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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`
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`CONF {MATION NO.
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`10/777,524
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`02/11/2004
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`Gosse Jan Adema
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`DX0670KB 1B
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`8025
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`12/07/2007
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`7590
`28008
`DNAX RESEARCH INC.
`LEGAL DEPARTMENT
`901 CALIFORNIA AVENUE
`PALO ALTO, CA 94304
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`EXAMINER
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`BUNNER, BRIDGET E
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`ART UNIT
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`1647
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`MAIL DATE
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`12/07/2007
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`PAPER NUMBER
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL—90A (Rev. 04/07)
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`

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`Application No.
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`Applicant(s)
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`10/777,524
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`ADEMA ET AL.
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`Office Action Summary
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`Examiner
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`Bridget E. Bunner
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`Art Unit
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`1647 -
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`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 timely filed
`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).
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`Status
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`1)IXI Responsive to communication(s) filed on 09 October 2007.
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`2a)IZI This action is FINAL.
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`2b)I:I This action is non-final.
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`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under EX parte Quayle, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IZI Claim(s) 21 and 23-29 is/are pending in the application.
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`4a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`5)I:I Claim(s) _ is/are allowed.
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`6)IXI Claim(s) 211 23-29 is/are rejected.
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`7)I:I Claim(s) _ is/are objected to.
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`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I 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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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I AII
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`b)I:I Some * c)I:I None of:
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`Certified copies of the priority documents have been received.
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`Certified copies of the priority documents have been received in Application No.
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`Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attach ment(s)
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`1) D Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date
`.
`U.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`5) I:I Notice of Informal Patent Application
`6) D Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20071 129
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`Application/Control Number: 10/777,524
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`Page 2
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`Art Unit: 1647
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`DETAILED ACTION
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`A request for continued examination under 37 CFR 1.114, including the fee set forth in
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`37 CFR l.l7(e), was filed in this application after final rejection. Since this application is
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`eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR l.l7(e)
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`has been timely paid, the finality of the previous Office action has been withdrawn pursuant to
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`37 CFR 1.114. Applicant's submission filed on 09 October 2007 has been entered.
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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 U.S.C. § 112, first paragraph
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`35 U.S.C. 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 of this title.
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`The following is a quotation of the first paragraph of 35 U.S.C. 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 U.S.C. 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 page 2-7 of
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`the previous Office Action (07 August 2007), pg 3-14 of the Office Action of 27 December
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`Application/Control Number: 10/777,524
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`Page 3
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`Art Unit: 1647
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`2006, pages 4-9 of the Office Action of 05 April 2006 and for claims 21-29 at pg 3-6 of the
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`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 purif1cation 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 (09 October 2007), as they pertain to the rejections have been
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`fully considered but are not deemed to be persuasive for the following reasons.
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`(i)
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`At page 2 of the Response of 09 October 2007, Applicant asserts that there is no legal
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`requirement for a certain level of specificity regarding the expression, role or fianction of a
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`protein that must be achieved to satisfy the utility requirement. Applicant states that the utility
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`must merely be capable of providing some identifiable benefit. It is noted that Applicant cites
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`MPEP § 2107.02 (V11) and § 2107.03 (11).
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`Applicant’s arguments have been fully considered but are not found to be persuasive.
