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 .
Response to Amendment
The Amendment filed February 25, 2026 has been entered. Examiner acknowledges the cancellation of claims 27 and 31. Claims 1-3, 6, 8-10, 12-21, 23-26, 28-30 and 32 remain pending in the application. Applicant’s amendments to the Claims have overcome the objections and 112(b) rejections previously set forth in the previous Office Action mailed November 28, 2025. Therefore, the objections and 112(b) rejections have been withdrawn.
Response to Arguments
Applicant's arguments filed February 25, 2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that the cited art fails to teach “a slot extending inwardly from a periphery” and aligned with the connector and that Susienka (WO-2020036869-A1) connects filtration packets by tie rods or clips. This argument is not persuasive. Claim 1 does not require the slot to be U-shaped, open-sided from a face view, configured to receive tubing, configured to receive a hose barb, or limited to the specific slot geometry shown in Applicant’s drawings. Under the broadest reasonable interpretation, the recited slot encompasses an opening, recess, passage, throughway, or receiving region extending inwardly from a peripheral boundary of the insert plate structure and aligned with the connector. Susienka’s spacer/endcap connection structure, including the annular/tubular receiving structure associated with the co-radial annular seals, protruding member, and gasket aligned with the fluid ports, satisfies the claimed slot/connector relationship. Applicant’s reliance on tie rods or clips does not overcome the rejection because the claimed connector is not limited to the structure that mechanically connects the filtration packets together.
Regarding claims 14-19, Applicant argues that Susienka’s removable film merely covers fluid ports and does not seal a plurality of pods between hard bases. This argument is not commensurate with the scope of the claims. Claim 14 does not require the plastic film to wrap the entire plurality of pods, form a complete outer package, or correspond to the particular figures relied upon by Applicant. In the rejection, Sartorius (DE -102018004909-A1) teaches the hard-base/pod-stack arrangement, and Susienka teaches a removable film covering fluid ports and associated seals to maintain sterility. When applied to the Sartorius assembly, the film seals the fluid-port region of the plurality of pods located between the hard bases, as broadly claimed. Claims 17-19 remain unpatentable because Sayer and Almasian teach the additional dependent limitations and are relied upon for those additional features.
Regarding claims 20 and 21, Applicant’s arguments against anticipation are moot in view of the present obviousness rejection. Sartorius teaches the filtration module, insert plate/end face, recess, connecting component, and fluid port arrangement, and Pall teaches filter capsule assemblies supplied to bags or protective wrapping before use. It would have obvious to enclose the Sartorius filtration module in a sterile barrier to maintain cleanliness or sterility during shipping, storage, and pre-use handling.
Regarding claims 24 and 25, Applicant argues that Sayer’s raised end portion is not an applicator and that Bodnar’s potting boat would not have been combined with Sayer. This argument is not persuasive. Sayer is relied upon for the fluid treatment assembly, fluid openings, through holes, linings, raise sealing portions, and curable liquid sealant around fluid openings. Bodnar is relied upon for the known technique of introducing curable liquid sealant into a filtration device through apertures using a hollow elongated applicator/potting boat. It would have been obvious to apply Bodnar’s applicator based sealant introduction technique to Sayer’s inlet and outlet/opening regions to provide controlled placement of sealing material.
Applicant has argued that various dependent claims are allowable by virtue of their dependency upon allowable claims. This argument is not persuasive because these claims remain rejected. Accordingly, Applicant’s remarks do not overcome the rejections, and the claims remain rejected for the reasons set forth above and in the claim rejections below.
Claim Objections
Claims 16, 18 and 19 are objected to because of the following informalities: grammatical inconsistency and/or typographical errors. Appropriate correction is required.
Regarding claim 16, the claim recites “two plastic films”, but then recites “wherein the plastic film overhangs the perimeter of the hard bases”. The claim should be amended for grammatical consistency.
Regarding claims 18 and 19, each claim recites “The apparatus of claims 14”. This should be corrected to “The apparatus of claim 14”.
Claim Interpretation
For purposes of examination under the broadest reasonable interpretation, the term “pod” is interpreted as encompassing the previously recited filtration devices/modules disclosed in the prior art, including modular filter units, filter cassettes, filtration packets, or process-scale filtration devices, because the claim does not recite structural features that distinguish “pods” from such filtration devices.
