After years of hard work, you finally have an invention and file for a patent application. Some time later, the application is reviewed by an examiner at the US Patent and Trademark Office (USPTO), and an Office Action is issued that states various reasons why the application is being rejected. One of the reasons is that your invention is 'obvious'.

Obvious? How is that possible?

The patentability requirement of nonobviousness is a hurdle often faced by inventors negotiating meaningful patent protection from the USPTO. Recent decisions from the courts have made an obviousness rejection more difficult to overcome (Box 1). But, as we outline below, a better understanding of the obviousness hurdle and how to overcome it may mean the difference between success and failure in the prosecution process and ultimately obtaining protection for your innovations.

I could have thought of that

The legal analysis underlying a conclusion of obviousness is complex, and the USPTO, courts, attorneys and commentators have grappled with the concept for just about as long as patent protection has been available in the US1. Therefore, we start with a gross oversimplification: obviousness is exactly what one would think. In essence, it is the examiner concluding, 'I could have thought of that'.

To be more technically correct, obviousness is the legal conclusion that (back when the invention was made) a hypothetical person with adequate background and skill in the relevant technical field would have followed an existing motivation to solve a known problem in order to combine the teachings from the references (unearthed by the examiner) that were in existence at the time of filing, and thus create the invention (note that the 'known problem' does not have to be the same problem that the inventor is solving).

In practice, an examiner may peruse the application, look at the listing of claims being made and pick out certain aspects of those claims. He or she may then search the literature that was available prior to the filing date of the application and find those aspects, piece by piece, in one or more references. In drafting the obviousness rejection, the examiner will articulate some rational basis as to why one might combine these references to produce the claimed invention.

As is apparent from such a scenario, the conclusion of obviousness is necessarily made looking back, and therefore, hindsight is an important problem. Examiners do what they can with their limited time to review the application and the plethora of papers thrown at them by attorneys. However, to overcome such a rejection, the inventor may need to explain to the examiner (and to the attorney) why the conclusion of obviousness is not a reasonable one and why the picture painted by the examiner is not an accurate portrayal of the state of the technical field at the time of invention.

Prepare to attack

As an inventor, you may think, "Okay, so the examiner takes two or three patents (or other references) that do not even deal with the same problem as my invention and then calls the invention 'obvious'? That must be easy to overcome." Not necessarily. That is why your input is key.

After the initial obviousness rejection from the USPTO, the 'burden of persuasion' is on you, the applicant. There are different ways to go about responding to the rejection, which can be generally divided into the two categories of 'attack' and 'rebut'.

To illustrate the difference in practical terms, which would you prefer: being asked by your attorney to talk about the field and state of the art at the time of filing (gathering evidence to attack) or being told to conduct a complicated and expensive set of experiments in a short, fixed time period (gathering evidence to rebut)? Naturally, attacking is preferable. Therefore, the discussion that follows is focused on this. Do remember, however, that you are attacking the rejection, not the examiner. It is the examiner's job to play the devil's advocate, and by doing this job properly, the examiner can actually make your patent (once issued) stronger by building a strong foundational administrative history2.

The presentation of evidence against obviousness—that is, a presentation of relevant facts from which a legal conclusion of nonobviousness should follow—is an area of frequent deficiency among applicants. For many years, a de minimis approach has generally been used to respond to obviousness rejections. However, recent developments in the law instruct otherwise.

Therefore, it is important for you—the inventor—and your attorney to dig deep and present the best evidence in support of your invention. Furthermore, the best evidence and arguments should be presented sooner rather than later during prosecution.

Consideration of what evidence to present against a finding of obviousness should be done in concert with the attorney's arguments and overall strategy. Evidence is normally presented into the prosecution record by submitting published articles, affidavits or declarations, which are testimonial evidence and/or testimonial presentation of other evidence (e.g., unpublished results; Box 2), and/or by visiting the USPTO and meeting with the examiner (Box 3).

Upon presenting evidence and arguments against the obviousness rejection, the examiner must consider all evidence anew and determine obviousness based on the entire record. The examiner may thereafter maintain the rejection, withdraw the rejection or issue a new rejection. However, the examiner should clearly state his or her findings of fact, both to allow an opportunity to challenge those findings and to build a clear record3.

