UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`14/831,838
`
`08/20/2015
`
`Ian Gibbons
`
`4127.0100004
`
`1012
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE, NW.
`WASHINGTON, DC 20005
`
`WAGE MICHAEL P
`
`ART UNIT
`
`2886
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/14/2019
`
`ELECTRONIC
`
`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.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`
`following e—mail address(es):
`e-offiee @ sternekessler. com
`
`eoffieeaetion @ appeoll.eom
`htung @ theranos.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0,7709 A0170” Summary
`
`Application No.
`14/831 ,838
`Examiner
`MICHAEL P LAPAGE
`
`Applicant(s)
`Gibbons et al.
`Art Unit
`2886
`
`AIA (FITF) Status
`No
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 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). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f 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). Responsive to communication(s) filed on the IDS filed 09/30/2015.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a)D This action is FINAL.
`
`2b)
`
`This action is non-final.
`
`3)[:] 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)[:] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`83—103 and 105—1 12 is/are pending in the application.
`
`5a) Of the above claim(s)
`
`is/are withdrawn from consideration.
`
`E] Claim(s)
`
`is/are allowed.
`
`Claim(s) 83—103 and 105—1 12 is/are rejected.
`
`[:1 Claim(s)
`
`is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
`
`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabte. 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
`
`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10)[:] The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 09/23/2015 is/are: a)[:] accepted or b). 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)[:] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:I All
`
`b)D Some**
`
`C)D None of the:
`
`1.[:] Certified copies of the priority documents have been received.
`
`2.[:] Certified copies of the priority documents have been received in Application No.
`
`3:] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper N0(S)/Mai| Date 03/27/2019X2; 07/03/2019X2; 07/18/2019_
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20190801
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 2
`
`Notice of Pre-AIA or AIA Status
`
`1.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Continued Examination Under 37 CFR 1. 114
`
`2.
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office
`
`action under EX Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since
`
`this application is eligible for continued examination under 37 CFR 1.114, and the fee
`
`set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has
`
`been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 03/27/2019
`
`has been entered.
`
`Drawings
`
`3.
`
`The drawings are objected to under 37 CFR 1.83(a) because they fail to show
`
`the cartridge that comprises both a reagent unit and an assay unit as described in the
`
`specification. Any structural detail that is essential for a proper understanding of the
`
`disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected
`
`drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office
`
`action to avoid abandonment of the application. Any amended replacement drawing
`
`sheet should include all of the figures appearing on the immediate prior version of the
`
`sheet, even if only one figure is being amended. The figure or figure number of an
`
`amended drawing should not be labeled as “amended.” if a drawing figure is to be
`
`canceled, the appropriate figure must be removed from the replacement sheet, and
`
`where necessary, the remaining figures must be renumbered and appropriate changes
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 3
`
`made to the brief description of the several views of the drawings for consistency.
`
`Additional replacement sheets may be necessary to show the renumbering of the
`
`remaining figures. Each drawing sheet submitted after the filing date of an application
`
`must be labeled in the top margin as either “Replacement Sheet” or “New Sheet”
`
`pursuant to 37 CFR 1.121 (d).
`
`If the changes are not accepted by the examiner, the
`
`applicant will be notified and informed of any required corrective action in the next Office
`
`action. The objection to the drawings will not be held in abeyance.
`
`Claim Objections
`
`4.
`
`Claim 108 is objected to because of the following informalities:
`
`a.
`
`Claim 108,
`
`line 23,
`
`it is believed “configured to holds” should read —
`
`configured to hold--.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 112
`
`5.
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION—The specification shall concludewith one or more claims particularly
`pointing out and distinctlyclaiming the subject matterwhich the inventoror a joint inventor
`regards as the invention.
`
`The following is aquotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specifications hall conclude with one or more claims particularlypointing outand distinctly
`claiming the subject matterwhich the applicant regards as his invention.
`
`6.
`
`Claim 108-112 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-
`
`AIA), second paragraph, as being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor or a joint inventor, or for
`
`pre-AIA the applicant regards as the invention.
`
`As to claim 108, it is unclear whether or not the cartridge should include the
`
`“assay unit” and “reagent unit”. The instant figures and description do not appear to
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 4
`
`support this claimed limitation. Specifically it appears the two units work in conjunction
`
`with the cartridge. For example at some points applicant refers to the assay unit as a
`
`tubular tip, presumably similar to what is shown in figure 5. At other times applicant
`
`refers to the assay unit itself as the cartridge. To further confuse the issue applicant
`
`never clearly presents a figure that includes both units and the cartridge, or a figure that
`
`has a cartridge containing both tips. Lastly based on the claim itself applicant appears
`
`to potentially be claiming the units as the liquid structures that interact with the sample.
`
`Therefore the claim is considered indefinite as it is unclear as to what is the correct
`
`interpretation for the noted limitations, as such the claim will be interpreted to cover all
`
`the potential
`
`limitations.
`
`Claim Rejections - 35 USC § 103
`
`7.
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
`
`correction of the statutory basis for the rejection will not be considered a new ground of
`
`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status.
`
`8.
`
`The following is aquotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identicallydisclosedordescribed
