Athelia receives an Office Action rejecting her patent application under § 103 (obviousness). With Alexander's guidance, she must overcome the rejection using secondary considerations - objective evidence of non-obviousness including commercial success, long-felt need, and unexpected results. This chapter provides deep instruction on the Graham factors (scope of prior art, differences from claimed invention, level of ordinary skill, secondary considerations), the nexus requirement linking evidence to claimed features, and post-KSR standards for combining prior art references. The narrative demonstrates how secondary considerations can tip the balance and overcome prima facie obviousness when primary references seem damaging.
Graham v. John Deere Co., 383 U.S. 1 (1966) established four-factor framework for analyzing obviousness under 35 U.S.C. § 103: (1) Scope and content of prior art - what was known in the field before filing date; (2) Differences between prior art and claimed invention - specific limitations distinguishing claims from references; (3) Level of ordinary skill in the art (PHOSITA) - education, experience, and knowledge of hypothetical skilled artisan; (4) Secondary considerations (objective indicia of non-obviousness) - real-world evidence bearing on obviousness question. All four factors must be considered; cannot decide obviousness based on primary references alone.
Pre-KSR: Teaching, Suggestion, Motivation (TSM) test required explicit teaching in references, suggestion in knowledge of skilled artisan, or market/design motivation to combine. Post-KSR v. Teleflex, 550 U.S. 398 (2007): More flexible approach - can use common sense, ordinary innovation, market forces, design incentives, obvious to try when finite alternatives exist. Examiner must still articulate reasoning with rational underpinning - cannot rely on conclusory statements. Hindsight bias problem: Must evaluate obviousness from perspective of PHOSITA at time of filing, not with knowledge of applicant's solution.
Real-world evidence rebutting prima facie obviousness: Commercial success - significant sales/market share of product embodying claimed invention. Long-felt but unresolved need - problem existed for years without solution until claimed invention. Failure of others - skilled artisans tried and failed to solve problem. Unexpected results - claimed invention achieves results not predictable from prior art. Copying by competitors - others in industry copied invention rather than designing around. Licensing - others paid to license invention. Skepticism of experts - skilled artisans doubted invention would work. Secondary considerations carry substantial weight and can overcome strong prima facie obviousness case.
Prior art reference "teaches away" when it criticizes, discourages, or discredits the path that leads to claimed invention. In re Oetiker, 977 F.2d 1443 (Fed. Cir. 1992): Teaching away requires more than merely disclosing alternative approach or expressing preference - must actively discourage pursuing claimed solution. Teaching away negates motivation to combine references, rebutting prima facie obviousness. Distinguishes from references that are merely silent about claimed approach or neutral between alternatives.
"Person Having Ordinary Skill In The Art" is hypothetical skilled artisan from whose perspective obviousness is evaluated. Factors determining PHOSITA level: Educational background (degree level), work experience in field (years), types of problems encountered (routine vs. complex), rapidity of innovations (fast-moving vs. stable art), sophistication of technology (cutting-edge vs. mature). Higher PHOSITA skill level makes more combinations "obvious" - more knowledge and capability assumed. Lower PHOSITA skill level narrows range of obvious combinations. Critical to properly define PHOSITA as it shapes entire § 103 analysis.
Secondary considerations evidence must have nexus (connection) to claimed invention, not to unclaimed features. Commercial success nexus: Success must result from claimed features, not marketing, brand, or non-claimed product features. If product includes claimed invention plus many other features, must show success derives from claimed elements specifically. Unexpected results nexus: Unexpected properties must flow from claimed combination/structure, not from known properties of individual elements. Establishing nexus often requires comparative evidence showing products without claimed features lack the success/results, while products with claimed features achieve them.
Rejection preventing patentee from obtaining multiple patents on obvious variants of same invention, even when claims aren't identical (which would be statutory double patenting). OTDP applies to: Claims in continuing application that are obvious variants of claims in commonly-owned earlier patent. Terminal disclaimer overcomes OTDP by: (1) disclaiming terminal portion of later patent to expire with earlier patent, (2) requiring common ownership of both patents (ties enforcement together). OTDP prevents extending patent term by filing obvious variations in later applications while maintaining same priority date.
KSR International v. Teleflex (2007) rejected rigid TSM test, establishing more flexible standards: Common sense combinations allowed when combining elements according to known methods yields predictable results. Obvious to try when finite number of identified, predictable solutions exist. Market forces and design incentives can supply motivation to combine. Ordinary innovation - routine engineering/scientific adaptations are obvious. However, examiner still must articulate reasoning beyond conclusory statements - "common sense" requires rational explanation rooted in prior art or knowledge in field. Secondary considerations remain critical for rebutting prima facie case.
Question: Patent claims portable music player with (A) 10GB storage, (B) white earbuds, (C) click-wheel interface. Product achieves $100M sales. Evidence shows: (1) Prior art disclosed 10GB storage, (2) White earbuds were marketing decision unrelated to claims, (3) Click-wheel was novel. Can applicant establish nexus between commercial success and claimed invention for § 103 secondary considerations?
