2145 Consideration of Applicant’s Rebuttal Arguments
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This MPEP section is applicable to applications subject to the first inventor to file (FITF) provisions of the AIA except that the relevant date is the "effective filing date" of the claimed invention instead of the "time the invention was made," which is only applicable to applications subject to pre-AIA 35 U.S.C. 102.
If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case.
Rebuttal evidence and arguments can be presented in the specification, by counsel, or by way of an affidavit or declaration under 37 CFR 1.132. However, arguments of counsel cannot take the place of factually supported objective evidence.
- Office personnel should consider all rebuttal arguments and evidence presented by applicants.
Rebuttal evidence may include evidence of “secondary considerations,” such as “commercial success, long felt but unsolved needs, [and] failure of others.”
Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art.
- Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties.
- A showing of unexpected results must be based on evidence, not argument or speculation. (conclusory statements that claimed compound possesses unusually low immune response or unexpected biological activity that is unsupported by comparative data held insufficient to overcome prima facie case of obviousness).
- Rebuttal evidence may include evidence that the claimed invention was copied by others.
- It may also include evidence of the state of the art, the level of skill in the art, and the beliefs of those skilled in the art.
Rebuttal evidence may include a showing that the prior art fails to disclose or render obvious a method for making the compound, which would preclude a conclusion of obviousness of the compound. A conclusion of obviousness requires that the reference(s) relied upon be enabling in that it put the public in possession of the claimed invention.
- The Hoeksema court further noted that once a prima facie case of obviousness is made by the PTO through citation of references, the burden is on the applicant to produce contrary evidence establishing that the reference being relied on would not enable a skilled artisan to produce the different compounds claimed.
Consideration of rebuttal evidence and arguments requires Office personnel to weigh the proffered evidence and arguments. Office personnel should avoid giving evidence no weight, except in rare circumstances.
However, to be entitled to substantial weight, the applicant should establish a nexus between the rebuttal evidence and the claimed invention, i.e., objective evidence of nonobviousness must be attributable to the claimed invention. The Federal Circuit has acknowledged that applicant bears the burden of establishing nexus, stating:
In the ex parte process of examining a patent application, however, the PTO lacks the means or resources to gather evidence which supports or refutes the applicant’s assertion that the sales constitute commercial success.
- When considering whether proffered evidence is commensurate in scope with the claimed invention, Office personnel should not require the applicant to show unexpected results over the entire range of properties possessed by a chemical compound or composition.
Evidence that the compound or composition possesses superior and unexpected properties in one of a spectrum of common properties can be sufficient to rebut a prima facie case of obviousness.
- For example, a showing of unexpected results for a single member of a claimed subgenus, or a narrow portion of a claimed range would be sufficient to rebut a prima facie case of obviousness if a skilled artisan “could ascertain a trend in the exemplified data that would allow him to reasonably extend the probative value thereof.”
On the other hand, evidence of an unexpected property may not be sufficient regardless of the scope of the showing.
- Usually, a showing of unexpected results is sufficient to overcome a prima facie case of obviousness.
However, where the claims are not limited to a particular use, and where the prior art provides other motivation to select a particular species or subgenus, a showing of a new use may not be sufficient to confer patentability.
Accordingly, each case should be evaluated individually based on the totality of the circumstances.
Evidence pertaining to secondary considerations must be taken into account whenever present; however, it does not necessarily control the obviousness conclusion.
Office personnel should not evaluate rebuttal evidence for its “knockdown” value against the prima facie case, or summarily dismiss it as not compelling or insufficient.
- If the evidence is deemed insufficient to rebut the prima facie case of obviousness, Office personnel should specifically set forth the facts and reasoning that justify this conclusion.
Many basic approaches that a practitioner may use to demonstrate nonobviousness also continue to apply in the post-KSR era.
- Since it is now clear that a strict teaching-suggestion-motivation approach is not the only way to establish a prima facie case of obviousness, it is true that practitioners have been required to shift the emphasis of their nonobviousness arguments to a certain degree.
However, familiar lines of argument still apply, including teaching away from the claimed invention by the prior art, lack of a reasonable expectation of success, and unexpected results.
- Indeed, they may have even taken on added importance in view of the recognition in KSR of a variety of possible rationales.
The following cases exemplify the continued application of the principle that when evidence has been presented to rebut an obviousness rejection, it should not be evaluated simply for its “knockdown” value. Rather, all evidence must be reweighed to determine whether the claims are nonobvious.
Example 1:
The claims at issue in PharmaStem Therapeutics, Inc. v. Viacell, Inc., were directed to compositions comprising hematopoietic stem cells from umbilical cord or placental blood, and to methods of using such compositions for treatment of blood and immune system disorders. The composition claims required that the stem cells be present in an amount sufficient to effect hematopoietic reconstitution when administered to a human adult. The trial court had found that PharmaStem’s patents were infringed and not invalid on obviousness or other grounds. On appeal, the Federal Circuit reversed the district court, determining that the claims were invalid for obviousness.
