Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I and Species B (Claims 1-7, and 9-13) in the reply filed on July 13, 2026, is acknowledged.
Claims 8 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 13, 2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority (EP21217113.6, filed on December 19, 2022) under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 3 objected to because of the following informalities:
The phrase “the sleeve not covering the first end and the second end of the bundle” should be corrected to read “the sleeve not covering the first end and the second end of the bundle.” to correct typographical errors.
Appropriate correction is required.
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 claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 12 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitations “the potted bundle” and “the solidified potting resin.” There is a lack of antecedent basis for these limitations in the claim. Claim 1 introduces a bundle of hollow fiber membranes but does not introduce the bundle as being potted or introduces a potting resin. Claim 13 depends on Claim 12 and is similarly rejected by virtue of dependency.
Claim Rejections - 35 USC § 103
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 correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over GRAF (DE19809501C1).
Regarding Claim 1, GRAF discloses a method for producing a hollow fiber bundle and a hollow fiber dialyzer/filter (¶[0001]). The method includes bundling hollow fibers together before cutting, including combining strands of hollow fibers exiting a spinning machine into a thicker hollow fiber bundle. The hollow fiber bundle is cut with a thermal cutting device while the open ends of the hollow fibers are simultaneously melted. The thermal cutting melts and seals the fiber ends. The hollow fiber bundle is subsequently inserted into a filter housing open at both ends, followed by sealing the two ends of the filter housing using potting molds, injecting potting compound to seal the two ends of the hollow fiber bundle, cutting the ends of the hollow fiber bundle in the area of the potting compound, and attaching filter housing caps (¶¶[0007]–[0010]).
In one embodiment, the thermal cutting device includes a laser beam cutting device that melts the fiber ends during cutting. The hollow fiber bundle is moved rotationally or translationally transversely to the fiber direction through the thermal cutting beam. The laser beam passes through the bundle to cut the fibers across the entire bundle cross-section, with the cutting plane positioned at the focal point of the laser beam. Alternatively, a heated mechanical knife or heated wire is used for cutting, with the fibers being sealed during the cutting process as the fibers melt (¶¶[0012]–[0014]). Based on the disclosure that the hollow fiber bundle is moved transversely to the fiber direction through the thermal cutting beam, the resulting cut end faces are perpendicular to the longitudinal axis of the bundle and parallel to each other.
Regarding the limitation “at least one slanting end face,” the recited slanting end face is considered an obvious matter of design choice. GRAF discloses gathering the hollow fiber bundles using a reel wheel or other bundling methods (¶[0016]). In view of the disclosed bundling process, the slanting end face is merely an incidental variation in the starting end-face configuration produced during bundling and cutting, rather than a configuration associated with a distinct function or result, and the claim does not recite any particular function or result attributable to the slanting configuration. Accordingly, the particular end-face configuration is an obvious matter of choice (In re Dailey, 357 F.2d 669, 672–73; 1966).
Regarding Claim 5, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 1. GRAF discloses thermally cutting the hollow fiber bundle while melting and sealing the fiber ends during the cutting process (¶¶[0012]–[0014]).
Regarding the limitation “wherein the first end and the second end of the bundle are melted simultaneously,” simultaneously melting the first end and the second end is considered an obvious matter of design choice. A person skilled in the art would perform the same melting operation at both ends simultaneously to reduce processing time while obtaining the same sealed fiber ends.
Regarding Claim 7, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 1. GRAF discloses inserting the hollow fiber bundle into a filter housing open at both ends, sealing the two ends of the filter housing using potting molds, and injecting potting compound to seal the two ends of the hollow fiber bundle (¶[0009]).
Regarding Claim 12, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 1. GRAF discloses sealing the ends of the hollow fiber bundle by injecting potting compound and subsequently cutting the ends of the hollow fiber bundle in the area of the potting compound (¶[0009]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over GRAF as applied to claim 1 above, and further in view of SANGER et al. (DE102010024976A1, hereinafter SANGER).
Regarding Claim 2, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 1. However, GRAF does not explicitly disclose that the first end and the second end of the bundle are constricted at positions near a first end and a second end of the shortest fibers within the bundle prior to melting the first end and the second end of the bundle.
