Having Trouble Getting a Biotech Patent to Issue? Expert Declarations Can Clear the Way.

Biotech innovation is regularly faced with a thicket of prior art that applicants must navigate during patent prosecution. Examiners at the U.S. Patent and Trademark Office (USPTO) often combine various pieces of prior art to reject the claims as obvious. As we discuss in our recent article, arguments that can be made to overcome obviousness rejections, focus on the following with respect to the cited prior art:

• all the elements of the claims are not disclosed;

• a lack of a motivation to combine;

• no reasonable expectation of success; and

• “secondary considerations” such as unexpected results.

A well-crafted declaration supporting “no reasonable expectation of success” and/or the related argument of unexpected results, unlike attorney argument alone, can be the key element that overcomes an obviousness rejection.

In this article, we explain how to use declarations of scientists (e.g., inventors), referred to as 37 CFR 1.132 declarations, to effectively attack reasonable expectation of success and/or demonstrate unexpected results as part of overcoming a prima facie obviousness rejection, and in support of secondary considerations, respectively. These declarations are particularly helpful in biotech patent applications, where a declaration of a scientist, such as an inventor, is often effective at overcoming obviousness rejections during patent prosecution. While preparing a 1.132 declaration can incur somewhat significant internal resource and monetary costs (e.g., conducting experiments and drafting the declaration), the potential payoff in terms of its impact in convincing examiners and obtaining valuable patent protection often justifies the investment. Furthermore, a declaration can often be used in related cases, deriving more benefits and spreading out the cost over multiple applications.

I. Why Use 37 CFR 1.132 Declarations

Under U.S. patent law, a claimed invention must be non-obvious to be patentable. An invention is obvious if a skilled artisan could combine teachings in prior art documents (patent publications, scientific literature, etc.) to generate the claimed invention, and the skilled artisan would have a motivation to combine the documents with a reasonable expectation of success.

In many biotech fields, there is dense prior art that can make the claimed invention seem like a simple combination of previous teachings. However, biotech inventions are frequently unpredictable. For example, a new biologic may behave very differently from similar compounds, or changing PCR steps may save time or allow new functionalities. Even relatively small changes in complex systems can lead to large effects, or sometimes opposite effects to what is expected.

Examiners are not required to and, in our experience, often do not accept mere attorney arguments regarding prior art, especially if the arguments relate to reasonable expectation of success/unexpected results or motivation to combine. However, attorney arguments supported by a declaration of a skilled artisan regarding the teachings of prior art document(s), the state of the art at the time of filing, and/or the interpretation of experimental data showing the unexpected results, are frequently persuasive. Such information can, and should be, included in a declaration under 37 CFR 1.132 that is filed with a response to an office action.

II. The What, When, and How of 37 CFR 1.132 Declarations

What are they?

A 1.132 declaration is a formal statement filed during patent prosecution to present evidence that refutes an Examiner’s rejection. For obviousness rejections, the declaration can include experimental data, expert opinions, or other forms of evidence that demonstrate why the claimed invention is non-obvious. The USPTO requires that a 1.132 declaration includes clear and convincing evidence. The evidence can include experimental results and comparisons to prior art, that are discussed in the declaration from an expert, which must directly relate to the inventive concept(s) in the claims. Note, a vague assertion of unexpectedness without supporting evidence will not be sufficient.

When to file?

Although 1.132 declarations can be filed at virtually any time during patent prosecution, the best time to submit a 1.132 declaration is in response to a non-final office action, so there is an opportunity to amend the claims or submit additional evidence in response to a final office action. Furthermore, declarations before or especially after an examiner interview after a non-final office action, can be very effective. If the unexpected results are strong, but the Examiner remains unconvinced, the declaration will be helpful in an appeal to the Patent and Trademark Appeal Board. Note 1.132 declarations filed after a final office action must include a “showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier presented,” (MPEP 716.01(A)(3); 37 CFR 1.16(e)).

How to draft?

An effective 1.132 declaration requires tight collaboration between the legal team and the inventors. Patent professionals should work closely with scientists to ensure that the data is robust and the declaration is scientifically sound; and scientists should review and provide feedback on the declaration, confirming its accuracy and their comfort in its contents. It is likely that the scientist whose declaration is provided (i.e., signs the 1.132 declaration) will be deposed if there is litigation involving a patent that issues from an application where the 1.132 declaration was filed.