Analysis Points: Nexus requires success attributable to claimed features, not unclaimed features or factors unrelated to claims. Here: (A) 10GB storage was known - no nexus; (B) White earbuds not claimed - irrelevant; (C) Click-wheel is only claimed feature not in prior art. Must show sales success resulted from click-wheel specifically. If consumer surveys, reviews, or market analysis show click-wheel drove purchasing decisions, nexus established. If success came from brand (Apple), design (aesthetics), marketing (ads), or unclaimed features, no nexus. Often need comparative evidence: products with click-wheel succeeded, products without failed. Weak nexus here unless strong evidence click-wheel was driver.
Question: Patent application in pharmaceutical chemistry field. If PHOSITA defined as "PhD organic chemist with 10 years drug development experience" vs. "Bachelor's degree chemist with 2 years experience," how does this affect obviousness analysis of combining two drug compounds to achieve synergistic effect?
Analysis Points: PhD with 10 years: Higher skill level means greater knowledge of chemistry, drug interactions, structure-activity relationships, and prior art. More likely to recognize potential synergy and be motivated to combine compounds. Broader range of combinations would be "obvious" to this PHOSITA. Bachelor's with 2 years: Lower skill level means less knowledge, narrower expertise, less experience predicting drug interactions. Many combinations that seem "obvious" to PhD would be non-obvious to this PHOSITA. Critical to accurately define PHOSITA based on actual field - not hypothetical genius or complete novice. Evidence: industry hiring standards, expert testimony, academic requirements for researchers in field. Higher PHOSITA = more combinations obvious = harder to get patent. Lower PHOSITA = fewer combinations obvious = easier to patent.
Question: After KSR v. Teleflex, examiner rejects claims as obvious, stating: "It would have been common sense to combine Reference A and Reference B." References are from completely different fields (Reference A = automotive braking; Reference B = computer networking). Can examiner rely solely on "common sense" without further explanation?
Analysis Points: NO. KSR allows common sense reasoning but requires rational underpinning with articulated reasoning. "Common sense" cannot be conclusory label - must explain why PHOSITA would have been motivated to combine references from different fields. Examiner must identify: (1) common problem both references address, (2) analogous art relationship (even if different fields, are they directed to same purpose?), (3) teaching in references suggesting combination, or (4) known principle applicable across fields. Cross-field combinations need stronger justification than intra-field. Proper response: Challenge examiner to articulate specific reasoning beyond "common sense" label. Argue references are non-analogous art, not directed to same problem, and PHOSITA would have no reason to consult networking reference when solving braking problem. KSR expanded flexibility but didn't eliminate requirement for reasoned analysis.
Question: Reference A discloses medical device with three possible attachment mechanisms: screws (described as "preferred embodiment"), clips, or adhesive. Examiner combines Reference A (using clips) with Reference B to reject claims. Applicant argues Reference A "teaches away" from clips by preferring screws. Does this argument succeed under In re Oetiker?
Analysis Points: NO. Under Oetiker, teaching away requires more than expressing preference for alternative or disclosing multiple options. Reference A affirmatively discloses clips as viable option - doesn't criticize, discourage, or discredit clip attachment. Calling screws "preferred" doesn't teach away from clips - merely indicates ranking of alternatives, all of which are disclosed as workable. Successful teaching-away argument would require: Reference A states "clips should be avoided due to mechanical failure risk" or "adhesive is unsuitable for medical applications" or "other attachment methods are inferior and unreliable." Disclosure of multiple options with preference = not teaching away. Active discouragement/criticism of claimed approach = teaching away.
Question: Patent claims pharmaceutical formulation combining Drug X + Drug Y. Applicant submits evidence: (1) Drug X alone reduces symptom by 30%, (2) Drug Y alone reduces symptom by 30%, (3) Drug X + Drug Y together reduce symptom by 80% (not merely additive 60%, but 80% synergistic effect), (4) Combination also costs 5x more to manufacture than either drug alone. Does unexpected results evidence overcome § 103 obviousness?
Analysis Points: Likely YES. Synergistic effect (80% vs. expected 60%) is unexpected result showing more than predictable combination. Manufacturing cost is irrelevant to patentability - § 103 asks only whether invention would have been obvious, not whether it's commercially viable or cost-effective. Key factors: (1) Results were unexpected - exceeded predictions from prior art, (2) Results have nexus to claimed combination - synergy flows from X+Y interaction, not unrelated factors, (3) Results are superior - 80% reduction is significant improvement. Proper analysis: Prior art taught 30% reduction from each drug individually. PHOSITA might try combining them expecting additive effect (60%), but 80% synergistic result was not predictable from teachings. This unexpected superiority is strong secondary consideration evidence. However, must also address whether prior art suggested trying combination in first place - if references taught against combining, or if combination was unknown/untried approach, unexpected results add to non-obviousness case.
