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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`wwwusptogov
`
`
`
`
`
`14/095,928
`
`12/03/2013
`
`Yukari HATAOKA
`
`069804—0375
`
`3160
`
`20277
`7590
`09’0””
`MCDERMOTT WILL&EMERY LLP —
`The McDermott Building
`HAQ, SHAFIQUL
`500 North Capitol Street, NW.
`WASHINGTON, DC 20001
`
`PAPER NUMBER
`
`1678
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/09/2015
`
`ELECTRONIC
`
`Please find below and/0r attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`
`mweipdocket @ mwe.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Application No.
`Applicant(s)
`
` 14/095,928 HATAOKA, YUKARI
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`1678SHAFIQUL HAQ if?“
`
`-- 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 g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`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).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 12/03/2013.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)lX| This action is non-final.
`2a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:I 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 O.G. 213.
`
`Disposition of Claims*
`5)IXI Claim(s) 1-21is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)|:l Claim(s) _ is/are allowed.
`7)I:l Claim(s) _ is/are rejected.
`
`8)I:I Claim(s)
`is/are objected to.
`
`9)|XI Claim(s 1-21 are subject to restriction and/or election requirement.
`I
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usoto. ov/ atents/init events"
`
`
`
`
`h/index.‘s or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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).
`
`Priority under 35 U.S.C. § 119
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)I:I All
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I:I 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)
`
`
`
`3) D Interview Summary (PT0_413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) D Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mai| Date .
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20150901
`
`

`

`Application/Control Number: 14/095,928
`
`Art Unit: 1678
`
`Page 2
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`DETAILED ACTION
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`Status of Claims
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`1. Claims
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`1-21
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`are pending and are subjected to
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`restriction and/or election
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`requirement.
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`Election/Restriction
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`1. Restriction to one of the following inventions is required under 35 U.S.C. 121:
`
`l.
`
`Claims 1-9, drawn to a method of
`
`immobilizing Albumin, classified for
`
`example, in CPC group G01N33/00 and subgroup G01N33/531.
`
`ll.
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`Claims 10-15, drawn to a sensor, classified for example,
`
`in CPC group
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`A61 K39/00 and subgroup A61 K39/385.
`
`lll.
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`Claims 16-21, drawn to a method of detection of a target substance,
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`classified for example, in CPC group G01 N33/00 and subgroup G01 N33/53.
`
`2.
`
`Inventions l and II are related as process of making and product made. The
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`inventions are distinct if either or both of the following can be shown: (1) that the
`
`process as claimed can be used to make another and materially different product or
`
`(2) that the product as claimed can be made by another and materially different
`
`process (MPEP § 806.05(f)).
`
`In the instant case the process as claimed can be
`
`used to make
`
`another
`
`and materially different product, as
`
`for
`
`example,
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`immobilization of a hapten (as for example, biotin) by supplying biotin to the
`
`substrate of step (a) to form a peptide bond with the carboxyl group of the substrate.
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`Further,
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`the product,
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`i.e. sensor with immobilized albumin can be obtained by
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`adsorption of albumin on a self-assembled hydrophobic monolayer.
`
`

`

`Application/Control Number: 14/095,928
`
`Art Unit: 1678
`
`Page 3
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`3.
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`Inventions II and III are related as product and process of use. The inventions can
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`be shown to be distinct
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`if either or both of the following can be shown:
`
`(1) the
`
`process for using the product as claimed can be practiced with another materially
`
`different product or (2) the product as claimed can be used in a materially different
`
`process of using that product. See MPEP § 806.05(h).
`
`In the instant case the
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`product (the sensor having albumin) can be used in a materially deferent process
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`such as covalent conjugation of biomolecules or hapten by reacting the amino group
`
`of the albumin with a biomolecule (example streptavidin) or a hapten (e.g. biotin)
`
`having an activated NHS group.
`
`Inventions l and III are directed to related process requiring chemical formula II. The
`
`related inventions are distinct if: (1) the inventions as claimed are either not capable
`
`of use together or can have a materially different design, mode of operation,
`
`function, or effect;
`
`(2) the inventions do not overlap in scope,
`
`i.e., are mutually
`
`exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP §
`
`806.05(j). For example, the process of Group I is for method of immobilizing albumin
`
`on a self-assembled monolayer, which requires a step of preparing a substrate
`
`having chemical formula (I), which is not required step in the process of Group III
`
`invention. Group II
`
`invention is for detection of antibody, which requires a step of
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`supplying sample to a sensor to bind antibody, which is not required by the process
`
`of Group | invention. Therefore, the process of Group | invention differ materially in
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`design, performance, structure, mode of operation, function, and effect.
`
`