SANGER discloses a method for manufacturing a separation apparatus (¶[0001]). For a separation apparatus having the hollow fiber bundle cast into the housing at both ends, a clamp is attached to both end faces of the housing, and the hollow fiber bundle is inserted into the housing with a length greater than the housing such that the bundle protrudes from both end faces into the areas of the clamps (¶[0006]). The protruding ends of the hollow fiber bundle are circumferentially enclosed by the ring-shaped clamps and thermally sealed by infrared heating (¶[0019]). Based on the disclosure, it is reasonable to interpret the annular clamps as constricting the first end and the second end of the hollow fiber bundle at positions near the ends of the shortest fibers, since the hollow fiber bundle protrudes into the areas of the clamps and all hollow fibers are circumferentially enclosed prior to thermal sealing.
The annular clamp arrangement disclosed by SANGER circumferentially encloses the protruding end of the hollow fiber bundle to ensure that all hollow fibers are securely captured during thermal sealing (¶¶[0005]–[0006]). In view of GRAF thermally cutting and melting the ends of the hollow fiber bundle, a person skilled in the art would incorporate the annular clamp arrangement into the thermal cutting process for circumferentially constricting the first and second ends of the hollow fiber bundle prior to thermal cutting to predictably ensure that all hollow fibers are securely captured during thermal sealing.
Therefore, it would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the annular clamp arrangement, as disclosed by SANGER, into the method for producing a hollow fiber bundle by GRAF.
Regarding Claim 3, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 1. However, GRAF does not explicitly disclose forming a sleeve around the bundle prior to melting the first end and the second end of the bundle, wherein the sleeve is shorter than the shortest fibers and does not cover the ends of the bundle.
SANGER discloses a method for manufacturing a separation apparatus (¶[0001]). The method includes inserting the fiber bundle with a foil covering into the housing. The foil wrapping is then grasped and pulled out through the clamp attached to the housing at one end face, wherein the foil wrapping facilitates handling of the fiber bundle during assembly (¶[0007]). The hollow fibers are longer than the housing and protrude from both end faces of the housing. After removal of the foil covering, the protruding fiber ends are thermally sealed by infrared heating (¶[0019]).
The foil covering disclosed by SANGER facilitates easier handling of the hollow fiber bundle during assembly (¶[0007]). In view of GRAF forming the hollow fiber bundle prior to thermal cutting and melting, a person skilled in the art would incorporate the foil covering around the hollow fiber bundle prior to melting to predictably facilitate easier handling of the bundle during assembly.
Regarding the limitation “wherein the sleeve is shorter than the shortest fibers and does not cover the ends of the bundle,” the particular length and placement of the sleeve is considered an obvious matter of design choice. SANGER discloses surrounding the hollow fiber bundle with a foil covering to facilitate handling during assembly, with the hollow fibers protruding from both ends of the housing (¶¶[0007], [0019]). Selecting the length and placement of the foil covering such that the fiber ends extend beyond the foil covering and remain uncovered would have been a routine design choice that maintains the handling function of the foil covering while leaving the fiber ends accessible (In re Dailey, 357 F.2d 669, 672–73; 1966).
Therefore, it would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the foil covering arrangement, as disclosed by SANGER, into the method for producing a hollow fiber bundle by GRAF.
Regarding Claim 4, modified GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 2. SANGER discloses a clamp comprising two clamping jaws connected by a spring-loaded clamping device. The clamping device includes two parallel bolts on which the clamping jaws are slidably guided, and the clamping jaws include arms having bores for receiving the bolts (¶¶[0010]–[0011]). Based on the disclosure, it is reasonable to interpret the clamping device as being mounted on a supporting platform that stabilizes the parallel bolts and clamping jaws during operation.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over GRAF as applied to claim 1 above, and further in view of JUNG et al. (US20120318461A1, hereinafter JUNG).
Regarding Claim 6, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 5. The hollow fiber bundle is guided rotationally or translationally transversely to the fiber direction through a thermal cutting beam, wherein the fiber ends are melted and sealed during the cutting process (¶¶[0012]–[0013]).
However, GRAF does not explicitly disclose the bundle reshaping device comprising two conveyor belts mounted on vertical drive rollers, wherein each conveyor belt forms a closed loop driven by a plurality of vertical drive rollers, the two conveyor belts are spaced apart from each other with facing surfaces and define a first section and a second section, and each conveyor belt comprises at least one heating unit within the first section and at least one cooling unit within the second section.