`as set forth in section 102, ifthe differences between the subject mattersoughtto be patented
`and the priorart are such that the subject matteras awhole would have been obvious at the
`time the invention was made to a person having ordinaryskill in the art to which said subject
`matter pertains. Patentabilityshall not be negatived by the manner in which the invention was
`made.
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 5
`
`9.
`
`Claim 83-92, 85-101, 103, 105, 107-110 and 112 is/are rejected under pre-AIA
`
`35 U.S.C. 103(a) as being unpatentable over Jacobs etal. (U.S. Patent No.
`
`6,797,518 B1) in view Beumer et al. (U.S. PGPub No. 2011/0115905 A1).
`
`As to claims 83 and 87, Jacobs discloses and shows in figures 13-15, a method
`
`for providing quality control, said method comprising:
`
`receiving a cartridge (20) in an instrument (item 10 shown in figure 1), wherein
`
`the cartridge comprises a sample (col. 4, ll. 9-19 and II. 35-37);
`
`moving at least a portion of the sample from the cartridge into a sample container
`
`(44) (col. 4, II. 59-61; col .5,
`
`II. 36-45);
`
`moving the sample container to an image capture device via a fluid transfer
`
`device comprising a pipette (42, where the examiner is interpreting the proboscis as a
`
`form of pipette), wherein the instrument comprises the image capture device (i.e.
`
`spectrophotometer, the examiner notes that the term “image” is addressed via Beumer
`
`below) (col. 6, II. 61-67);
`
`capturing an image of conditions under which a detection mechanism measures
`
`a characteristic of the sample (col. 7, II. 15-29);
`
`determining, using a processor (at the very least one of the computers as
`
`disclosed are used to process the spectrophotometric data), based on the image
`
`whether there is an undesirable condition (i.e. quality requirements are not met) under
`
`which the detection mechanism is operated (col. 4, II. 19-23; col. 7, ll. 1-9 and II. 39-43);
`
`and
`
`moving the sample container to a sample processing station for starting the
`
`assay (col. 7,
`
`II. 44-52).
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 6
`
`Jacobs does imply taking an image with the spectrophotometer (68) (col. 6, ll. 47-
`
`60).
`
`Jacobs does not explicitly disclose moving the sample container to an image
`
`capture device via a fluid transfer device comprising a pipette, wherein the instrument
`
`comprises the image capture device or performing the image capture before performing
`
`the assay or wherein the image includes an image of the sample or wherein the image
`
`includes an image of one or more: the sample container or the detection mechanism.
`
`However, Beumer does disclose and show in figure 5 and in ([0008]-[00012]) the
`
`use of a camera to capture an image of a sample liquid in a pipette tip (i.e. an image of
`
`the sample container) to simply detect the volume or presence of liquid in the tip (i.e.
`
`before assay).
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs moving the sample
`
`container to an image capture device via a fluid transfer device comprising a pipette,
`
`wherein the instrument comprises the image capture device or performing the image
`
`capture before performing the assay or wherein the image includes an image of the
`
`sample or wherein the image includes an image of one or more: the sample container or
`
`the detection mechanism in order to provide the advantage of increased accuracy in
`
`ensuring the correct amount of fluid has been aspirated or dispensed properly ([0005]-
`
`[0006D.
`
`As to claim 88 and 92, Jacobs discloses and shows in figures 13-15, a method of
`
`performing an analysis on a blood sample, comprising:
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 7
`
`receiving a cartridge (20) in an instrument (10), wherein the cartridge
`
`comprises (col. 4, ll. 9-19 and II. 35-37):
`
`the blood sample (col. 4, II. 35-37);
`
`an assay unit (where the examiner is interpreting that inherently if various
`
`assays are to be performed as disclosed, sometype of assay “unit” is required)
`
`configured to perform an assay on the blood sample (col. 5, II. 24-28); and
`
`a reagent unit (i.e. the equipment that contains the reagents) the comprising a
`
`reagent for performing the assay (col. 5,
`
`II. 12-16);
`
`moving at least a portion of the blood sample from the cartridge into a sample
`
`container (42) via a fluid transfer device comprising a pipette (44) (col. 4, II. 59-61; col
`
`.5,
`
`II. 36-45),
`
`wherein the instrument comprises an image capture device coupled to the
`
`sample container (i.e. spectrophotometer, the examiner notes that the term “image” is
`
`addressed via Beumer below) (col. 6, II. 61-67);
`
`performing the assay, capturing an image of the blood sample in the sample
`
`container with the image capture device (col. 7,
`
`II. 15-29);
`
`determining aquality of the blood sample based on the image (col. 7, ll. 1-9 and
`
`II. 39-43);
`
`detecting a presence or absence of an undesirable quality in the blood sample
`
`for performing the assay on the blood sample (col. 7, ll. 1-9 and II. 39-43; where the
`
`determine of quality would implicitly yield a determination of a undesirable quality if one
`
`happens to be present);
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 8
`
`moving the sample container to a sample processing station in the instrument for
`
`performing the assay in response to detecting the absence of the undesirable quality
`
`(col. 7, ll. 1-9 and II. 39-43, implicitly the sample is still move to some station if an
`
`undesirable quality is measured).
`
`Jacobs does not explicitly disclose moving the sample container to an image
`
`capture device via a fluid transfer device comprising a pipette, wherein the instrument
`
`comprises the image capture device or performing the image capture before performing
`
`the assay.
`
`However, Beumer does disclose and show in figure 5 and in ([0008]-[00012]) the
`
`use of a camera to capture an image of a sample liquid in a pipette tip to simply detect
`
`the volume or presence of liquid in the tip (i.e. before assay).
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs moving the sample
`
`container to an image capture device via a fluid transfer device comprising a pipette,
`
`wherein the instrument comprises the image capture device or performing the image
`
`capture before performing the assay in order to provide the advantage of increased
`
`accuracy in ensuring the correct amount of fluid has been aspirated or dispensed
`
`properly ([0005]—[0006]).
`
`Jacobs in view of Beumer does not explicitly disclose providing an alert in
`
`response to detecting the presence of the undesirable quality.
`
`However, the examiner takes Office Notice that one having ordinary skill in the
`
`art would provide an alert system when detecting something outside of the desired
`
`value.
`
`

