`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`APPLICATION NO.
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`CONF {MATION NO.
`
`13/355,458
`
`01/20/2012
`
`Ian Gibbons
`
`30696—733201
`
`1056
`
`21971
`
`7590
`
`10/11/2012
`
`WILSON, SONSINI, GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`EXAMINER
`
`REYES, CHRISTOPHER R
`
`ART UNIT
`
`1636
`
`MAIL DATE
`
`10/11/2012
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`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)
`
`

`

`
`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`13/355,458
`
`GIBBONS ET AL.
`
`Examiner
`CHRISTOPHER REYES
`
`Art Unit
`4171
`
`-- 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 1MONTH(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 CFR1. 136( a).
`In no event however may a reply be timely filed
`after SIX () 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)I:I Responsive to communication(s) filed on 20 January 2012.
`
`2a)I:l This action is FINAL.
`
`2b)I:l This action is non-final.
`
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:l 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZI Claim(s) 1-91 is/are pending in the application.
`
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
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`6)I:I Claim(s) _ is/are allowed.
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`7)|:| CIaIm(s) _ is/are rejected.
`
`
`8)I:l Claim(s)
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`is/are objected to.
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`9)|Zl Claim(s) E are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`
`11)|:| The drawing(s) filed on _ is/are: a)|:l accepted or b)I:l 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).
`
`12)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
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`13)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)|:l All
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`b)I:I Some * c)|:l None of:
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`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. _
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`3.|:I 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.
`
`Attachment(s)
`
`1) I] Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) El Information Disclosure Statement(s) (PTO/SB/OS)
`Paper No(s)/Mai| Date _.
`US. Patent and Trademark Office
`
`4) D Interview Summary (PTO-413)
`Paper N°(5 )/Mai| Date. _
`5)I:I Notice of Informal Patent Application
`)6|:| Other:
`
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20121001
`
`
`
`

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`Application/Control Number: 13/355,458
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`Page 2
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`Art Unit: 4171
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`Claims 1-91 are pending.
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`DETAILED ACTION
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`Election/Restrictions
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`1.
`
`Restriction to one of the following inventions is required under 35 U.S.C. 121:
`
`Claims 1-20, drawn to a method detecting the presence or concentration
`
`of an analyte in a sample fluid contained in a container, the method
`
`comprising: (a) illuminating the container along a first region having a first
`
`path length to yield a first measurement of light intensity; (b) if the
`
`measurement falls outside a predetermined dynamic range, moving the
`
`sample fluid to another region in the container having another path length;
`
`(c) illuminating the container along the another region to yield another
`
`measurement of light intensity transmitted across the another path length;
`
`and optionally (d) repeating steps (b) and (c) until a measurement of light
`
`intensity falls within predetermined dynamic ranges, thereby detecting the
`
`presence or concentration of the analyte, classified in class 356, subclass,
`
`300.
`
`Claims 21 -27, drawn to an automated system comprising: (a) a pipette tip
`
`or closed tube adapted to engage with an aspirator wherein said pipette
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`tip or tube comprises two opposing ends, at least one of which is closed or
`
`sealable; and (b) a centrifuge configured to receive said sealed pipette tip
`
`or closed tube to effect said separating of one or more components in a
`
`biological fluid, classified in class 210, subclass 787.
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`

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`Application/Control Number: 13/355,458
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`Page 3
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`Art Unit: 4171
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`Claims 28-33, drawn to a method for isolating components in a sample,
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`the method comprising: (a) loading a sample into a pipette tip or a tube
`
`comprising two opposing ends, at least one of which is sealable or sealed;
`
`(b) sealing the pipette or the tube on the at least one end of the pipette tip;
`
`(c) centrifuging the sealed pipette tip or the tube, thereby forming an
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`interfacial region that separates the sample into a supernatant and a
`
`pellet; (d) imaging the centrifuged pipette tip or the tube to determine the
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`location of the interfacial region; and (e) automatically aspirating the
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`supernatant based on the location of the interfacial region, classified in
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`class 210, subclass 787.
`
`IV.
`
`Claims, 34-37, drawn to a method for characterizing an analyte suspected
`
`to be present in a sample, the method comprising: (a) obtaining a digital
`
`image of the sample, wherein the digital image comprises at least a two-
`
`dimensional array of pixels, and wherein each pixel comprises a plurality
`
`of intensity value, each of which corresponds to a distinct detection
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`spectral region; (b) correlating, with the aid or a programmable device, the
`
`obtained intensity values with a predetermined set of values that define a
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`dynamic range of each detection spectral region; and (c) predicting the
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`presence and/or quantity of said analyte in the sample based on said
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`correlating of the obtained intensity values with a predetermined set of
`
`values, classified in class 382, subclass 100.
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`

