1 Examiners' Summary for Examination Guidelines Update: Developments in the Obviousness Inquiry...

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Examiners' Summaryfor

Examination Guidelines Update:

Developments in the Obviousness

Inquiry After KSR v.Teleflex

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The 2010 KSR Guidelines Update . . .

IS effective as of its publication on September 1, 2010 in the Federal Register (75 Fed. Reg. 53643).

IS accessible, together with other post-KSR obviousness training materials for examiners, at http://www.uspto.gov/patents/law/exam/ksr_training_materials.jsp.

IS a summary of some, but not all, precedential Federal Circuit decisions concerning obviousness since KSR.

DOES provide examples of obvious and nonobvious claims.

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The 2010 KSR Guidelines Update . . .

IS NOT a new USPTO policy with respect to obviousness.

IS NOT a replacement for the 2007 KSR Guidelines.

DOES NOT identify any new obviousness rationales.

DOES NOT provide any per se rules. Each case must be decided on its own facts.

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Structure of the 2010 KSR Guidelines Update

Section 1– purpose of the documentSection 2 – review of the law of obviousnessSection 3 – impact of the KSR decisionSection 4 – examples from cases discussing

obviousnessA. "Combining Prior Art Elements"B. "Substituting One Known Element for Another"C. "The 'Obvious to Try' Rationale"

Section 5 – cases discussing consideration of evidence

Appendix – summary of "teaching points" from the cases

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Important Points

In 2007, the Supreme Court's KSR decision reaffirmed that the familiar Graham v. Deere analysis, requiring evaluation of

1. the scope and content of the prior art;2. the difference between the prior art and the

claimed invention;3. the level of ordinary skill in the art; and4. secondary considerations,

was still the proper way to evaluate any question of obviousness.

Nothing has happened since 2007 to change that!

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Important Points

As explained in the 2007 KSR Guidelines, every obviousness rejection requires

(a) appropriate findings of fact;

(b) a reasoned explanation; and

(c) a legal conclusion of obviousness.

This is so regardless of the rationale or line of reasoning used to formulate the rejection.

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Important Points

No examiner may choose to disregard the Supreme Court's decision in KSR or the associated examiner guidance materials when determining whether or not an obviousness rejection should be made.

If properly formulated, a rejection that relies on a traditional pre-KSR-style "motivation statement" is an appropriate rejection in light of the KSR decision.

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Important Points

The cases in the 2010 KSR Guidelines Update were chosen to provide examiners with examples of both obvious and nonobvious claims. The technologies and rationales included are those most thoroughly discussed in the cases since 2007. Many other cases are already available, and even more will become available as decisions are rendered. While important new decisions are routinely added to the MPEP, Office personnel are encouraged to keep up with current trends in the law by attending end-of-year case reviews, and by accessing cases via USPQ or the Federal Circuit's Web site.

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Important Points

1. Any determination of whether or not a claimed invention is obvious requires the examiner to consider and weigh all evidence that has properly been made of record.

2. If an applicant presents evidence in support of the nonobviousness of a claim, the examiner must reweigh all evidence. Evaluating an applicant's evidence only for its "knockdown" effect is not appropriate.

3. Even if evidence is entitled to little weight, it should still be considered and addressed by the examiner.

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Important Points

An Appendix listing the example cases along with one or more "teaching points" drawn from each case is included with the 2010 KSR Guidelines Update.

Examiners should use the teaching points as a quick way to locate examples that may be particularly relevant to them.

The teaching points are not a substitute for reading the complete discussion of a case. Reading the entire court decision will also be informative, and is recommended particularly when the facts of the case are very similar to those in the application before the examiner.

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A. Combining Prior Art Elements:SUMMARY

• It can be important for an examiner to identify a reason to combine prior art elements.

• Even though the components are known, the combining step is technically feasible, and the result is predictable, the claimed invention may be nonobvious when the combining step involves such additional effort that no one of ordinary skill would have undertaken it without a recognized reason to do so.

• Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

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A. Combining Prior Art Elements:

4.1. In re Omeprazole Patent Litigation

The claimed pharmaceutical formulation including two layers of coatings over the active ingredient omeprazole (marketed as Prilosec®) was not obvious, even though –

• the coating materials and methods for applying them were known

• a formulation of omeprazole and a single-layer coating was known

• using a coating and a subcoating was known generally, although not specifically for omeprazole

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Why was the claimed formulation nonobvious over the references applied?

