Obviousness Combination

An obviousness combination is a § 103 rejection in which an examiner asserts that a claimed invention would have been obvious to a person of ordinary skill in the art (POSITA) at the time of filing based on combining two or more prior art references — none of which alone anticipates the claim. THE STRUCTURE: the examiner identifies: (1) a primary reference that discloses most of the claim elements; (2) one or more secondary references that disclose the missing elements; (3) a reason (motivation) a POSITA would have combined those references; and (4) a reasonable expectation that the combination would succeed. WHY COMBINATIONS ARE COMMON: few inventions consist of a single completely novel element; most inventions combine known elements in a new way or apply known techniques to a new problem; § 103 is designed to prevent the patenting of incremental improvements that a skilled practitioner could arrive at from existing knowledge; the Supreme Court recognized in KSR International Co. v. Teleflex Inc. (2007) that the primary instinct of a POSITA is to solve a problem by combining what is known, and that this is the ordinary course of innovation. THE APPLICANT'S CHALLENGE: when facing a combination rejection, the applicant must either: (a) challenge the technical logic of the combination (the prior art doesn't actually support the combination as alleged); (b) argue there was no motivation to combine; (c) argue teaching away; (d) argue no reasonable expectation of success; (e) show secondary considerations of non-obviousness; or (f) amend the claims to avoid the cited combination.

Before KSR: the Federal Circuit had developed the 'Teaching, Suggestion, or Motivation' (TSM) test — to sustain a combination rejection, there had to be explicit teaching, suggestion, or motivation in the prior art (or common general knowledge) to combine the references in the specific manner claimed; while protective of applicants, the rigid TSM test was criticized for allowing invalid patents when the motivation existed implicitly but wasn't explicitly stated in the prior art. KSR INTERNATIONAL CO. v. TELEFLEX INC. (S.Ct. 2007) — THE SHIFT: the Supreme Court unanimously rejected the rigid TSM test as inconsistent with Graham v. John Deere's framework; the Court held that the obviousness analysis must be flexible, considering whether a POSITA would have had REASON to combine references, including: (1) KNOWN TECHNIQUE + KNOWN PROBLEM: applying a known technique to a known problem to yield predictable results; (2) FINITE KNOWN SOLUTIONS: if there are a finite number of identified, predictable solutions to a problem and a POSITA would have had reason to try each with a reasonable expectation of success (the 'obvious to try' rationale); (3) DESIGN INCENTIVE OR MARKET PRESSURE: combining known elements according to known methods due to design incentive or market forces; (4) COMMON SENSE: a POSITA would have combined the elements as a matter of common sense in the field, even without a specific prior art reference suggesting the combination; KSR AFTERMATH: examiners more freely rely on broad 'common sense' motivation; the Federal Circuit requires that examiners provide sufficient articulation of the motivation, not just a bare assertion — but post-KSR, the bar for motivation is significantly lower than pre-KSR.

Teaching away is a doctrine under which a prior art reference that actively discourages or criticizes the combination (or a specific claim element) provides evidence against obviousness. THE STANDARD: a reference teaches away from a combination when it: (1) explicitly criticizes, discredits, or discourages the claimed approach; (2) leads a POSITA away from the claimed invention; (3) expresses a preference for an alternative incompatible with the claimed invention; (4) suggests that the modified element would result in degraded performance or unworkability. WHAT IS NOT TEACHING AWAY: the mere fact that a reference does not combine with another reference is not teaching away — many prior art references could theoretically combine without warning against it; a preference for a different embodiment is not teaching away — it must be a warning against the direction of the claimed invention; silence is not teaching away. HOW APPLICANTS USE TEACHING AWAY: cite specific language from the primary or secondary reference that warns against the precise combination the examiner proposes; for example: if the secondary reference states that element X should be avoided in the context where the examiner proposes to combine it, that is strong evidence of teaching away; bring in the technical reasoning: explain the mechanical, chemical, or electrical reasons why the combination would have been discouraged based on principles a POSITA would have understood; WEIGHT OF TEACHING AWAY: teaching away is one of the most powerful tools in overcoming a combination rejection; it can demonstrate not only absence of motivation to combine but also that the combination was technically discouraged — shifting the analysis strongly toward non-obviousness.

In addition to motivation, a § 103 combination rejection requires that a POSITA would have had a reasonable expectation of SUCCESS from making the combination. THE STANDARD: the expectation of success must be reasonable (not certain, but more than speculative); in predictable arts (mechanical, electrical), success is often presumed if the elements are known and the combination is straightforward; in unpredictable arts (chemistry, biology, pharma), the expectation of success requires more evidence — the biological or chemical interactions are complex and the result of combining elements is often not predictable. HOW APPLICANTS USE LACK OF EXPECTATION OF SUCCESS: in biotech and pharma, point to the biological complexity: if combining a known drug scaffold with a known pharmacophore from a different drug class is non-obvious because the combination's pharmacokinetics and pharmacodynamics were unpredictable; cite experimental failures: if the prior art is replete with failed attempts to make similar combinations (linking to the failure of others secondary consideration), there was no reasonable expectation of success; provide expert evidence: a § 1.132 declaration from a POSITA explaining why the combination was not expected to succeed, citing technical principles or prior art failures; DISTINCTION FROM TEACHING AWAY: reasonable expectation of success addresses whether the POSITA thought the combination WOULD WORK; teaching away addresses whether the POSITA was DISCOURAGED FROM TRYING; both can coexist — the prior art may neither discourage nor encourage a combination, but the outcome was still unpredictable; UNPREDICTABILITY IS FIELD-SPECIFIC: courts expect less predictability in pharma/biotech (molecular interactions are complex) than in electronics (adding a known chip to a known circuit is typically predictable).

Secondary considerations (objective indicia of non-obviousness) established by Graham v. John Deere (1966) must be considered even when the primary § 103 combination analysis supports obviousness. THE FOUR MAIN CONSIDERATIONS: (1) LONG-FELT NEED: the combination was not made by others despite years of having all the constituent elements available — suggests the combination was not obvious; (2) FAILURE OF OTHERS: prior workers who had access to all the prior art references and tried to solve the same problem failed; (3) COMMERCIAL SUCCESS (with nexus): the claimed combination achieved commercial success tied to the specific inventive combination (not prior art features or marketing); (4) UNEXPECTED RESULTS: the combination produced results that were qualitatively or quantitatively better than what a POSITA would have expected from the prior art. NEXUS IN COMBINATION CASES: the nexus requirement is especially critical for combinations; if the commercial success or other secondary consideration is due to one element that was already in the prior art, the nexus fails; the nexus must tie the evidence directly to the COMBINATION — the specific way in which the references were combined in a manner a POSITA would not have been motivated to attempt. STRENGTH RELATIVE TO PRIMA FACIE CASE: if the examiner's combination rejection is strong (highly motivated combination, highly predictable outcome, both elements well-known, finite and obvious alternatives), secondary considerations need to be substantial to overcome; if the prima facie case is weak (uncertain motivation, unpredictable result), even modest secondary consideration evidence may tip the balance.