`

`Application/Control Number: 14/831 ,838
`Art Unit: 2886
`
`Page 9
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify providing an alert in response to
`
`detecting the presence of the undesirable quality in order to provide the advantage of
`
`expected results in providing said alert the user is capable of taking immediate and
`
`efficient action on a sample falling outside of the desired measured value.
`
`As to claims 98 and 108, Jacobs discloses and shows in figures 13-15 a system
`
`for performing an analysis on a blood sample, comprising:
`
`a cartridge comprising (the combined structure that supports both the assay unit
`
`and reagent unit):
`
`an assay unit (the inherent structure required to hold the supply of assay
`
`as disclosed) configured to perform a biological assay on the blood sample, the assay
`
`unit containing at least a portion of the blood sample (col. 5, II. 24-45); and
`
`a reagent unit (the inherent structure required to hold the supply of
`
`reagents as disclosed) comprising a reagent to be used in the biological assay
`
`(implicitly the point of said reagents) (col. 5,
`
`II. 12-16);
`
`wherein the assay unit and the reagent unit are not in fluid communication
`
`with each other and are movable relative to each other (col. 5, II. 12-16 and 24-
`
`45; where the examiner is interpreting that inherently the two units aren’t in fluid
`
`communication until which point the fluid transfer device 44 is moved to the
`
`reagent unit to extract the desired regents); and
`
`an instrument comprising:
`
`

