Application No.: 10/777,524
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`Docket No.: 140942001311
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`REMARKS
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`Claims 21 and 23-29 are pending.
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`Summary of Examiner Interview
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`Applicants gratefully acknowledge the Examiner’s time and comments during an
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`interview on May 3, 2007. We discussed the outstanding rejections and the evidence already of
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`record.
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`Rejection Under 35 U.S.C. §101 and § 112, first paragraph
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`Claims 21 and 23-29 remain rejected under 35 U.S.C. § 101 and § 112, first paragraph as
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`allegedly lacking a credible, specific, or substantial asserted utility or a well established utility for
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`reasons of record. Briefly, the Examiner continues to assert that the disclosed utilities are neither
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`specific nor substantial because it is not clear what specific role or function FDFO3 is correlated
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`with or which specific hematopoietic cells FDF03 regulates or develops. According to the
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`Examiner, the specification does not disclose definitive differential expression of FDF03.
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`Applicants traverse this rejection for reasons of record as well as those discussed below.
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`Applicants again submit that there is no legal requirement for a certain level of specificity
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`regarding the expression, role or function of a protein that must be achieved to satisfy the utility
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`requirement. The utility must merely capable of providing some identifiable benefit according to
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`the perspective of one of ordinary skill in the art. An applicant is not required to provide evidence
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`sufficient to establish that an asserted utility is true “beyond a reasonable doubt” or “as a matter of
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`statistical certainty.” M.P.E.P. § 2107.02 (VII). An applicant is only required to provide evidence
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`if, when considered as a whole, leads the skilled artisan to conclude that the asserted utility is more
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`likely than not true. M.P.E.P. § 2107.03 (11). Furthermore, for inventions with pharmaceutical or
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`therapeutic utilities, a reasonable correlation between the evidence and the asserted utility is
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`sufficient. Any of the utilities disclosed for FDF03 satisfies this standard.
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`As evidence that a person of ordinary skill in the art would conclude that the specification
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`provides a specific and substantial utility, we offer the declaration of Dr. Lewis Lanier. Dr. Lanier
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`Application No.: 10/777,524
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`Docket No.: 140942001311
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`is a scientist in the field of immunology and has considerable experience assessing the usefulness of
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`new molecules within discrete populations. According to Dr. Lanier, there are at least two utilities
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`that are immediate, well-defined, and real world uses of FDF03. First, Dr. Lanier opines that the
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`FDF03 protein is immediately useful as a marker for monocytes and cells of the myelomonocytic-
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`lineage. See Declaration at M. Despite the examiner’s assertions that additional, more definitive
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`data is required, Dr. Lanier (a person of ordinary skill in the art) believes that the specification
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`provides sufficient evidence to persuade him that the FDF03 protein is a suitable marker for the
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`discrete population of myelomonocytic cells as described in the specification. Second, Dr. Lanier
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`believes that the specification describes an immediate, well-defined, real world use for FDF03 as a
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`regulator of antigen presentation in cells of the myelomonocytic lineage (a use that is subsequently
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`confirmed in later published documents). See Declaration at 115. As noted by Dr. Lanier, the mere
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`fact that FDF03 plays a role in antigen presentation provides a specific and meaningful use
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`regardless of the precise role played by FDF03.
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`In sum, Applicants submit that the specification provides more than one specific, substantial,
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`and credible use for FDF03 that fulfills the utility standard. The exacting, precise standard used by
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`the Examiner is without legal basis and demands considerably more than necessary for the person of
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`ordinary skill in the art to appreciate the immediate, well-defined, and real world uses of FDF03
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`disclosed in the instant specification.
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`As the specification provides adequate utility for the reasons discussed above, Applicants
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`submit that the specification also provides sufficient written description on how to use the claimed
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`FDF03 polypeptide.
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`For at least these reasons as well as those already of record, Applicants respectfully
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`submit that the rejection under 35 U.S.C. §§ 101 and 112 are overcome and should be withdrawn.
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`Application No.1 10/777,524
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`Docket No.: 140942001311
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`CONCLUSION
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`In view of the above, each of the presently pending claims in this application is believed
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`to be in immediate condition for allowance. Accordingly, the Examiner is respectfully requested to
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`withdraw the outstanding rejection of the claims and to pass this application to issue. If it is
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`determined that a telephone conference would expedite the prosecution of this application, the
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`Examiner is invited to telephone the undersigned at the number given below.
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`In the event the U.S. Patent and Trademark office determines that an extension and/or
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`other relief is required, applicant petitions for any required relief including extensions of time and
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`authorizes the Commissioner to charge the cost of such petitions and/or other fees due in connection
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`with the filing of this document to Deposit Account No. 03-1952 referencing docket
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`no. 140942001311. However, the Commissioner is not authorized to charge the cost of the issue fee
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`to the Deposit Account.
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`Dated: October 9, 2007
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`Respectfully submitted,
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`/Laurie L. Hill/
`By:
`Laurie L. Hill, PhD.
`Registration No.: 51,804
`MORRISON & FOERSTER LLP
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`12531 High Bluff Drive, Suite 100
`San Diego, California 92130-2040
`(858) 720-7945
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