UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`111270,080
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`11109/2005
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`William J. Schnell
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`25633-446700
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`6531
`
`27717
`7590
`SEYFARTH SHAW LLP
`131 S. DEARBORN ST., SUIIB 2400
`CHICAGO, IL 60603-5803
`
`02/04/2011
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`EXAMINER
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`DEAK, LESLIE R
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`ART UNIT
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`PAPER NUMBER
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`3761
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`MAILDATE
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`DELIVERY MODE
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`02/04/2011
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`PAPER
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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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`PTOL-90A (Rev. 04/07)
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`Office Action Summary
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`Application No.
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`Applicant(s)
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`11/270,080
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`Examiner
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`SCHNELL ET AL.
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`Art Unit
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`3761
`LESLIE R. DEAK
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 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 )IZ! Responsive to communication(s) filed on 20 December 2010.
`2a)[8J This action is FINAL.
`2b)0 This action is non-final.
`3)0 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 Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)[8J Claim(s) 9-15. 18 and 33-54 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 9-15. 18 and 33-54 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`9)0 The specification is objected to by the Examiner.
`1 O)IZ! The drawing(s) filed on 21 March 2006 is/are: a)IZ! accepted or b)O 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).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
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`Priority under 35 U.S.C. § 119
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`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
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`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
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`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08·06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20110201
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`Application/Control Number: 11 /270,080
`Art Unit: 3761
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`Page 2
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`DETAILED ACTION
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`Claim Rejections - 35 USC § 102
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`1.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless -
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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 year prior to the date of application for patent in
`the United States.
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`2.
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`Claims 9-15 and 18 are rejected under 35 U.S.C. 102(b) as being anticipated by
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`US 6,526,357 to Soussan et al.
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`In the specification and figures, Soussan discloses the apparatus as claimed by
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`Applicant. With regard to claim 9, Soussan discloses a tubular blood set 10 with a
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`pressure sensing pod 28 with a housing 80 defining a blood chamber 84, pressure
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`chamber 86, connected to blood flow-through tubing (generally at port 88 in FIGS 4, 5)
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`a length of pressure tubing at 91 /93 connected to the pressure chamber with a flexible
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`diaphragm 82 between the blood chamber and the pressure chamber (see FIGS 4-6
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`and accompanying text). With regard to the recitation of a connector, Soussan is silent
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`as to the actual structural component. However, since the pods 80 are connected to
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`lines 93 that subsequently connect to pressure transducers 92, it follows naturally that
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`the Soussan apparatus comprises some sort of connector means. The diaphragm 82
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`disclosed by Soussan flexes in the directions claimed by Applicant (see FIG 5).
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`With regard to claim 10, Applicant is setting forth the intended use of the claimed
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`apparatus. It has been held that a recitation with respect to the manner in which a
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`claimed apparatus is intended to be employed does not differentiate the claimed
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`apparatus from a prior art apparatus satisfying the claimed structural limitations. See
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`MPEP § 2114.
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`With regard to claim 11, Soussan discloses that the pressure tubing 93 connects
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`a pressure transducer 92 and a device 97 to apply pressure to chamber 86 to move the
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`diaphragm in a desired direction (see FIGS 5-6).
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`With regard to claim 12, Soussan discloses that the tubing lines are generally
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`flexible (see column 8, lines 60-64), and the pressure tubing lines comprise clamps
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`such as 94a (see FIG 6).
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`With regard to claims 13 and 14, the pressure pod disclosed by Soussan is
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`circular, thereby comprising a U-shape facing the chamber, wherein the diaphragm
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`does not block flow through either channel (see FIGS 4-5).
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`With regard to claim 15, Soussan discloses that the blood chamber 84 connects
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`to blood flow tubing, which connects to a pump segment (see FIG 1 ).
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`With regard to claim 18, Soussan discloses that the pressure pod comprises
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`access ports 88, 90 for communicating with the blood side of the chamber (see FIG 5).
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`Claim Rejections - 35 USC § 103
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`3.
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, 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 obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`Application/Control Number: 11 /270,080
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`4.
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`Claim 44 is rejected under 35 U.S.C. 103(a) as being unpatentable over US
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`6,526,357 to Soussan et al.
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`In the specification and figures, Soussan discloses the apparatus substantially as
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`claimed by Applicant (see rejections above). With regard to the recitation of a
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`connector, Soussan is silent as to the actual structural component. However, since the
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`pods 80 are connected to lines 93 that subsequently connect to pressure transducers
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`92, it follows naturally that the Soussan apparatus comprises some sort of connector
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`means.
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`5.
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`Claims 33-41, 45-54 are rejected under 35 U.S.C. 103(a) as being unpatentable
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`over US 6,526,357 to Soussan et al in view of US 5,693,008 to Brugger et al.
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`In the specification and figures, Soussan discloses the apparatus substantially as
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`claimed by Applicant. With regard to claims 33 and 47-49, Soussan discloses a tubular
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`blood set 10 with a pressure sensing pod 28 with a housing 80 defining a blood
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`chamber 84, pressure chamber 86, connected to blood flow-through tubing (generally at
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`port 88 in FIGS 4, 5) a length of pressure tubing 93 connected to the pressure chamber
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`with a flexible diaphragm 82 between the blood chamber and the pressure chamber
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`(see FIGS 4-6 and accompanying text). The diaphragm 82 disclosed by Soussan flexes
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`in the directions claimed by Applicant (see FIG 5).