`

`Application/Control Number: 14/831,838
`Art Unit: 2886
`
`Page 10
`
`a fluid transfer device (44) comprising a pipette configured to move the assay
`
`unit from the cartridge to adetector (68) (col. 4, II. 59-61; col .5,
`
`II. 36-45; col. 6, ll. 61-
`
`67); and
`
`a detector (68) configured to detect a signal from the assay unit indicative of the
`
`presence of an analyte in the blood sample (col. 6, II. 61-67; col. 7, ll. 1-9 and II. 39-43),
`
`wherein the fluid transfer device is further configured to move the assay unit to
`
`the detector (col. 5, lines 33-45), and
`
`wherein the assay unit is configured to holds the at least the portion of the blood
`
`sample in a non-flowing manner during detection (col. 5, lines 33-45, based on the 112
`
`interpretation,
`
`implicitly once the assay unit is picked up by metering tip 44 is held in a
`
`non-flowing manner during detection as claimed).
`
`Jacobs does not explicitly disclose an image capture device configured to
`
`capture an image of the blood sample prior to preforming a biological assay on the
`
`blood sample and to have the fluid transfer device move the assay unit to the detector.
`
`However, Beumer does disclose and show in figure 5 and in ([0008]-[00012]) the
`
`use of a camera to capture an image of a sample liquid in a pipette tip to simply detect
`
`the volume or presence of liquid in the tip (i.e. before assay).
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs an image capture device
`
`configured to capture an image of the blood sample prior to preforming a biological
`
`assay on the blood sample and to have the fluid transfer device move the assay unit to
`
`the detector in order to provide the advantage of increased accuracy in ensuring the
`
`correct amount of fluid has been aspirated or dispensed properly ([0005]-[0006]).
`
`

`

`Application/Control Number: 14/831,838
`Art Unit: 2886
`
`Page 11
`
`As to claims 86 and 87, Jacobs does not explicitly disclose wherein the
`
`undesirable conditions includes a presence of one or more undesirable materials or
`
`wherein the undesirable materials include one or more: bubbles, particles, fibers, debris,
`
`and precipitates that interfere with the measurement of the characteristic of the sample.
`
`However, Beumer does disclose and show in figure 5 and in ([0008]-[00012];
`
`[0029]) the use of a camera to capture an image of a sample liquid in a pipette tip to
`
`detect bubbles or artifacts.
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs wherein the undesirable
`
`materials include one or more: bubbles, particles, fibers, debris, and precipitates that
`
`interfere with the measurement of the characteristic of the sample in order to provide
`
`the advantage of increased accuracy in ensuring no foreign object or bubbles are
`
`present that could result in incorrect subsequent measurements ([0005]—[0006]).
`
`As to claim 86, Jacobs as modified by Beumer discloses a method, wherein the
`
`detection mechanism is a different mechanism from a mechanism used to capture the
`
`image (i.e. where the spectrophotometer (detection mechanism) as modified is different
`
`from the image capture device) (col. 6,
`
`II. 47-54).
`
`As to claim 89, Jacobs as modified by Beumer does not explicitly disclose a
`
`method, further comprising adjusting the sample if the undesirable condition is
`
`detected.
`
`However, the examiner takes Office Notice that in both references the goal is to
`
`ensure the sample is in a desired state, or without imperfections in someform.
`
`It is
`
`obvious to one having ordinary skill
`
`in the art that in detecting these quality or desired
`
`

