IP: Patentability Analysis

Determine if claims may have novelty or obviousness issues.

Background

Determining patentability is important for an inventor when deciding if they should file a patent application. Intellectual Property professionals have the expertise to determine if a patent will face any potential issues when being examined for issuance of a patent. A patentability analysis begins with a prior art search for determination of novelty and nonobviousness. A patent application must also meet standards for utility and enablement as set by the United States Patent and Trademark Office (USPTO), but for the purposes of this simulation, the focus will be on prior art. These guidelines are described in the Manual of Patent Examining Procedures (MPEP) (see Resources section below). 

Novelty, in intellectual property terms, can be anything that has not been already demonstrated in the public domain. Examples of prior art include patents, publications, and non-patent literature (e.g., published manuscripts, web posts, published theses). For example, a new method of purifying a particular family of proteins could be patentable, assuming the inventor or someone else has not already patented, attempted to patent, or published the method in an academic journal, a conference proceeding, or a presentation.

Non-obviousness can be an invention that is not readily apparent to a Person Of Ordinary Skill In The Art (POSITA). Obviousness is determined by comparing a particular technology’s claims (the invention) with one or more pieces of prior art. 


Illustration of a Patentability Analysis:

The table below is a comparison of the inventor’s claims (invention) and prior art found in different references (columns). The examiner is comparing the client’s invention to prior art documents A, B, and C, which have some overlap with claims or features of claims in the invention.

Description of invention: The inventors discovered that protein X and a mutation of protein X (mutant protein X) can treat patients with the protein x-associated disease, X-itis. The mutant protein X treatment is especially useful in patients that did not respond to the currently prescribed anti-inflammatory treatment for X-itis.
-Prior art A teaches the protein X.
-Prior Art B teaches the use of protein X to treat the protein X-associated disease, X-itis.
-Prior Art C teaches that truncation of the genus of proteins from which protein X is a species can increase protein activity, but does not specifically point out protein X.

Invention Prior Art A (publication) Prior Art B (publication) Prior Art C  (conf. poster)    
Claim 1-A protein X. X (anticipation) X (anticipation)      
Claim 2-The protein of claim 1, comprising a point mutation.          
Claim 3- A truncated segment of protein X of claim 1.     X (obviousness)    
Claim 4-The truncated segment of the protein X of claim 3, comprising a chemical modification to increase solubility.     X (obviousness)    
Claim 5- The use of protein X for treatment of all protein X-associated diseases   X (anticipation)      
Claim 6- The use of the mutated protein X of claim 2 for treatment of all protein X-associated diseases.          

An Examiner could make anticipation and obviousness rejections over several features of the claimed invention, as shown in the above table.

Claim 1 appears to be anticipated by Prior Art A and Prior Art B (e.g., the invention claim features overlap completely).

Claim 2 appears to be free of the prior art.

Claim 3 could be rejected as obvious over Prior Art C. The Examiner could argue that Prior Art C taught that truncating family members of Protein X resulted in increased activity, so it would be obvious to modify protein X in the same manner. We could rebut this with unexpected results or arguments why it would not be expected to work in the same manner.

Claim 4 could be rejected as obvious over Prior Art C if the chemical modification is well known in the art to increase solubility of biologics. We could use the same arguments as suggested in claim 3, if available.

Claim 5 appears to be anticipated by Prior Art B.

Claim 6 appears to be free of the prior art.

The Process

  1. Review invention disclosure.
  2. Draft claims for an invention from an invention disclosure (potential claims and features). Examples of claims can be “A composition comprising…” or “A method of producing X, performing the steps x, y, and z.”
  3. Perform a prior art search and analysis using the draft claims.
  4. Perform patentability analysis using draft claims.
  5. Suggest ways to distinguish the invention from the other prior art.
  6. Finalize claims and submit U.S. Provisional Patent Application.

An important difference between a Prior Art Search (step 3) and a Patentability Analysis (step 4) is that a prior art search only determines if a claim is not novel or not obvious based on the discovered prior art, but does not determine utility or enablement. A prior art analysis would not go into the legal framework behind determining whether a process satisfies the enablement or utility requirements. For consideration of infringement, patent experts perform a freedom to operate analysis (see FTO analysis job sim).


The Exercise

Read the lists of claims and disclosures. Determine if the claims are novel and non-obvious. 

For this exercise, you are a patent scientist, junior patent agent, or intern to a patent attorney or senior patent agent.


Task 1 – Perform a prior art search and analysis using invention claims (step 4 of the process).

Review the claims and features from the hypothetical client’s invention, and prior art (that are conveniently pulled for this exercise). Determine where they might overlap in novelty and non-obviousness, put an X in the claim for that patent.

Feel free to do your own search to find other prior art.

Task 2 – Identify claims and/or claim features that do not overlap with prior art.

Make a note of the overlap of prior art teachings and claims (does it anticipate (extinguish novelty) or render the claim obvious?). Distinguishing novel and non-obvious claims allows the IP expert to make recommendations to the client. 

The Deliverable

Similar to the table above, create a Claims Chart that lists claims and compares them side-by-side.

Sample Deliverables:

 

Resources:

Skills used to perform this task: 

  • Strategy
  • Market research
  • Technical writing
  • Reading comprehension

Skills used in this field:

  • Technical expertise (STEM field)
  • Legal compliance
  • Project management
  • Collaborating with clients
  • Dealing with conflict

Authored by Luisalberto Gonzalez, PhD, alum of the Washington University in St. Louis Chemistry program.

Vetted by a patent professional in the Greater St. Louis area.

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