1. The patentee had discovered that the single-coating prior art product was subject to degradation, and that the degradation could be reduced by adding a subcoating.

2. Absent prior recognition of the problem, there would have been no reason to add a subcoating. Even though the modification would have been technically feasible, it would have amounted to extra effort and expense for no expected return without the patentee's discovery of the problem.

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Teaching point: Even where a general method that could have been applied to make the claimed product was known and within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown.

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4.2. Crocs, Inc. v. U.S. Int'l Trade Comm'n

The claimed molded foam footwear, which included a foam base and a foam heel strap that (1) could pivot with respect to the base and (2) maintained a desired position behind the wearer's heel as a result of friction, was not obvious, even though –

• molded foam footwear as claimed, except for the strap, was known in the prior art

• flexible heel straps for shoes were known in the prior art

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Prior Art

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Why was the claimed foam footwear nonobvious over the references applied?

1. The prior art did not teach foam heel straps, or that a foam heel strap should be placed in contact with a foam base.

2. The prior art considered friction between a foam shoe base and a heel strap to be disadvantageous, and taught the use of washers to reduce friction.

3. Even if all elements had been taught by the prior art, the combination provided a result that was not predictable. Because the strap maintained its position without being in constant contact with the wearer's foot, the comfort of the wearer was increased.

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Teaching point: A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results.

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A. Combining Prior Art Elements:4.3. Sundance, Inc. v. DeMonte

Fabricating Ltd.

The claimed segmented and mechanized cover for trucks, swimming pools, or other structures was obvious over the prior art applied.

• One reference taught that a reason for making a segmented cover was ease of repair, in that a single damaged segment could be readily removed and replaced when necessary.

• A second reference taught the advantages of a mechanized cover for ease of opening.

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Fabricating Ltd.

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Fabricating Ltd.

Prior Art

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Fabricating Ltd.

Why was the claimed segmented and mechanized cover obvious?

1. The segmentation aspect of the first reference and the mechanization function of the second perform in the same way after combination as they had before.

2. A person of ordinary skill in the art would have expected that adding replaceable segments as taught by the first reference to the mechanized cover of the other would result in a cover that maintained the advantageous properties of both of the prior art covers.

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Fabricating Ltd.

Teaching point: A claimed invention is likely to be obvious if it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they have been combined.

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4.4. Ecolab, Inc. v. FMC Corp.

The claimed method of treating meat to reduce the incidence of pathogens by spraying it with an antibacterial solution at a pressure of "at least 50 psi" was obvious over the prior art applied.

• The parties agreed that a single prior art reference taught the claimed method, except for the pressure limitation of "at least 50 psi."

• A second reference had taught the advantages of spray-treating at pressures of 20 to 150 psi when treating meat with a different antibacterial agent.

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Why was the claimed method of spray-treating meat with an antibacterial solution obvious?

1. The were apparent reasons to combine the prior art teachings. The pressure would increase contact between the antibacterial solution and bacteria on the meat, and would also aid in physically washing bacteria off the meat.

2. A person of ordinary skill in the art would have recognized these reasons, and would have known how to implement the combined teachings of the references.

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Teaching point: A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do so.

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4.5. Wyers v. Master Lock Co.

Two claimed barbell-shaped hitch pin locks used to secure trailers to vehicles were obvious over the prior art references applied.

• One lock featured a removable sleeve that allowed the lock to be adjusted for towing apertures of different sizes.

• The other lock included an external covering to protect the inner lock mechanism from contaminants.

• Wyers admitted that each of several prior art references taught the claimed locks, except for the removable sleeve and the external covering.

• Secondary references taught the missing elements.

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Wyers Patent Figures

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Prior Art

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Why were the claimed barbell-shaped hitch pin locks obvious?

1. The prior art references teaching sealed padlocks were analogous art because they were in the same field of endeavor. However, even if they were not in the same field of endeavor, they were reasonably pertinent to the problem of avoiding contamination of a locking mechanism for tow hitches.

2. As to the sleeve improvement, the need for different sizes of hitch pins was well known, and a single adjustable unit was more convenient for users as well as economically desirable as a space-saver on store shelves.

3. As to the external covering, both the need to reduce contaminants and the use of coverings to do so was known in the art.