Regarding claim 1, the limitations “a slot extending inwardly from a periphery thereof, the slot configured and positioned to align with the connector” is interpreted broadly. The claim does not require the slot to be U-shaped, open-sided in a face view, configured to receive tubing, configured to receive a hose barb, or visible only from a planar face of the insert plate. The claim also does not limit “periphery” to only the two-dimensional outer perimeter of the plate face. Under the broadest reasonable interpretation, the periphery may include an outer boundary or peripheral region of the insert plate structure, including in cross-section, and the claimed slot may encompass an opening, recess, channel, passage, throughway, or receiving region extending inwardly from such peripheral boundary and aligned with a connector.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is 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.
Regarding claim 18, recitation of “wherein each end plate has at least one groove for holding a strapping band.” However, claim 18 depends from claim 14, and claim 14 recites “two hard bases” but does not recite an “end plate”. Therefore, it is unclear whether the recited “end plate” refers to the “hard bases” of claim 14, to end plates of the plurality of pods, to end plates of holder hardware, or to another structure.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 8-10, 12 and 14-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Susienka et al. (WO-2020036869-A1) .
Regarding claim 1, Susienka discloses an apparatus for treating a biological fluid (Susienka title p. 3 last par. “bioprocessing”), comprising: a plurality of pods (Susienka p. 12 par. 1 “filter module 100”); each of the plurality of pods comprising filtration media (Susienka p. 4 par. 1), at least one inlet connectable to a feed stream containing biological fluid (Susienka title and background “bioprocessing” includes filtration of biological fluids which requires an inlet and Susienka p. 12 par. 2 describes that one of the fluid ports may be an inlet) at least one outlet (Susienka p. 5 par. 3) and at least one vent port (Susienka p. 12 par. 2 describes that one or more outlet ports may be a vent port); and a first insert plate and a second insert plate opposite the first insert plate (Susienka p. 12 par. 1 “opposite rigid endcaps” 10’), wherein the plurality of pods is disposed therebetween; wherein in a pod adjacent to the first and/or second insert plate, at least one of the at least one inlet and the at least one outlet comprises a connector, wherein the connector is configured to be in fluid communication with another connector or manifold, and the first and/or the second insert plate comprises a slot extending
inwardly from a periphery thereof, the slot configured and positioned to align with the connector (Susienka p. 21-22 discloses co-radial annular seal/protruding member/gasket structure is configured and positioned to align with respective fluid ports of the endcaps). Under BRI, Susienka’s annular/tubular throughway, recess or receiving structure associated with the co-radial annular seal (360) satisfies the claimed “slot extending inwardly from a periphery thereof” illustrated in Fig. 11A/11B which confirms the connection geometry.
Regarding claim 2, Susienka discloses the apparatus of claim 1, wherein the at least one vent port (Susienka p. 12 par. 2) optionally terminates at a vent filter (Susienka p. 26 par. 2 “Aervent®-50 filter”).
Regarding claim 3, Susienka discloses the apparatus of claim 1, wherein the at least one inlet further comprises a sterile-to-sterile connector and/or the at least one outlet further comprises a sterile-to-sterile connector (Susienka p. 18 par. 1).
Regarding claim 6, Susienka discloses the apparatus of claim 1, wherein the at least one inlet from each of the plurality of pods is connected to be in fluid communication via a manifold (Susienka p. 4 par. 1 “manifold endcaps”), and/or the at least one outlet from each of the plurality of pods is connected to be in fluid communication via a manifold.
Regarding claim 8, Susienka discloses the apparatus of claim 1, wherein the at least one vent port (Susienka p. 12 par. 2) from each of the plurality of pods is connected to be in fluid communication via a manifold (Susienka p. 4 par. 1 “manifold endcaps”).
Regarding claim 9, Susienka discloses the apparatus of claim 6, wherein the manifold comprises a sterile-to-sterile connector (Susienka p. 18 par. 1 discloses any of the ports may be a sterile-to-sterile connector).
Regarding claim 10, Susienka discloses the apparatus of claim 1, wherein the filtration media comprises media effective for virus filtration, depth filtration (Susienka p. 13 par. 1) or adsorptive filtration and optionally the filtration media comprises a chromatography membrane.