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`Soussan fails to disclose that the pressure pod is substantially dome-shaped.
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`However, Brugger discloses an extracorporeal fluid tubing set with pressure pod
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`transducers that are substantially dome-shaped (see FIGS 3, 4). It has been held that
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`matters relating to ornamentation only which have no mechanical function cannot be
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`relied upon to patentably distinguish the claimed invention from the prior art. See MPEP
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`§ 2144.04(1). It is the position of the Examiner that it would have been obvious to one
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`having ordinary skill in the art at the time of invention to form the pressure pod disclosed
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`by Soussan in the shape disclosed by Brugger since such a shape is known in the art
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`and does not appear to affect the operation of the apparatus.
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`With regard to claims 34 and 50, Applicant is setting forth the intended use of the
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`claimed apparatus. It has been held that a recitation with respect to the manner in which
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`a claimed apparatus is intended to be employed does not differentiate the claimed
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`apparatus from a prior art apparatus satisfying the claimed structural limitations. See
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`MPEP § 2114.
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`With regard to claims 35 and 51, Soussan illustrates that pressure tubing 93 is
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`connected to connector 91 of the pod, at the other end having a connection to a
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`pressure transducer 92/98.
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`With regard to claims 36 and 52, it is the position of the Examiner that any item is
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`capable of disconnection from another part, thereby meeting the limitations of the
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`claims.
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`With regard to claims 37-38, 45-46, and 53, Brugger discloses that the pressure
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`pod further comprises an access port that is sealed from the atmosphere by partition or
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`septum 200, the connection of which to a needle irreversible opens the septum (see
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`column 6, lines 32-40). It is the position of the Examiner that the disclosure of Brugger
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`teaches that it is well known in the art of fluid handling to use a partition to seal a
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`chamber from the atmosphere when atmospheric interference is not desired.
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`Accordingly, it is the position of the Examiner that taken together, the references
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`reasonably suggest the sealing of the pressure chamber of the Soussan device with a
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`partition until outside interference is desired, as suggested by Brugger.
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`With regard to claims 39 -41 and 54, it has been held that where the only
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`difference between the prior art and the claims was a recitation of relative dimensions of
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`the claimed device and a device having the claimed relative dimensions would not
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`perform differently than the prior art device, the claimed device was not patentably
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`distinct from the prior art device. See MPEP 2144.04(1V)(B). It is the position of the
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`Examiner that it is within the skill of a worker in the art to manipulate the dimensions of
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`the pressure pod to optimize performance.
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`Response to Arguments
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`6.
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`Applicant's arguments filed 20 December 2010 have been fully considered but
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`they are not persuasive.
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`7.
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`Applicant argues that Soussan fails to disclose that apparatus comprises a length
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`of pressure tubing between the pods and a connector to pressure measuring
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`equipment. Applicant relies on Soussan FIG 6 to show that the pods 80 are directly
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`connected to machine 60. The Examiner notes that Soussan discloses that FIG 6 is
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`merely a schematic representation of the disclosed apparatus, not a representative
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`figure. Furthermore, the pods 80 are connected to pressure transducers 92 via lines 93.
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`The lines 93 represent the "pressure tubing" claimed by Applicant. Applicant does not
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`set forth that the pressure tubing must be separate from a reusable monitoring
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`apparatus such as Soussan's apparatus 60. Applicant argues that using the claimed
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`pressure tubing allows the pods to be placed at the most desirable locations on the
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`blood flow set. While this may be true, Applicant has not set forth any structural
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`limitations that distinguish the instantly claimed tubing from that shown by Soussan.
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`8.
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`With regard to claim 11, Applicant argues that Soussan fails to show that the
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`pressure tubing may be attached sequentially to a device such as a syringe to apply
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`pressure to the pods. The Examiner notes that claim 11 does not recite a syringe.
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`Furthermore, Soussan specifically discloses that pressure tubing 93 is connected to
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`pressure tubing 99, which, in turn, is connected to dry gas source 96 and dry gas pump
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`97 that may apply pressure to the pods 80.
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`9.
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`With regard to claim 48, Applicant argues that Soussan discloses only a straight
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`diaphragm. The Examiner notes that in FIG 5, Soussan discloses that the diaphragm
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`may flex into a dome shape. Furthermore, claim 48 is rejected over a combination of
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`Soussan and Brugger.
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`10.
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`Applicant argues that Brugger's dome shaped diaphragm is not capable of freely
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`flipping back and forth to vary the size of the chambers. Applicant has not claimed such
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`movement. Furthermore, Applicant has not set forth any structural limitations that
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`distinguish the instantly claimed diaphragm from that disclosed by Brugger. As such, it
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`is the position of the Examiner that, absent any claimed structural limitations, the
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`Brugger diaphragm is capable of the movement argued by Applicant.
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`Conclusion
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`11.
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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. In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action. In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the mailing date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to LESLIE R. DEAK whose telephone number is (571 )272-
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`4943. The examiner can normally be reached on Monday - Friday, 8:30am-5:00pm.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Tanya Zalukaeva can be reached on 571-272-1115. The fax phone number
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`for the 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
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`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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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`/Leslie R. Deak/
`Primary Examiner, Art Unit 3761
`2 February 2011
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