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`RECEIVED
`CENTRAL FAX CENTER
`DEC 2 0 2010·
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`(Docket No. 446700)
`
`In re the Application of:
`
`William J. Schnell, et al
`
`Serial No.: 11/270,080
`
`Filed: November 9, 2005
`
`For: DIAPHRAGM PRESSURE POD FOR
`MEDICAL FLUIDS
`
`TO: MAIL STOP: Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Customer No. 27717
`
`Art Unit: 3761
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Dear Sir:
`
`AMENDMENT
`
`In response to the Office Action of June 30, 2010, a three-month extension of
`
`time is requested to respond to the Office Action, so that the due date for response will
`
`be December 30, 2010.
`
`Please charge Deposit Account No. 19-1351 for the large entity extension fee,
`
`and any other fees that may be required.
`
`Amendments to the specification begin on page 2.
`
`Amendments to the claims begin on page 4.
`
`The Remarks begin on page 9.
`
`12121/2010 HttARZ11 00000054 191351
`1110.00 DA
`01 FC:li!Sl
`
`11270080
`
`12981879¥.1
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`Please amend the first complete paragraph and the subsequent paragraph of
`
`page 18 as follows:
`
`When the extracorporeal blood processing procedure is complete; it is necessary
`
`to rinse the blood back to the patient in a step known as "rinse back." To accomplish
`
`this, pressure tubing 42 may be disconnected from the pressure monitor transducer 43,
`
`and the venol;l& portion of the set, which draws.blood from the patientr can be removed
`
`from the patient. °Then, pressure tubing 42 is connected with a cor:iventional syringe 52
`
`(Fig. 1), which is depressed to add air or other fluid to the system to cause diaphragm
`
`26 to assume its second position as shown in Fig. 4 (26a). A slide clamp 54 or other
`
`type of clamp then may close off pressure tubing 42, to keep diaphragm 26 under
`
`pressure and firmly in its second position 26a during the rinse back process, so that the
`
`blood containing volume of pod 12 is minimized. Saline solution or the like flows into
`
`the system through an access site such as parenteral solution line 35, to replace blood
`
`in the set with saline solution, and to return blood back to the patient through the
`
`remaining patient connection. Alternatively or additionally, saline solution may be
`
`added to the separated, veRobls end of the set of set portion 16 for rinseback, to
`
`terminate the procedure ..
`
`Thus, by one embodiment of this invention, blood pressure in a blood flow tube
`
`may be monitored through a length of pressure tubing. 42 connecting to a diaphragm
`
`pod 12 as described, with the diaphragm being positioned near a first position that
`
`essentially·maximizes the blood holding volume in the pod, although varying, for
`
`example negative. pressures in the chamber can result in differing positions of the
`
`diaphragm. Then, at the end of the extracorporeal blood flow procedure, pressure
`
`12981879v.1
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`sensing pod 12 may be pressurized to move diaphragm 26 28 to its second position
`
`26a, to cause the blood holding volume of the pod to be substantially minimized, without
`
`blocking flow through the blood flow tube and pod. Parenteral .solution such as saline is
`
`then passed into the tube and pod to replace the blood, while the blood is returned to
`
`the patient
`
`Please amend the bottom paragraph of specification page 20:
`The pressure ~ressure sensing diaphragm in pod ao defines a dome 28 a which
`
`has a maximum depth 29 of about 6-7 mm. (such as 6.3 mm), and a width of the
`
`chamber defined by the dome of about 23-25 mm., specifically 24 mm.
`
`129S1879v.1
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`p9': 4/14
`
`LISTING OF CLAIMS AS AMENDED:
`
`1. • 8. (Cancelled)
`
`I
`
`9.
`
`(Currently Amended) A tubular blood flow set which comprises a pressure
`
`sensing pod defining~ chamber, said pod being connected in flow-through relation to
`
`blood flow tubing of said set, said set defining a length of pressure tubing connected at
`
`one end with said chamber, for connection with a pressYFe seRsiRg elevise at the other
`
`pressure tubing end, with a pressure measuring equipment connector with said ood
`
`being spaced from said connector; and a flexible diaphragm searingly mounted within
`
`said pod between connections of said blood flow tubing and said pressure tubing; said
`
`diaphragm being moveable between first and second positions, the diaphragm in said
`
`first position bowing outwardly to substantially maximize volume in said chamber that
`
`communicates with said blood flow tubing, the diaphragm in said second position
`
`bowing inwardly to substantially minimize but not eliminate the blood volume in said
`
`chamber that is in$ide of said diaphragm, said diaphragm in use being in contact on one
`
`side thereof with flowing blood.
