Secondary Considerations of Obviousness

Secondary considerations (or 'objective indicia of non-obviousness') are real-world marketplace facts that help establish whether an invention was truly non-obvious at the time it was made: GRAHAM v. JOHN DEERE CO. (S.Ct. 1966): established the four-factor test for obviousness: (1) scope and content of the prior art; (2) differences between the prior art and the claims; (3) level of ordinary skill in the art (POSITA); (4) secondary considerations; Graham explicitly held that secondary considerations 'might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented' and are always relevant; NOT OPTIONAL: secondary considerations are not merely supplemental — they are part of the required obviousness analysis; an examiner or court that ignores secondary considerations commits legal error; BUT NOT DISPOSITIVE: strong prior art evidence of obviousness is not automatically overcome by secondary considerations; courts balance all four Graham factors; WHY THEY MATTER IN PRACTICE: KSR International v. Teleflex (S.Ct. 2007) made it easier for courts to find obviousness using a flexible, expansive view of prior art combinations; in response, secondary considerations have become MORE important as a counterweight; strong secondary consideration evidence can overcome a facially strong obviousness rejection; TYPES OF SECONDARY CONSIDERATIONS: (a) commercial success; (b) long-felt but unsolved need; (c) failure of others; (d) copying by competitors; (e) unexpected results; (f) industry recognition and praise; (g) skepticism of experts; (h) licenses under the patent (others pay for it); all share the common thread: if the invention was obvious, why didn't the market produce it earlier?

Commercial success is the most commonly cited secondary consideration — and the nexus requirement is its most frequently litigated element: COMMERCIAL SUCCESS: a product embodying the claimed invention achieved substantial sales or market penetration; the commercial success of the product is evidence that the invention solved a real problem the market valued; LOGIC: if the invention were obvious, competitors would have made it earlier; the fact that it sold well suggests it wasn't obvious (otherwise someone would have already done it); NEXUS REQUIREMENT: the commercial success must be attributable to the patented invention itself — not to other factors; Tokai Corp. v. Easton Enterprises (Fed. Cir. 2011): the patentee must show a nexus — a legally and factually sufficient connection between the evidence of commercial success and the claimed invention; FACTORS DESTROYING NEXUS: (a) MARKETING POWER: if the commercial success is due to the patentee's brand, marketing budget, or distribution channels rather than the invention's merits; (b) DESIGN-AROUNDS EXCLUDED: if competitors exist who design around the claims and sell competing products, the patentee's sales may reflect market advantage, not inventive merit; (c) INDUSTRY CONDITIONS: if the market grew for unrelated reasons (rising commodity prices, regulatory change); (d) BLOCKING PATENTS: if the patentee's commercial success is partly due to using the patent to exclude competitors, the success may reflect exclusion rather than inventive merit; PRESUMPTION OF NEXUS: when the patent owner's commercially successful product embodies the claimed invention and is covered by the claims at issue, a rebuttable presumption of nexus arises; the burden then shifts to the opponent to show the success is attributable to other factors; QUANTIFICATION: commercial success evidence should include market share data, revenue figures, growth rates, and comparison to pre-invention sales of competing products.

Three of the most powerful secondary considerations when clearly established: LONG-FELT BUT UNSOLVED NEED: the problem that the claimed invention solves was known and recognized in the industry for a long period before the invention; LOGIC: if the problem was known and the solution was obvious, someone would have solved it sooner; a 20-year unsolved problem suggests the solution was not obvious; REQUIREMENTS: (a) the need must be long-felt — recognized in the art for years or decades; (b) the need must be real — not a hypothetical problem but one that practitioners were actively trying to solve; (c) the invention must actually solve the need — if the patented claims don't address the identified problem, this factor is inapplicable; (d) NEXUS: the claimed features must be what solves the need, not unclaimed features; FAILURE OF OTHERS: skilled researchers in the field tried and failed to solve the same problem; EVIDENCE: prior art references showing failed attempts; expert testimony from researchers who worked on the problem; publications documenting the state of the art before the invention; LOGIC: if others with ordinary skill tried and failed, the solution was not obvious to a POSITA; SKEPTICISM OF EXPERTS: at the time of the invention, established experts in the field expressed doubt that the problem could be solved or predicted the approach would not work; EVIDENCE: expert publications; conference proceedings; laboratory notes from skeptical researchers; LOGIC: experts believed the approach was unlikely to succeed → the invention's success demonstrates it wasn't obvious; COMBINATION EFFECT: long-felt need + failure of others + expert skepticism together are extremely compelling — all three indicate the art considered the solution non-obvious.