The Federal Circuit discussed the evidence presented at trial. It pointed out that the patentee, PharmaStem, had not invented an entirely new procedure or new composition. Rather, PharmaStem’s own specification acknowledged that it was already known in the prior art that umbilical cord and placental blood-based compositions contained hematopoietic stem cells, and that hematopoietic stem cells were useful for the purpose of hematopoietic reconstitution. PharmaStem’s contribution was to provide experimental proof that umbilical cord and placental blood could be used to effect hematopoietic reconstitution in mice. By extrapolation, one of ordinary skill in the art would have expected this reconstitution method to work in humans as well.
The court rejected PharmaStem’s expert testimony that hematopoietic stem cells had not been proved to exist in cord blood prior to the experiments described in PharmaStem’s patents. The court explained that the expert testimony was contrary to the inventors’ admissions in the specification, as well as prior art teachings that disclosed stem cells in cord blood. In this case, PharmaStem’s evidence of nonobviousness was outweighed by contradictory evidence.
Despite PharmaStem’s useful experimental validation of hematopoietic reconstitution using hematopoietic stem cells from umbilical cord and placental blood, the Federal Circuit found that the claims at issue would have been obvious. 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. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.”
Example 2:
It was found to be an error in In re Sullivan, for the Board to fail to consider evidence submitted to rebut a prima facie case of obviousness.
The claimed invention was directed to an antivenom composition comprising F(ab) fragments used to treat venomous rattlesnake bites. The composition was created from antibody molecules that include three fragments, F(ab)2, F(ab) and F(c), which have separate properties and utilities. There have been commercially available antivenom products that consisted of whole antibodies and F(ab)2 fragments, but researchers had not experimented with antivenoms containing only F(ab) fragments because it was believed that their unique properties would prevent them from decreasing the toxicity of snake venom. The inventor, Sullivan, discovered that F(ab) fragments are effective at neutralizing the lethality of rattlesnake venom, while reducing the occurrence of adverse immune reactions in humans. On appeal of the examiner’s rejection, the Board held that the claim was obvious because all the elements of the claimed composition were accounted for in the prior art, and that the composition taught by that prior art would have been expected by a person of ordinary skill in the art at the time the invention was made to neutralize the lethality of the venom of a rattlesnake.
Rebuttal evidence had not been considered by the Board because it considered the evidence to relate to the intended use of the claimed composition as an antivenom, rather than the composition itself. Appellant successfully argued that even if the Board had shown a prima facie case of obviousness, the extensive rebuttal evidence must be considered. The evidence included three expert declarations submitted to show that the prior art taught away from the claimed invention, an unexpected property or result from the use of F(ab) fragment antivenom, and why those having ordinary skill in the art expected antivenoms comprising F(ab) fragments to fail. The declarations related to more than the use of the claimed composition. While a statement of intended use may not render a known composition patentable, the claimed composition was not known, and whether it would have been obvious depends upon consideration of the rebuttal evidence. Appellant did not concede that the only distinguishing factor of its composition is the statement of intended use and extensively argued that its claimed composition exhibits the unexpected property of neutralizing the lethality of rattlesnake venom while reducing the occurrence of adverse immune reactions in humans. The Federal Circuit found that such a use and unexpected property cannot be ignored – the unexpected property is relevant and thus the declarations describing it should have been considered.
Nonobviousness can be shown when a person of ordinary skill in the art would not have reasonably predicted the claimed invention based on the prior art, and the resulting invention would not have been expected. All evidence must be considered when properly presented.
Example 3:
The case of Hearing Components, Inc. v. Shure Inc., involved a disposable protective covering for the portion of a hearing aid that is inserted into the ear canal. The covering was such that it could be readily replaced by a user as needed.
At the district court, Shure had argued that Hearing Components’ patents were obvious over one or more of three different combinations of prior art references. The jury disagreed, and determined that the claims were nonobvious. The district court upheld the jury verdict, stating that in view of the conflicting evidence presented by the parties as to the teachings of the references, motivation to combine, and secondary considerations, the nonobviousness verdict was sufficiently grounded in the evidence.
Shure appealed to the Federal Circuit, but the Federal Circuit agreed with the district court that the jury’s nonobviousness verdict had been supported by substantial evidence. Although Shure had argued before the jury that the Carlisle reference taught an ear piece positioned inside the ear canal, Hearing Components’ credible witness countered that only the molded duct and not the ear piece itself was taught by Carlisle as being inside the ear canal. On the issue of combining references, Shure’s witness had given testimony described as “rather sparse, and lacking in specific details.” In contradistinction, Hearing Components’ witness “described particular reasons why one skilled in the art would not have been motivated to combine the references.” Finally, as to secondary considerations, the Federal Circuit determined that Hearing Components had shown a nexus between the commercial success of its product and the patent by providing evidence that “the licensing fee for a covered product was more than cut in half immediately upon expiration” of the patent.
