www.uspto.gov
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`
`15/689,905
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`08/29/2017
`
`Timothy Michael Kemp
`
`4127.003000S
`
`7617
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE, N.W.
`WASHINGTON, DC 20005
`
`GORDON BRIAN R
`
`ART UNIT
`
`1798
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`01/29/2020
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
`e-office @ sternekessler. com
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`eofficeaction @ appcoll.com
`htung @ theranos.com
`
`PTOL-90A (Rev. 04/07)
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`

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`017/09 A0170” Summary
`
`Application No.
`15/689,905
`Examiner
`BRIAN R GORDON
`
`Applicant(s)
`Kemp et al.
`Art Unit
`1798
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`AIA (FITF) Status
`N0
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`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.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
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`Status
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`1). Responsive to communication(s) filed on 1—6—2020.
`CI A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)[:] This action is FINAL.
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`2b)
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`This action is non-final.
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`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.
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`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 Expade Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s)
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`21—27 and 29—34 is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`
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`[:1 Claim(s) _ is/are allowed.
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`Claim(s) 21—27 and 29—34 is/are rejected.
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`Claim(s) fl is/are objected to.
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`) ) ) )
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`)
`are subject to restriction and/or election requirement
`C] Claim(s
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`httpfiwww.”smogovmatentszinit_events[pph[index.'sp or send an inquiry to PPeredhack@g§ptg.ggv.
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`Application Papers
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`10):] The specification is objected to by the Examiner.
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`11). The drawing(s) filed on 8—29—17 is/are: a)I:I 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).
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`Priority under 35 U.S.C. § 119
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`12)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)I:I All
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`b)C] Some**
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`c)[j None of the:
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`1C] Certified copies of the priority documents have been received.
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`2E] Certified copies of the priority documents have been received in Application No.
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`3C] 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)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) [3 Notice of References Cited (PTO-892)
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`2) C] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
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`3) E] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`[:1 Other-
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`4)
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20200121
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`

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`Application/Control Number:15/689,905
`Art Unitzl798
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`Page2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`1.
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`The present application is being examined under the pre—AIA first to invent provisions.
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`Continued Examination Under 37 CFR 1.114
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`2.
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`A request for continued examination under 37 CFR 1.114, including the fee set forth in
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`37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex
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`Parte Quayle, 25 USPQ 74, 453 0.6. 213 (Comm'r Pat. 1935). Since this application is eligible for
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`continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been
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`timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114.
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`Applicant's submission filed on January 6, 2020 has been entered.
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`Response to Amendment
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`3.
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`It is noted that applicant has amended claim 1 to scope that is different from that of
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`claim 21 previously indicated as allowable. Furthermore, applicant has added additional new
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`claims that are also different in scope ofthe previously indicated allowable claims. None of the
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`claims as now presented were previously considered. Although applicant has now submitted
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`such claims, it is noted that applicant failed to specify where each ofthe amendments and new
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`claims are supported within the originally filed specification. The claims now provide for a scope
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`where the identification detector is not required to be located in the reader assembly as in
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`claim 21 and the identification detector is further attributed to having the functionality ofthat
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`of the communication assembly. There is no description of an invention as claimed in the
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`amended claim 21. Furthermore, the examiner fails to locate and where the system is absent of
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`an identification detector as in claim 29 is described in the originally filed specification nor
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`

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`Application/Control Number:15/689,905
`Art Unit:l798
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`Page3
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`where the external device is only external ofthe reader assembly. The specification does not
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`describe any further embodiments of the invention other than that as previously indicated as
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`allowable. There is no description of the identification detector being located anywhere else
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`other than being an element of the reader assembly as illustrated in Figure l. The drawings do
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`not illustrate any further embodiments ofthe identification detector being located in other
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`location other than being an element of the reader assembly nor the system being absent of an
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`identification detector. Nor is there any description ofthe external device being only external
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`to the reader assembly as now claimed. Therefore, the claims are directed to new matter. If
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`applicant disagrees, it is hereby requested that applicant specify and provide for the specific
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`text of the originally filed specification that describes the embodiments of invention as
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`presently claimed and further what figures illustrate the embodiments ofthe invention as now
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`claimed.
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`It is unclear how the system of the new claims can function as claimed because if there
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`is no identification detector present in the reader, then it is not possible for the reader
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`assembly to read/detect the identifier on the cartridge nor transmit any identification
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`information to the external device such that the appropriate protocol stored on the external
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`device can be transmitted to the reader assembly. Clarification is requested.
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`Drawings
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`4.
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`The drawings are objected to under 37 CFR l.83(a). The drawings must show every
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`feature of the invention specified in the claims. Therefore, the identification detector being a
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`distinct element that is not an element of the reader assembly, cartridge, and external device
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`as in claim 21, a reader assembly comprising an analyte detector as in claims 21 and 29, and a
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`