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`Application/Control Number: 13/355,458
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`Page 4
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`Art Unit: 4171
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`V.
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`Claims 38-45, drawn to a method for characterizing an analyte suspected
`
`to be present in a sample of biological fluid, the method comprising: (a)
`
`providing said sample of biological fluid; (b) allowing said analyte to react
`
`with one or more reagents that specifically react with said analyte to
`
`generate an optically detectable signal; and (c) measuring said optically
`
`detectable signal with a plurality of detection spectral regions, wherein the
`
`presence of said optically detectable signal with a dynamic range of at
`
`least one detection spectral region is indicative of the concentration of said
`
`analyte, classified in class 356, subclass 300.
`
`VI.
`
`Claims 46-52, drawn to a method for increasing the accuracy of an assay,
`
`the method comprising: (a) imaging a sample in a first tip to determine the
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`volume of the first sample; (b) imaging one or more reagents in a second
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`tip to determine the volume of the one or more reagents; (c) mixing the
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`sample and the one or more reagents to form a reaction mixture; (d)
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`imaging the reaction mixture; (e) calibrating based on said determined
`
`volumes of the sample and the one or more reagents; and (f) calculating a
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`concentration of an analyte using the calibration, classified in class 73,
`
`subclass 1.02.
`
`Vll.
`
`Claims 53-64, drawn to an automated system for separating one or more
`
`components in a biological fluid comprising: (a) a centrifuge comprising at
`
`least one bucket configured to receive a container to effect said separating
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`of one or more components in a fluid sample; (b) the container, wherein
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`Page 5
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`Art Unit: 4171
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`the container includes at least one shaped feature that is complementary
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`to a shaped feature of the bucket, classified in class 210, subclass 787.
`
`Vlll. Claims 65-68, drawn to a setup comprising: (a) a vessel configured to
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`accept and confine a sample, wherein the vessel comprises an interior
`
`surface, an exterior surface, an open end, and an opposing closed end;
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`(b) a tip configured to extend into the vessel through the open end,
`
`wherein the tip comprises a first open end and second open end, wherein
`
`the second open end is inserted into the vessel, wherein the vessel or the
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`tip further comprises a protruding surface feature that prevents the second
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`open end of the tip from contacting the bottom of the interior surface of the
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`closed end of the vessel, classified in class 422, subclass 501.
`
`lX.
`
`Claims 69-71, drawn to a sample processing apparatus comprising: (a) a
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`sample preparation station, assay station, and/or detection station; (b) a
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`control unit having computer-executable commands for performing a
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`point-of-service service at a designated location with the aid of at least
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`one of said sample preparation station, assay station, and detection
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`station; and (c) at least one centrifuge configured to perform centrifugation
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`of a sample from a fingerstick, classified in class 210, subclass 787.
`
`X.
`
`Claims 72-82, drawn to a method for dynamic feedback, the method
`
`comprising (a) taking an initial measurement of a sample within a
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`container using a detection mechanism; (b) based on said initial
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`measurement, determining, using a processor, whether the sample
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`