`

`Application/Control Number: 14/831,838
`Art Unit: 2886
`
`Page 12
`
`states, the intent is to do something about them (i.e. remove bubbles, dispose of
`
`samples if contaminated) when detecting them or both systems would next to no
`
`purpose.
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs in view of Beumer by
`
`adjusting the sample if the undesirable condition is detected in order to provide the
`
`advantage of expected results in using quality metrics for example to make expected
`
`adjustments to the sample under test (e.g. removing bubbles, or disposing of
`
`contaminated samples).
`
`As to claims 95, and 96, Jacobs does not explicitly disclose, wherein the
`
`undesirable quality is selected from lipemia, icteria, hemolysis, presence of precipitates,
`
`incorrect sample type, incorrect sample volume, presence of bubbles, and non-
`
`uniformity of color or a method, wherein the undesirable quality is insufficient sample
`
`volume.
`
`However, Beumer does disclose in ([0020]; [0029]) where the undesirable quality
`
`is bubbles or an insufficient sample volume.
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs wherein the undesirable
`
`quality is selected from lipemia, icteria, hemolysis, presence of precipitates, incorrect
`
`sample type, incorrect sample volume, presence of bubbles, and non-uniformity of color
`
`or a method, wherein the undesirable quality is insufficient sample volume in order to
`
`provide the advantage of increased versatility and accuracy in measuring more data
`
`

`

`Application/Control Number: 14/831,838
`Art Unit: 2886
`
`Page 13
`
`regarding the sample under test one can ensure the final determination regarding the
`
`sample is more accurate.
`
`As to claim 97, Jacobs discloses, a method wherein the sample container is a
`
`sample tip (44 is explicitly shown as a tip) (Fig. 7 and 8).
`
`As to claims 99 and 109, Jacobs discloses a method, wherein the cartridge
`
`comprises all reagents for performing the assay on the blood sample (col. 5, II. 12-16;
`
`where the examiner is interpreting that implicitly the cartridge has all the agents required
`
`to perform the assay, or the cartridge would not be capable of serving the function to
`
`provide the reagents to perform the assay).
`
`As to claims 100, 101 and 112 Jacobs does not explicitly disclose a method,
`
`wherein the instrument further comprises a centrifuge or wherein the blood sample is
`
`centrifuged in the centrifuge to obtain a column of packed red cells in a total sample
`
`column.
`
`However, Jacobs does disclose in (col. 1, II. 22-31) the use of centrifuging a
`
`blood sample prior to spectrophotometric analysis as performed in Jacobs. Further it is
`
`obvious to one having ordinary skill
`
`in the art that in centrifuging the blood the result is
`
`packed red cells in a total sample column.
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs with the use of wherein
`
`the instrument further comprises a centrifuge or wherein the blood sample is centrifuged
`
`in the centrifuge to obtain a column of packed red cells in a total sample column in order
`
`to provide the advantage of expected results in using a known technique to perform a
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`

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`Application/Control Number: 14/831,838
`Art Unit: 2886
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`Page 14
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`known function and yield a known result, in preparing a blood sample for efficient
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`spectrophotometric measurement.
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`As to claim 103, Jacobs discloses a method, wherein the instrument further
`
`comprises a detector (spectrophotometer 68) configured to detect the assay unit (i.e.
`
`fluid in tip 44) (col. 6,
`
`II. 47-48; col. 7, II. 20-26).
`
`As to claim 105, Jacobs discloses a method wherein the fluid transfer device (a)
`
`transfers at least a portion of the blood sample into the one or more assay units, (b)
`
`engages with the one or more assay units, and (c) moves tips (col. 5, II. 24-53).
`
`As to claim 107, Jacobs discloses a method, wherein the cartridge further
`
`comprises a tip, and wherein the fluid transfer device engages in response to a
`
`signal received from an assay, the signal being indicative of the presence of an analyte
`
`in the blood sample (col. 5, II. 33-45; where the examiner is interpreting that implicitly a
`
`signal is used to control the system in Jacobs).
`
`As to claim 110, Jacobs discloses a system wherein fluid transfer device is
`
`further configured to engage with the assay unit and to move the assay unit to the
`
`detector (col. 5,
`
`II. 33-45).
`
`10.
`
`Claims 93 and 94 are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over Jacobs et al. in view Beumer et al. further in view of
`
`Applicant’s admitted prior art (AAPA hereinafter).
`
`As to claims 93 and 94, Jacobs in view of Beumer does not explicitly disclose a
`
`method, wherein the blood sample is a blood sample obtained by a fingerstick or
`
`wherein the blood sample has a volume of 200 uL or less.
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`