Regarding claim 12, Susienka discloses the apparatus of claim 1, wherein the plurality of pods is combined and loaded onto a cart having holder hardware (Susienka p. 16 “holder” 200) comprising a side A and a side B (Susienka Fig. 3 shows holder 200 possesses two sides).
Regarding claim 14, Susienka discloses an apparatus for sealing a sterilized filtration device, comprising: a container comprising two hard bases (Susienka p. 16 “individual
modules 100, 100A, 100B, etc. may be assembled and interconnected along with a manifold endcap 150 at each end to create a continuous, sealed fluid flow path”) and a plastic film (Susienka abstract “removable film may cover one or more fluid ports”), having a plurality of pods disposed therebetween (Susienka p. 12 par. 1 “packets” 10), wherein one of the hard bases has a protruded hose barb fitting connected to tubing and a sterile-to-sterile connector (Susienka p. 17 hard base “manifold endcap…may terminate in hose barb fittings 70 as shown” and Susienka p. 26 par. 2 describes “one skilled in the art would recognize that tubing 95 with suitable sterile-to-sterile connectors 96 (as in Fig. 13) could be attached to the hose barbs 70 or other suitable fittings”), the plastic film sealing the plurality of pods between the hard bases (Susienka p.18 last par. describes “film” 300 is used to protect one or more fluid ports and p. 19 “film 300 should be dimensioned to completely cover the fluid port 12 with which it is associated (in FIG. 8, the seals 20, 30 can be seen through the film 300; this is depicted this way for clarity to show the location of the seals 20 and 30, it should
be understood that the film 300 is intended to cover the fluid port 12 and the seals 20 and 30 (if present))” and as shown in Fig. 9 by example the film 300 is placed between each of the end caps which are interposed between each of the hard bases (150) as shown in Fig. 5).
Regarding claim 15, Susienka discloses the apparatus of claim 14, wherein the plastic film is thermally welded, bonded or otherwise joined (Susienka p. 18 last par. describes thermally bonded or affixed or sealed using an adhesive) to at least part of a perimeter of the hard bases (Susienka Fig. 8 illustrates the film 300 attaches to at least a part of a perimeter of the hard base).
Regarding claim 16, Susienka discloses the apparatus of claim 15, comprising two plastic films, wherein the plastic film overhangs the perimeter of the hard bases (Susienka Fig. 8 illustrates multiple films 300 which cover the fluid ports and overhang the perimeter of the hard bases “endcap” when fully assembled).
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Susienka et al. (WO-2020036869-A1) as applied to claim 12 above, and further in view of Sartorius "Pilot Filter Holder Operating Instructions" hereafter referred to as “Holder manual”.
Regarding claim 13, Susienka discloses the apparatus of claim 12, but does not expressly disclose that the holder hardware comprises a pressure gauge, a hydraulic pump, a clamp rod, a frame, and two platens.
Sartorius’s Holder manual discloses a movable cart-mounted filtration holder specifically configured to house multiple Sartoclear Depth Filter cassettes. The device comprises a frame on casters, holder hardware including a hydraulic pump, pressure gauge (Holder manual p. 10 § 3.1), release valve, and opposing pressure plate on one side (Side A) and clamping plates on the other (Side B) that compress the cassette stack between them (Holder manual p. 10. Illustrates the filter holder arrangement).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the holder hardware taught by the Holder manual of Sartorius with the plurality of filtration pods/modules of Susienka because both references are directed to modular filtration/cassette assemblies that require controlled compression, alignment, and support during operation.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Susienka et al. (WO-2020036869-A1) as applied to claim 14 above, and further in view of Sayer (US-20140042072-A1) and Almasian (US-7137974-B2).
Regarding claim 17, Susienka discloses the apparatus of claim 14.
Susienka does not disclose at least one alignment key in at least one hard base.
Sayer teaches fluid treatment assemblies including a stack of fluid treatment segments. Each fluid treatment segment has an array of fluid treatment units positioned between opposite end plates and a retainer that compresses the end plates and the array of fluid
treatment units against one another (Sayer abstract). Sayer further teaches these treatment segments having a keying mechanism on the end plates (Sayer claim 8) where fluid openings may be located (Sayer par. [0037]).