`
`10.
`
`(Currently Amended) The blood flow set of Claim 9 in which said
`
`diaphragm occupies substantially said fif&t second position when the interior of said fl.ow
`
`set is filled with negatively pressurized blood.
`
`11.
`
`(Currently Amended) The blood flow set of Claim 9 in which said flexible
`
`pressure tubing js attached to said pressure sensing pod and carries at said other
`
`pressure tubing end 6arries a connector for sequential connection with (1) a pressure
`
`sensing device and (2) a device to apply positive pressure through said outlet port to
`
`said chamber, to drive said diaphragm to the second position.
`
`1298187911.1
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`12.
`
`(Original) The blood flow set of Claim 11 in which said pressure tubing is
`
`flexible and carries a flow clamp to retain said positive pressure at said diaphragm.
`
`13.
`
`(Original) The blood flow set of Claim 9 in which said pod has a bottom
`
`wall facing said chamber, :which bottom wall defines a transverse channel having a wall
`
`of U or V-shaped cross-section, whereby the diaphragm in the second position does not
`
`block flow through the channel.
`
`14.
`
`(Original) The blood flow set of Claim 13 in which said channel wall is U-
`
`shaped and substantially contiguous with a wall portion of said flow tubing of said set.
`
`15.
`
`(Original) The blood flow set of Claim 9 in which said chamber connects
`
`to flow tubing which is pump segment tubing.
`
`16.-17. (Cancelled)
`
`18.
`
`(Original) The blood flow set of Claim 9 in which an access port is
`
`provided to communicate with the chamber interior at a side of said diaphragm opposed
`
`to said pressure tubing.
`
`19.-32. (Cancelled)
`
`33.
`
`(Original) A' pressure transmitting pod defining a chamber, said pod being
`
`for connection in flow-through relation to fluid flow tubing of a fluid flow set, said pod
`
`having a flexible, fluid impermeable diaphragm dividing the pod into separate
`
`compartments, a first of said compartments communicating with flow connectors for
`
`said fluid flow tubing, a second of said compartments communicating with ~ connection
`
`port for connection with a length of pressure tubing at one end thereof, which tubing is
`
`for sealed connection at its .other end to a remote pressure connector of a pressure
`
`sensing machine, to transmit pressure from the second of said compartments through
`
`12981S79v.1
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`the pressure tubing to the pressure sensing machine for pressure monitoring, said
`
`diaphragm having a dome shape, and being sufficiently flexible to easily distort in a
`
`manner reflective of pressure changes, to vary the volumes of said one and other
`
`compartments.
`
`34.
`(Original} The pressure pod of claim 33 in which said diaphragm of dome
`shape can vary the volume of said compartments at a pressure variation of 500 mm Hg
`
`by at least 2.5 cc.
`
`35.
`
`(Original) The pressure pod of claim 33 in which said pressure tubing is
`
`permanenUy connected to said connection port of the pod, said pressure tubing having
`
`at Its other end a remote tubing connector for connection to said machine remote
`
`pressure port during medical treatments.
`
`36.
`
`(Original) The pressure pod of claim 33 in which said pressure tubing is·
`
`capable of disconnection from the connection port of the pod.
`(Currently Amended} The pressure pod of claim 33 3§ in which said pod
`connection port is sealed from the atmosphere by an internal partition, said seal being
`
`37.
`
`operable by sealing attachment with a connector of said pressure tubing.
`
`38.
`
`(Currently Amended) The pressure pod of claim 37 36 in which said ·
`
`partition is irreversibly opened by a connection of said pod connection port to a
`
`connector of said pressure tubing.
`
`39.
`
`(Original) The pressure pod of claim 33 in which said pod defines a
`
`chamber which has a length at least twice its width.
