Patent Applications: Inventive Step Objections 27 August 2022

Introduction

When is an idea eligible for patent deemed inventive? What criteria are applied for assessing inventiveness? Which strategies work best to disprove the innovative step objection? These are the basic questions for anyone interested in applying for a patent.

In India, for a patent to be granted, it must satisfy the requirements outlined in Section 2(1)(j) regarding novelty, Section 2(1)(ja) regarding an inventive step or non-obviousness for a “person competent in the field” concerning achieving the goals of financial gain, technical advancement, or both, and Section 2(1)(ac) concerning industrial application. It also must not violate Sections 3 and 4 of the Indian Patent Act, 1970.

If we had to rank these three needs according to significance, “Industrial Application” might be the most important, followed by “Novelty” and then “Inventive Step.” The industrial applicability, or “Utility” as it is known in many countries, is easier to prove than innovation, nevertheless.

It can be the simplest to locate the Industrial Application. The need for novelty is less complex; it only calls for a “new” product or “process” in all cases. However, proving the same or defending an application to overcome an objection on such grounds may be very tough and complex when it comes to the “inventive step.” It is important to remember that the standards for patent eligibility—novelty and industrial application—were once separated, with the requirement for the Inventive Step being relatively recent.

Novel Approach and Non-Obviousness

 A compilation and repackaging of previously existing knowledge is not acceptable for an invention or innovation, as per the Inventive Step’s guiding principle. When a patent is obvious, it means that previous art references (which can be combined to expose every last element of a patent claim) would be known to someone with an “ordinary” understanding of the subject matter. 

The abstract concept is simply unworkable, thus it needs to be grounded in reality and incorporate advancements in technology beyond what is now considered state-of-the-art. The US Supreme Court considered three elements known as the Graham Test—the breadth of the prior art, how the claims differ from the prior, and the degree of artistic skill—when determining whether a claim was not obvious. 

The Inventive step was inspired by the historic case of M/s. Bishwanath Prasad Radhey Shyam Appellant v. M/s. Hindustan Metal Industries was heard before the Indian Supreme Court. Enercon (India) Limited v. Alloys Wobben is a significant case in India concerning the application of the Inventive Step interpretation.

The Indian Patent Act of 1970 does not define the word “state-of-the-art,” but several case laws suggest that it relates to prior knowledge and use that, if applied and would have been expected, would have violated the patentee’s claim. 

Any innovation that was made publicly available before the date of priority of the invention through written or spoken descriptions or any other method is referred to as “state-of-the-art” and encompasses any product, method, or information about any of these.

The inventive step can be assessed using a straightforward approach to problem-solving. A single invention cannot include the combined teaching of the art(s); so, it must be creative and difficult for a person with expertise in the art to understand.

Defining the inventive step in terms of improved efficacy, precision, selectivity, and so forth is another way to support it. The Windsurfing International v. Tabur Marine case established the four-step analysis of obviousness, which the court reiterated in the Bishwanth Prasad case. 

Recognizing creative steps in the form of previously disclosed (usage, art, or knowledge) is the first stage. Second, one must distinguish between stuff that is already known and innovation that has been asserted by an informed individual; Third, it is imperative to establish or observe differences between the claimed innovation of the previously indicated competent individual, and Fourth, the scope of the invention.

The innovative step is important because it allows companies to keep coming up with new ideas without worrying about violating patent laws. Rather than stopping natural progress, this clause allows firms to continue improving their systems to save money and resources.

It is important to evaluate the functional component of the invention separately from its structural aspect. Finding a solution to a particular problem requires a lot of trial and creativity. An innovator can never begin to search for a workable solution before a problem is identified as being in the domain. Finding a solution requires a great deal of work, as well as extensive parameter calibration and optimization for both process and product characteristics. 

An observer may perceive a solution as obvious once it has been achieved or is short, which is known as hindsight bias and is covered in more detail in the section that follows. In light of the aforementioned prior arts, the claimed procedure’s function on the necessary substrate may be taken into consideration when evaluating the current invention.

Individuals with Ordinary Skill in the Art or Someone with Skill in the Art (PHOSITA)

Determining whether a subject matter is novel or not can be done so easily and unambiguously through a search; however, determining an inventive step can always be difficult because it calls for both an objective verification and a subjective assessment, or whether someone with the necessary skills could have made the invention given the information available at a given time, place, and causality. 

This analysis of the three dynamic factors—time, distance, and causation—is crucial because, as is customary, the study of a proposed invention submitted in a patent application takes place at a later period and necessitates evaluation of an earlier innovation.

