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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/053,848
`
`11/09/2020
`
`Daniel Malek
`
`808 18US006
`
`7187
`
`Solventum Intellectual Properties Company
`2510 Conway Ave E
`3M Center, 275-6E-21
`St Paul, MN 5514
`
`KURTZ, BENJAMIN M
`
`1778
`
`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
`
`06/05/2024
`
`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):
`
`IPDocketing @ Solventum.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1,3-9 and 11-15 is/are pending in the application.
`)
`Claim(s)
`Sa) Of the above claim(s) 14-15 is/are withdrawn from consideration.
`[] Claim(s)__ is/are allowed.
`Claim(s) 1,3-9 and 11-13 is/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)M The drawing(s)filed on 11/9/20 is/are: a) accepted or b)C) 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)() None ofthe:
`b)( 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.
`3.1.) 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 20240531
`
`Application No.
`Applicant(s)
`171053,848
`Malek et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`BENJAMIN M KURTZ
`1778
`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
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`1) Responsive to communication(s) filed on 4/16/24.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
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`2a)() This action is FINAL. 2b)¥)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.
`
`

`

`Application/Control Number: 17/053,848
`Art Unit: 1778
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`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
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`The present application, filed on or after March 16, 2013,
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`is being examined
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`underthefirst inventor to file provisions of the AIA.
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`Election/Restrictions
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`Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR
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`1.142(b), as being drawn to anonelected invention, there being no allowable generic or
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`linking claim.
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`Claim Rejections - 35 USC § 102 and 103
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`In the event the determination of the status of the application as subject to AIA 35
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`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 (i.e., changing from AIA to pre-AlA) for the rejection will
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`not be considered a new groundofrejection if the prior art relied upon, and the rationale
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`supporting the rejection, would be the same undereither status.
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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 madein this Office action:
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`A person shall be entitled to a patent unless —
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`(a)(1) the claimed invention waspatented, described in a printed publication, orin public use,
`on sale, or otherwise available to the public beforethe effectivefiling date of the claimed
`invention.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis forall
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`obviousness rejections set forth in this Office action:
`
`Apatent fora claimed invention may notbe obtained, notwithstanding thatthe claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention and the prior artare suchthat the claimed invention as a whole would have
`been obvious beforethe effective filing date of the claimed inventionto a person having
`
`

`

`Application/Control Number: 17/053,848
`Art Unit: 1778
`
`Page 3
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`ordinary skillin the art to which the claimed invention pertains. Patentability shall notbe
`negated by the manner in whichthe invention was made.
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`Claim(s) 1, 3-9 and 11-13 is/are rejected under 35 U.S.C. 103 as obvious
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`over Rottger et al. US 5.919.370 in view of Schneider et al. US 2014/0039415.
`
`Claim 1, Rottger teaches a hydrophilic, integrally asymmetric, semi-permeable
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`hollower fiber membrane made from a hydrophobic aromatic sulfone polymer(polyether
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`sulfone, polysulfone), and at least one hydrophilic polymer(polyvinylpyrrolidone,
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`polyethylene glycol), the membrane comprising an inner surface facing towardsits
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`lumen, an outer surface facing outwards and an intermediate wall having a wall
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`thickness and comprising an open pore separating layer (A) and a supporting layer (B)
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`having an asymmetric, sponge like structure without finger pores, wherein adjoining to a
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`wall of the inner surface, the hollow fiber membrane comprises an essentially isotropic
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`zone, after which the pore size abruptly increases up to a maximum, after which the
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`pore size decreases, then adjoining an essentially isotropic supporting layer which then
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`is adjoined by the outer surface, wherein the separating layer has a cut off of greater
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`than 300,000 Da(fig. 3, abstract, col. 3, lines 15-60, col. 4, lines 55-65, col. 5, lines 29-
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`33). Rottger teaches the recited cut-off for the separating layer. One of ordinary skill
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`in
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`the art would readily recognize that one of the main factors affecting the cut-off is the
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`nominal pore size of the separating layer. Therefore, for the separating layer to have the
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`cut off as taught by Rottger the separating layer would likewise have the recited pores
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`sizes or at the very least such pore sizes would have been obvious to one of ordinary
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`skill in the art to achieve the desired cut off. Rottger specifically teaches that the pores
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`sizes of the separating layer (A) are smaller than the pores sizes of layer (C) (col. 3,
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`

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`Application/Control Number: 17/053,848
`Art Unit: 1778
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`Page 4
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`lines 20-40). Rottger also teaches the range of pores for layer (C) are between 50nm
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`and 2000nm (col. 3, lines 60-64). Therefore, providing the separating layer of Rottger
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`with a nominal pore size in the range of 45-150nm would have been an obvious range
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`given the rangeof pore sizes of layer (C) of Rottger and the relationship between the
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`pores sizes of layers (A) and (C). Rottger teaches the zone with maximum pore sizes
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`would be the supporting layer (B) but does not teach the recited range of pore sizes
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`within the zone.
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`Schneider teaches a hydrophilic, integrally asymmetric, semi-permeable hollow
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`fiber membrane made from a hydrophobic aromatic sulfone polymer and at least one
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`hydrophilic polymer, the membrane comprising an inner surface, and outer surface and
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`an intermediate wall having a wall thickness and comprising an open pore separating
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`layer and a supporting layer having an asymmetric, sponge like structure without finger
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`pores, wherein adjoining to a wall of the inner surface, the hollow fiber membrane
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`comprises an essentially isotropic zone, after which the pore size abruptly increases up
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`to amaximum, after which the pore size decreases, then adjoining an essentially
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`isotropic supporting layer which then is adjoined by the outer surface (paragraph 12, 23-
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`24). Rottger recognizes that the zone with maximum pore sizes has large pores such
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`that the hydraulic resistance is negligible in comparison to the two separating layers (A)
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`and (C) (col. 3, lines 20-40). Schneider also recognizes that the zone with the maximum
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`pore sizes has a low hydraulic resistance dueto the relatively large pores (paragraph
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`23). Schneider goes on to teach that the supporting layer, which would contain the zone
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`with the maximum pore sizes, should have pore diameters of at least 1/10 of the
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`membrane thickness and that having this relationship provides for the general through
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`