`
`40.
`
`(Original) The pressure pod of claim 39 in which said diaphragm has a
`
`width which is at least twice the depth of the dome of said diaphragm.
`
`12981879'/.1
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`41.
`
`(Original) The pressure pod of claim 33 in which said diaphragm has a
`I
`
`width which is at least twiee the depth of the dome of said diaphragm.
`
`42. -43. (Cancelled)
`
`44.
`
`(New} The tubular blood flow set of claim 9 in which said pressure tubing
`
`carries a connector at its other end for connection with said pressure measuring
`
`equipment connector.
`
`45.
`
`(New) The tubular blood flow set of claim 44 in which said chamber has a
`
`removable seal therein whereby the flexible diaphra.gm is maintained in a desired, initial
`
`position prior to opening of said seal.
`
`46.
`
`(New) The pressure transmitting pod of claim 45 in which said dome-
`
`shaped diaphragm can bow outwardly in either of two opposed directions.
`
`47.
`
`(New) The pressure transmitting pod of claim 33 in which said dome-
`
`shaped diaphragm can bow outwardly in either of two opposed directions.
`
`I
`
`48.
`
`(New) The tubular blood flow set of claim 9 in which said diaphragm is
`
`dome shaped and can bow outwardly in either of two opposed directions.
`
`49.
`
`(New) A pressure transmitting pod defining a chamber, .said pod being in
`
`connection in flow-through relation to fluid flow tubing of a fluid flow set, said pod having
`
`a flexible, fluid impermeable diaphragm dividing the pod into separate compartments, a
`
`first of said compartments communicating with flow connectors for said fluid flow tubing,
`
`a second of said compartments communicating with a connection port for connection to
`
`pressure tubing of a pressure sensing machine, to transmit pressure from the second of
`
`I
`
`said compartments to the pressure sensing machine for pressure monitoring, said
`
`diaphragm having a dome shape, and being sufficiently flexible to easily distort in a
`
`12981879v.1
`
`7
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`manner reflective of pressure changes, to vary the volumes of said one and other
`
`compartments. said dome shaped diaphragm being capable of bowing outwardly to
`
`form said dome shape in either of two opposed directions.
`
`50.
`
`(New) The pressure pod of claim 49 in which said diaphragm of dome
`
`shape can vary the volume of said compartments at a pressure variation of 500 mn Hg
`
`by at least 2.5 cc.
`
`51.
`
`(New) The pressure pod of claim 49 in which said pressure tubing is
`
`permanently connected to said connection port of said pod, said pressure tubing having
`
`at its other end the remote tubi~g connector for connection to a machine remote
`
`pressure port during medical treatments .
`
`. 52.
`
`(New) The pressure pod of claim 49 in which said pressure tubing is
`
`capable of disconnection from the connection port of the pod.
`
`53.
`
`(New) The pressure pod of claim 52 in which said pod connection port is
`
`sealed from the atmosphere by an internal partition, said seal being operable by sealing
`
`attachment with a connector of said pressure tubing.
`
`54.
`
`(New) The pressure pod of claim 49 in which said pod defines a chamber
`
`which has a length at least twice its width and said diaphragm has a width at least twice .
`
`the depth of the dome of said diaphragm.
`
`12981879v.1
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`REMARKS
`
`12-20-18 14 :01
`
`Pg: 9/14
`RECEIVED
`·CENTRAL FAX CENTER
`DEC 2 0 2010
`
`Reconsideration of this application and allowance of the claims is respectfully
`
`requested.
`
`The withdrawn claims are cancelled, subject to the right to their inclusion in a
`
`divisional application.
`
`Amendments to specification page 18 are for improvement of the clarity of the
`
`disclosure, and to correct clerical errors.
`
`The amendment to the last paragraph of specification page 20 also is for editorial
`
`improvement.
`
`Amendments to claim 9 are supported by the disclosures of this application, and
`
`particularly at the last seven lines of the first full paragraph of specification page 16.
`
`New claims 44 and 45 are supported at Figs. 10 and 11, for example, along with
`
`the related portions of the specification.
`
`New claims 46-48 are supported for example at the first complete paragraph on
`
`specification page 17, with the disclosure of first position 26 and second position 26a
`
`(Fig. 4), found in the frfth line of the paragraph.
