USPTO Publishes Obviousness Examination Guidelines Following KSR International Co. v. Teleflex Inc.
Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc. (Guidelines) "to help USPTO examiners make appropriate decisions regarding the obviousness of claimed inventions in light of the Supreme Court’s decision in KSR International Co. v. Teleflex Inc., 550 U.S. __, 82 USPQ2d 1385 (2007) (KSR):"
These guidelines do not constitute substantive rule making and hence do not have the force and effect of law. They have been developed as a matter of internal Office management and are not intended to create any right or benefit, substantive or procedural, enforceable by any party against the Office. Rejections will continue to be based upon the substantive law, and it is these rejections that are appealable. Consequently, any failure by Office personnel to follow the guidelines is neither appealable nor petitionable.According to the Guidelines:
In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts. Factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap. The rationales discussed below outline reasoning that may be applied to find obviousness in such cases.
If the search of the prior art and the resolution of the Graham factual inquiries reveal that an obviousness rejection may be made using the familiar teaching-suggestion-motivation (TSM) rationale, then such a rejection using the TSM rationale can still be made. Although the Supreme Court in KSR cautioned against an overly rigid application of TSM, it also recognized that TSM was one of a number of valid rationales that could be used to determine obviousness. Office personnel should also consider whether one or more of the other rationales set forth below support a conclusion of obviousness. Note that the list of rationales provided below is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn 41 stated that ‘‘ ‘[R]ejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’’’
The Notice sets forth the following "rationales" for asserting an obviousness rejection, and sets forth explicit factual findings that an Examiner must articulate to support an obviousness rejection made using any of these rationales:
- Combining prior art elements according to known methods to yield predictable results;
- Simple substitution of one known element for another to obtain predictable results;
- Use of known technique to improve similar devices (methods, or products) in the same way;
- Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
- ‘‘Obvious to try’’—choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
- Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other arket forces if the variations would have been predictable to one of ordinary skill in the art;
- Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
. . . If an applicant disagrees with any factual findings by the Office, an effective traverse of a rejection based wholly or partially on such findings must include a reasoned statement explaining why the applicant believes the Office has erred substantively as to the factual findings. A mere statement or argument that the Office has not established a prima facie case of obviousness or that the Office’s reliance on common knowledge is unsupported by documentary evidence will not be considered substantively adequate to rebut the rejection or an effective traverse of the rejection under 37 CFR 1.111(b). Office personnel addressing this situation may repeat the rejection made in the prior Office action and make the next Office action final. See MPEP § 706.07(a).
V. Consideration of Applicant’s Rebuttal Evidence
Office personnel should consider all rebuttal evidence that is timely presented by the applicants when reevaluating any obviousness determination. Rebuttal evidence may include evidence of ‘‘secondary considerations,’’ such as ‘‘commercial success, long felt but unsolved needs, [and] failure of others’’83, and may also include evidence of unexpected results. As set forth in section III. above, Office personnel must articulate findings of fact that support the rationale relied upon in an obviousness rejection. As a result, applicants are likely to submit evidence to rebut the fact finding made by Office personnel. For example, in the case of a claim to a combination, applicants may submit evidence or argument to demonstrate that:
- one of ordinary skill in the art could not have combined the claimed elements by known methods (e.g., due to technological difficulties);
- the elements in combination do not merely perform the function that each element performs separately; or
- the results of the claimed combination were unexpected.
Once the applicant has presented rebuttal evidence, Office personnel should reconsider any initial obviousness determination in view of the entire record.84 All the rejections of record and proposed rejections and their bases should be reviewed to confirm their continued viability. The Office action should clearly communicate the Office’s findings and conclusions, articulating how the conclusions are supported by the findings. The procedures set forth in MPEP § 706.07(a) are to be followed in determining whether an action may be made final.
See MPEP § 2145 concerning consideration of applicant’s rebuttal evidence. See also MPEP § 716 to § 716.10 regarding affidavits or declarations filed under 37 CFR 1.132 for purposes of traversing grounds of rejection.
"Any problem that is identified in the patent application can lead to an Examiner then saying that the road to solution of that problem is obvious," writes Proessor Wegner after his initial reading of the new Guidelines. "There are numerous references in the KSR Guidelines to the 'problem' and how this can lead to an obviousness determination. Manifestly, there will be many if not most situations where the drafting of the application without consideration of artificially generated 'problems' may represent the best practice."
Focussing on advantageous results, rather than problems solved, may be a subtle but important lesson for many practitioners.
Click here for a USPTO Powerpoint presentation on the new guidelines.