4. The components of the claim inventions functioned as expected when combined.

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Teaching point: The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

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A. Combining Prior Art Elements:4.6. DePuy Spine, Inc. v. Medtronic

Sofamor Danek, Inc.

The claimed polyaxial screw for use in spinal surgeries that included a compression member for pressing a screw head against a receiver member to obtain a rigidly locked screw was nonobvious over the prior art references applied, even though –

• One reference disclosed all of the elements of the claim except for the rigidity-conferring compression member.

• A second reference taught a splint for immobilizing long bones that was capable of polyaxial movement until rigidly secured by a compression member.

• The accused infringer argued that combining the references would have produced the rigidly locked screw as claimed.

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A. Combining Prior Art Elements: 4.6. DePuy Spine, Inc. v. Medtronic

Sofamor Danek, Inc.

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Sofamor Danek, Inc.

Prior Art

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Sofamor Danek, Inc.

Why was the claimed polyaxial screw nonobvious over the references applied?

1. The "predictable result" of KSR requires that the combination work for its intended purpose. The first reference had taught that a rigid device would not serve as a surgical screw due to increased likelihood of failure.

2. This teaching away would have deterred a person of ordinary skill from combining the references as argued by the accused infringer.

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Sofamor Danek, Inc.

Teaching point: Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended purpose. An inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.

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B. Substituting One Known Element for Another:SUMMARY

• The substitution rationale applies when the claimed invention can be viewed as resulting from substituting a known element for an element of a prior art invention.

• A person of ordinary skill in the art must have been technologically capable of making the substitution.

• The result obtained must have been reasonably predictable.

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B. Substituting One Known Element for Another:

4.7. In re ICON Health & Fitness, Inc.

The claimed treadmill with a folding tread base, which employed a gas spring to enhance stability of the unit when the base was in an upright position for storage, was obvious over the prior art references applied.

• One reference taught a folding treadmill with all of the claim elements other than the gas spring.

• A second reference taught a folding bed that used a dual-action gas spring that reduced both the force required to open the bed from the closed position, as well as the force required to lift the bed from the open position.

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Why was the claimed folding treadmill obvious?

1. Although it was from a different field of endeavor from the claimed invention, the second reference was reasonably pertinent to the problem to be solved. The folding mechanism itself did not depend on whether the item being folded was a bed or a treadmill.

2. Any necessary modification to account for the smaller size of a treadmill as compared with a bed would have been within the level of ordinary skill.

3. The fact that the second reference taught a dual action spring did not disqualify the reference. The claims at issue did not preclude a dual action spring.

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Teaching point: When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved.

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4.8. Agrizap, Inc. v. Woodstream Corp.

The claimed stationary device for electrocution of pests such as rats and gophers that used a resistive electrical switch was obvious over the prior art references applied.

• The prior art taught a stationary pest control device that was the same as the claimed device except that it employed a mechanical pressure switch rather than a resistive electrical switch.

• Other references taught resistive electrical switches in the contexts of both a hand-held pest control device and a cattle prod.

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B. Substituting One Known Element for Another :

4.8. Agrizap, Inc. v. Woodstream Corp.

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4.8 Agrizap, Inc. v. Woodstream Corp.

Prior Art

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Why was the claimed pest control device that used a resistive electrical switch obvious?

1. The claimed invention is a simple substitution of one art-recognized switch for another.

2. The function of the resistive electrical switch was well-known and predictable.

3. The problem solved by using a resistive electrical switch rather than a mechanical switch in the hand-held pest-control device – malfunction due to dirt and moisture – also pertained to the stationary pest-control device.

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Teaching point: Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that would have been recognized by those of ordinary skill in the art as useful for applicant’s purpose.

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4.9. Muniauction, Inc. v. Thomson Corp.

The claimed method for auctioning municipal bonds over the Internet was obvious over the prior art references applied.

• The only difference between the prior art bidding system and the claimed invention was the use of a conventional Web browser.

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Why was the claimed method for auctioning municipal bonds over the Internet obvious?

1. Although Thomson argued that incorporating a Web browser into a prior art auction system would have been obvious in light of KSR, the district court credited Muniauction's evidence of skepticism by experts, copying, praise, and commercial success in determining that the claims were not obvious.

2. The Federal Circuit disagreed, finding that the claims were obvious because there was an insufficient nexus between the claimed invention and the proffered evidence.

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Teaching point: Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for those functions.

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4.10. Aventis Pharma Deutschland v. Lupin Ltd.