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`The Examiner acknowledges that the applicant does not have to provide evidence sufficient to
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`establish that an asserted utility is true “beyond a reasonable doubt” and that “[in] most cases, an
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`Applicant's assertion of utility creates a presumption of utility that will be sufficient to satisfy the
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`utility requirement of 35 U.S.C. 101” (MPEP § 2107.02 (section 111)). However, as stated in In
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`re Fisher, “[A]n application must show that an invention is useful to the public as disclosed in its
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`current form, not that it may prove useful at some fiJture date after further research” (see Fisher,
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`421 F.3d at 1371, 76 USPQ2d at 1230 (Fed. Cir. 2005); see also MPEP § 2107.01(B)). 1n the
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`previous Off1ce Actions of 07 August 2007, 27 December 2006, 05 April 2006 and 12 July 2005,
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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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`the Examiner made a prima facie showing that the claimed invention lacks utility and provided
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`sufficient evidentiary basis for factual assumptions relied upon in establishing the prima facie
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`showing. Essentially, Applicant has not provided evidence to demonstrate that the claimed
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`FDF03 polypeptide is supported by a specific and substantial asserted utility or a well established
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`utility at the time of filing of the instant application. The Examiner has fillly considered all
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`evidence of record and has responded to each substantive element of Applicant’s response (see
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`point (ii) below). It is noted to Applicant that MPEP § 2107.02 (part VI) also states that “only
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`where the totality of the record continues to show that the asserted utility is not specific,
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`substantial, and credible should a rejection based on lack of utility be maintained”.
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`(ii)
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`The declaration of Dr. Lanier under 37 CFR 1.132 filed 09 October 2007 is insufficient to
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`overcome the rejection of claims 21 and 23-29 based upon lack of utility under 35 U.S.C. §101
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`and insufficiency of disclosure under 35 U.S.C. § 112, first paragraph as set forth in the last
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`Office action. In assessing the weight to be given expert testimony, the examiner may properly
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`consider, among other things, (1) the nature of the fact sought to be established, (2) the strength
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`of any opposing evidence, (3) the interest of the expert in the outcome of the case, and (4) the
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`presence or absence of factual support for the expert's opinion. See Ex parte Simpson, 61
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`USPQ2d 1009 (BPAI 2001), Cf. Redac Int'l. Ltd. v. Lotus Development Corp, 81 F.3d 1576, 38
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`USPQ2d 1665 (Fed. Cir. 1996), Paragon Podiatg Lab., Inc. v. KLM Lab., Inc., 948 F.2d 1182,
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`25 USPQ2d 1561, (Fed. Cir. 1993). In the instant case, (1) the nature of the fact sought to be
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`established is whether or not the specification of the instant application provides a specific and
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`substantial asserted utility or a well established utility for the claimed FDF03 polypeptide of
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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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`SEQ ID NO: 2. (2) The opposing evidence, as cited by the examiner, indicates that, at the time
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`of filing, even if FDF03 was a putative Ig receptor expressed on monocytes and dendritic cells,
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`immunoglobulin superfamily members included a wide range of receptors with diverse
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`biological fianctions (see Huang et al. 1997; previously made of record). Additionally, although
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`the post-filing date references, such as Foumier et al. 2000, which study FDF03, are interesting,
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`they clearly indicate that at the time of filing, further characterization of FDF03 was required and
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`Applicant’s invention was incomplete.
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`(3) Dr. Lanier is one of the inventors of the instant
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`application.
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`(4) Finally, Dr. Lanier does not base his opinion on any particular facts other than
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`his own considerable experience in the field. Affidavits or declarations are provided as evidence
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`and must set forth facts, not merely conclusions. In re Pike and Morris, 84 USPQ 235 (CCPA
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`1 949).
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`As discussed in the previous Office Action of 07 August 2007, the specification of the
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`instant application does not disclose that the FDF03 polypeptide of the instant application has
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`any filnctional activity (including involvement in antigen presentation or negative regulation of
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`activation of dendritic cells and monocytes). Basic research to determine the functional
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`properties of the claimed protein is still required. Although the specification discloses that “[t]he
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`proteins likely play a role in regulation or development of hematopoietic cells, e.g. lymphoid
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`cells, which affect immunological responses, e.g. antigen presentation and the resulting effector
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`functions” (pg 68, line 37 through pg 69, lines 1-3), this asserted utility is not specific or
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`substantial because it is not clear what specific role or function FDF03 is correlated with (such as
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`proliferation, differentiation, apoptosis, cell-cell adhesion, regulation of cytokine production, T
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`cell activation, antigen capture and presentation, among others) or which specific hematopoietic
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`Application/Control Number: 10/777,524
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`Page 6
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`Art Unit: 1647
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`cells FDF03 regulates or develops. Absent such identification, the FDF03 polypeptide has not
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`been 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 stated in In re Fisher, “[A]n application must show that an invention is useful to the
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`public as disclosed in its current form, not that it may prove useful at some filture date after
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`further research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must
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`show that the claimed invention has a significant and presently available benefit to the public.”