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`Application/Control Number: 14/831,838
`Art Unit: 2886
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`Page 15
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`However, AAPA does disclose in ([0009]; [0011]) that the common and well
`
`known fingerstick method is used to extra less than 200 uL.
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs in view of Beumer with a
`
`method, wherein the blood sample is a blood sample obtained by a fingerstick or
`
`wherein the blood sample has a volume of 200 uL or less in order to provide the
`
`advantage of expected results in using a common and well-known technique to cheaply
`
`extra a small amount of desired blood from the patient under test.
`
`11.
`
`Claim 102 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over Jacobs et al. in view Beumer et al. further in view of Esteves
`
`Reis etal. (U.S. PGPub No. 2014/0352410 A1).
`
`As to claim 102, Jacobs in view of Beumer does not explicitly disclose a method
`
`of claim 101, further comprising detecting plasma volume of the blood sample, the
`
`detecting of the plasma volume including measuring, based on the image, (a) length of
`
`the total sample column, (b) length of the column of packed red cells, and (c) known
`
`volume of the sample containers wherein the undesirable quality is insufficient plasma
`
`volume.
`
`However, Esteves Reis does disclose in ([0004]) the use of measuring a plasma
`
`volume via known lengths of the sample column, packed red cells and known volume
`
`(obviously of the tube used to hold the sample). Further the intended result of the
`
`undesirable quality being insufficient plasma volume is implied in measuring all the
`
`known things.
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`

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`Application/Control Number: 14/831,838
`Art Unit: 2886
`
`Page 16
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`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs in view of Beumer with a
`
`method of claim 101, further comprising detecting plasma volume of the blood sample,
`
`the detecting of the plasma volume including measuring, based on the image, (a) length
`
`of the total sample column, (b) length of the column of packed red cells, and (c) known
`
`volume of the sample containers wherein the undesirable quality is insufficient plasma
`
`volume in order to provide the advantage of using a well-known method to determine a
`
`further variable of the sample under test.
`
`12.
`
`Claims 106 and 111 are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over Jacobs et al. in view Beumer et al. further in view of Alavie et
`
`al. (U.S. PGPub No. 2006/0210435 A1).
`
`As to claims 106 and 111, Jacobs in view of Beumer does not explicitly disclose
`
`a method, wherein the cartridge further comprises control reagents for performing a
`
`control assay in parallel with the assay on the blood sample or wherein the cartridge
`
`further comprises control reagents for performing a control assay in parallel with the
`
`biological assay on the blood sample.
`
`However, Alavie does disclose in ([0006], lines 18-20) that it is commonplace in
`
`the art to have a second control reagent line to be added to confirm the even of a
`
`positive result.
`
`It would have been obvious to one having ordinary skill in the art before the
`
`effective filing date of the claimed invention to modify Jacobs in view of Beumer with the
`
`use of a method, wherein the cartridge further comprises control reagents for
`
`performing a control assay in parallel with the assay on the blood sample or wherein the
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`

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`Application/Control Number: 14/831,838
`Art Unit: 2886
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`Page 17
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`cartridge further comprises control reagents for performing a control assay in parallel
`
`with the biological assay on the blood sample in order to provide the advantage of
`
`increased efficiency in using a control reagent line in combination with the cartridge one
`
`can obviously increase accuracy and efficiency in doing so in parallel to confirm a
`
`positive result as taught by Alavie.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to MICHAEL P LAPAGE whose telephone number is
`
`(571)270-3833. The examiner can normally be reached on Monday-Friday 8-5:30.
`
`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
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`(AIR) at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Tarifur Chowdhury can be reached on (571) 272-2287. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571 -
`
`273-8300.
`
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`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
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`

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`Application/Control Number: 14/831,838
`Art Unit: 2886
`
`Page 18
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`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
`
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`
`/Michael P LaPage/
`Primary Examiner, Art Unit 2886
`
`