`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`15/881,602
`
`
`
`
` FILING DATE
`
`
`01/26/2018
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`Ammar Al-Ali
`
`MAS.780R1
`
`9078
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP Le
`
`MASIMO CORPORATION (MASIMO)
`2040 MAIN STREET
`FOURTEENTH FLOOR
`IRVINE,CA 92614
`
`FLANAGAN, BEVERLY MEINDL
`
`3993
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/27/2018
`
`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):
`jayna.cartee @ knobbe.com
`efiling @knobbe.com
`
`PTOL-90A (Rev. 04/07)
`
`
`
`
`
`Applicant(s)
`Application No.
` 15/881 ,602 AL-ALI, AMMAR
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`3993BEVERLY M. FLANAGAN Na
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Anyreply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply betimely filed
`
`Status
`1)L] Responsive to communication(s) filed on
`LJ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon__
`2a)L] This action is FINAL.
`2b) This action is non-final.
`3)L] Anelection was made bythe applicant in responsetoarestriction requirementset forth during the interview on
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`___} the restriction requirement and election have been incorporated into this action.
`4)[] Since this application is in condition for allowance exceptfor formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`
`
`Disposition of Claims*
`5)X] Claim(s) 1-23 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)IX] Claim(s) 1-7 and 12-17 is/are allowed.
`7)X] Claim(s) 8-10 and 19-23 is/are rejected.
`8)X] Claim(s) 17 is/are objected to.
`
`9)L] Claim(s)
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`
`
`
`
`nite://www.usoto.gov/patenis/init events/pph/index.isp or send an inquiry to PPHieedback@uspto.qov.
`
`Application Papers
`10)L] The specification is objected to by the Examiner.
`
`11)L] The drawing(s)filed on
`is/are: a)L_] accepted or b)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).
`
`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)L] All
`b)[-] Some** c)L] None ofthe:
`1..] Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies of the certified copies of the priority documents have been receivedin 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) X Notice of References Cited (PTO-892)
`:
`.
`2) X Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 2/1/18.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`3) CT] Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
`4)] Other:__.
`
`.
`
`Part of Paper No./Mail Date 20180618
`
`
`
`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 2
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`DETAILED ACTION
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`AIA - Reissue
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`The present reissue application wasfiled on or after September 16, 2012 and
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`therefore is being examined underthe current AIA reissue provisions of 35 USC 251
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`and 37 CFR 1,172, 1,175 and 3.73."
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`Related Proceedings
`
`Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to
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`timely apprise the Office of any prior or concurrent proceeding in which Patent No.
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`9,775,570 is or was involved. These proceedings would include interferences, reissues,
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`reexaminations, andlitigation.
`
`Applicantis further reminded of the continuing obligation under 37 CFR 1.56, to
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`timely apprise the Office of any information whichis material to patentability of the
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`claims under consideration in this reissue application.
`
`These obligations rest with each individual associated with thefiling and
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`prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and
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`1442.04.
`
`It is noted that while the examination of the current reissue application falls under the pre-AlAfirst to
`"
`invent provisions due to the filing date of US Patent No. 9,775,570; the application for reissue filing date is
`after September 16, 2012 and therefore is subject to the reissue rule changes enacted under the Leahy-
`Smith American Invents Act (AIA), see Federal Register, Vol. 77, No. 157, pg. 48820, August 16, 2012.
`
`
`
`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 3
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`Preliminary Amendment
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`Applicant’s preliminary amendment filed January 26, 2018 has been entered and
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`made of record. Claims 1-4, 6, 8 and 10-16 are amended. Claims 5, 7, 9, 17 and 18
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`remain as originally patented. Claims 19-23 are newly presented.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or more claimsparticularly
`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-AlA), 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.
`
`Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA),
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`second paragraph, as being indefinite for failing to particularly point out and distinctly
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`claim the subject matter which the inventor or a joint inventor, or for pre-AlA the
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`applicant regards as the invention.
`
`Claim 1 recites the limitation "at least first oxygen saturation value"in lines 24
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`and 27. Thereis insufficient antecedent basis for this limitation in the claim. As claims
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`2-7 depend from claim 1 they are likewise rejected.
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`Claim Rejections - 35 USC § 102/103
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`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
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`correction of the statutory basis for the rejection will not be considered a new groundof
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`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 4
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`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
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`the same under either status.
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`The following is a quotation of the appropriate paragraphs of pre-AlIA 35 U.S.C.
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`102 that form the basis for the rejections underthis section madein this Office action:
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`(b) the invention was patented or described in a printed publication in this or a foreign country
`or in public use or on sale in this country, more than one yearprior to the date of application
`for patent in the United States.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousnessrejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102, if the differences between the subject matter sought to be patented
`and the prior art are such that the subject matter as a whole would have been obviousat the
`time the invention was made to a person having ordinaryskill in the art to which said subject
`matter pertains. Patentability shall not be negatived by the manner in which the invention was
`made.
