Trouble Getting Biotech Patents to Issue? Don't Blame the Examiner.

Why Your Biotech Patent Keeps Getting Rejected, and What to Do About It.

If your biotech patent application keeps getting rejected, it’s tempting to blame the patent examiner. But in most cases, the real issue is a weak patenting strategy or poor execution — both of which can be fixed.

Here’s how to diagnose what’s going wrong and turn things around.

Point 1 – Are You Relying on Only One Examiner and One Claiming Strategy?

If you have only one application, one examiner, and one claiming strategy, you’re putting your biotech invention at unnecessary risk. When a single examiner controls the fate of your entire patent family, a negative decision or entrenched position can stall your protection for years.

For important biotech inventions, a smarter approach is to diversify your claiming strategies across multiple patent applications that have at least slightly different detailed descriptions, so the USPTO assigns them to different examiners.

And test your favorite claim elements in narrow or less important claims first. This way you can get one or several examiners’ views of the element before pursuing your most important claims. You cannot shop for an easy examiner, but you can assure you get a fair examination.

Point 2 – Did You Build Rapport with the Examiner?

A well-prepared examiner interview can make or break your biotech patent prosecution. These calls are your opportunity to guide the examiner’s understanding of your invention, clarify misunderstandings, and build trust. When rapport is strong, examiners are often more open to considering your arguments and proposed claim amendments.

Go into every interview with clear, concise talking points that connect directly to your claim language. Make sure your arguments are aligned with the scope of your claims, and avoid overreaching. Good rapport doesn’t mean an easy allowance, but it can mean a fair and productive path forward.

Point 3 – Did You Use Data Effectively?

In biotech, data is your strongest ally and is important in your specification and during prosecution in inventor declarations. Data should be directly relevant to the claims and commensurate in scope with your arguments. Overly general or misaligned data won’t persuade an examiner and can even weaken your position.

Make sure that experimental results filed with the USPTO clearly show how your invention meets patentability requirements. Data that’s tightly matched to the claim scope gives you a stronger foundation to rebut rejections and distinguish your invention from prior art.

Point 4 – Is Your Patent Application Strong Enough?

The quality of your initial patent application sets the stage for everything that follows. A robust application anticipates likely rejections and builds in multiple fallback positions — different claim types, narrower claims, and well-supported variations. Without these, your options for overcoming examiner pushback are limited.

If you compromised on budget during drafting, you may have sacrificed the strategic depth needed for biotech patents to succeed. In high-stakes cases, cutting corners early can cost far more in the long run.

And let’s talk data again. Biotech applications are much stronger if they provide data showing surprising results that is commensurate in scope with the claims that you want allowed.

The Good News

Even after multiple final rejections, you can still get valuable biotech patents allowed — if:

• Your application includes solid experimental support.

• Your invention solves an unsolved problem not addressed by prior art.

• You have convincing data showing a clear improvement.

Bottom line:

If your strategy failed, there’s usually something you could have done differently at the initial filing.

Figure it out — and don’t repeat the mistake.

💬 Want to discuss how to rescue a stalled biotech patent?

💬 Contact Us to discuss how to rescue a stalled biotech patent.

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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.

8/10/25 Published (EJV)