Inventor insight

How can you help as an inventor? Prepare for the rejection early. Thoroughly search the literature and discuss possible arguments with the attorney. Tell the attorney any information that may be useful in attacking an obviousness rejection, such as your reasoning or other evidence that one trained in the field would come to a different conclusion after consideration of the references used by the examiner.

For example, in the case of Forest Laboratories, Inc. v. Ivax4, the US Court of Appeals for the Federal Circuit, in considering whether it would have been obvious to resolve the positive enantiomer compound found in citalopram (named escitalopram), examined the state of the science at the time of invention and found that a person with ordinary skill in the art would generally have been motivated to develop new compounds rather than undertake the difficult and unpredictable task of resolving a known racemate. The court also found that a person of ordinary skill would have had no reasonable expectation of success in resolving the racemate, given the relatively new and unpredictable technique of high performance liquid chromatography at the time of the invention and evidence of failed attempts to purify the citalopram racemate at that time (in the mid-1980s).

The Forest Labs case highlights the importance of painting a picture of the state of the art when the invention was made. One commentator has likened the inventive moment to finding just the right needles in the haystack5. If the roadmap to those needles was available after the fact (hindsight), it may be easy to forget the massive haystack that had enveloped those needles before the roadmap was known.

Along these lines, good record keeping is important. You should save the praise the invention received after it was unveiled. Publications in top journals and overall praise from peers are good forms of evidence against obviousness. Also save the comments of the peers who doubted your predictions. One of the best weapons against a conclusion of obviousness could be a rejected grant proposal with a comment from a peer stating the invention won't work.

You, the inventor, can play devil's advocate too: if you received your invention as a grant proposal, what criticisms might you make? How would you back up those criticisms? This thought process can be extremely effective in generating the type of evidence your attorney needs to attack the rejection.

Consideration of commercial impact, to the extent that the commercial impact can be attributed to the invention (and not merely to aggressive marketing), may also lead to evidence in the form of unexpected results or technological advantages not previously appreciated by peers.

Whenever possible, evidence should be presented with arguments that are clear, succinct and easily understandable. Technical jargon should be avoided. Though examiners are technically trained, they have only a limited period of time to become acquainted with the technical details of your particular invention. Even more importantly, in litigating the issued patent, the validity decision falls on judges, who, for the most part, are not technically trained. According to Judge Arthur M. Smith, "This is a challenge which can be met only by very clear writing addressed to this 'non-technical' audience"6.

A stitch in time saves nine

If this all sounds hard, there are things that can be done to make it easier. You can build a plan of response to the obviousness rejection into the application at the time of initial filing—a poorly or hastily written application cannot be fixed later!

Have in-depth discussions with your attorney to prepare a comprehensive and accurate patent application that will explain the invention in the proper context and aid in attacking an obviousness rejection during prosecution. For example, the application may detail the general state of related technology at the time of filing and how the invention is unique. The application should give the reader an accurate picture of the haystack of ideas you faced at the time your invention was developed. This picture not only will set the stage for the presentation of the invention to the examiner but also will serve to refresh your and your attorney's memory when faced with an obviousness rejection some years later.

Keep in mind that the patent application "constitute[s] one of the most difficult legal instruments to draw with accuracy"7. Many other (less meritorious) patent applications are written so that even an experienced patent attorney is left to wonder, 'What is the invention, anyway?'6. Careful research and preparation will make your well-drafted application stand out on the examiner's desk at the outset of prosecution.

Conclusion—inventors taking action

Inventor input is crucial to overcome the obviousness hurdle during patent prosecution. When faced with a rejection based on obviousness, it is important for an inventor to consider and discuss with an attorney the available evidence that may be used to attack the rejection. In view of the available evidence, the inventor and attorney should review the examiner's stated reasoning behind the rejection and point out flaws in that reasoning. Inventors should also participate in drafting and editing any prepared declaration and be prepared to speak directly with the examiner in an interview.

Active participation by the inventor in attacking an obviousness rejection not only will aid in procuring the patent but also will build a strong prosecution administrative history for a patent that may later be litigated.