`
`Claim(s) 8-10 and 19-23 is/are rejected underpre-AlA 35 U.S.C. 102 (b) as
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`anticipated byor, in the alternative, under pre-AlA 35 U.S.C. 103(a) as obvious over
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`Baker, Jr. (U.S. Patent Application Publication No. 2009/0247848).
`
`In regard to claims 8-10 and 19-23, Baker, Jr. teaches a system for reducing
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`nuisance alarms where the system is a pulse oximetry system 10 that includes a sensor
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`12 and a pulse oximetry monitor 14 where the sensor 12 includes an emitter 16 for
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`emitting light into a patient’s tissue and a detector 18 is provided in the sensor 12 for
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`detecting light originating from the emitter 16 (see para. 0023 and Fig. 1).
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`In one
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`method, the receive data operation 602 includes receiving an electronic signal from a
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`sensor and processing that signal to generate data (see para. 0049 and Fig. 6). The
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`received data are analyzed in the generate estimate operation 604 and one or more
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`statistical parameters describing the data are calculated in the calculatedstatistical
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`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 5
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`parameters operation 606 (see paras. 0050-0051). After the calculations have been
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`made, an alarm condition operation 608 is performed where an adjusted alarm condition
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`is determined based on a predetermined alarm condition (see para. 0060). The
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`predetermined alarm condition may be defined by a predetermined acceptable range
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`that is defined by two predetermined thresholds that may be user selected or provided
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`by the device manufacturer (see para. 0060). The alarm condition adjustment operation
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`608 retrieves or otherwise accesses the predetermined alarm condition and then
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`adjusts it and the adjustment may include changing the value of a predetermined
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`threshold (see para. 0061). A generate alarm operation 610 is then performedin which
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`the adjusted alarm condition is used to determineif an alarm should be generated (see
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`para. 0064). Baker, Jr. also teaches performing the method 600 continuously which
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`would result in second and subsequent determinations of oxygen saturation values over
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`second and subsequentperiods of time as well as the determination of second and
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`subsequent alarm thresholds. Baker, Jr. also teaches a method 800 that includes a
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`generate delay operation 812 that identifies a delay period which is used to delay the
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`generation of the alarm (see paras. 0084 and 0085). With further respectto claim 10,
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`Baker, Jr. teachesthat the lowerlimit of SaQz may be set at 88.3%(see para. 0044).
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`With further respect to claims 19 and 20,it is inherent that in Baker, Jr. the difference
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`between an alarm value and a prior oxygen saturation would diminish based on the
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`prior oxygen saturation of the patient, particularly as the algorithm is used to continually
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`adjust the alarm threshold. Furthermore, the lower the patient’s oxygen saturation level,
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`the smaller the difference between the alarm threshold and the patient’s measured
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`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 6
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`oxygen saturation. With further respect to claims 21 and 22, with the continued
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`calculations in Baker, Jr., the diminishmentin difference between the measured oxygen
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`saturation level and the alarm threshold could be either stepwise or proportional and
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`would in turn be dependent upon the individual patient's measurements.
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`Allowable Subject Matter
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`Claim 11 is objected to as being dependent upon a rejected baseclaim, but
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`would be allowable if rewritten in independent form including all of the limitations of the
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`base claim and any intervening claims.
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`Claims 1-7 and 12-18 are allowed.
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`The following is a statementof reasons for the indication of allowable subject
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`matter: Independent claims 1 and 12 recite that the second alarm threshold has a value
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`less than the at leastfirst (one) oxygen saturation value and greater than a lowerlimit
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`and at an offset from the at leastfirst (one) oxygen saturation value, wherein the offset
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`is diminished as a difference betweenthe atleastfirst (one) oxygen saturation value
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`and the lowerlimit diminishes.” This feature is not taught by the prior art. Baker,Jr,
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`which is exemplary of the prior art, while it teaches changing or reconfiguring the
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`threshold valuesfor triggering an alarm, does not teach that the second alarm threshold
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`is at an offset from the measured oxygen saturation value and that the offsetis
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`diminished asa difference between the measured oxygen saturation value and the
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`lowerlimit diminishes. Baker, Jr. also does teach a lowerlimit, just an alarm threshold
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`(see the rejection above). Accordingly, claims 1-7 and 12-18 are allowed.
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`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 7
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`Amendments in Reissue Applications
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`Applicantis notified that any subsequent amendmentto the specification, claims
`
`or drawings must comply with 37 CFR 1.173(b)-(g). In addition, for reissue applications
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`filed before September 16, 2012, when any substantive amendmentis filed in the
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`reissue application, which amendment otherwise placesthe reissue application in
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`condition for allowance, a supplemental oath/declaration will be required. See MPEP §
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`1414.01.
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`The provisions of 37 CFR 1.173(b)(1), (d), (f) and (g) govern amendments to the
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`specification (other than the claims) in reissue applications. The following guidanceis
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`provided as to the procedure for amending the specification:
`
`a)
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`All amendments which include deletions or additions must be made by
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`submission of the entire text of each added or rewritten paragraph containing the
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`bracketing and/or underlining required by 37 CFR 1.173(d).
