What is a 35 USC 103 Rejection?

A 35 USC 103 rejection, also known as an "obviousness rejection," occurs when the USPTO examiner determines that your invention, while not identically disclosed in a single prior art reference, would have been obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date.

Section 103 states that a patent may not be obtained "if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains."

The Graham Factors for Determining Obviousness

In Graham v. John Deere Co. (383 U.S. 1, 1966), the Supreme Court established a framework for analyzing obviousness that includes:

1. Scope and Content of the Prior Art: What does the prior art teach?
2. Differences Between Prior Art and Claims: What elements of the claimed invention are not in the prior art?
3. Level of Ordinary Skill in the Art: What would a person with ordinary skill in the relevant field know?
4. Secondary Considerations: Evidence of non-obviousness such as:
   • Commercial success
   • Long-felt but unsolved needs
   • Failure of others
   • Unexpected results
   • Skepticism of experts
   • Licensing or copying by competitors

KSR Rationales for Obviousness

In KSR International Co. v. Teleflex Inc. (550 U.S. 398, 2007), the Supreme Court expanded on the obviousness analysis, rejecting the rigid application of the "teaching-suggestion-motivation" (TSM) test. The USPTO has since identified seven rationales that examiners commonly use to support obviousness rejections:

1. Combining Prior Art Elements: Combining known elements according to known methods to yield predictable results
2. Simple Substitution: Substituting one known element for another to obtain predictable results
3. Use of Known Technique: Applying a known technique to improve a similar device in the same way
4. Known Work in One Field: Applying a known solution from one field to a similar problem in the same field
5. Obvious to Try: Choosing from a finite number of identified, predictable solutions with a reasonable expectation of success
6. Design Incentives: Using known design incentives or market forces to prompt variations, resulting in predictable results
7. Combination Teachings: Teaching, suggestion, or motivation in the prior art that would lead one to modify or combine prior art references

Effective Strategies for Responding to 103 Rejections

When facing an obviousness rejection, consider these strategic approaches:

1. Claim Amendments: Add elements or limitations not taught or suggested by the prior art
2. Attack the Prima Facie Case: Show that one or more of the Graham factors has not been properly established:
   • Demonstrate that a claimed element is missing entirely from the cited references
   • Show that the examiner has misinterpreted the prior art
   • Argue that the examiner has failed to establish a proper level of skill in the art
3. Challenge the Proposed Combination:
   • Show that the prior art teaches away from the proposed combination
   • Demonstrate that the combination would render the prior art unsatisfactory for its intended purpose
   • Argue that the combination would change the principle of operation of the primary reference
   • Show that the references are not analogous art
4. Challenge the Rationale for Combining:
   • Attack the examiner's KSR rationale by showing it doesn't apply to your specific case
   • Show that the combination would not have been obvious to try
   • Demonstrate that the results of the combination would not have been predictable
5. Present Secondary Considerations:
   • Submit evidence of commercial success linked to the claimed invention
   • Provide evidence of long-felt but unsolved need
   • Demonstrate unexpected results with experimental data
   • Show evidence of industry praise or skepticism of experts

Important Federal Circuit Case Law on Obviousness

Understanding landmark cases can strengthen your response:

• KSR Int'l Co. v. Teleflex Inc. (550 U.S. 398, 2007): Rejected the rigid application of the TSM test and established a more flexible approach to obviousness
• In re Kubin (561 F.3d 1351, Fed. Cir. 2009): Applied the "obvious to try" standard from KSR in biotechnology
• Procter & Gamble Co. v. Teva Pharms. USA, Inc. (566 F.3d 989, Fed. Cir. 2009): Showed how secondary considerations like unexpected results can overcome a prima facie case of obviousness
• In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (676 F.3d 1063, Fed. Cir. 2012): Emphasized that secondary considerations are not mere afterthoughts but integral to the obviousness analysis
• Belden Inc. v. Berk-Tek LLC (805 F.3d 1064, Fed. Cir. 2015): Illustrated how teaching away can be used to overcome obviousness rejections
• Acorda Therapeutics, Inc. v. Roxane Labs., Inc. (903 F.3d 1310, Fed. Cir. 2018): Addressed the nexus requirement between commercial success and claimed features
• OSI Pharmaceuticals, LLC v. Apotex, Inc. (939 F.3d 1375, Fed. Cir. 2019): Found claims non-obvious where prior art did not provide a reasonable expectation of success

Patent Filing Strategies to Avoid 103 Issues

Proactive filing strategies can help avoid obviousness rejections:

• Draft claims of varying scope: Include a range from broad to narrow claims to maximize protection while minimizing obviousness risks
• Emphasize unexpected results: Include experimental data in the specification showing surprising or unexpected benefits
• Describe problems with prior art approaches: Explain why existing solutions were inadequate or taught away from your invention
• Include fallback positions: Draft dependent claims with features that can be incorporated into independent claims if needed
• Consider continuation applications: Use a continuation strategy to pursue additional claim scope if the market or prior art landscape changes
• Document the invention process: Maintain detailed records of the discovery process, especially evidence of skepticism, failed approaches, or unexpected results
• Conduct thorough prior art searches: Identify and address potential obviousness combinations before filing

Practice Trends in 103 Rejections

Understanding general trends in obviousness rejections can inform prosecution strategy:

• Technical Fields: Obviousness rejections may vary by technology center, with different technical fields facing different challenges
• Evidence Types: The most effective evidence often includes experimental data showing unexpected results compared to the prior art
• Interview Benefits: Conducting examiner interviews can help clarify misunderstandings about the prior art or the claimed invention
• Argument Types: "Teaching away" and "missing element" arguments often provide clear paths to overcome obviousness rejections
• Declaration Evidence: Expert declarations can be particularly effective for establishing the level of ordinary skill in the art

Checklist for Responding to a 103 Rejection

1. Understand the rejection: Identify which KSR rationale the examiner is using
2. Review the cited references: Read each reference completely, not just the portions cited by the examiner
3. Create a claim chart: Map each claim element to the references to identify missing elements
4. Check for teaching away: Look for statements that discourage the proposed combination
5. Identify non-analogous art: Determine if references are from the same field or address the same problem
6. Evaluate potential claim amendments: Consider adding limitations not taught or suggested by the prior art
7. Assess secondary considerations: Gather evidence of commercial success, unexpected results, etc.
8. Consider expert declarations: Determine if expert testimony would strengthen your case
9. Prepare response strategy: Choose between amendment, argument, or a combination
10. Request an interview: Consider discussing complex issues with the examiner before filing a written response