www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/052,990
`
`11/04/2020
`
`Emre Ozer
`
`P00497US. family
`
`1047
`
`Leveque Intellectual Property Law,P.C.
`241 E. 4th Street, #102
`Frederick, MD 21701
`
`BOYER, RANDY
`
`PAPER NUMBER
`
`ART UNIT
`
`1771
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/23/2024
`
`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):
`
`eofficeaction @appcoll.com
`michelle @levequeip.com
`uspto@levequeip.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Office Action Summary
`
`Application No.
`17/052,990
`Examiner
`Randy Boyer
`
`Applicant(s)
`Ozer et al.
`Art Unit
`1771
`
`AIA (FITF) Status
`Yes
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom 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) MONTHSfrom 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, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s)filed on 5 February 2024.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`1,3-4,6,8,10 and 13-24 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 13-23 is/are withdrawn from consideration.
`[] Claim(s)__ is/are allowed.
`Claim(s) 1,3-4,6,8,10 and 24is/are rejected.
`[) Claim(s)__ is/are objectedto.
`C] Claim(s)
`are subjectto restriction and/or election requirement
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)() The drawing(s) filedon__ is/are: a)C) 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:
`—_c)LJ None ofthe:
`b)LJ Some**
`a)¥) All
`1.) Certified copies of the priority documents have been received.
`2.1 Certified copies of the priority documents have been received in Application No.
`3.4%} 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) [[] Notice of References Cited (PTO-892)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240819
`
`

`

`Application/Control Number: 17/052,990
`Art Unit: 1771
`
`Page 2
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`DETAILED ACTION
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`Response to Amendment
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`1.
`
`Examiner acknowledges Applicant’s response filed 5 February 2024 containing
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`amendments to the claims and remarks.
`
`2.
`
`Claims 1, 3, 4, 6, 8, 10, and 13-24 are pending. Claims 13-23 are withdrawn as
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`being directed to unelected inventions. Consequently, only claims 1, 3, 4, 6, 8, 10, and
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`24 are pending for examination.
`
`3.
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`The previous objection with respect to claim 10 is withdrawnin view of Applicant’s
`
`amendmentsto the claim.
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`4.
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`The previous rejection of claims 1, 3, 4, 6, 8, 10, and 24 under 35 U.S.C. 102(a)(1)
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`is maintained. The rejection follows.
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`Claim Rejections - 35 USC § 102
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`5.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section madein this Office Action:
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`A personshall be entitled to a patent unless —
`
`(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
`on sale, or otherwise available to the public before the effective filing date of the claimed
`invention.
`
`6.
`
`Claims 1, 3, 4, 6, 8, 10, and 24 are rejected under 35 U.S.C. 102(a)(1) as being
`
`anticipated by Wikswo (US 2014/0356849).
`
`7.
`
`With respect to claims 1, 3, 4, 6, 8, 10, and 24, Wikswodisclosesa fluid delivery
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`device (see Wikswo, paragraph [0220]) comprising aninlet portal (851, 852, 853) to allow
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`

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`Application/Control Number: 17/052,990
`Art Unit: 1771
`
`Page 3
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`fluid passage into a chamber(“organ N”): an outlet portal to allow fluid passage from the
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`chamber (see Wikswo, paragraph [0221]); a biosensor (870); an actuator, wherein the
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`actuator unambiguously derivable from the disclosure of “selectively operable valves”
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`(see Wikswo, paragraphs [0223] and [0227]); wherein the biosensor (870) is in fluid
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`communication with the fluid (see Wikswo, paragraph [0224]) and is associated with a
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`valve having actuator capability,
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`the valve being in communication with the sensor
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`measured conditions upon which the valve permits or inhibits delivery of fluid from the
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`chamber (see Wikswo, paragraphs [0234]-[0236] and [0285]). The valve having actuator
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`capability may be a single unit which respondsto a selected fluid parameter (see Wikswo,
`
`paragraphs [0223] and [0227]). The device may compriseaplurality of fluidic switches
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`(i.e. valves) (see Wikswo, paragraphs [0223] and [0227]). The device maybe integral to
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`a microfluidic chip (see Wikswo, Abstract), the chip being associated with a pump for
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`assisting fluid flow (see Wikswo, Abstract). The biosensor may detect changes in
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`electrochemical or fluorescent signals (See Wikswo, paragraph [0103]). The biosensor
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`may belinked to molecules detectable by light sensors (see Wikswo, paragraph [0311]).
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`The inlet and outlet ports mayinclude a seal (see Wikswo, paragraph [0347]). The valve
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`may belinked to a control system capable of processing data which permits or inhibits
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`delivery of fluid (see Wikswo, paragraph [0296]). Examiner notes that the specific
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`limitations of claim 24 do not structurally limit the claimed device over that disclosed by
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`Wikswo. Claims directed to an apparatus mustbe distinguished from the prior art on the
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`basis of structural differences. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d
`
`1464, 1469 (Fed. Cir. 1990) (“[A]pparatus claims cover what a device is, not what a device
`
`does.”) (emphasis in original).
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`

