`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`(22
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria. Virginia 223l3-l450
`www.uspto.gov
`
`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`02/ | 1/2004
`08/07/2007
`.
`
`l0/777.524
`7590
`28008
`DNAX RESEARCHINC.
`LEGAL DEPARTMENT
`901 CALIFORNIA AVENUE
`PALO ALTO CA 94304
`
`Gossc Jan Adema
`
`DX0670KB_I B
`
`8025
`
`RUNNER, BRIDGET E
`
`ART UNIT
`I647
`
`PAPER NUMBER
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`MAIL DATE
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`DELIVERY MODE
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`08/07/2007
`
`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
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`

`

`Application No.
`
`10/777,524
`
`Applicant(s)
`
`ADEMA ET AL.
`
`Office Action Summary
`
`Examine,
`
`Art Unit
`
`B'Idge‘ 5' Bunner --
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event however may a reply be timelyifiled
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply'Is specified above. the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will by statute cause the application to become ABANDONED (35 U. S C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed may reduce any
`earned patent term adjustment See 37 CFR 1. 704(b).
`
`Status
`
`1)IZI Responsive to communication(s) filed on 27 June 2007.
`2am This action is FINAL.
`2b)E] This action is non-final.
`3)[] Since this application is in condition for allowance except for formal matters. prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quay/e, 1935 CD. 11, 453 0.6. 213.
`
`
`
`Disposition of Claims
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`4)IZ] Claim(s) 21 and 23—29 is/are pending in the application.
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`4a) Of the above Claim(s) _ is/are withdrawn from consideration.
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`5H] Claim(s) __ is/are allowed.
`BIE Claim(s) 21 and 23-29 is/are rejected.
`7):] Claim(s) __ is/are objected to.
`8)EI Claim(s)
`are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)D The specification is objected to by the Examiner.
`10):] The drawing(s) filed on _ is/are: a)I:] accepted or b)E] objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`11)[___] The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`2)]: Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`a)[] All
`b)El Some * c)EI None of:
`1E] Certified copies of the priority documents have been received.
`2.[:] Certified copies of the priority documents have been received in Application No.
`3.[:] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) [:1 Notice of References Cited (PTO-892)
`2) E] Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) [:1 Information Disclosure Statement(s) (PTO/SB/OB)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
`
`4) El Interview Summary (PTO-413)
`Paper No(s)/Mail Date. 2.0070503 -
`5) I] Notice of Informal Patent Application
`6) I] Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
`
`Part of Paper No./Mail Date 20070730
`
`

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`Application/Control Number: 10/777,524
`Art Unit: 1647
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`Page 2
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`DETAILED ACTION
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`Status ofApplication, Amendments and/0r Claims
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`Claims 21 and 23-29 are under consideration in the instant application.
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`Claim Rejections - 35 USC § 101 and 35 US. C. § 112, first paragraph
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`35 USC. 101 reads as follows:
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`Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or
`any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and
`requirements ofthis title.
`
`The following is a quotation of the first paragraph of 35 USC 112:
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`The specification shall contain a written description of the invention, and of the manner and process of making
`and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it
`pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode
`contemplated by the inventor of carrying out his invention.
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`1.
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`Claims 21 and 23-29 are rejected under 35 USC. 101 because the claimed invention is
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`not supported by either a credible, specific and substantial asserted utility or a well established
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`utility. Novel biological molecules lack well established utility and must undergo extensive
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`experimentation. The basis for this rejection is set forth for claims 21 and 23-29 at pg 3-14 of
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`the previous Office Action (27 December 2006), page 4-9 of the Office Action of 05 April 2006
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`and for claims 21-29 at pg 3-6 of the Office Action of 12 July 2005.
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`The claims are directed to a substantially pure or isolated polypeptide comprising the
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`amino acid sequence of SEQ ID NO: 2. The claims recite a composition comprising the
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`polypeptide and a polypeptide fused to a detection or purification tag. The claims recite a kit
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`comprising the polypeptide. The claims recite that the polypeptide is recombinantly produced.
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`Applicant’s arguments (27 June 2007), as they pertain to the rejections have been fully
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`considered but are not deemed to be persuasive for the following reasons.
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`