III. Crafting an Effective 37 CFR 1.132 Declaration

A successful 1.132 declaration is more than just a technical document—it is a factually accurate, persuasive document supported by data. Typically, the declaration is signed by one of the inventors on the application, but it could be signed by a skilled artisan or a technical expert who is not an inventor. The declaration should contain a caption with bibliographic details about the application (typically mirroring the caption in the response). Then the following sections (as needed) are separated into numbered paragraphs:

• Introduction: details about the declarant, and their background demonstrating experience in the field of the invention (e.g., education, work history, publications, inventor status, etc.);

• Purpose: a clear statement explaining that the declaration is submitted as part of/in support of a response to the specific office action being addressed;

• Experimental Methods: a summary of the methods used to generate the unexpected results. It is important to provide a more detailed write-up of the experiment as well, which can be submitted along with the declaration. Controls and statistical analyses strengthen the unexpected results.

• Unexpected Results: a thorough explanation of the unexpected results of the claimed invention. These results could be improvements in efficacy, stability, specificity, or other performance metrics, and should be tied directly to the scientific data. The declaration should clearly explain why the results would not have been predictable based on the known prior art, including the cited prior art if possible, and how the unique aspects of the invention contribute to the surprising outcome. This is the most important part of the declaration, and the language should be carefully reviewed and consistent with the claim language and scope.

• Clear Causality: an explicit statement, backed by the data and/or sound scientific explanation, that the unexpected results are directly linked to at least one inventive element in the claims is very important. The inventive feature could be any inventive feature, such as a mutation of a nucleic acid or amino acid, a new chemical compound, a new combination of known elements, a composition with a new characteristic (e.g., cell surface marker), a new step in a process, etc.

• Legal Statements for Declarations¹: if as suggested here, a declaration is used and not an affidavit, then the declaration must include that “willful false statements and the like are punishable by fine or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity of the application or any patent issuing thereon. The declarant must set forth in the body of the declaration that all statements made of the declarant's own knowledge are true and that all statements made on information and belief are believed to be true.” (37 CFR 1.68).

• Signature and Date Line: place for the declarant to sign and date the declaration.

Best Practices for Drafting

• Use clear, concise, and consistent language.

• Describe the methods and results using words that are aligned with claim language; or at the very least, tie the parts from the experiment to claim language.

• Avoid internal jargon and ensure that the data is presented in an accessible manner to the Examiner.

• Ensure experimental data is reproducible and based on scientifically rigorous protocols that can be understood by, and have enough detail to be convincing to, a skilled artisan (See our prior post on experimental writeups).

• Organize and structure the declaration logically, with a clear connection between the experimental data and the conclusion, which will be cited by the patent attorney in their argument for non-obviousness in the citing response.

Common Pitfalls to Avoid

• Vague conclusions of unexpected results without experimental backup.

• Weak or non-quantitative data that does not clearly demonstrate the invention’s unexpected results.

• Failure to demonstrate causality between the unexpected result and the inventive feature of the claims.

Conclusion

In the competitive and fast-paced biotech industry, securing patent protection can be challenging because of a thicket of prior art, but is critical to the value of most biotech companies. Using 37 CFR 1.132 declarations to demonstrate unexpected results/success where there was not a reasonable expectation, can be a highly effective strategy for overcoming obviousness rejections. By presenting compelling scientific data and analysis showing unexpected results/success that is aligned with claim language and scope, biotech companies can show that their inventions are not simply routine combinations of prior art, but rather groundbreaking advancements. Patent professionals and companies can and should leverage these declarations to improve their chances of securing robust patent protection for their innovative products.

FOOTNOTE

¹ Evidence submitted under 37 CFR 1.132 can be submitted as an affidavit rather than a declaration. The substantive content of an affidavit or a declaration can be identical. However, an affidavit “is a statement in writing made under oath before a notary public, magistrate, or officer authorized to administer oaths” (MPEP 716) and, as such, does not require the legal statements of a declaration. (see, e.g., 37 CFR 1.68; 28 U.S.C. § 1746; MPEP § 602).

---

About DHL

Double Helix Law (DHL) has decades of experience building strong patent portfolios for life science companies. Learn more about DHL and meet the team.

Want to stay updated on life science patent law? Subscribe to get notified of updates

---

The content on this website (including all pages, articles, and comments) is not legal advice, and does not and is not intended to form or constitute any attorney-client relationship. The content is not a solicitation for business; it is for educational and entertainment purposes only, and reflects the personal views of the author(s) only and not those of any past, present, or future client of DHL. Any content should be double-checked for accuracy and current applicability, and liability is disclaimed for any error or omission.

4/21/25 Published (MM, EJV)