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`b)
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`An entire paragraph of specification text may be deleted by a statement
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`deleting the paragraph without presentation of the text of the paragraph.
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`9)
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`d)
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`Applicant must indicate the precise point where each amendment is made.
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`All bracketing and underlining is made in comparison to the original
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`patent, not in comparison to any prior amendmentin the reissue application. Thus, all
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`paragraphs which are newly addedto the specification of the original patent must be
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`submitted as completely underlined each time they are re-submitted in the reissue
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`application.
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`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 8
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`The provisions of 37 CFR 1.173(b)(2), (c)-(e) and (g) govern amendmentsto the
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`claims in reissue applications. The following guidance is provided as to the procedure
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`for amending the claims:
`
`a)
`
`For each claim that is being amended, the entire text of the claim must be
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`presented with the bracketing and/or underlining required by 37 CFR 1.173(d).
`
`b)
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`For each newclaim addedto the reissue,the entire text of the added
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`claim must be presented completely underlined.
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`C)
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`A patent claim should be canceled bya direction to cancel that claim.
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`There is no need to present the patent claim surrounded by brackets.
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`d)
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`A newclaim (previously added in the reissue) should be canceled by a
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`direction to cancel that claim.
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`e)
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`Pursuant to 37 CFR 1.173(b)(2), each claim that is amended or added
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`should include the appropriate status indicator following the claim number,e.g.,
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`“(amended)”, “(twice amended)”, “(new)”, and “(canceled)”.
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`f)
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`Pursuant to 37 CFR 1.173(c), each amendment submitted mustsetforth
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`the status of all patent claims andall added claims as of the date of the submission. The
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`status to be set forth is whetherthe claim is pending or canceled.
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`g)
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`Also pursuant to 37 CFR 1.173(c), each claim amendment must be
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`accompanied by an explanation of the support in the patent’s disclosurefor all changes
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`made in the claim(s), whether insertions or deletions.
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`h)
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`Pursuant to 37 CFR 1.173(e), original patent claims are never to be
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`renumbered. A patent claim retains its numberevenif it is canceled in the reissue
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`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 9
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`proceeding, and the numbering of any added claims must begin after the last original
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`patent claim.
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`i)
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`Pursuant to 37 CFR 1.173(g), all bracketing and underlining is madein
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`comparison to the original patent, not in comparison to any prior amendment in the
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`reissue application.
`
`The provisions of 37 CFR 1.173(b)(3) govern amendments to the drawings in
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`reissue applications. The following guidanceis provided as to the procedurefor
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`amending drawings:
`
`a)
`
`Amending the original or printed patent drawing sheets by physically
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`changing or altering them is not permitted.
`
`b)
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`Where a change to the drawings is desired, applicant must submit a
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`replacement sheet for each sheet of drawings containing a figure to be revised. Any
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`replacement sheet must comply with 37 CFR 1.84 and includeall of the figures
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`appearing on the original version of the sheet, even if only one figure is being amended.
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`Each figure that is amended mustbe identified by placing the word “Amended”at the
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`bottom ofthat figure. Any addedfigure must beidentified as “New”. In the event that a
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`figure is canceled, the figure must be identified as “Canceled” and also surrounded by
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`brackets.
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`C)
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`All changesto the figure(s) must be explained, in detail, beginning on a
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`separate sheet which accompanies the papersincluding the amendment to the
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`drawings.
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`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 10
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`d)
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`If desired, applicant may include a marked-up copy of any amended
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`drawing figure, including annotations indicating the changes made. Such a marked-up
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`copy must be clearly labeled as “Annotated Marked-up Drawings’, and it must be
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`presented in the amendment or remarks section that explains the change to the
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`drawings.
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`Failure to fully comply with 37 CFR 1.173(b)-(g) will generally result in a
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`notification to applicant that an amendmentbeforefinal rejection is not completely
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`responsive. Such an amendmentafterfinal rejection will not be entered.
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`Anyinquiry concerning this communication or earlier communications from the
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`examiner should be directed to BEVERLY FLANAGANwhosetelephone numberis
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`(571) 272-4766. The examiner can normally be reached on Mondaythrough Friday.
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`If attempts to reach the examiner by telephone are unsuccessful, Supervisory
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`Reexamination Specialist Gay Spahn can be reached on (571) 272-7731. The fax
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`phone numberfor the organization wherethis application or proceeding is assigned is
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`571-273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`
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`Application/Control Number: 15/881 ,602
`Art Unit: 3993
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`Page 11
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`you have questions on accessto the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automatedinformation
`
`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/Beverly M. Flanagan/
`Beverly M. Flanagan
`Primary Examiner
`CRU — Art Unit 3993
`
`Conf:
`
`/JRd/ and /GAS/
`
`