JUNG discloses a high frequency induction heating double steel belt press apparatus for manufacturing a thermoplastic/filament hybrid composite (¶[0001]). The apparatus supplies thermoplastic tapes to both sides of a widely dispersed bundle of glass fibers and transfers the glass fibers and thermoplastic tapes between a pair of oppositely rotating permeable steel belts while heating, compressing, and cooling the materials. The apparatus includes inlet and outlet sprockets for transferring the steel belts, an induction coil unit surrounding the steel belts, and a downstream cooling unit for cooling the thermoplastic/filament hybrid composite after hot melting and impregnation (¶[0010]).
FIG. 2 illustrates the double steel belt press apparatus 100 including a pair of permeable steel belts 110a, 110b rotated in opposite directions, inlet sprockets 112a, 112b and outlet sprockets 114a, 114b positioned at opposite sides of the steel belts, induction coil units 120a, 120b surrounding the overlapping portion of the steel belts, and cooling units 130a, 130b positioned downstream of the induction coil units. The cooling units cool and compress the material after heating by the induction coil units (¶[0027]). Each steel belt may be a caterpillar belt, and the glass fibers and thermoplastic tapes pass through a gap between the upper and lower steel belts while being heated, compressed, and cooled (¶¶[0031]–[0032]).
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FIG. 2 of JUNG
The outlet sprockets 114a, 114b are driving sprockets that pull the permeable steel belts 110a, 110b, while the inlet sprockets 112a, 112b are driven sprockets. The induction coil units 120a, 120b surround the steel belts and heat the belts by magnetic hysteresis as the belts are conveyed through the apparatus (¶¶[0038]–[0039]). The cooling units 130a, 130b are positioned downstream of the induction coil units 120a, 120b to cool and compress the glass fibers and thermoplastic tapes while hardening the material. The cooling units may be press rollers through which cooling water flows to cool the permeable steel belts while applying compressive force (¶¶[0046]–[0047]).
The high frequency induction heating arrangement disclosed by JUNG enables rapid heating through accurate and uniform temperature control while reducing power for heating the thermoplastic tapes and glass fibers to 10% of the state of the art (¶[0016]). In view of GRAF thermally processing a bundle of hollow fibers formed from material capable of being melted, a person skilled in the art would recognize that a double steel belt heating and cooling arrangement is likewise suitable for transporting and thermally processing the hollow fiber bundle, and it would have been obvious to incorporate the arrangement to transport the hollow fiber bundle through controlled heating and cooling to predictably provide rapid and uniform thermal processing (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417; 2007).
Regarding the limitation “vertical drive rollers,” the particular orientation of the drive rollers is considered an obvious matter of design choice. JUNG discloses the conveyor belts mounted on rollers, with the outlet sprockets operating as driving sprockets to pull the conveyor belts (¶¶[0034], [0038]). A person skilled in the art would select a vertical orientation of the drive rollers as a routine mechanical arrangement without changing the belt-driving function.
Therefore, it would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the double steel belt heating and cooling arrangement, as disclosed by JUNG, into the method for producing a hollow fiber bundle by GRAF.
Claims 9-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over GRAF as applied to claim 1 above, and further in view of BAUMEISTER et al. (EP3620228A1, hereinafter BAUMEISTER).
Regarding Claim 9, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 7. However, GRAF does not explicitly disclose closing the mouths of the tubular housing by sequentially dipping each end of the tubular housing into a melt of thermoplastic resin and allowing the melt to solidify.
BAUMEISTER discloses a process for producing a filtration and/or diffusion device, such as a capillary dialyzer or an ultrafilter (¶[0001]). The process includes a bundle of hollow fiber membranes disposed within a tubular housing, wherein a first end of the bundle and a corresponding first end of the tubular housing are dipped into a melt of thermoplastic resin and the melt is allowed to solidify. In a further embodiment, the second end of the bundle and the corresponding second end of the tubular housing are dipped into the melt of thermoplastic resin and the melt is allowed to solidify (¶¶[0010]–[0013]). Upon solidification, the thermoplastic resin forms continuous polymer blocks that seal the fiber ends and housing mouths to form potting caps that prevent leakage of potting resin during formation of the end walls (¶[0023]).
The thermoplastic resin sealing arrangement disclosed by BAUMEISTER closes the fiber ends and the mouths of the housing simultaneously in a single process step, providing a simpler and faster process (¶[0039]). In view of GRAF sealing the ends of the hollow fiber bundle and housing during manufacture, a person skilled in the art would incorporate the thermoplastic resin dipping arrangement to close the fiber ends and housing mouths simultaneously in a single process step, predictably simplifying and accelerating the sealing process.