`

`Application/Control Number: 14/095,928
`
`Art Unit: 1678
`
`Page 4
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`5. Restriction for examination purposes as indicated is proper because all
`
`these
`
`invention listed in this action are independent or distinct for the reasons given above
`
`and there would be a serious search and examination burden if restriction were not
`
`required because one or more of the following reasons apply:
`
`1. The inventions have acquired a separate status in the art in view of their
`
`different classification i.e. different groups or different subgroups;
`
`2. The inventions have acquired a separate status in the art due to their
`
`recognized divergent subject matter;
`
`3. The invention require a different
`
`field of search (for example, searching
`
`different classes/subclasses or electronic resources, or employing different
`
`search queries);
`
`4. The prior art applicable to one invention would not
`
`likely be applicable to
`
`another invention;
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`5. The inventions are likely to raise different non-prior art issues under 35 U.S.C
`
`101 and/or 35 U.S.C 112, first paragraph.
`
`
`Applicant is advised that a reply to this requirement to be complete must
`
`include (i) an election of a invention to be examined even though the
`
`requirement may be traversed (37CFR 1.143) and (ii) identification of the claims
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`encompassing the elected invention.
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`

`

`Application/Control Number: 14/095,928
`
`Art Unit: 1678
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`Page 5
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`6. The election of the invention may be made with or without traverse. To reserve a
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`right
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`to petition,
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`the election must be made with traverse.
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`If the reply does not
`
`distinctly and specifically point out supposed errors in the restriction requirement, the
`
`election shall be treated an as election without
`
`traverse. Traversal must be
`
`presented at the time of election in order to be considered timely. Failure to timely
`
`traverse the requirement will result in the loss of right to petition under 37 CFR
`
`1.144.
`
`lf claims are added after the election, applicant must indicate which of these
`
`claims are readable on the elected invention.
`
`Should applicant traverse on the ground that the inventions are not patentably
`
`distinct, applicant should submit evidence or identify such evidence now of record
`
`showing the species to be obvious variants or clearly admit on the record that this is
`
`the case.
`
`In either instance, if the examiner finds one of the inventions unpatentable
`
`over the prior art, the evidence or admission may be used in a rejection under 35
`
`U.S.C. 103(a) of the other invention.
`
`7. The examiner has required restriction between product and process claims. Where
`
`applicant elects claims directed to the product, and the product claims are
`
`subsequently found allowable, withdrawn process claims that depend from or
`
`otherwise require all the limitations of the allowable product claim will be considered
`
`for rejoinder. fl claims directed to a nonelected process invention must require all
`
`the limitations of an allowable product claim for that process invention to be rejoined.
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`In the event of rejoinder,
`
`the requirement for restriction between the product
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`claims and the rejoined process claims will be withdrawn, and the rejoined process
`
`