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`Page 6
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`Art Unit: 4171
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`concentration falls into a desired range, and determining, using a
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`processor, (i) a degree of dilution to be performed if the sample
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`concentration is higher than the desired range, or (ii) a degree of
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`concentration to be performed if the sample concentration is lower than
`
`the desired range; and (c) adjusting the sample concentration according to
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`the determined degree of dilution or the determined degree of
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`concentration, classified in class 356, subclass 300.
`
`XI.
`
`Claims 83-91, drawn to a method for providing quality control, the method
`
`comprising: (a) capturing an image of conditions under which a detection
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`mechanism measures a characteristic of a sample; and (b) determining,
`
`using a processor, based on the image whether there are undesirable
`
`conditions under which the detection mechanism is operated, classified in
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`class 382, subclass 100.
`
`The inventions are distinct, each from the other because of the following reasons:
`
`2.
`
`Inventions ll, VII, VIII, and IX are directed to related products. 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). In the instant
`
`case, inventions ll, VII, and IX as claimed each requires a centrifuge component and
`
`may be useable with some of the process inventions, however, each product is limited
`
`such that each can have a materially different design. The product of Invention ll
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`Page 7
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`Art Unit: 4171
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`requires that the centrifuge element be present in an automated system that comprises
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`a tube or pipette tube connected with an aspirator. This limitation is not shared b
`
`invention VII or XI.
`
`Invention IX requires that the centrifuge element be part of a system
`
`that is at least in part controlled by computer elements. This limitation is not shared by
`
`inventions VII or II.
`
`Invention VII requires only a centrifuge with buckets designed to
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`accommodate vessels of certain shapes and is not required to be useable with the
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`products of either Invention II or IX.
`
`Invention Vllll does not require a centrifuge
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`element and thus may have a substantially different design than the other product
`
`inventions. Furthermore, the inventions as claimed do not encompass overlapping
`
`subject matter and there is nothing of record to show them to be obvious variants.
`
`3.
`
`Inventions ll, VII, and IX are each related to Invention III as product and process
`
`of use. The inventions can be shown to be distinct 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, since the process of Invention Ill may be practiced with any of Inventions ll, VII,
`
`and IX,
`
`it is clear that for each pairing of a product invention with Invention III, the
`
`process can be practiced with another materially different product.
`
`4.
`
`Inventions ll, VIII are each related to each of Inventions I and VI as product and
`
`process of use. The inventions can be shown to be distinct 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
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`

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`Page 8
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`Art Unit: 4171
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`used in a materially different process of using that product. See MPEP § 806.05(h).
`
`In
`
`the instant case since the process of Invention I or Invention VI may be practiced with
`
`either Invention II or Invention VII,
`
`it is clear that for each pairing of a product invention
`
`with a process Invention, the process can be practiced with another materially different
`
`product.
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`5.
`
`Inventions IX is related to each of Inventions IV and X as product and process of
`
`use. The inventions can be shown to be distinct 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
`
`since the product of Invention IX can be used with both Invention IX and Invention X,
`
`it
`
`is clear that for each pairing, the product as claimed can be used in a materially different
`
`process of using that product.
`
`6.
`
`Inventions I is unrelated to each of Inventions Ill, VII, IX, and XI. Inventions are
`
`unrelated if it can be shown that they are not disclosed as capable of use together and
`
`they have different designs, modes of operation, and effects (MPEP § 802.01 and §
`
`806.06).
`
`In the instant case, the different inventions Ill, VII, and IX are directed to
`
`centrifugation steps that are not required by the method of Invention I. Additionally,
`
`none of Inventions Ill, VII, and IX is required to have a design capable of detecting a
`
`concentration.
`
`Invention XI is directed to making a determination of whether a detection
`
`mechanism is operating under undesirable conditions on the basis of an image and is
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`not required to be useable for detection of a concentration. Thus, each of Inventions Ill,
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`

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`Page 9
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`Art Unit: 4171
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`VII, IX, and XI may have a different design, mode of operation, and effect than Invention
`
`I.
`
`7.
`
`Inventions I, IV, V, VI and X are directed to related processes. 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). In the instant
`
`case, the inventions as claimed each are limited such that each invention can have a
`
`materially different design and not overlap in scope with other inventions.
`
`Invention I
`
`requires measuring an intensity of light along multiple path lengths, which is not
`
`required of any of the other inventions.
`
`Invention IV requires the recording of a two-
`
`dimensional image and processing with a computer processor, which is not required of
`
`any of the other inventions.
`
`Invention V requires that a concentration be determined on
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`the basis of detection of an optical signal generated during a chemical reaction wherein
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`the signal is measured in several detection regions. No other Invention is limited in this
`
`way.
`
`Invention VI requires a calibration step be performed, which is not required of any
`
`other invention.
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`Invention X requires that a measured concentration value result in
`
`modification of a solution if the concentration value is not what is desired. No other
`
`Invention shares this required step. Furthermore, the inventions as claimed do not
`
`encompass overlapping subject matter and there is nothing of record to show them to
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`be obvious variants.
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`