Therefore, it would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the thermoplastic resin dipping arrangement, as disclosed by BAUMEISTER, into the method for producing a hollow fiber bundle by GRAF.
Regarding Claim 10, modified GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 9. BAUMEISTER discloses mounting a potting collar on each end of the tubular housing before dipping the ends of the housing into the melt of thermoplastic resin, wherein the potting collars enclose the ends of the hollow fiber bundle protruding from the housing (¶[0032]).
Regarding Claim 11, modified GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 9. BAUMEISTER discloses a support ring disposed within the tubular housing at each end of the housing (¶[0033]). The support ring is a separate annular component mounted on a ledge inside the tubular housing (Claim 6). The support ring comprises a tubular projection extending toward the end of the housing and protruding from the mouth of the housing by 0 to 5 mm (¶[0034]), which overlaps the claimed range “0 to 5 mm.”
Regarding Claim 13, GRAF makes obvious the process for producing a filtration and/or diffusion device of Claim 12. GRAF discloses attaching filter housing caps to the ends of the filter housing (¶[0009]). However, GRAF does not explicitly disclose that the filter housing is tubular or that the end caps feature a fluid port.
BAUMEISTER discloses a process for producing a filtration and/or diffusion device, such as a capillary dialyzer or an ultrafilter (¶[0001]). The process includes mounting an end cap featuring a fluid port on each end of the tubular housing (¶[0038]).
The end cap closes the end region of the tubular housing, while the fluid port provides an inlet or outlet communicating with the open lumens of the hollow fibers, representing a well-known design that provides controlled fluid access to the hollow fibers while maintaining a sealed housing and reducing leakage. In view of GRAF attaching filter housing caps after reopening the hollow fibers, a person skilled in the art would incorporate an end cap featuring a fluid port to provide controlled fluid access to the hollow fibers while maintaining the sealed housing.
Therefore, it would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the end cap featuring a fluid port, as disclosed by BAUMEISTER, into the filter housing of the method for producing a hollow fiber bundle by GRAF.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,161,974 (hereinafter ’974) in view of GRAF.
Regarding Claim 9, claim 1 of ’974 recites producing a filtration and/or diffusion device by sealing the ends of a hollow fiber bundle and corresponding ends of a tubular housing with a melt of thermoplastic resin, forming end walls by potting, and reopening the fibers by cutting the potted bundle. However, claim 1 of ’974 does not explicitly disclose melting the ends of the bundle before transferring the bundle into the tubular housing.
GRAF discloses thermally cutting a hollow fiber bundle while simultaneously melting and sealing the open fiber ends, followed by inserting the bundle into a filter housing (¶¶[0007]–[0010]). The bundle is moved transversely to the fiber direction through the thermal cutting beam, resulting in parallel end faces perpendicular to the longitudinal axis of the bundle (¶¶[0012]–[0014]).
Regarding the limitation “at least one slanting end face,” the particular end-face configuration is considered an obvious matter of design choice for the reasons previously discussed with respect to the rejection of Claim 1.
In view of claim 1 of ’974 sealing the ends of the hollow fiber bundle during manufacture, a person skilled in the art would incorporate the thermal cutting process disclosed by GRAF to melt and seal the fiber ends before insertion into the tubular housing for subsequent assembly and potting.
Regarding Claim 10, modified ’974 makes obvious the process of Claim 9. Claim 1 of ’974 recites a potting collar mounted on each end of the tubular housing, wherein the mouth of the potting collar is dipped into the melt of thermoplastic resin and sealed instead of the end of the tubular housing.
Regarding Claim 11, modified ’974 makes obvious the process of Claim 9. Claim 6 of ’974 recites a support ring disposed within the tubular housing at each end, wherein the support ring is a separate annular component mounted on a ledge and comprises a tubular projection protruding from the mouth of the tubular housing. Selecting the extent of protrusion of the tubular projection within the claimed range of 0 to 5 mm would have been an obvious matter of routine dimensional optimization.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAK L. CHIU whose telephone number is (703)756-1059. The examiner can normally be reached M-F: 9:00am - 6:00pm (CST).
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/TAK L. CHIU/Examiner, Art Unit 1771
/KRISHNAN S MENON/Primary Examiner, Art Unit 1771
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