`

`Application/Control Number: 14/095,928
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`Art Unit: 1678
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`Page 6
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`claims will be fully examined for patentability in accordance with 37 CFR 1.104.
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`Thus,
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`to be allowable,
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`the rejoined claims must meet all criteria for patentability
`
`including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the
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`elected product are found allowable, an otherwise proper restriction requirement
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`between product claims and process claims may be maintained. Withdrawn process
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`claims that are not commensurate in scope with an allowable product claim will not
`
`be rejoined. See MPEP § 821.04(b). Additionally,
`
`in order to retain the right
`
`to
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`rejoinder in accordance with the above policy, applicant is advised that the process
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`claims should be amended during prosecution to require the limitations of
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`the
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`product claims. Failure to do so may result in a loss of the right to rejoinder. Further,
`
`note that the prohibition against double patenting rejections of 35 U.S.C. 121 does
`
`not apply where the restriction requirement is withdrawn by the examiner before the
`
`patent issues. See MPEP § 804.01.
`
`Species Election
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`8. Each of the compound of Formula (I), (II) and (Ill) encompasses a plurality of distinct
`
`species, and Applicant is required under 35 U.S.C. 121 to elect a single disclosed
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`species for each of Formula (I), Formula (II) and Formula (III) for prosecution on the
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`merits to which the claims shall be restricted if no generic claim is finally held to be
`
`allowable. The election of a single species should include election of a single
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`species of a self-assembled monomer and a single species for “R” including the
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`amino acid (i.e. one molecule of the amino acid) that provides the “”R.
`
`

`

`Application/Control Number: 14/095,928
`
`Art Unit: 1678
`
`Page 7
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`There is a search and/or examination burden for the patentably distinct species
`
`as set forth above because at least the following reason(s) apply:
`
`-
`
`the species have acquired a separate status in the art due to their recognized
`
`divergent subject matter.
`
`-
`
`the species of patentably distinct species require a different field of search
`
`(e.g. searching different class/subclass or electronic resources, or employing
`
`different search strategies or search queries)
`
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include (i) an election of a species or a grouping of patentably indistinct
`
`species to be examined even though the requirement m be traversed (37 CFR
`
`1.143) and (ii) identification of the claims encompassing the elected species or
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`grouping of patentably indistinct species,
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`including any claims subsequently
`
`added. An argument that a claim is allowable or that all claims are generic is
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`considered nonresponsive unless accompanied by an election.
`
`The election of the species may be made with or without traverse. To preserve a
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`right
`
`to petition,
`
`the election must be made with traverse.
`
`If the reply does not
`
`distinctly and specifically point out supposed errors in the election of species
`
`requirement, the election shall be treated an as election without traverse. Traversal
`
`must be presented at the time of election in order to be considered timely. Failure to
`
`timely traverse the requirement will result
`
`in the loss of right to petition under 37
`
`

`

`Application/Control Number: 14/095,928
`
`Art Unit: 1678
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`Page 8
`
`CFR 1.144.
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`If claims are added after the election, applicant must indicate which of
`
`these claims are readable on the elected species.
`
`Should applicant traverse on the ground that the species are not patentably
`
`distinct, applicant should submit evidence or identify such evidence now of record
`
`showing the species to be obvious variants or clearly admit on the record that this is
`
`the case.
`
`In either instance, if the examiner finds one of the inventions unpatentable
`
`over the prior art, the evidence or admission may be used in a rejection under 35
`
`U.S.C. 103(a) of the other invention.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration
`
`of claims to additional species which are written in dependent form or otherwise
`
`include all the limitations of an allowed generic claim as provided by 37 CFR 1.141.
`
`If claims are added after the election, applicant must indicate which are readable
`
`upon the elected species. MPEP § 809.02(a).
`
`9. Applicant is reminded that upon the cancellation of claims to a non-elected invention,
`
`the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more
`
`of the currently named inventors is no longer an inventor of at least one claim
`
`remaining in the application. Any amendment of inventorship must be accompanied
`
`by a petition under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(1)
`
`Conclusion
`
`2. Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SHAFIQUL HAQ whose telephone number is 571-
`
`

`

`Application/Control Number: 14/095,928
`
`Art Unit: 1678
`
`Page 9
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`272-6103. The examiner can normally be reached on Monday-Friday 8:00 AM-5:00
`
`PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Bao-Thuy Nguyen can be reached on (571)272-0824. The fax phone
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`number for the organization where this application or proceeding is assigned is 571 -
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`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.
`
`/SHAFIQUL HAQ/
`
`Primary Examiner, Art Unit 1641
`
`