Federal Circuit, 2012 - 676 F.3d 1063
Patent covered once-daily extended-release formulation of cyclobenzaprine (muscle relaxant drug). Prior art disclosed immediate-release cyclobenzaprine requiring multiple daily doses (twice-daily or three-times-daily). District court held patent invalid as obvious under § 103, reasoning that converting immediate-release to extended-release formulation was routine pharmaceutical practice - obvious to try with predictable results.
Generic drug manufacturers (Anchen, Mylan, others) filed Abbreviated New Drug Applications (ANDAs) seeking to market generic extended-release cyclobenzaprine before patent expiration. Patent holder (Eurand) sued for infringement under Hatch-Waxman Act. Defense: Patent invalid as obvious. District court agreed - granted summary judgment of obviousness invalidity. Eurand appealed to Federal Circuit.
Are strong secondary considerations (commercial success, unexpected clinical benefits, long-felt need) sufficient to overcome prima facie obviousness when prior art suggests combination and result seems predictable from known pharmaceutical principles?
REVERSED. Federal Circuit held secondary considerations evidence created genuine dispute of material fact precluding summary judgment. While prima facie case of obviousness existed (known drug + known extended-release technique = predictable result), secondary considerations were so strong they could tip balance toward non-obviousness.
Court emphasized: "When secondary considerations are present, though they are not always dispositive, they must be considered as part of all the evidence in making the obviousness determination." Secondary considerations are not just tie-breakers - they can outweigh strong prima facie case.
Court found sufficient nexus between commercial success and claimed invention. Sales were of product embodying patented formulation - not driven by marketing, brand alone, or unclaimed features. Unexpected clinical results (improved efficacy and safety) flowed directly from claimed extended-release design. Long-felt need addressed specifically by claimed once-daily formulation innovation.
For Prosecution: When responding to § 103 obviousness rejections, do not concede defeat if prima facie case seems strong. Gather and submit secondary considerations evidence: sales data, market studies, licensing agreements, expert testimony about long-felt need, clinical results showing unexpected benefits. Even "routine" combinations can be non-obvious if secondary considerations are compelling.
For Litigation: Secondary considerations can defeat summary judgment of obviousness even in pharmaceutical cases where "obvious to try" arguments are common. Federal Circuit takes secondary considerations seriously - they are not mere afterthought but core part of Graham analysis.
In Chapter 8, Athelia faces § 103 obviousness rejection and must marshal secondary considerations evidence to overcome it. Alexander teaches her to present: (1) commercial success of Guardian Queen examination system, (2) long-felt need for examiner-applicant bond structure, (3) unexpected results from claimed configuration, (4) failure of 47 prior candidates to achieve same bonding. The Cyclobenzaprine case demonstrates this strategy is not just narrative device - it's real Federal Circuit doctrine that wins cases. Understanding how to identify, develop, and present secondary considerations is essential Patent Bar skill.
(a) In General. - A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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. Patentability shall not be negated by the manner in which the invention was made.
(b) Exceptions. -
(1) Inventions Made Abroad. - [Repealed by AIA]
(2) Biotechnological Processes. - A claimed invention that is a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) shall be considered nonobvious if: (A) claims to the process and the composition of matter are owned by the same person or subject to an obligation of assignment to the same person.
(3) Joint Research Agreements. - Subject matter developed by another person, which qualifies as prior art only under one or more of subsections 102(a)(2), shall not preclude patentability under this section where the subject matter and claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.
Supreme Court's Framework for § 103 Analysis:
Under § 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented.
Four Graham Factors (mandatory consideration):
All factors must be considered in every § 103 analysis. Secondary considerations are not optional afterthought - they are integral part of inquiry.
Supreme Court's Rejection of Rigid TSM Test:
The Court held that the Federal Circuit's rigid application of "teaching, suggestion, or motivation" (TSM) test was incompatible with Supreme Court precedent. § 103 forbids issuance of patent when "differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious." The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.
Flexible Approach Factors:
Important Limitation: Examiner must still articulate reasoning with rational underpinning. "Common sense" and "obvious to try" are not talismanic phrases - require specific explanation based on prior art and knowledge in field. Hindsight bias remains prohibited.
In determining the scope and content of the prior art, the examiner must consider:
After determining scope and content of prior art, examiner must identify specific differences between prior art and claimed invention. These differences form basis of obviousness analysis. Examiner must explain how references teach or suggest each claimed limitation, and why PHOSITA would have been motivated to combine teachings.
Evidence of Non-Obviousness: Secondary considerations (objective indicia) are factual inquiries that guard against hindsight bias. When present, they must be considered as part of obviousness determination. Types of secondary considerations evidence:
Nexus Requirement: Secondary considerations must have nexus (connection) to claimed invention, not to unclaimed features or external factors.