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`Application/Control Number: 17/052,990
`Art Unit: 1771
`
`Page 4
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`Responseto Arguments
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`8.
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`Applicant’s argumentsfiled 5 February 2024 have been fully considered but they
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`are not persuasive.
`
`9.
`
`Examiner understands Applicant’s arguments to be:
`
`Wiksworelates to synthetic organs on chips, for the
`purpose of investigating organ interactions and drug
`responses. As such, Wikswo does not disclose any
`implantable device. The presently claimed devices
`and methods are directed to devices implantable into
`mammalian, bird, amphibian, arthropod, fish, or reptile
`body either directly or within a biocompatible implant
`device, and to methods which are carried out in vivo
`with implantable devices.
`
`Wikswo is directed towards non-implantable devices
`for the purposeof investigating organ interactions and
`drug responses without the need for animaltesting.
`
`Wikswo does not disclose or imply a biosensor to
`sense and detect fluid properties to generate one or
`more sensor measured conditions and to output the
`one or more sensor measured conditions to the control
`unit wherein the biosensor detects one of a variety of
`signals.
`
`Wikswo’s sensor is not one as presently claimed,
`linked to the controlled release (or prevention of
`release) of fluid from a chamber,i.e. drug delivery.
`
`Any sensor disclosed in Wikswois used to measure a
`pressure drop of the fluid or to detect properties of the
`effluent outputted by the bio-object responsive to the
`perfusion, andis totally different from the biosensor for
`detecting properties of the fluid within the chamberfor
`biosafety as defined in claim 1.
`
`10.|With respect to Applicant’s first and second arguments, Examiner notes (1) the
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`claims at issue areall directed to an apparatus per se and (2) that the subjectlimitation
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`“implantable” simply means “capable of being implanted.” In this regard, Applicant points
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`

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`Application/Control Number: 17/052,990
`Art Unit: 1771
`
`Page 5
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`to no distinguishing structural features associated with such limitation. Claims directed
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`to an apparatus must be distinguished from the prior art on the basis of structural
`
`differences. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir.
`
`1990) (“[A]pparatus claims cover what a device /s, not what a device does.”) (emphasis
`
`in original). Moreover, there is nothing in Wikswo to suggest that the device disclosed
`
`therein is not implantable and could not be implanted and Applicant has put forward no
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`convincing argument or evidence to support the position that Wikswo could not be
`
`implanted.
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`11.|With respect to Applicant’s third, fourth, and fifth arguments, see discussion supra
`
`at paragraph 7. Wikswo indicates that
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`“[a] key feature of
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`the Invented Chip
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`Carrier/Cartridge is the ability of the microcontroller to implement complicated fluid and
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`drug delivery protocols to the biological material on the chip” (see Wikswo, paragraph
`
`[0361]).
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`Conclusion
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`12.
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first replyis filed within TWO
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`MONTHS of the mailing date of this final action and the advisory action is not mailed until
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`after the end of the THREE-MONTHshortened statutory period, then the shortened
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`statutory period will expire on the date the advisory action is mailed, and any extension
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`fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory
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`

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`Application/Control Number: 17/052,990
`Art Unit: 1771
`
`Page 6
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`action.
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`In no event, however, will the statutory period for reply expire later than SIX
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`MONTHS from the mailing date of this final action.
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`13.=Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Randy Boyer whosetelephone number is (571) 272-7113.
`
`The examiner can normally be reached Monday through Friday from 10:00 A.M. to 7:00
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`P.M. (EST).
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Prem C. Singh, can be reached at (571) 272-6381. The fax numberfor the
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`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
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`
`(PAIR) system.
`
`Status information for published
`
`applications may be obtained from either Private PAIR or Public PAIR. Status information
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`
`If you would like assistance from a USPTO Customer Service
`
`Representative or access to the automated information system, call 800-786-9199 (IN
`
`USA OR CANADA)or 571-272-1000.
`
`/Randy Boyer/
`
`Primary Examiner, Art Unit 1771
`
`