4 TIPS TO GET DIFFICULT BIOTECH PATENTS TO ISSUE IN THE U.S.

(Check out the short version of this post, if you don't want all the details in this patent professional version.)

Introduction:

It can often be difficult to get valuable patents covering biotech inventions to issue in the U.S. This is especially true if your patent team files quick and minimal patent applications and Office Action Responses, and uses a traditional reactive patent prosecution “strategy”. Alternatively, in this post, we provide 4 proactive and effective patent prep and pros tips, that we have successfully used to get difficult biotech patents to issue in the U.S. for clients.

1. FILE A ROBUST PATENT APPLICATION

   • It starts at the top; Give yourself your best chance at success with a robust patent application filing that includes the following:

     • Numerous types of claims.

       • Active ingredient compositions, combination compositions, reaction mixtures, formulations, methods of using, methods of making, etc.

     • Claimed embodiments that cover various combinations of claim elements and claim scope.

       • Narrow concept A with broad concept B and broad concept A with narrow concept B.

       • A1+B1+B2+C1; A1+C1+D1, A1+B2+C2, A1+C1+C2+C3+C4, etc.

     • Different claiming strategies to cover an inventive concept.

       • e.g., Recombinant virus with novel surface marker, Recombinant virus with novel genome encoding novel surface marker, Method of activating a cell expressing target receptor A by contacting the cell with the recombinant virus, etc.

     • Well thought-out fallbacks for key claim elements based on a good understanding of the prior art.

       • Numerous broad to narrow fallbacks for key concepts (e.g., numerous ranges of values around prior art and focused on “sweet spot” supported by working examples).

       • Negative limitation(s) excluding inferior related elements taught in art.

       • Novel sequence(s) and combination(s) of method steps, etc.

   • Working examples that provide surprising results to support key embodiment.

     • Ideally surprising results provide a function/feature that solves problem(s) identified in art and disclosed in your patent application.

   
   

2. FILE A DECLARATION DURING PROSECUTION WITH SUPPORTIVE AND SURPRISING DATA

   • Strengthen your Office Action response with a Declaration that supports your arguments.

     • See our prior Declarations blog post.

     • Signed by an inventor, skilled artisan or knowledge leader (KOL).

     • Assure Declarant carefully reviews and agrees with arguments, conclusions, and accuracy of factual statements in Declaration.

       • Assure Declarant understands they will likely be deposed re: Declaration if patent is litigated.

     • Include surprising experimental data to support conclusions.

     • Cite and quote prior art to support statements in Declaration re: long-standing problems in the art.

   
   

3. INTERVIEW YOUR PATENT EXAMINER

   • Better understand issues that your patent examiner has with your pending claims.

   • Build rapport with your examiner.

     • Be respectful to your examiner.

     • Avoid negative confrontations.

     • Let examiner see that you are reasonable and personable.

   • Assure your examiner understands your technology and best patentability arguments.

     • Explain key claim(s) using diagrams (preferably in application) when possible.

   • Assure your examiner understands the real-world impact of your claimed invention.

   • Have inventor participate in interview, and assure inventor understands

     1. the boundaries for issues discussed at the interview;

     2. the impact of statements made during the interview; and

     3. that the patent professional will lead the interview.

   • Interviews can be particularly effective after filing a Declaration, or after sending a draft Declaration to the examiner.

   
   

4. FILE MULTIPLE PATENT APPLICATIONS COVERING RELATED INVENTIONS TO ASSURE A FAIR EXAMINATION

   • File national stage, non-provisional U.S., divisional U.S., and continuation-in-part (CIP) applications for related inventions.

     • Gets your related claimed inventions examined by numerous patent examiners.

     • Gives you feedback on different claiming strategies.

       • File initial applications with tertiary claim strategies that provide insight into more valuable strategies for future continuations (CONs).

     • Opportunities often arise in biotech to file a CIP(s) within 2-4 years (e.g., adding more working Example(s)) after an initial provisional filing with highly related disclosures to a pending application, as a fallback application.

       • CIPs usually get different examiners in the U.S.

   • Aggressively pursue CONs after identification of a promising claim strategy with a fair examiner that understands your claimed invention and the prior art.

     • File Track One application(s) for expedited examination.

     • Build promising claiming strategy using many of the same elements.

       • Examiners appreciate that they can utilize their prior understanding and examination for efficiency.

Conclusion:

We have effectively used these 4 patent prep and pros tips to get difficult biotech patents to issue in the U.S. for our clients. We are confident that these tips will help you get difficult patents to issue for your clients too.

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.

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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.

7/9/25 Published (EJV) (Thanks to MM, VV, and DV for their review and suggestions.)