`

`Application/Control Number: 10/777,524
`Art Unit: 1647
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`Page 3
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`(i)
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`At page 3 of the Response of 27 June 2007, Applicant states that the Examiner appears to
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`be relying heavily on in re Fisher 421 F.3d 1365 (2005), a case whose facts are easily
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`distinguishable from the current application. At page 3 through the top of page 4 of the
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`Response, Applicant reviews the facts of in re Fisher.
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`The Examiner takes no issue with Applicant's general comments regarding the legal
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`standard for utility..
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`(ii)
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`At the middle of page 4 of the Response, Applicant argues that the specification meets
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`the standard discussed in Fisher by disclosing more than merely a generic utility for FDF03 as
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`well as providing evidence that the asserted utilities are significant and have a presently available
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`benefit to the public. Applicant points out that the specification at page 68 through page 69
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`disclosed that the FDF03 protein “likely plays a role in regulation or development of
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`hematopoietic cells, ...e.g., antigen presentation and the resulting effector functions”. Applicant
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`asserts that the evidence demonstrates that FDF03 does indeed play a role in the regulation in
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`mast cells and antigen presenting cells. Applicant argues that the specification further discloses
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`FDF03 as a cell surface marker that is discretely and specifically expressed on cells of the
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`myelomonocytic lineage, e.g., monocytes (page 54, lines 18-22; page 87, lines 35 through page
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`88, line 6). Applicant contends that these are specific and substantial utilities that are supported
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`by copious evidence already of record. Applicant adds that the evidence shows that the asserted
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`utilities were accurate as disclosed in the specification and immediately useful. Applicant states
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`that the very specific, disclosed utilities cannot be construed as being generic or without
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`Application/Control Number: 10/777,524
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`Page 4
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`Art Unit: 1647
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`immediate benefit to the public as such a use cannot be assigned to just any new protein or even
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`any new protein expressed on antigen presenting cells.
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`Applicant’s arguments have been fully considered but are not found to be persuasive.
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`The specification does not teach any methods or working examples to demonstrate that the
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`FDF03 polypeptide of the instant application has any functional activity. At the time the instant
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`application was filed, one skilled in the art would not have known the utility and function of
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`polypeptide in the instant specification, even if it was a putative Ig receptor expressed on
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`monocytes and dendritic cells because, as discussed in the related art (see Huang et al.,
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`Biopolymers 43: 367-3 82, 1997), immunoglobulin superfamily members include a wide range of
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`receptors with diverse biological activities. Basic research to determine the functional properties
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`of the claimed protein is still required. Although the specification discloses that “[t]he proteins
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`likely play a role in regulation or development of hematopoietic cells, e. g. lymphoid cells, which
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`affect immunological responses, e.g. antigen presentation and the resulting effector functions”
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`(pg 68, line 37 through pg 69, lines 1-3), this asserted utility is not specific or substantial because
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`it is not clear what specific role or function FDF03 is correlated with (such as proliferation,
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`differentiation, apoptosis, cell-cell adhesion, regulation of cytokine production, T cell activation,
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`antigen capture and presentation, among others) or which specific hematopoietic cells FDF03
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`regulates or develops. Absent such identification, the FDF03 polypeptide has not been
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`researched and understood to the point of providing an immediate, well-defined, real world
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`benefit to the public meriting the grant of a patent.
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`As discussed in the previous Office Actions of 27 December 2006 and 05 April 2006, the
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`specification at the time of filing does not disclose that FDF03 is involved in antigen
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`Application/Control Number: 10/777,524
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`Page 5
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`Art Unit: 1647
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`presentation or negatively regulates activation of dendritic cells and monocytes. The
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`specification at the time of filing also does not disclose that FDFO3 is an inhibitory receptor or
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`any physiological activity of FDF03. Although the post—filing date references, which study
`FDFO3, are interesting, they clearly indicate that at the time of filing, further characterization of
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`FDF03 was required and Applicant’s invention was incomplete. As stated in In re Fisher, “[A]n
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`application must show that an invention is useful to the public as disclosed in its current form,
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`not that it may prove useful at some future date after further research” (see Fisher, 421 F.3d at
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`1371, 76 USPQ2d at 1230; see also MPEP § 2107.01(B)). Additionally, the asserted patentable
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`utility of using FDF03 as a marker to identify dendritic cells or cells of myelomonocytic lineage
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`is not specific or substantial because the instant application does not disclose the biological role
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`of the FDF03 protein or its significance. One skilled in the art would not readily use the
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`polypeptide as a cell marker in a real world sense since the protein has not been shown to be
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`specific to limited cell types and is not associated with any disease or disorder. The specification
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`of the instant application only teaches that FDF03 is expressed on the cell surface of monocytes
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`and dendritic cells. The specification does not disclose if there is differential expression of
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`FDF03 on normal cells vs. cells of a disease/disorder. The specification and post-filing date
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`references also do not provide any evidence to indicate that FDFO3 is not expressed on other
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`cells of the immune system, such as stem cells, progenitor cells, stromal cells, eosinophils,
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`basophils, megakaryocytes, just to name a few. There is also no indication in the specification
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`that neutrophils, which are derived from a monocyte progenitor cell, express FDF03. In other
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`words, the specification does not teach definitive differential cell expression of FDF03. Thus, if
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`one skilled in the art was to perform a cell separation technique on a blood sample using FDFO3
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`