The claimed stereochemically pure 5(S) stereoisomer of the blood pressure drug ramipril was obvious over the prior art references applied.

• The prior art taught a mixture of stereoisomers of ramipril.

• It was also known that the presence of multiple S stereocenters in drugs similar to ramipril was associated with enhanced therapeutic efficacy.

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Why was the claimed stereochemically pure 5(S) stereoisomer of the blood pressure drug ramipril obvious?

1. The Federal Circuit stated that in view of the Supreme Court’s decision in KSR, it was not necessary to identify an explicitly stated motivation statement in the prior art in order to render the claimed 5(S) ramipril obvious.

2. Separation of the stereoisomers was within the level of ordinary skill.

3. In this case, an expectation of similar properties in light of the prior art was sufficient, even without an explicit teaching that the compound would have a particular utility.

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Teaching point: A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art.

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4.11. Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd.

The claimed compound rabeprazole, a proton pump inhibitor for treating stomach ulcers and related disorders, was nonobvious over the prior art references applied, even though –

• The prior art compound lansoprazole shared a common core structure with rabeprazole and was useful for the same indications.

• Lansoprazole differed from rabeprazole only in that it had a trifluoroethoxy substituent in place of a methoxypropoxy substituent, and therefore was suitable as a lead compound.

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Claims Prior ArtRABEPRAZOLE

LANSOPRAZOLE

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Why was the claimed compound rabeprazole nonobvious?

1. There was no sufficient reason advanced for modifying lansoprazole.

2. The prior art created the expectation that rabeprazole would be less useful than lansoprazole because the proposed modification would have been expected to reduce the lipophilicity of the compound. Lipophilicity was known to be an advantageous property for such compounds.

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Teaching point: A claimed compound would not have been obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead compound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain the claimed compound.

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4.12. Procter & Gamble Co. v. Teva Pharms. USA

The claimed compound risedronate, aka 3-pyr EHDP, a member of a class of compounds known to inhibit bone resorption called bisphosphonates, was nonobvious over the prior art applied, even though –

• the prior art taught thirty-six structurally similar compounds that were potentially useful with regard to osteoporosis, including 2-pyr EHDP, which is a positional isomer of risedronate.

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Why was the claimed compound risedronate nonobvious?

1. There was no reasonable expectation of success, and hence no prima facie case of obviousness, because the necessary modifications would not have been routine.

2. Even if there had been a prima facie case, there was credible evidence that risedronate had unexpectedly superior properties when compared to the prior art.

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Teaching point: It is not necessary to select a single compound as a ‘‘lead compound’’ in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious.

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4.13. Altana Pharma AG v. Teva Pharms. USA

The claimed compound pantoprazole belongs to a class of compounds known as proton pump inhibitors that are used to treat gastric acid disorders in the stomach.

PANTOPRAZOLE

Although the Federal Circuit's decision did not include a final determination of obviousness, the case is nevertheless instructive as to the issue of selecting a lead compound.

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Why was the prior art compound designated compound 12, which was one of eighteen compounds disclosed, an appropriate choice as a lead compound?

COMPOUND 12

1. Compound 12 was structurally similar to pantoprazole, differing only in that compound 12 had a methyl group at the 3-position of the pyridine ring, while pantoprazole had a methoxy group.

2. Compound 12 was one of the more potent compounds of the eighteen disclosed, and was therefore a natural choice for further development.

3. The Federal Circuit stated that a “restrictive view of the lead compound test would present a rigid test similar to the teaching-suggestion-motivation test that the Supreme Court explicitly rejected in KSR."

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Teaching point: Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound.

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C. Obvious To Try:SUMMARY

• Although the case law in this area is developing quickly in the chemical arts, the rationale has been applied in other art areas as well.

• "Obvious to try" is not a new line of reasoning since KSR. The Federal Circuit in In re Kubin stated that KSR resurrects its own wisdom in In re O’Farrell , 853 F.2d 894 (Fed. Cir. 1988), concerning differentiation between proper and improper applications of this line of reasoning.

• Courts appear to be applying the KSR requirement for “a finite number of identified predictable solutions” in a manner that places particular emphasis on predictability and the reasonable expectations of those of ordinary skill in the art.

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C. Obvious To Try:4.14. In re Kubin

The claimed isolated nucleic acid molecule was obvious over the prior art references applied.