The phraseology used to describe the “Inventive Step” requirement varies depending on who is interpreting it. The Indian Patent Act refers to a “Person Skilled in the Art,” although the level of skill may never be precisely defined in practice. The US Patent Act defines the hypothetical reference person as a “Person Having Ordinary Skill in the Art (PHOSITA)”, providing a certain amount of discretion to the user in defining the terms “ordinary” and “skill. The US Patent Act defines the hypothetical reference person as a “Person Having Ordinary Skill in the Art (PHOSITA)”, leaving the examining authority with some discretion over the identification of an inventive step, and without any particular definitional limitations on the terms “ordinary” and “skill.”

Retrospective Prejudice

Hindsight bias is the tendency to predict a consequence after it has already occurred. Legal systems frequently exhibit hindsight bias. Hindsight bias affects the criteria used in patent law to determine patentability, such as inventive steps or non-obviousness. while someone evaluates prior events or acts while they are aware of how those actions or events transpired, this is known as hindsight bias. 

This bias is especially apparent when analyzing the likelihood, predictability, or predictability of earlier art from an ex-ante perspective. Because hindsight bias causes individuals to believe that the subject of the judgment should have known what would happen and made plans for it, it also causes people to judge other people harshly.

Hindsight bias is a critical issue in patent law because determining whether an invention incorporates an inventive step is a highly subjective determination that can be influenced by the evaluator’s recollections of the past, and because it frequently appears at the center of patent inspection and litigation. Hindsight bias arises in inventive step analysis when juries, judges, and patent examiners evaluate patent applications while being aware of the invention in question and how it differs from previously established methods or tools. 

Because of their understanding, those judges are more likely to rule that an invention is obvious and refuse to issue a patent. While courts have employed many measures to combat hindsight bias, relatively few of these tactics have proven effective.

Less hindsight is reduced by simple teaching than by processes that force evaluators to adopt a foresight mindset and produce alternate possible outcomes. Some additional steps that are known to reduce the influence of hindsight bias should be taken by patent offices in conjunction with courts. Knowledge and experience in a particular field reduce hindsight bias, allowing patent examiners who are knowledgeable in technical matters and acquainted with the obviousness standard to evaluate an invention impartially.

Strategies

It becomes difficult to persuade the Controller that it would be evident for PHOSITA to utilize the claimed combination of the prior arts when the Controller asserts that the claimed topic of discussion lacks an innovative step as a result of a combination of previous arts.

The counterintuitive (CI) Approach is a tactic for supporting the applicant’s arguments based on “Prior art Teachings and Motivation”. This method establishes the creative process or non-obviousness status by limiting the combination(s) of the different previous art. It is with the help of these arguments that the controller is convinced that it “wouldn’t be clear to an individual skilled in the field to go against what is known and integrate the prior arts.” 

The reasoning put forth to dispute the inventive step in Indian Patent Application No.: 201817044581 is admirable. The case’s first examination report (FER) raises problems related to inventive step, non-patentability, scope, clarity, and definitiveness as well as the adequate disclosure of information. 

The invention is related to a stable liquid pharmaceutical formulation that contains the following ingredients: (A) infliximab; (B) 0.001 to 5% (w/v) of a surfactant consisting of sodium dodecyl sulfate, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene alkyl ether, alkyl phenyl polyoxyethylene ether, polyoxyethylene-polyoxypropylene copolymers, or a combination of two or more of these; (C) 0.1 to 30% (w/v) of one or more sugar and/or its derivative chosen from the group consisting of sorbitol, mannitol, sucrose, and trehalose; and (D) a buffer consisting of Histidine or acetate.

The technical aspects of the invention were distinguished from those of the referenced prior arts, and this distinction was used to support the non-obviousness or inventive step claim. 

The response draft offered unique technical improvements over the FER-cited materials. During the examination process, the learned examiner’s cited prior arts are presented at the beginning of the argument. The technical features of the invention are then illustrated, along with how their inclusion advances the idea and fixes an existing issue with the specific technology. 

For example, the invention’s liquid formulation relates to infliximab, whereas the relevant sources discuss adalimumab. Moreover, adalimumab is a human antibody, but infliximab is derived from a murine source. The architectures and amino acid sequences of the two antibodies differ. The formulations have the same composition but differ in excellent ways due to the varied antibodies, allowing for improved stability, low viscosity, and long-term storage capacity. This makes the invention unique and non-obvious. The specific instances and supplementary materials provided in the defense provide strong support for the technical features of the invention. 

Conclusion

While addressing the absence of creative actions, it is usually desirable to back the main line of arguments with technically competent approaches. Examining whether an invention is obvious to a person of ordinary skill—that is, if it represents an inventive step—is a crucial stage in deciding whether or not to grant a patent for it. 

An incremental invention cannot be limited to a workshop improvement; rather, it must improve the underlying technology in comparison to what is already known. Therefore, for a patent application to be approved, it must meet the inventive step requirement in addition to the novelty and industrial applicability requirements.

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