Although the Hearing Components case involves substantial evidence of nonobviousness in a jury verdict, it is nevertheless instructive for Office personnel on the matter of weighing evidence. Office personnel routinely must consider evidence in the form of prior art references, statements in the specification, or declarations under 37 CFR 1.131 or 1.132. Other forms of evidence may also be presented during prosecution. Office personnel are reminded that evidence that has been presented in a timely manner should not be ignored, but rather should be considered on the record. However, not all evidence need be accorded the same weight. In determining the relative weight to accord to rebuttal evidence, considerations such as whether a nexus exists between the claimed invention and the proffered evidence, and whether the evidence is commensurate in scope with the claimed invention, are appropriate. The mere presence of some credible rebuttal evidence does not dictate that an obviousness rejection must always be withdrawn. Office personnel must consider the appropriate weight to be accorded to each piece of evidence. An obviousness rejection should be made or maintained only if evidence of obviousness outweighs evidence of nonobviousness.
I. ARGUMENT DOES NOT REPLACE EVIDENCE WHERE EVIDENCE IS NECESSARY
Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection.
The arguments of counsel cannot take the place of evidence in the record.
II. ARGUING ADDITIONAL ADVANTAGES OR LATENT PROPERTIES
Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present But Not Recognized in the Prior Art
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.
“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”
III. ARGUING THAT PRIOR ART DEVICES ARE NOT PHYSICALLY COMBINABLE
“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.”
- However, the claimed combination cannot change the principle of operation of the primary reference or render the reference inoperable for its intended purpose.
IV. ARGUING AGAINST REFERENCES INDIVIDUALLY
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
V. ARGUING ABOUT THE NUMBER OF REFERENCES COMBINED
Reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention.
VI. ARGUING LIMITATIONS WHICH ARE NOT CLAIMED
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
VII. ARGUING ECONOMIC INFEASIBILITY
The fact that a combination would not be made by businessmen for economic reasons does not mean that a person of ordinary skill in the art would not make the combination because of some technological incompatibility.
VIII. ARGUING ABOUT THE AGE OF REFERENCES
“The mere age of the references is not persuasive of the unobviousness of the combination of their teachings, absent evidence that, notwithstanding knowledge of the references, the art tried and failed to solve the problem.”
IX. ARGUING THAT PRIOR ART IS NONANALOGOUS
X. ARGUING IMPROPER RATIONALES FOR COMBINING REFERENCES
A. Impermissible Hindsight
Applicants may argue that the examiner’s conclusion of obviousness is based on improper hindsight reasoning. However, “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.”
Applicants may also argue that the combination of two or more references is “hindsight” because “express” motivation to combine the references is lacking.
- However, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.”
B. Obvious To Try Rationale
An applicant may argue the examiner is applying an improper “obvious to try” rationale in support of an obviousness rejection.
An “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. “
[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp.
- If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
- In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”
“The admonition that ‘obvious to try’ is not the standard under § 103 has been directed mainly at two kinds of error. In some cases, what would have been ‘obvious to try’ would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful....
- In others, what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.”
C. Lack of Suggestion To Combine References
A suggestion or motivation to combine references is an appropriate method for determining obviousness, however it is just one of a number of valid rationales for doing so.
- The Court in KSR identified several exemplary rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham.
D. References Teach Away from the Invention or Render Prior Art Unsatisfactory for Intended Purpose
1. The Nature of the Teaching Is Highly Relevant
A prior art reference that “teaches away” from the claimed invention is a significant factor to be considered in determining obviousness; however, “the nature of the teaching is highly relevant and must be weighed in substance.
- A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.”
Furthermore, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….”
2. References Cannot Be Combined Where Reference Teaches Away from Their Combination
It is improper to combine references where the references teach away from their combination.
3. Proceeding Contrary to Accepted Wisdom Is Evidence of Nonobviousness
The totality of the prior art must be considered, and proceeding contrary to accepted wisdom in the art is evidence of nonobviousness.
Furthermore, “[k]nown disadvantages in old devices which would naturally discourage search for new inventions may be taken into account in determining obviousness.”
E. Applicability of KSR to All Technologies
At the time the KSR decision was handed down, some observers questioned whether the principles discussed were intended by the Supreme Court to apply to all fields of inventive endeavor.
- Arguments were made that because the technology at issue in KSR involved the relatively well-developed and predictable field of vehicle pedal assemblies, the decision was relevant only to such fields.
- The Federal Circuit has soundly repudiated such a notion, stating that KSR applies across technologies:
This court also declines to cabin KSR to the “predictable arts” (as opposed to the “unpredictable art” of biotechnology).
- In fact, this record shows that one of skill in this advanced art would find these claimed “results” profoundly “predictable.”
- Thus, Office personnel should not withdraw any rejection solely on the basis that the invention lies in a technological area ordinarily considered to be unpredictable.