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`Application/Control Number: 17/053,848
`Art Unit: 1778
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`Page 5
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`flow resistance to be sufficiently low and at the same time the mechanical stability of the
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`membraneis sufficiently high (paragraph 24). Therefore, one of ordinary skill in the art
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`would readily recognize that the pore sizes of the support layer would need to be
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`balanced; smaller pore sizes provide more mechanical stability but higher hydraulic
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`resistance to flow and larger pore sizes provide lower hydraulic resistance to flow but
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`have lower mechanicalstability. Additionally, Schneider offers a teaching of a general
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`rule for the pores of the support layer to be at least 1/10 of the membrane thickness.
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`Rottger discloses the thickness of the membrane can vary from 10-1000 microns and
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`therefore the pores of the support layer should be at least 1-100 microns. The recited
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`range of 15-50 microns encompassesa little over a third of the range taught by Rottger
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`in view of Schneider and represents an optimization of the pore sizes to ensure
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`optimum flow resistance and mechanical stability as the prior art clearly recognizes the
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`pore sizes of the support layer as a result effective variable. [W]here the general
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`conditions of a claim are disclosed in the prior art, it is not inventive to discover the
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`optimum or workable ranges by routine experimentation,
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`In re Aller, 105 USPQ 233
`
`(1955).
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`Claims 3-7 and 9, Rottger further teaches the essentially isotropic zone adjoining
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`to the inner surface of the wall of the inner surface of hollow fiber membrane has a
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`proportion in the range of 1-5%of the total thickness of the membrane(col. 3, lines 50-
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`55); the essentially isotropic zone adjoining to the wall of the inner surface comprises
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`the open pore separating layer(fig. 3); the membrane having a thickness of up to 1000
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`micron (col. 12, lines 54-67); the inner diameter of the hollow fiber membraneis 200-
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`5000 micron (col. 12, lines 54-67); the pores of the outer surface exhibit a pore diameter
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`

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`Application/Control Number: 17/053,848
`Art Unit: 1778
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`Page 6
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`0.05-2 micron (col. 3, lines 60-65); and the zone with maximum poresize is located ata
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`distance from the inner surface in the range between 15-40%of the thickness of the
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`membrane(fig. 3).
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`Claim 8, Rottger does not teach the recited range of maximum poresizes (less
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`than 3 micron) for the inner surface. The separating layer defines the pores of the inner
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`surface and therefore, the diameters of the pores of the inner surface determine the cut
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`off of the overall membrane. Oneof ordinary skill
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`in the art would immediately recognize
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`that the pores of the inner surface are critical to the functioning of the membraneforits
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`intended use. One of ordinary skill would also immediately recognize that if the pores of
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`the inner surface are too large then the intended cutoff will not be attained. Therefore,it
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`would have been obviousto optimize the maximum diameters of the pores of the inner
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`surface to ensure the membraneis capable of meeting the desired cut off. [W]here the
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`general conditions of aclaim are disclosed in the prior art, it is not inventive to discover
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`the optimum or workable ranges by routine experimentation,
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`In re Aller, 105 USPQ 233
`
`(1955).
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`Claims 11-13 recite operating parameters of the membrane and certain
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`mechanical characteristics of the membrane. Rottger teaches all of the claimed
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`structural characteristics of the membrane of claim 1, namely, the same material having
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`the recited layers and cut off. Therefore, the operating parameters and mechanical
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`characteristics are considered inherent to a membrane meeting the structural
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`requirements of the membraneof claim 1. Schneider further teaches the recited tensile
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`strength (paragraph 28).
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`

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`Application/Control Number: 17/053,848
`Art Unit: 1778
`
`Page 7
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`Response to Arguments
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`Applicant’s arguments with respect to claim(s) 1 have been considered but are
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`moot because the new ground of rejection does not rely on any reference applied in the
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`prior rejection of record for any teaching or matter specifically challenged in the
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`argument.
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`Conclusion
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`Anyinquiry concerning this communication or earlier communications from the
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`examiner should be directed to BENJAMIN M KURTZ whosetelephone numberis
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`(571)272-8211. The examiner can normally be reached Monday-Friday 8:30-5.
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`Examinerinterviews are available via telephone,
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`in-person, and video
`
`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO AutomatedInterview Request
`
`(AIR) at http:/Awww.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Bobby Ramdhanie can be reached on 571-270-3240. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Centeris
`
`available to registered users. To file and manage patent submissions in Patent Center,
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`visit: httos://patentcenter.uspto.gov. Visit https:/Avww.uspto.gov/patents/apply/patent-
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`center for more information about Patent Center and
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`

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`Application/Control Number: 17/053,848
`Art Unit: 1778
`
`Page 8
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`https://www.uspto.gov/patents/docx for information about filing in DOCX format. For
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`additional questions, contact the Electronic Business Center (EBC) at 866-217-9197
`
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`
`If you would like assistance from a USPTO Customer Service
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`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/BENJAMIN M KURTZ/
`Primary Examiner, Art Unit 1778
`
`