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`Application/Control Number: 13/355,458
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`Page 10
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`Art Unit: 4171
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`8.
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`Inventions XI, IV, and VI are directed to related processes. 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). In the instant case, the
`
`inventions as claimed are each limited to different effects and are mutually exclusive.
`
`Invention XI requires that an image be analyzed to determine whether the detection
`
`mechanism is operating under undesirable conditions. The image information of
`
`Invention IV is used to calculate a concentration. The image information of Invention VI
`
`is used to perform a calibration step. Furthermore, the inventions as claimed do not
`
`encompass overlapping subject matter and there is nothing of record to show them to
`
`be obvious variants.
`
`9.
`
`Invention XI is unrelated to each of Inventions II, III, V, VII, VIII, IX, and X.
`
`Inventions are unrelated if it can be shown that they are not disclosed as capable of use
`
`together and they have different designs, modes of operation, and effects (MPEP §
`
`802.01 and § 806.06).
`
`In the instant case, Invention XI requires two-dimensional
`
`images. None of Inventions II, III, V, VIII, IX, and X is required to be capable of
`
`producing images and thus may have different designs, modes of operation, and effects
`
`than Invention XI.
`
`10.
`
`Inventions X is unrelated to each of Invention Ill and VII.
`
`Inventions are
`
`unrelated if it can be shown that they are not disclosed as capable of use together and
`
`they have different designs, modes of operation, and effects (MPEP § 802.01 and §
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`

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`Page 11
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`Art Unit: 4171
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`806.06).
`
`In the instant case, Invention X requires the calculation of a concentration
`
`value and the adjustment of a solution depending on that value.
`
`Invention III and VII are
`
`directed to centrifugation and are not required to have a design useable with Invention
`
`X.
`
`11.
`
`Inventions X,
`
`I, IV, V, and VI are directed to related processes. 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). In the instant
`
`case, the inventions as claimed are each limited to different effects and scopes that do
`
`not overlap.
`
`Invention X requires a solution be adjusted if a concentration value is not
`
`satisfactory.
`
`Invention I requires that an intensity of light be measured along multiple
`
`path lengths until a measurement that falls in the assays dynamic range is detected.
`
`Invention IV requires a two-dimensional image and a computer processor that
`
`determines a concentration based on that image.
`
`Invention V requires that a reaction
`
`be performed.
`
`Invention VI requires a calibration step. Furthermore, the inventions as
`
`claimed do not encompass overlapping subject matter and there is nothing of record to
`
`show them to be obvious variants.
`
`12.
`
`Inventions III is unrelated to each of Inventions IV, V, VI, and VIII.
`
`Inventions are
`
`unrelated if it can be shown that they are not disclosed as capable of use together and
`
`they have different designs, modes of operation, and effects (MPEP § 802.01 and §
`
`806.06).
`
`In the instant case, the Invention III is directed to a method of centrifugal
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`Art Unit: 4171
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`separation.
`
`Inventions lV-Vl are directed to imaging and concentration detection and
`
`are not required to include steps of centrifugal separation.
`
`Invention VIII is not required
`
`to have a design that is capable of being useable with the method of Invention Ill.
`
`13.
`
`Invention V is related to each of Inventions ll, VIII, and IX as product and process
`
`of use. The inventions can be shown to be distinct 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, for each pairing of the process with a product, the process can be practiced with a
`
`materially different product.
`
`14.
`
`Inventions V and VII are unrelated.
`
`Inventions are unrelated if it can be shown
`
`that they are not disclosed as capable of use together and they have different designs,
`
`modes of operation, and effects (MPEP § 802.01 and § 806.06).
`
`In the instant case, the
`
`different inventions are not disclosed as capable of use together and can have different
`
`designs, modes of operation, and effects.
`
`Invention V requires detection of a reaction.
`
`Invention VII is a product of a centrifuge that is not capable or mediating a reaction or
`
`detecting an optical signal emitted therefrom.
`
`15.
`
`Inventions II is related to each of Inventions IV and X, and Invention IV is related
`
`to Invention VII as product and process of use. The inventions can be shown to be
`
`distinct 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.
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`Art Unit: 4171
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`See MPEP § 806.05(h).
`
`In the instant case since for each pairing involving Invention II,
`
`the product invention can be used in a materially different process, and for each pairing
`
`involving invention IV, each the process can be practiced with a materially different
`
`product.
`
`16.
`
`The following pairs of inventions are related as product and process of use:
`
`Invention IV and Invention VIII; Invention VI and Invention IX, VIII and X. The inventions
`
`can be shown to be distinct 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 for the
`
`pairings involving Invention VIII,
`
`it is clear that the product can be used in a materially
`
`different process. From an earlier paragraph, it has been shown that Invention IX can
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`also be used with Invention V. Thus the product Invention IX can be used in a
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`materially different process as well.
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`17.
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`Inventions VI and VII are unrelated.
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`Inventions are unrelated if it can be shown
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`that they are not disclosed as capable of use together and they have different designs,
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`modes of operation, and effects (MPEP § 802.01 and § 806.06).
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`In the instant case, the
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`different inventions are drawn to different designs, modes of operation, and effects, and
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`are not disclosed as capable of use together.
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`Invention VII is drawn to a product of a
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`centrifuge. The method of Invention VI does not have any steps that require the use of
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`a centrifuge and thus there is no overlap between the inventions.
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`

