What are Rule 132 Declarations and When Do I Need Them? Episode 96

Not to Be Confused with Inventorship Declarations

I know what you’re thinking—“Wasn’t Episode 29 about declarations?”—because of course you’ve memorized all my episode topics. Episode 29 was about inventorship declarations.

An inventorship declaration is a one-page document that you have to file with the Patent Office, where you declare—under penalty of fine and jail—that you are the inventor of the application you’re filing. In other words, you’re saying that you didn’t steal someone else’s invention and try to file it as your own.

That’s one kind of declaration—you’re declaring that you’re the inventor.

Rule 132 Declarations: A Different Kind of Declaration

But this is a different kind of declaration. It’s called a Rule 132 declaration because there’s a rule in the Code of Federal Regulations, specifically 37 CFR § 1.132. So we just call it a 132 declaration, and it’s used when your application gets rejected—usually when you have to prove something to the examiner.

One thing you have to know is that argument is not proof.

Why You Can’t Rely Solely on Attorney Argument

So if the examiner says that your invention, which combines A and B, is obvious to a person having ordinary skill in the art and therefore not patentable, and you respond by saying, “It’s not obvious to a person having ordinary skill in the art, so it’s patentable”—that’s just an attorney argument.

You have to provide factual evidence to back up your claim that it’s not obvious. If you say, “This combination produced unexpected results, and unexpected results mean that it’s not obvious,” then yes, that’s true—unexpected results support nonobviousness—but what are your facts to show that the results were unexpected?

What a Rule 132 Declaration Does

What you have to do is file a declaration that contains facts and arguments. You declare that the facts in the document are true. Usually, it must be submitted before your final rejection. You can submit a Request for Continued Examination (RCE) and then file a declaration, but you generally can’t just submit one after a final rejection without doing something else.

Who Submits the Declaration and What It Contains

Most of the time, you get an expert in the field to lay out facts and opinions to help you overcome a rejection—usually an obviousness rejection, though sometimes it may be for another reason.

So what goes in it?

First, you have to say who you are. Are you an employee of the inventor? Were you paid by the inventor for your opinion? That’s fine—people often get paid for their time—but you need to disclose it.

Then you write down your qualifications. Let’s say it’s a drug patent. You might say you have a bachelor’s in chemistry, a Ph.D. in pharmacology, 20 years of experience in drug development, and 15 published papers in the field.

An Example: Hair Loss Treatment

Then you present some facts. Let’s say the patent is for a drug that combines two different hair loss drugs into a combination treatment.

Drug A reduces hair loss by 10%. Drug B reduces hair loss by 10%. You come up with a new treatment that just puts Drug A and Drug B together in one pill.

The examiner might say it’s obvious to combine them because it would be expected to result in a slightly better hair loss treatment.

That kind of makes sense. But let’s say everyone in the industry thought that combining Drug A and Drug B would form a dangerous compound or that they would counteract each other and have no effect on hair loss at all.

In that case, the expert would write a declaration laying out all these facts and explain why no one would have thought to combine the two. That makes the invention non-obvious—because no one expected it to work.

Why the Expert Declaration Is So Important

You can’t just have the attorney say this. I mean, you can try—but the examiner probably isn’t going to change her mind. She’ll just say it’s an unsupported attorney argument.

Because maybe when you originally wrote the application, you didn’t include all the reasons the combination was non-obvious. You need to get this evidence into the record.

What If You Don’t Want to Pay an Expert?

Now, in theory, if you don’t want to pay an expert, the attorney can submit a declaration stating that certain scientific papers are true copies of journal articles. If those papers support your argument, that’s fine.

But it’s much more powerful to have an actual expert say that something is non-obvious. Because the standard for obviousness isn’t what’s obvious to a patent attorney or examiner—it’s what’s obvious to a person having ordinary skill in the art.

So if we’re talking about a new drug treatment, that person is going to be a pharmacologist. If a pharmacologist is on record saying the combination isn’t obvious, that’s going to be more persuasive.

This doesn’t mean your application will be allowed for sure—but it definitely puts you in a better position.

When and Why Rule 132 Declarations Are Filed

That’s just one example of how a Rule 132 declaration is used. The most common use is to have someone considered a person of ordinary skill in the art explain why a modification of the prior art or addition of a feature isn’t obvious.

How to Possibly Avoid the Need for One

One way to hopefully avoid needing a Rule 132 declaration—especially for scientific-type patents—is to include a lot of experiments and test results in the application itself.

That way, the attorney can make arguments based on the existing record, and the examiner can directly see the advantages and how the invention is superior to the prior art.

Using Colleagues or Third Parties

Another good strategy is to see if you have colleagues who are willing to write a declaration at no cost. That’s better, because they are third parties and not directly tied to the invention. They have no vested interest in the outcome, so their declarations carry more weight than those from someone who stands to benefit from the patent being granted.

That’s pretty much the basics of a Rule 132 declaration.

I’m Adam Diament, and until next time, keep on inventing.