Almasian teaches a sterile to sterile connection device used in biopharmaceutical fluid systems comprising a connector and one of more coupling devices (Almasian abstract). To ensure proper orientation and secure fit, Almasian provides a key on one component engaging a keyway on the other (Almasian col. 6 and Fig. 6).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the keying mechanism on the end plate of Sayer using the key/keyway alignment mechanism of Almasian’s sterile connector into the hard-base interface of Susienka’s modular filtration system to ensure accurate registration of inlet/outlet channels and sterile connectors. Susienka already teaches multi-module sterile filtration, and demonstrates the same context of sterile hose-barb and sealed endcap connections. Further Almasian discloses sterile barrier plugs, hose-barb connectors, and a fully sterilized assembly, demonstrating compatibility with the Susienka-type modular sterile device. A skilled engineer would have recognized that misalignment between the two hard bases could compromise seal integrity or sterility, making the keying mechanism suggested by Sayer by incorporating Almasian’s keyed alignment an obvious, predictable enhancement.
Regarding claim 18, the combination of Susienka, Sayer and Almasian discloses the apparatus of claim 14, wherein each end plate has at least one groove for holding a strapping band.
Sayer’s end plates incorporate an aperture 60 which may incorporate a crook of the aperture defined by the handle. Sayer discloses “for some embodiments, the elongate structure may comprise one or more bands or straps that encircle and compress and/or seal the fluid treatment segment. The ends of each band may be connected, for example, via a buckle” in these embodiments a person or ordinary skill in the art would recognize the crook of the aperture provides at least one groove for holding a strapping band.
Regarding claim 19, the combination of Susienka, Sayer and Almasian discloses the apparatus of claim 14, further comprising at least one hose barb adapter or at least one blind end cap, and wherein each hose barb adapter or blind end cap adaptor further comprises a gasket and a snap fit connection. (Almasian col. 7 line 11 discloses seals may be in the form of O-rings or gaskets and further discloses that the connector “may be held together by a variety of devices any of which are suitable so long as they allow for the easy rotation of the two elements relative to each other” providing an example of a mating rim and in other embodiments describes “snap connections” [col. 5 line 46]).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sartorius (DE-102018004909-A1: An English machine translation is provided with this office action and is used for claim mapping in the prior art rejection below), and further in view of Pall "Pall Stax Capsule Filters".
Regarding claim 20, Sartorius discloses an assembly comprising a filtration module comprising filtration media (Sartorius “processing unit” par. [0005]) and one or more fluid ports (Sartorius “channels” 24 and 26); and an insert plate having a thickness and configured to attach to a face of said filtration module (Sartorius par. [0066, 0075-0077, 0107], “inlet plate” 230 and “outlet plate” 232), said insert plate having at least one recess configured and positioned to receive a connecting component (Sartorius par. [0077] “channel recess” 234 formed in the inlet/outlet plate connecting to channel region 220 of the adapter channel 214) that is fluidly connectable to one of said fluid ports such that said connecting component is contained within the thickness of said insert plate when said insert plate is attached to said face of said filtration module (Sartorius inlet plate and outlet plate collectively form the adapter plate which forms the fluid channels which assemble to fluidly connect the processing units by means of the adapter channel).
Sartorius does not expressly disclose the filtration module enclosed in a sterile barrier.
Pall discloses Stax capsule assemblies and manifolds used in filtration systems. Pall teaches single-use depth-filter capsules which are supplied in shipping bags to maintain sterility before installation (See section 4.2.1 step 2).
It would have been obvious to one of ordinary skill in the art prior to the effective
filing date of the claimed invention to enclose the Sartorius filtration module in a sterile barrier as taught or suggested by Pall because both references relate to modular filtration assemblies used in sterile or controlled filtration environments. A person of ordinary skill in the art would have been motivated to maintain the cleanliness/sterility of the filtration module during shipping, storage, and pre-use handling by enclosing the module in a sterile barrier, which represents the predictable use of known sterile packaging for filtration modules.
Regarding claim 21, Sartorius discloses an assembly comprising a filtration module comprising filtration media (Sartorius “processing unit” par. [0005]) and one or more fluid ports (Sartorius “channels” 24 and 26); said filtration module having an end face (Sartorius par. [0066, 0075-0077, 0107], “inlet plate” 230 and “outlet plate” 232), said end face having at least one recess configured and positioned to receive a connecting component (Sartorius par. [0077] “channel recess” 234 formed in the inlet/outlet plate connecting to channel region 220 of the adapter channel 214) that is fluidly connectable to one of said fluid ports such that said connecting component is contained within the recess (Sartorius inlet plate and outlet plate collectively form the adapter plate which forms the fluid channels which assemble to fluidly connect the processing units by means of the adapter channel), said filtration module being enclosed in a sterile barrier (Pall section 4.2.1 step 2).
