine the impact of claimed function or effect on the claim's protection scope.

If the examiner finds a reference capable of determining the novelty and/or creativity, the examiner should resolutely require the applicant further define the functional limitation, say, to the scope disclosed by the written description, to prevent the finally authorized claim from having contents that have not been disclosed in the written description or do not belong to the common knowledge in the field. In this way, the claim may be granted a right scope of protection, and the public interests may also be guaranteed, thus effectively simplifying the examination process.

(Translated by Wang Hongjun)