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`Application/Control Number:15/689,905
`Art Unit:l798
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`Page4
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`system absent of an identification detector as in claim 29 must be shown or the feature(s)
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`canceled from the c|aim(s). No new matter should be entered.
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`Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to
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`the Office action to avoid abandonment of the application. Any amended replacement drawing
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`sheet should include all of the figures appearing on the immediate prior version of the sheet,
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`even if only one figure is being amended. The figure or figure number of an amended drawing
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`should not be labeled as ”amended." If a drawing figure is to be canceled, the appropriate
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`figure must be removed from the replacement sheet, and where necessary, the remaining
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`figures must be renumbered and appropriate changes made to the brief description of the
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`several views of the drawings for consistency. Additional replacement sheets may be necessary
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`to show the renumbering of the remaining figures. Each drawing sheet submitted after the
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`filing date of an application must be labeled in the top margin as either ”Replacement Sheet" or
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`”New Sheet" pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the
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`applicant will be notified and informed of any required corrective action in the next Office
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`action. The objection to the drawings will not be held in abeyance.
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`Claim Objections
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`5.
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`The numbering of claims is not in accordance with 37 CFR 1.126 which requires the
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`original numbering of the claims to be preserved throughout the prosecution. When claims are
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`canceled, the remaining claims must not be renumbered. When new claims are presented,
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`they must be numbered consecutively beginning with the number next following the highest
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`numbered claims previously presented (whether entered or not).
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`Misnumbered claims 31—33 been renumbered 32—34.
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`

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`Application/Control Number:15/689,905
`Art Unitzl798
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`Page5
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`Claim Rejections - 35 USC § 112
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`6.
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`The following is a quotation ofthe first paragraph of 35 U.S.C.112(a):
`
`(a) IN GENERAL—The specification shall contain a written description of the invention, and
`of the manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to
`make and use the same, and shall set forth the best mode contemplated by the inventor orjoint
`inventor of carrying out the invention.
`
`The following is a quotation ofthe first paragraph of pre—AIA 35 U.S.C.112:
`
`The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person
`skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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`7.
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`Claims 21—27 and 29—34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre—AIA),
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`first paragraph, as failing to comply with the written description requirement. The claim(s)
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`contains subject matter which was not described in the specification in such a way as to
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`reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for
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`pre—AIA the inventor(s), at the time the application was filed, had possession ofthe claimed
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`invention. See Response to Amendments above.
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`8.
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`The following is a quotation of 35 U.S.C.112(b):
`(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out
`and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
`
`The following is a quotation of 35 U.S.C.112(pre—A|A), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`9.
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`Claims 21—27 and 29—34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre—AIA),
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`second paragraph, as being indefinite for failing to particularly point out and distinctly claim the
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`

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`Application/Control Number:15/689,905
`Art Unit:l798
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`Page6
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`subject matter which the inventor or a joint inventor, or for pre—AIA the applicant regards as
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`the invention.
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`10.
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`In addition to remarks above, as to claim 21, it is unclear what is the structural nexus of
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`the identifier detector to the other claimed elements. As noted above, the specification does
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`not disclose any other location of such detector other than being an element in the reader
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`assembly. However, the claim as drafted does not require the identification reader to be an
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`element of the reader.
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`11.
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`It addition the remarks above, in claims 21 and 29, it is unclear what is the structural
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`nexus to the external device and other claimed elements. It is noted that external device is now
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`only required to be external to the reader.
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`12.
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`As to claim 29, it is unclear how the invention as claimed can function because there is
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`no structural element provided for in reader assembly (as described in the originally filed
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`specification) to identify the identifier ofthe cartridge such that cartridge can be identified and
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`the appropriate corresponding protocol to be determined such that it possible for such
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`protocol to be transmitted from the external device to the controller as claimed.
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`Conclusion
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`13.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to BRIAN R GORDON whose telephone number is (571)272—1258.
`
`The examiner can normally be reached on M—F, 8—4z30pm.
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`Examiner interviews are available via telephone, in—person, and video conferencing
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`using a USPTO supplied web—based collaboration tool. To schedule an interview, applicant is
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`

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`Application/Control Number:15/689,905
`Art Unit:l798
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`Page7
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`encouraged to use the USPTO Automated Interview Request (AIR) at
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`http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jill Warden can be reached on 571—272—1267. The fax phone numberfor the
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`organization where this application or proceeding is assigned is 571—273—8300.
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see https://ppair—my.uspto.gov/pair/PrivatePair. Should you have questions on access
`
`to the Private PAIR system, contact the Electronic Business Center (EBC) at 866—217—9197(toll—
`
`free). Ifyou would like assistance from a USPTO Customer Service Representative or access to
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`the automated information system, call 800—786—9199 (IN USA OR CANADA) or 571—272—1000.
`
`/BRIAN R GORDON/
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`Primary Examiner, Art Unit 1798
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`