Surprising Results: A "Key Ingredient" For Your Patent Portfolio Build

Like many technology areas, the vast majority of, if not all, biotech/biopharma inventions build on prior art teachings. Thus, a major challenge can be to determine whether these inventions are patentable over the prior art. To be patentable over the prior art, a claimed invention must not only be novel in view of the prior art (i.e., no single prior art reference discloses all the elements/features of the claim), it must be non-obvious as well [FN1]. Obviousness typically relies on combining teachings from various references that together disclose all the elements/features of the claim. The challenge is determining whether an invention is not obvious over the prior art, especially if we try to take subjectivity out of the analysis [FN1.1].

So how do we attempt to objectively determine whether an invention is not obvious in view of the prior art [FN2]?

1. Is there a suggestion or motivation to combine prior art teachings of specific prior art references, to arrive at the claimed invention?

2. Is there a reasonable expectation of success at arriving at the claimed invention based on this combination of prior art teachings?

3. Does the prior art disclose every claim element?

Knowledge generally available to one skilled in the art should be considered in answering the above questions. In addition to these 3 key questions, objective indicia (sometimes referred to as "secondary factors") of non-obviousness are considered.

The most widely cited objective indicia include the following [FN3]:

• Commercial success;

• Long-felt but unsolved needs;

• Failure of others; and

• Unexpected results (i.e., surprising results).

Other objective indicia include the following:

• Copying by others;

• Industry praise;

• Industry skepticism;

• Licensing acquiescence; and

• Simultaneous invention by others.

Keep in mind, the above obviousness analysis is usually carried out specifically in view of a few prior art publications, which are sometimes combined with facts that are well-known in the art. Thus, an obviousness analysis involves breaking a claim down into its elements, and identifying teachings in these few (usually 2 to 4) prior art publications that teach these elements. Claim charts, likely the subject of a future DHL blog post, are often used to aid in such analysis to confirm that the prior art publications do in fact teach all the elements of the claim.

In our experience of prosecuting, analyzing, and asserting life sciences patents for over 20 years, one of the objective indicia rises to the top in many obviousness determinations: SURPRISING RESULTS.

Surprising results not only are an objective indicia of non-obviousness, they relate to the 3 key questions for obviousness analysis noted above, too. In our view, surprising/unexpected results are relevant to a determination of whether there is a reasonable expectation of success. Furthermore, an important treatise on patent law suggests that unexpected results should be considered as evidence related to a motivation to combine prior art references [FN4]. Courts have commented on the importance of unexpected results vs. other objective indicia of non-obviousness. [FN5]. Finally, from a psychological perspective, surprising results can provide strong evidence to convince an examiner, judge, and jury that an invention was not obvious. Thus, a key ingredient to help your life sciences patent portfolio build is surprising results.

What are the practical implications of the importance of surprising results?

Ideally, at least one of the working examples in your patent application(s), demonstrates surprising results of a key claimed invention. Keep in mind that for biotech "surprising results" often ideally are generated using a series of compositions and/or methods that are commensurate in scope with the claimed invention vs. results generated using prior art compositions and methods. For example, if the invention relates to a formulation with an important pH range, the surprising results ideally are generated experimentally across a range of values that span different points along the entire claimed pH range, and compared to a prior art range. Furthermore, keep in mind that you can introduce surprising results during patent prosecution as part of an inventor Declaration, even if you have not disclosed the surprising results in a patent application as filed. [FN6]

Surprising results can be important considerations for many patent strategy and associated business-related decisions for any company, especially private biotech companies like the ones we often represent. Surprising results are important with respect to your patent portfolio build:

• Should we file a patent application on a new discovery?

• Do we have surprising results?

• How can we overcome this prior art rejection to get a key patent to issue?

• Are surprising results disclosed in our pending patent application?

• Even if they are not disclosed, do we have or can we generate surprising results that we can present during prosecution in an inventor Declaration?

From a defensive standpoint, surprising results are important as you assess the strength/validity of your competitors’ patents:

• Should we take a license to a competitor's patent?

• Should we develop a product despite a competitor's patent/family?

If the competitor's patent(s) covers our product or process, is/are the competitor's patent(s) valid over the prior art? Have they disclosed surprising results commensurate in scope with their claimed invention in view of key prior art publications?

Therefore, as you build out your patent portfolio, especially focused on key inventions, and as you continue to update your patent strategy, don't forget to take into account the importance of surprising results.

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Footnotes: 

FN1  

Many foreign jurisdictions like Europe and China, have a similar requirement, but it is framed as the invention must involve an "inventive step" over the prior art, and the analysis is framed as more of a problem/solution analysis. 

FN 1.1.

There is a preliminary question of whether a publication or activity qualifies as prior art under 35 U.S.C. 102. This topic is beyond the scope of this post, but might be the subject of future posts. Unfortunately, this is a complex question that can involve a lot of uncertainty under the major changes to this statute as part of the America Invests Act that went into effect in 2013, for which we still don't have much case law clarification.

FN2  

35 U.S.C. 103 provides the statutory requirement of non-obviousness. The basic factual inquiries laid out in Graham v. John Deere (1966) must be considered, as cited by the U.S. Supreme Court in the important KSR v. Teleflex case (2007). However, in our view these factors are too general to be super helpful in most analyses:  

• (A) Determining the scope and content of the prior art; 

• (B) Ascertaining the differences between the claimed invention and the prior art; and 

• (C) Resolving the level of ordinary skill in the pertinent art. 

See also MPEP 2141 for USPTO examination guidelines for determining obviousness. 

 More helpful in most situations in our view, and that of the vast majority of patent attorneys, agents, and examiners in our experience, is the long-held principle that three basic criteria must be met to establish.  In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991).  First, there must be some motivation to combine teachings from various references, either in the references themselves or in the knowledge generally available to one skilled in the art.  Second, there must be a reasonable expectation of success.  Finally, the prior art references when combined must teach or suggest all the claim limitations.  In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991).  See also MPEP §2143 to §2143.03 for decisions pertinent to each of these criteria. 

FN3  

Objective indicia of nonobviousness including unexpected results, must be considered in an obviousness analysis. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). See also, MPEP 2141; 2-5 CHISUM ON PATENTS § 5.05 (2015); "https://irlaw.umkc.edu/cgi/viewcontent.cgi?article=1349&context=faculty_works", Christopher M. Holman, University of Missouri - Kansas City, School of Law (2018); and in re Cyclobenzaprine; Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1075 (Fed. Cir. 2012). 

  FN4 2-5 CHISUM ON PATENTS § 5.05 (2015); 

FN5 

See e.g., Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 2011 U.S. Dist. LEXIS 4889, at *52-53 (E.D. Mich. 2011) ("The case law has sometimes referred to [unexpected and surprising results] as a 'secondary' consideration, placing it in the category with commercial success, copying, failure of others and long-felt but unsolved need. These sources of evidence provide only an indirect basis for inferring nonobviousness, whereas the Court views evidence of surprising or expected properties as more direct and technological evidence bearing more directly on the statutory inquiry as to 'the differences between the subject matter sought to be patented and the prior art."'). 

 FN6 

See for example, Holman (2018), and Chemours Company FC, LLC v. Daikin Industries, Ltd., Nos. 20-1289, -1290 (Fed. Cir. July 22, 2021) at 12 "In some cases, test data generated after the filing date has been successfully used to show that the success of an invention would not have been predicted based on the prior art.“   

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11/07/24 Published (EJV)