• The polypeptide encoded by the claimed nucleic acid was known by partial structure and binding properties.

• The prior art taught that a skilled artisan would have been able to make the claimed nucleic acid using standard biochemical techniques.

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C. Obvious To Try: 4.14. In re Kubin

Why was the claimed isolated nucleic acid molecule obvious?

1. The skilled artisan would have had a reason to try to isolate the claimed nucleic acid.

2. There were a limited number of methods available to accomplish the isolation.

3. There would have been a reasonable expectation of success.

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C. Obvious To Try: 4.14. In re Kubin

Teaching point: A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the ‘‘predictable’’ arts.

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C. Obvious To Try:4.15. Takeda Chem. Indus., Ltd. v. Alphapharm

Pty., Ltd.

The claimed compound pioglitazone, a member of a class of drugs known as thiazolidinediones (TZDs) which are useful to treat Type 2 diabetes, was nonobvious over the prior art applied, even though –

• there were many similar prior art TZD compounds, and the parties agreed that a compound designated "compound b" represented the closest prior art.

• pioglitazone could, in theory, be produced from compound b by a two-step modification involving homologation followed by ring-walking (i.e., replace methyl with ethyl, and move from 6- to 5-position on the pyridine ring).

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C. Obvious To Try: 4.15. Takeda Chem. Indus., Ltd. v.

Alphapharm Pty., Ltd.

Pioglitazone(RS)-5-(4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl)thiazolidine-2,4-

dione

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Why was the claimed compound pioglitazone nonobvious?

1. The prior art had taught certain disadvantageous properties of compound b that made it less desirable as a lead compound, thus teaching away from using compound b as a lead compound.

2. Although there had been a recognized need for treatments for diabetes, there had not been a finite number of predictable potential solutions.

3. There had been no reasonable expectation of successfully accomplishing the necessary chemical modifications, or of producing a therapeutically useful product.

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Teaching point: A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound.

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C. Obvious To Try :4.16. Ortho-McNeil Pharm., Inc. v.

Mylan Labs, Inc.

The claimed compound topiramate, useful as an anti-convulsant, was nonobvious over the prior art applied, even though –

• 2,3:4,5 di-isopropylidene fructose (DPF), a known compound, could be recognized as a synthetic precursor of topiramate.

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C. Obvious To Try :4.16. Ortho-McNeil Pharm., Inc. v.

Mylan Labs, Inc.

Claims Prior Art

TOPIRAMATE DPF

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C. Obvious To Try: 4.16. Ortho-McNeil Pharm., Inc. v.

Mylan Labs, Inc.

Why was the claimed compound topiramate nonobvious?

1. The inventors had been seeking an anti-diabetic drug, not an anti-convulsant, and therefore would not have looked to DPF as a starting material.

2. A person seeking an anti-diabetic drug would have had no reason to pursue the synthetic route that led to topiramate.

3. There was an element of serendipity involved in this case, such that even if topiramate had been synthesized, there would have been no reason to test it for anti-convulsant properties.

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C. Obvious To Try: 4.16. Ortho-McNeil Pharm., Inc. v.

Mylan Labs, Inc.

Teaching point: Where the claimed anticonvulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new antidiabetic drug, it would not have been obvious to try to obtain a claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives.

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C. Obvious To Try:4.17. Bayer Schering Pharma A.G. v.

Barr Labs., Inc.

The claimed oral contraceptive containingmicronized drospirenone was obvious overthe prior art references applied.

DROSPIRENONE

• Drospirenone was known to be a poorly water-soluble, acid-sensitive compound with contraceptive effects.

• It was also known in the art that micronization improves the solubility of poorly water soluble drugs.

• Unexpectedly, Bayer had found that a normal (uncoated) pill without micronization, as compared with an enteric-coated pill, resulted in the same bioavailability. The enteric coating had been expected to enhance bioavailability.

• Bayer then developed micronized drospirenone in a normal (uncoated) pill.

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C. Obvious To Try: 4.17. Bayer Schering Pharma A.G. v.

Barr Labs., Inc.

Why was the claimed oral contraceptive containing micronized drospirenone obvious?

Because both an enteric coating and micronization would have been expected to enhance bioavailability, it would have been obvious to try the micronization technique after the enteric coating failed to produce satisfactory results.

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C. Obvious To Try: 4.17. Bayer Schering Pharma A.G. v.