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`Application/Control Number: 13/355,458
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`Page 14
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`Art Unit: 4171
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`18.
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`Restriction for examination purposes as indicated is proper because all these
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`inventions listed in this action are independent or distinct for the reasons given above
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`and there would be a serious search and/or examination burden if restriction were not
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`required because at least the following reason(s) apply:
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`(a) the inventions have acquired a separate status in the art in view of their
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`different classification;
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`(b) the inventions have acquired a separate status in the art due to their
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`recognized divergent subject matter;
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`(c) the inventions require a different field of search (for example, searching
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`different classes/subclasses or electronic resources, or employing different
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`search queries);
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`(d) the prior art applicable to one invention would not likely be applicable to
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`another invention;
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`(e) 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.
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`
`Applicant is advised that the reply to this requirement to be complete must
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`include (i) an election of a invention to be examined even though the requirement
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`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
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`the elected invention.
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`The election of an invention may be made with or without traverse. To reserve a
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`right to petition, the election must be made with traverse. If the reply does not distinctly
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`and specifically point out supposed errors in the restriction requirement, the election
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`shall be treated as an election without traverse. Traversal must be presented at the time
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`

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`Application/Control Number: 13/355,458
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`Page 15
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`Art Unit: 4171
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`of election in order to be considered timely. Failure to timely traverse the requirement
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`will result in the loss of right to petition under 37 CFR 1.144. If claims are added after
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`the election, applicant must indicate which of these claims are readable upon the
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`elected invention.
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`Should applicant traverse on the ground that the inventions are not patentably
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`distinct, applicant should submit evidence or identify such evidence now of record
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`showing the inventions to be obvious variants or clearly admit on the record that this is
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`the case. In either instance, if the examiner finds one of the inventions unpatentable
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`over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C.
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`103(a) of the other invention.
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`19.
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`Applicant is reminded that upon the cancellation of claims to a non-elected
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`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
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`or more of the currently named inventors is no longer an inventor of at least one claim
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`remaining in the application. Any amendment of inventorship must be accompanied by
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`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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`20.
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`The examiner has required restriction between product or apparatus claims and
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`process claims. Where applicant elects claims directed to the product/apparatus, and all
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`product/apparatus claims are subsequently found allowable, withdrawn process claims
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`that include all the limitations of the allowable product/apparatus claims should be
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`considered for rejoinder. All claims directed to a nonelected process invention must
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`include all the limitations of an allowable product/apparatus claim for that process
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`invention to be rejoined.
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`

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`Application/Control Number: 13/355,458
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`Page 16
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`Art Unit: 4171
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`In the event of rejoinder, the requirement for restriction between the
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`product/apparatus claims and the rejoined process claims will be withdrawn, and the
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`rejoined process claims will be fully examined for patentability in accordance with 37
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`CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for
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`patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all
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`claims to the elected product/apparatus are found allowable, an otherwise proper
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`restriction requirement between product/apparatus claims and process claims may be
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`maintained. Withdrawn process claims that are not commensurate in scope with an
`
`allowable product/apparatus claim will not be rejoined. See MPEP § 821.04.
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`Additionally, in order for rejoinder to occur, applicant is advised that the process claims
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`should be amended during prosecution to require the limitations of the
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`product/apparatus claims. Failure to do so may result in no rejoinder. Further, note
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`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
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`issues. See MPEP § 804.01.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to CHRISTOPHER REYES whose telephone number is
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`(571 )272-7082. The examiner can normally be reached on Monday to Friday, 9:00 to
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`5:00 EST.
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`