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`(see Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230 (Fed. Cir. 2005); see also MPEP §
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`2107.01(B)). Additionally, the asserted patentable utility of using FDF03 as a marker to identify
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`dendritic cells or cells of myelomonocytic lineage is not specific or substantial because the
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`instant application does not disclose the biological role of the FDF03 protein or its significance.
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`One skilled in the art would not readily use the polypeptide as a cell marker in a real world sense
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`since the protein has not been shown to be specific to limited cell types and is not associated with
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`any disease or disorder. The specification of the instant application only teaches that FDF03 is
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`expressed on the cell surface of monocytes and dendritic cells. The specification does not
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`disclose if there is differential expression of FDF03 on normal cells vs. cells of a
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`disease/disorder. The specification and post-filing date references also do not provide any
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`evidence to indicate that FDF03 is not expressed on other cells of the immune system, such as
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`stem cells, progenitor cells, stromal cells, eosinophils, basophils, megakaryocytes, just to name a
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`few. There is also no indication in the specification that neutrophils, which are derived from a
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`monocyte progenitor cell, express FDF03. In other words, the specification does not teach
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`definitive differential cell expression of FDF03. Thus, if one skilled in the art was to perform a
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`Application/Control Number: 10/777,524
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`Page 7
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`Art Unit: 1647
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`cell separation technique on a blood sample using FDF03 as a marker, he/she may not simply
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`isolate myelomonocytic cells or dendritic cells, as asserted by Applicant. Furthermore, evidence
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`of mere expression on a tissue or cell type is not tantamount to a showing of a filnctional role of
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`the FDF03 polypeptide. Basic research to determine the filnctional properties of the claimed
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`protein is still required. Since this asserted utility is also not present in mature form, so that it
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`could be readily used in a real world sense, the 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, filrther 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 filrther 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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`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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`Application/Control Number: 10/777,524
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`Page 8
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`Art Unit: 1647
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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 pages 7-8 of the previous Off1ce Action (07 August 2007), at page 14 of the Office
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`Action of 27 December 2006, at pg 9 of the Office Action of 05 April 2006 and for claims 21-29
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`at pg 6 ofthe Office Action of 12 July 2005.
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`Applicant’s arguments (09 October 2007), as they pertain to the rejections have been
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`fully 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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`Application/Control Number: 10/777,524
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`Page 9
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`Art Unit: 1647
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`No claims are allowable.
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`Conclusion
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`All claims are drawn to the same invention claimed in the application prior to the entry of
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`the submission under 37 CFR 1.1 14 and could have been finally rejected on the grounds and art
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`of record in the next Office action if they had been entered in the application prior to entry under
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`37 CFR l.ll4. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action
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`after the filing of a request for continued examination and the submission under 37 CFR 1.1 14.
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`See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR l.l36(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 CFR
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`l.l36(a) will be calculated from the mailing date of the advisory action. In no event, however,
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`will the statutory period for reply expire later than SIX MONTHS from the mailing date of this
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`final action.
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`Application/Control Number: 10/777,524
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`Page 10
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`Art Unit: 1647
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Bridget E. Bunner Whose telephone number is (571) 272-0881.
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`The examiner can normally be reached on 8:30-4:30 M-F.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Manjunath Rao can be reached on (571) 272-0939. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto. gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`BEB
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`Art Unit 1647
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`29 November 2007
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`/Bridget E Bunner/
`Primary Examiner, Art Unit 1647
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`