Barr Labs., Inc.

Teaching point: A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable.

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C. Obvious To Try:4.18. Sanofi-Synthelabo v. Apotex,

Inc.

The claimed anti-thrombotic compound clopidogrel, which is the dextrorotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate, was nonobvious over the prior art applied, even though –

CLOPIDOGREL

• the racemate, or mixture of dextrorotatory and levorotatory (D- and L-) isomers of the compound, was known in the prior art

• the mixture was known to have anti-thrombotic properties

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C. Obvious To Try: 4.18. Sanofi-Synthelabo v.

Apotex, Inc.

Why was the claimed dextrorotatory isomer clopidogrel nonobvious?

1. The two isomers had not previously been separated. 2. Although the mixture was known to have anti-thrombotic

properties, the extent to which each of the individual isomers contributed to the observed properties of the racemate was not known and was not predictable.

3. The D-isomer had unusually advantageous properties, and Sanofi’s own researchers had thought that separating the isomers would be unproductive. That is, persons of ordinary skill in the art, prior to the separation of the isomers, would have had no reason to expect that the D-isomer would have such strong therapeutic advantages as compared with the L-isomer. In other words, the result had been unexpected.

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C. Obvious To Try: 4.18. Sanofi-Synthelabo v.

Apotex, Inc.

Teaching point: A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable.

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C. Obvious To Try:4.19. Rolls-Royce, PLC v. United

Techs. Corp.

The claimed fan blade with a swept-forward inner region, a swept-rearward intermediate region, and forward-leaning outer region, was nonobvious over the prior art applied, even though –

• United had argued that it would have been obvious for a person of ordinary skill in the art to try a fan blade design in which the sweep angle in the outer region was reversed as compared with prior art fan blades from rearward to forward sweep, in order to reduce endwall shock.

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Substituting One Known Element for Another:

4.19. Rolls-Royce, PLC v. United Techs. Corp.

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C. Obvious To Try: 4.19. Rolls-Royce, PLC v. United

Techs. Corp.

Why was the fan blade with a swept-forward inner region, a swept-rearward intermediate region, and forward-leaning outer region, nonobvious?

1. There had been no suggestion in the prior art that changing the sweep angle as Rolls-Royce had done would have addressed the issue of endwall shock.

2. According to the Federal Circuit, changing the sweep angle “would not have presented itself as an option at all, let alone an option that would have been obvious to try.” Rolls-Royce, 603 F.3d at 1339.

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C. Obvious To Try: 4.19. Rolls-Royce, PLC v. United

Techs. Corp.

Teaching point: An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness.

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C. Obvious To Try:4.20. Perfect Web Techs. v.

InfoUSA

The claimed method for managing bulk e-mail distribution, which required selecting the intended recipients, transmitting the e-mails, determining how many of the e-mails had been successfully received, and repeating the first three steps if a pre-determined minimum number of intended recipients had not received the e-mail, was obvious over the prior art references applied.

• Failure to meet a desired quota of e-mail recipients was a recognized problem in the field of e-mail marketing.

• There were three potential art-recognized solutions: increasing the size of the initial recipient list; resending e-mails to recipients who did not receive them on the first attempt; and selecting a new recipient list and sending e-mails to them.

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InfoUSA

Why was the e-mail marketing method obvious?

1. As a matter of “simple logic,” according to the Federal Circuit, selecting a new list of recipients was more likely to result in the desired outcome than resending to those who had not received the e-mail on the first attempt.

2. There had been no evidence of any unexpected result associated with selecting a new recipient list, and no evidence that the method would not have had a reasonable likelihood of success.

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InfoUSA

Teaching point: Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

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D. Consideration of Evidence:SUMMARY

• All evidence of nonobviousness that is presented in a timely manner should be considered by the examiner when deciding whether to make or maintain an obviousness rejection.

• After receiving evidence of nonobviousness in response to a rejection, an examiner must reweigh all available evidence before reaching a conclusion as to whether the rejection should be maintained. Evidence should not be evaluated merely for its "knockdown" effect.

• Evidence of nonobviousness, even if relevant and properly presented, may be insufficient to overcome a strong prima facie case of obviousness.

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D. Consideration of Evidence:5.1. PharmaStem Therapeutics, Inc.

v. Viacell, Inc.