Unexpected results are evidence that the patented invention achieves a result that was not predicted by — and is superior to what was expected from — the prior art: WHAT COUNTS AS 'UNEXPECTED': a result of a different kind from what was expected (not just a different degree); a result that contradicts what the prior art would have predicted; superiority in a particular parameter that was not predicted by prior art combinations; BUT NOT: a result that is merely better than what prior art explicitly taught (if the prior art predicted improvement, the better improvement is expected); the unexpected result must be attributable to the claimed invention, not unclaimed features; HOW TO ESTABLISH UNEXPECTED RESULTS: comparative testing: test the claimed invention side-by-side against the closest prior art compound/method; document that the claimed invention achieves significantly better results than the prior art; measure results using objective metrics; DECLARATION UNDER 37 C.F.R. § 1.132: file a declaration from the inventor or a technical expert presenting comparative test data; the declaration must show: (a) the tests were run under comparable conditions; (b) the closest prior art was used as the comparator (not a straw man); (c) the unexpected result is attributable to the claimed invention; PHARMACEUTICAL CONTEXT: unexpected results are very common in pharmaceutical patent prosecution; claiming a specific enantiomer of a known racemic mixture may be patentable if the specific enantiomer shows dramatically better efficacy or fewer side effects (unexpected relative to the racemate or the other enantiomer); TIMING: unexpected results can be presented even if not known at the time of filing (post-filing data is acceptable under MPEP 716.01); CAUTION: the testing methodology must be scientifically sound — a declaration using flawed testing or cherry-picked comparators will be rejected by the examiner.

Effective presentation of secondary considerations requires evidence, nexus, and timing: IN PROSECUTION: WHEN TO SUBMIT: after receiving a § 103 rejection (typically with the response to a first or second office action); can also be submitted during an appeal brief; WHAT TO SUBMIT: (a) § 1.132 DECLARATION: sworn statement from the inventor or expert presenting evidence; must identify the specific claimed features responsible for the secondary consideration; (b) MARKET DATA: sales figures, market share, third-party industry reports; (c) INDUSTRY STATEMENTS: press coverage, industry awards, expert testimonials; (d) COMPETITOR COPYING EVIDENCE: sales of competing products, competitor's patent filings disclosing the same invention; NEXUS ARGUMENT: explicitly tie every piece of evidence to specific claim limitations; 'Our commercial success in [market] is due to the claim's [specific limitation] because [mechanism]'; FAILURE MODE: presenting commercial success evidence without explaining why the specific claimed features (not unclaimed features or brand) drove the success; IN LITIGATION: EXPERT TESTIMONY: technical expert explains why the secondary considerations are relevant; damages expert quantifies commercial success relative to the patent's contribution; JURY PRESENTATION: secondary considerations are particularly persuasive to juries; show the timeline — problem was known for X years; others failed; invention solved it → jury can understand this narrative; TIMING BEFORE MARKMAN: secondary considerations may be relevant to claim construction if the specification's discussion of prior art context informs claim scope; OPPONENT'S RESPONSE: the opponent will argue: (a) lack of nexus (commercial success is due to advertising, not the invention); (b) 'long-felt need' wasn't actually that long; (c) unexpected results are just a different degree, not a different kind; (d) the 'failure of others' researchers weren't actually trying to solve the same problem.