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`Application/Control Number: 10/777,524
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`Art Unit: 1647
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`Page 6
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`as a marker, he/she may not simply isolate myelomonocytic cells or dendritic cells, as asserted
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`by Applicant. Furthermore, evidence of mere expression on a tissue or cell type is not
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`tantamount to a showing of a functional role of the FDFO3 polypeptide. Basic research to
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`determine the functional properties of the claimed protein is still required. Since this asserted
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`utility is also not present in mature form, so that it could be readily used in a real world sense, the
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`asserted utility is not substantial.
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`In the instant case, the claimed FDF03 polypeptide is not disclosed as having an activity
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`that can be specifically useful. Thus, further research is required to identify or reasonably
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`confirm a specific and substantial utility. See MPEP § 2107.01(I)(C), for example. Such further
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`research requirements make it make it clear that the asserted utility is not yet in currently
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`available form, i.e., it is not substantial. This further experimentation is part of the act of
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`invention and until it has been undertaken, Applicant’s claimed invention is incomplete. See
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`Brenner v. Manson, 148 U.S.P.Q. 689 (Sus. Ct., 1966), wherein the court held that:
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`"The basic quid pro quo contemplated by the Constitution and the Congress for
`granting a patent monopoly is the benefit derived by the public from an invention
`with substantial utility", "[u]nless and until a process is refined and developed to
`this point—where specific benefit exists in currently available form—there is
`insufficient justification for permitting an applicant to engross what may prove to
`be a broad field", “Congress intended that no patent be granted on a chemical
`compound whose sole "utility" consists of its potential role as an object of use-
`testing”, and "a patent is not a hunting license", "[i]t is not a reward for the search,
`but compensation for its successful conclusion."
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`(iii) At the bottom of page 4 of the Response of 27 June 2007, Applicant asserts that there is
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`no legal requirement for empirical evaluation or that a certain level of specificity regarding the
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`role or function of a protein must be achieved. Applicant argues that there is no requirement for
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`definitive evidence and disclosure of a detailed biologic profile to satisfy the utility requirement.
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`

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`Application/Control Number: 10/777,524
`Art Unit: 1647
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`Page 7
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`Applicant states that the utility must merely be capable of providing some identifiable benefit.
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`Applicant submits that any of the utilities disclosed for the FDF03 satisfies this standard.
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`Applicant’s arguments have been fully considered but are not found to be persuasive. A
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`specification can meet the legal requirements of utility and enablement for a new polypeptide as
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`long as the specification discloses at least one specific and substantial asserted utility for the new
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`polypeptide, or a well-established utility for the claimed polypeptide that would be primafacie
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`obvious to the skilled artisan. However, the instant disclosure of a novel immunoglobulin
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`superfamily member fails to provide any factual evidence that this specific FDF03 polypeptide is
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`associated with any particular disease, condition, or physiological process.
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`The specification at the time of filing does not disclose that FDFO3 negatively regulates
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`activation of dendritic cells and monocytes. The specification at the time of filing also does not
`disclose that FDF03 is an inhibitory receptor or any physiological activityof FDF03. Although
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`the post-filing date references, which study FDF03, are interesting, they clearly indicate that at
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`the time of filing, further characterization of FDF03 was required and Applicant’s invention was
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`incomplete.
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`2.
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`Claims 21 and 23-29 are also rejected under 35 U.S.C. 112, first paragraph. Specifically,
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`since the claimed invention is not supported by either a specific and substantial asserted utility or
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`a well established utility for the reasons set forth above, one skilled in the art clearly would not
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`know how to use the claimed invention. The basis for this rejection is set forth for claims 21 and
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`23-29 at page 14 of the previous Office Action (27 December 2006), at pg 9 of the previous
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`

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`Application/Control Number: 10/777,524
`Art Unit: 1647
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`Page 8
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`Office Action of 05 April 2006 and for claims 21-29 at pg 6 of the Office Action of 12 July
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`2005.
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`Applicant’s arguments (27 June 2007), as they pertain to the rejections have been fully
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`considered but are not deemed to be persuasive for the following reasons.
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`Specifically, since Applicant has not provided evidence to demonstrate that the FDF03
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`polypeptide of SEQ ID NO: 2 has a specific and substantial asserted utility or a well established
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`utility, one skilled in the art would not know how to use the claimed invention. It is noted that
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`the instant specification is required to teach one skilled in the art how to make and use the
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`FDF03 polypeptide.
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`

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`Application/Control Number: 10/777,524
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`Art Unit: 1647
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`Page 9
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`No claims are allowable.
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`Conclusion
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action. In the event a first reply is filed within TWO
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`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE-MONTH shortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
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`however, will the statutory period for reply expire later than SIX MONTHS from the mailing
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`date of this final action.
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`Any inquiry concerning this communication or earlier communications frOm the
`examiner should be directed to Bridget E. Bunner whose telephone number is (571) 272-0881.
`The examiner can normally be reached on 8:30-4:30 M-F.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`supervisor, Gary Nickol can be reached on (571) 272—0835. The fax phone number for the
`organization where this application or proceeding is assigned is 571-273-8300.
`Information regarding the status of an application may be obtained from the Patent
`Application Information Retrieval (PAIR) system. Status information for published applications
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`applications is available through Private PAIR only. For more information about the PAIR
`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
`like assistance from a USPTO Customer Service Representative or access to the automated
`information system, call 800-786—9199 (IN USA OR CANADA) or 571-272-1000.
`
`BEB
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`Art Unit 1647
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`30 Jul 2007
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`y
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`.
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`W (,6. @WO
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`BRIDGET E. BUNNER
`PRIMARY EXAMINER
`
`