The claimed compositions comprising hematopoietic stem cells from umbilical cord or placental blood, and methods of using them for treatment of blood and immune system disorders, were obvious over the prior art references applied, despite evidence offered by PharmaStem to show that –

• the prior art had not proved that hematopoietic stem cells existed in cord blood

• PharmaStem's own work validated the operability of hematopoietic reconstitution using hematopoietic stem cells from umbilical cord and placental blood

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v. Viacell, Inc.

Why was PharmaStem's evidence insufficient to overcome Viacell's arguments that the claimed compositions and methods were obvious?

1. PharmaStem’s specification acknowledged that it was already known that umbilical cord and placental blood-based compositions contained hematopoietic stem cells.

2. PharmaStem’s specification also acknowledged that hematopoietic stem cells were useful for the purpose of hematopoietic reconstitution.

3. There had been ample suggestion in the prior art that the claimed method would have worked. Absolute predictability is not a necessary prerequisite to a case of obviousness.

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v. Viacell, Inc.

Teaching point: Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness may be outweighed by contradictory evidence in the record or by what is in the specification. Although a reasonable expectation of success is needed to support a case of obviousness, absolute predictability is not required.

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D. Consideration of Evidence:5.2. In re Sullivan

In considering obviousness of the claimed antivenom composition comprising F(ab) fragments used to treat venomous rattlesnake bites, it was an error for the Board to fail to consider Sullivan's timely-presented evidence purporting to show that –

• the prior art taught away from the claimed composition

• an unexpected property arose from the use of F(ab) fragment antivenom

• those of ordinary skill would not have expected an antivenom comprising F(ab) fragments to work

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Why was it an error to refuse to consider evidence that the Board believed was directed to a mere statement of intended use for the claimed composition?

1. The composition was not disclosed in the prior art, so the issue before the Board had been obviousness rather than novelty.

2. If, as argued by Sullivan, the property of neutralizing the lethality of rattlesnake venom while reducing the occurrence of adverse immune reactions in humans was unexpected, it would weigh in favor of nonobviousness of the composition.

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Teaching point: All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented.

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D. Consideration of Evidence:5.3. Hearing Components, Inc.

v. Shure Inc.

In considering obviousness of the claimed disposable and user-replaceable protective covering for the portion of a hearing aid that is inserted into the ear canal, the district court heard conflicting evidence concerning –

• what the prior art references taught• whether the teachings of the prior art references

could be combined• the existence of a nexus between Hearing

Components' commercial success and the claimed invention

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v. Shure Inc.

Patented Invention

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v. Shure Inc.

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v. Shure Inc.

The Federal Circuit determined that the jury verdict of nonobviousness at the district court was supported by substantial evidence because –

1. The witnesses for Hearing Components were credible and their testimony was supported by particular examples.

2. Testimony by Shure's witnesses was sparse and unspecific.

3. Hearing Components provided details of a licensing agreement to show the required nexus between its commercial success and the claimed invention.

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v. Shure Inc.

Teaching point: Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated.

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D. Consideration of Evidence:5.4. Asyst Techs., Inc. v.

Emtrak, Inc.

The claimed processing system for tracking articles such as silicon wafers which move from one processing station to the next in a manufacturing facility was prima facie obvious over the prior art because –

• the only difference between the claimed invention and prior art processing systems was that the prior art taught the use of a bus for communication between each processing station and a central control unit, while the claims required a multiplexer for this purpose

• persons of ordinary skill in the art would have been familiar with both the bus and the multiplexer, and could have readily employed a multiplexer in place of the bus

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Emtrak, Inc.

Patented Invention

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Emtrak, Inc.

Why was Asyst's evidence of commercial success insufficient to overcome the prima facie case of obviousness?

1. The probative force of the Asyst’s evidence of commercial success was undermined by its failure to link the commercial success to the features of its invention that were not disclosed in the prior art.

2. Asyst’s evidence of praise by others was also unavailing because Asyst could not show that this was attributable to the substitution of a multiplexer for a bus, which was the only material difference between the prior art and the claimed invention.

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Emtrak, Inc.

Teaching point: Evidence of secondary considerations of obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art.

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Contact Info

For more information, please contact:

Pinchus [email protected] [email protected]

Mr. Laufer and Ms. Fonda are Legal Advisors in the Office of Patent Legal Administration (OPLA).

1 Examiners' Summary for Examination Guidelines Update: Developments in the Obviousness Inquiry...

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