`
`New claims 49-54 are supported by Fig. 4 and supporting specification such as
`
`page 27, as well as claims 33-40.
`
`The examiner has rejected claims 9-15 and 18 as anticipated by Soussan et al.
`
`U.S- Patent 6,526,357.
`
`The examiner is urged to note a distinction of claim 9 as amended over Soussan
`
`et al. The tubular blood flow set of claim 9 calls for u ... a pressure sensing pod defining
`
`a chamber ... " in which the set defines " ... a length of pressure tubing connected at one
`
`12981S79v. 1
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`9
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`end with said chamber, for connection at the other pressure tubing end with a pressure
`.. ,
`measuring equipment connector with said pod being spaced from said connector ... "
`
`To the· contrary in Soussan, it can be seen that the pressure pods 80 (Fig. 6) are
`
`directly connected to the IF'PParatus 60 (depicted by dashed lines as stated at column
`
`12, lines 42 et seq.). The claim 9 requirement of a length of typically flexible pressure
`
`tubing connected between the chamber and the connector to the pressure measuring
`
`equipment may seem like a small distinction, until the advantages are understood.
`
`It is to be understood that each pod 80 is part of a blood processing set in
`
`Soussan et al. Each of these pods must be directly connected as shown in Fig. 6 to
`
`machine 60 and the internal tubing lines 93 (a-d), and 99.
`
`The advantage of the invention is defined in claim 9 is significant. See for
`
`example the discussion at specification page 3, and page 4. Basically, since the "pod"
`
`is not " ... connected to the pressure port on the face of a dialysis machine, but is spaced
`
`therefrom ... " (page 3, third complete paragraph) the "pods" may be placed at the most
`
`desirable locations on the blood flow set in which they are carried, while at the same
`
`time inexpensive air pressure monitoring tubing may be used to connect the pod or
`
`pods to the machine, to permit the blood flow set to have a minimum length of blood
`
`flow tubing. No extra blood tubing is needed to route part of set to the pressure monitor
`
`machine 60 as in Soussan et al. Instead, the relatively expensive blood tubing may be
`shortened to just that whibh is absolutely needed for processing of the blood flow in the
`set and the like. Inexpensive, small bore air pressure monitoring tubing may be used to
`transfer air pressure from the respective pods in the set to the connectors of pressure
`measuring equipment, such as equipment 60 as illustrated in Soussan et al.
`
`1Z981879v.1
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`While the savings i;nay only be a few cents by the·shortening of blood tubing and
`
`;
`
`the use of less expensive ~ir pressure tubing, it is well known that in the field of
`
`medicine and, particutar1y dialysis, reimbursement is sufficiently low that these savings
`
`can be quite significant. particularly since there are thousands of patients who undergo
`
`dialysis three times weekly.
`
`Turning to claim 11, note an added advantage of the flexible pressure tubing
`
`. which is attached to the pressure sensing pod in that it permits sequential connection
`
`with the pressure sensing device, and also to a device, such as a syringe, to apply
`
`positive pressure through1the outlet port in the chamber to drive the chamber to the
`second position, to help remove all blood at the process's end. Nothing of this is taught
`
`in Soussan et al.
`
`Similarly, in dependent claim 12, the pressure tubing, non-existent in Soussan,
`
`carries a flow clamp to re,ain the positive pressure at the diaphragm, to keep the
`
`diaphragm in the desired second position.
`
`It .also should be noted as to claim 48 that the diaphragm in Soussan is simply a
`
`straight barrier. As specificatly disci.osed herein, the diaphragm of claim 48 is dome
`
`shaped and very soft. Thus, the diaphragm can flip back and forth at very low pressure .
`
`' changes. Wrth Soussan, the only way the diaphragm can change position is by
`
`stretching, which is a process that absorbs energy, and thus tends to require higher
`
`pressures.
`
`Accordingly, it is urged that claim 9, and its dependent claims, are patentably
`
`distinct over Soussan et al:·
`
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`T.he examiner has also rejected claims 33-41 as unpatentable over Soussan et
`
`al. U.S. Patent 6,526,357, in view of Brugger et al. U.S. Patent 5,693,008. Claim 33
`.
