Reminder: No Shortcuts to Enablement

Intellectual Property Tags: Amgen v. Sanofi, defensive publication, embodiment, enablement, Intellectual property protection, IP, IP.com, Manual of Patent Examining Procedure, MPEP, patent application, patent claims, patent evaluation, patent examination policy, patent examiner, patent litigation, Prior Art, Robert W. Behr, US Patent and Trademark Office, USPTO

Sound intellectual property protection requires continuous learning. As hundreds of thousands of patent applications pass through the US Patent and Trademark Office every year, examiners and inventors alike have opportunities to refresh their evaluation skills.

February 22, 2018: Deputy Commissioner for Patent Examination Policy, Robert W. Behr, issued a memo to the Patent Examining Corps [1]. The subject was Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials. This memo clarifies, “the applicability of US PTO guidance regarding the written description requirement of 35 U.S.C. § 112(a), specifically concerning the written description requirement for claims drawn to antibodies” (Behr).

Section I of the memo specifically addresses, “Federal Circuit Clarification of the Law of Written Description As It Applies to Antibodies” (Behr). Following an Amgen v. Sanofi case [U.S. Court of Appeals for the Federal Circuit (Federal Circuit)], the memo addresses what examiners can accept as an “adequate written description for claims drawn to antibodies” (Behr). After calling out the essentially watered-down claims descriptions provided in the patent in question, the Federal Circuit stated: “the ‘newly characterized antigen’ test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent” (Behr).

Based on that decision, the memo provides the following direction to patent examiners: “adequate written description of a newly characterized antigen alone should not be considered an adequate written description of a claimed antibody to that newly characterized antigen, even when the preparation of such an antibody is routine and conventional” (Behr).

Why this Applies to You

The need to elucidate the application of an idea is not limited to chemistry and biology. The Federal Circuit found that simply noting previous studies, tests, and materials does not replace the functional description of an innovation, even if the previous work is commonly known. It seems the patent examination policies are leaving little to chance when a writer wants to assume that the claims descriptions will be clear to someone with a working knowledge of the art.

This discussion comes down to the core element of enablement. A sufficient description of your invention allows any person skilled in the pertinent art to practice the invention without undue experimentation. Whether you are writing a defensive publication to exist solely as prior art, preparing a patent application, or a finalizing a patent description, if you do not lay out the implementation steps, then you might open a door for someone else to “discover” them. This can lead to misinterpretation or misunderstanding of your idea. Might that compromise novelty? Might that obfuscate the non-obvious point? At any rate, without careful attention to enablement, your work is subject to patent application denial and validity challenges.

Tips to Ensure that You Have Covered Enablement

Referencing other work can be helpful, but your invention description should be able to stand on its own. Don’t assume everyone knows what you mean. The Amgen case teaches that the patent examiners might be decreasing the value of the common denominator of knowledge.

Consider the following tips while constructing a patent application or defensive publication:

  • Assume a slightly lower common denominator for the reader’s skill in the art. If you’re a Ph.D. or have a similar advanced knowledge, try to think of how you might explain your invention to someone with an ordinary skill in the field, to avoid omissions. It doesn’t hurt to err on the side of caution and provide more foundational details.
  • Provide citations to other relevant documents in your disclosure that can help the patent examiner identify other references of interest
  • For computer software: Be sure to avoid a “black box” description that leaves too many unknown (and too many assumed) components. If you’re including a flowchart or block diagram, as is common, make sure that each component is described in a manner that discloses not only its ultimate function but also how it is implemented, i.e. the algorithm behind it that would need to be programmed into the processor [2]
  • For compounds and compositions: One of ordinary skill in the art must be able to make or synthesize a compound. Specifically, “[w]here a process for making the compound is not developed until after the date of invention, the mere naming of a compound in a reference, without more, cannot constitute a description of the compound.” [3]

Finally, stay current with the rules at the Federal level. If you are familiar with recent conflicts and decisions, then you can avoid problems and more smoothly and cost-effectively proceed through the IP protection process.

References

[1] Behr, Robert W. Memo to the Patent Examining Corps., United States Patent and Trademark Office, Alexandria, VA. 22 February 2018.

[2] US Patent and Trademark Office, Manual of Patent Examining Procedure (MPEP), § 2164.06(c).

[3] US Patent and Trademark Office, Manual of Patent Examining Procedure (MPEP), § 2121.02(I).