Recent test takers report that question #37 from the October 2003 (PM) test is in the patent bar exam database.
37. The specification of an application does not disclose the utility of the claimed composition. In fact, the claimed invention is useful for shrinking a specific class of tumors. In a first Office action, the primary examiner has properly determined that the claims lack utility, and has rejected all of the composition claims under the first paragraph of 35 USC 112 as lacking utility. Which of the following responses is in accord with the USPTO rules and the procedures of the MPEP for persuading the examiner that the rejection is improper?
(A) Explain that the rejection is statutorily improper because the first paragraph of section 112 is concerned with enablement and written description issues and therefore does not support a rejection for lack of utility.
(B) Point out that the rejection is based on an erroneous finding by the examiner because the specification, in fact, clearly discloses that the composition in question possesses “useful biological” properties.
(C) Show that the rejection is improper by filing probative evidence that the claimed composition has unambiguously proven to be useful for shrinking a specific class of tumors.
(D) File declarations by persons with ordinary skill in the art stating that they would immediately appreciate that the claimed composition is useful for shrinking a specific class of tumors due to the fact that similar compositions having the same characteristics as applicant’s claimed composition were known to be effective for this purpose.
(E) Argue that the rejection is improper because the examiner has failed to present evidence in support of his position that the claimed composition has no utility.
ANSWER: (D) is most correct answer. As explained at MPEP § 2107.02, II, B, under the heading “No Statement of Utility for the Claimed Invention in the Specification Does Not Per Se Negate Utility,” the fact that a specification does not contain a statement of utility for the claimed invention does not per se negate utility. This is because a claimed invention may have a well-established utility, and an invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention and (ii) the utility is specific, substantial, and credible. In this case, the declarations specify a specific substantial and credible utility and explain why the declarants (i.e., persons of ordinary skill in the art) would immediately appreciate that the applicant’s claimed composition would possess this utility. (A) is incorrect. A lack of utility deficiency under 35 U.S.C. § 101 also creates a lack of utility deficiency under the first paragraph of 35 U.S.C. § 112 as fully explained at MPEP § 2107.01, under the heading “IV. Relationship Between 35 U.S.C. 112, First Paragraph, And 35 U.S.C. 101.” (B) is not the most correct answer. 35 U.S.C. § 101 (and the first paragraph of 35 U.S.C. § 112) requires that the utility be specific. Therefore, the disclosure of a general utility such as “useful biological” properties does not satisfy this requirement as fully explained at MPEP § 2107.01, under the heading “I. Specific And Substantial Requirements.” Response (C) also would not be persuasive since the rejection is based on the fact that the applicant’s specification fails to identify any specific and substantial utility for the claimed composition or fails to disclose enough information about the invention to make its usefulness immediately apparent to those familiar with the technological field of the invention. This is explained at MPEP § 2107.01. The fact that the claimed composition has unambiguously proven to be useful for curing a form of cancer previously thought to be incurable does not negate these specification deficiencies. That is, notwithstanding this unambiguous proof, the fact remains that the applicant’s specification fails to identify any specific and substantial utility for the composition. Moreover, it is clear that the specification would not make this specific usefulness immediately apparent to those familiar with the technological field of the composition since the cancer was previously thought to be incurable. Finally, response (E) also would not be persuasive. Under current USPTO policy and procedure, the examiner is not required to present evidence in support of a rejection based on lack of utility where, as here, the specification does not identify a specific, substantial and credible utility and does not appear to provide sufficient information such that a well-established utility would be apparent to a person with ordinary skill in the art. See MPEP § 2107, under the heading “II. Examination Guidelines For The Utility Requirement.”
has the answer to this question changed? I’m assuming the correct answer is now E.
2107 does not state that the examiner must provide evidence to support the utility rejection. The applicant, however, must do so in order to rebut such a rejection. See the following:
The 35 U.S.C. 101 and
112 rejections shift the burden of coming forward
with evidence to the applicant to:
(i) Explicitly identify a specific and substantial
utility for the claimed invention; and
(ii) Provide evidence that one of ordinary
skill in the art would have recognized that the identified
specific and substantial utility was well-established
at the time of filing. The examiner should
review any subsequently submitted evidence of utility
using the criteria outlined above. The examiner
should also ensure that there is an adequate nexus
between the evidence and the properties of the now
claimed subject matter as disclosed in the application
as filed. That is, the applicant has the burden to establish
a probative relation between the submitted evidence
and the originally disclosed properties of the
claimed invention.
(C) Any rejection based on lack of utility
should include a detailed explanation why the claimed
invention has no specific and substantial credible utility.
Whenever possible, the examiner should provide
documentary evidence regardless of publication date
(e.g., scientific or technical journals, excerpts from
treatises or books, or U.S. or foreign patents) to support
the factual basis for the prima facie showing of
no specific and substantial credible utility. If documentary
evidence is not available, the examiner
should specifically explain the scientific basis for his
or her factual conclusions.
Also, even if you took the “shift the burden of coming forward with evidence” statement to mean that the examiner did, in fact, have to provide evidence to support his rejection, D would still be a correct answer. In light of the rather significant presumption you need to make for E to be correct, I would still go with D.
as stated in the question”….he primary examiner has properly determined that the claims lack utility…” so E is wrong
here’s my 2cents:
(E) would be correct if the application ASSERTED a utility and the examiner rejected it without providing evidence.
The examiner need not provide evidence where the application is SILENT re utility (and is not immediately evident to a posita)