`j
`calls for a pressure transmitting pod which has " ... a connection port for connection with
`
`. a length of pressure tubing at end thereof, which tubing is for sealed connection at its
`
`other end to a remote pressure connector of a pressure sensing machine ... "
`
`Here also, claim 33, like claim 9, is requiring that, in use, th.e air flow path of the
`
`pressure transmitting pod separates the pod from the pressure sensing machine by a
`
`length of pressure tubing. As taught in the specification, this pressure tubing can be
`
`permanently connected to the pod, or it can be a reusable length of pressure tubing that
`
`extends out from the pressure sensing machine, which is an opportunity for further cost
`'
`savings. This is to be compared with the disclosure of Soussan et al., and the general
`
`prior art, in which pods are directly connected to the pressure sensing machine.
`
`As previously stated, the use of lengths of pressure tubing which separate the
`
`pod and the pressure sensing machine create the significant opportunity for cost
`
`!
`
`savings, in that this permits shortening of the blood tubing of the set being used for
`
`conveying and processing blood,· by the use of air pressure tubing, which does not
`
`contact blood, and can be inexpensive and with reduced diameter because it is
`
`transmitting only air, and made of inexpensive material.
`!
`Furthermore, claim 33 calls for the diaphragm to have a dome shape, being
`
`sufficiently flexible to easier distort in the manner reflective of pressure changes and to
`
`vary the volumes of said one and other compartments. The dome shape is particularly
`
`advantageous, and clearly more advantageous than a flat, etastomeric barrier as shown
`
`in Fig. 5 of Soussan et al., because such a dome of flexible material can flip back and
`
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`forth at relatively low pressure variations, to provide significant changes in the volumes
`
`of the compartments on either side of the diaphragm of dome shape, at a very low
`
`pressure variation. See claim 34 as an illustration of this. Soussan et at. has a flat
`
`diaphragm that can only stretch, not flip, under pressure, thus requiring higher
`
`pressures.
`
`In dependent claim 35, the pressure tubing is stated to be "permanently
`
`connected" to the connection port of the pod, and the pressure has at its other end a
`
`remote tubing connector for connection to the machine remote pressure port during
`
`medical treatments. It is clear that there is no teaching of such a structure in Soussan
`
`et al., nor is there any reason that one might choose to so modify Soussan et al.
`
`Turning to Brugge~ et al., the branching connectors 64 and 90 extending from the
`
`respective pods are for administering saline and/or medication to the blood line. They
`
`are not connected to the air side of the diaphragm.
`
`Also, the examiner notes that the diaphragm 156 of Brugger et al. has a dome-
`
`like shape. However, it is not free to flip back and forth to widely vary the size of its
`
`I
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`respective chambers that it defines. It can be seen that the dome 26 of Fig. 4 of this
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`application can flip back and forth to bow outwardly in one direction or the opposite
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`direction between positions 26 and 26a .. That is not possible in Brugger et al. See
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`claims 46-54. Thus Brugger fails to exhibit the advantages of this invention.
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`12981879".1
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`12-20-10 14:01
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`Pg: 14~14
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`In view of the above, allowance of the claims is respectfully requested.
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`RECEIVED
`CENTRAL FAX CENTE
`DEC 20 2010
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`·
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`Respectfully submitted,
`
`Seyfarth Shaw LLP
`131 South Dearborn Street
`Suite 2400
`Chicago, Illinois 60603
`312-460-5000
`
`~·~·
`BY~~~~~~~~~-
`Garrettson Ellis
`Reg. No. 22, 792
`Attorney for Applicants
`
`SEYFARTH SHAW LLP
`131 So. Dearborn Street, Suite 2400
`Chicago, Illinois 60603
`(312) 460-5518
`
`. Certificate of Facsimile
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`I hereby certify that this correspondence is being sent Via Facsimile to the U.S. Patent
`o,ee Z,,...t?
`, 2010.
`and Trademark Office-(Fax No. 571-273-8300) on
`~~·
`Registered Attorney for Applicant
`t2M 2-I>,
`, 2010
`Date:
`I
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`1298187911.1
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