Claims 23 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Sartorius (DE-102018004909-A1: An English machine translation is provided with this office action and is used for claim mapping in the prior art rejection below) in view of Pall "Pall Stax Capsule Filters" as applied to claim 20 and 21 above, and further in view of Gaskleen "Gaskleen Sealed-In-Line Filter Assembly".
Regarding claim 23, Sartorius in view of Pall discloses the assembly of claim 21.
Neither Sartorius nor Pall disclose wherein said sterile barrier comprises a poly bag.
Gaskleen is a Sealed-In-Line Filter Assembly a part of the Pall family of products. Gaskleen discloses that this assembly is cleanroom manufactured and packaged and further specified that it is double-bagged, with an outer bag of aluminized mylar and an inner bag consisting of polyethylene. Both of these bags are manufactured from synthetic polymer material.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to apply the poly bag conventionally used by Gaskleen Filter Assembly as the sterile barrier for the assembly of Sartorius in view of Pall. Substituting the bag or autoclave wrapping of Pall with the poly bag barrier of Gaskleen represents a predictable application of an industry-standard packaging material to maintain asepsis of the modular assembly. A person of ordinary skill in the art would have been motivated to do so to preserve sterility of a pre-assembled filter train prior to use and would naturally apply to Sartorius in view of Pall’s filtration assembly.
Regarding claim 32, Sartorius in view of Pall and further in view of Gaskleen discloses the assembly of claim 20, wherein said sterile barrier comprises a poly bag (Gaskleen p. 1 “inner bag: polyethylene”).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Sayer (US-20140042072-A1) in view of Bodnar (US4227295).
Regarding claim 24, Sayer discloses a method of deploying a seal into a filtration device (Sayer abstract “fluid treatment assembly”) comprising filtration media (Sayer par. [0020] “permeable media”), an inlet (Sayer par. [0032] “feed opening”) and an outlet (Sayer par. [0032] “ permeate opening” and “retentate opening”), the method comprising inserting an applicator (Sayer par. [0032] “raised end portion”) into each of said inlet and outlet, and introducing a sealing material (Sayer par. [0032] “lining”) into said filtration device through each said applicator. Sayer further teaches that in some embodiments a curable liquid sealant may be applied around the fluid openings suggesting further use of an applicator through which a seal is applied.
Sayer does not expressly disclose inserting an applicator into each inlet and outlet and introducing sealing material through each applicator.
Bodnar teaches introducing a curable liquid sealant into a filtration device/casing through apertures (Bodnar abstract) using a hollow elongated potting boat applicator, with the liquid sealant migrating into the casing to form a seal. The sealant is applied by means of a hollow, elongated applicator known as a potting boat which is placed through the side apertures where the sealant is applied (Bodnar col. 2 par 2-3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the teaching of Bodnar to introduce curable sealing material into the inlet and outlet/opening regions of Sayer’s filtration device. Sayer already proposes curable sealing linings formed in place at the inlet/outlet openings. Bodnar provides the conventional way to introduce such curable sealant through an inserted applicator into the module openings to obtain uniform seals. This is a predictable, routine implementation of in-situ formation of seals at the exact interface Sayer targets. A person of ordinary skill in the art would have reasonably applied Bodnar’s applicator-based injection to Sayer’s port regions to deploy the curable sealing material into each opening prior to compression, improving process control and seal integrity.
Regarding claim 25, Sayer in view of Bodnar discloses the method of claim 24, wherein said sealing material comprises a material selected from the group consisting of cotton, rayon, foam, polyurethane (Bodnar col. 8 line 47), polyether, polyester and cellulose.
Claims 26 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Susienka et al. (WO-2020036869-A1) as applied to claim 1 above, in view of Matkovich (US5622626).
Regarding claim 26, Susienka discloses an apparatus for treating a biological fluid of claim 1.
Susienka does not disclose wherein inlets of two of the plurality of filtration devices are fluidly connected by a first Y-connector, and optionally wherein outlets of two of the plurality of filtration devices are fluidly connected by a second Y-connector.
Matkovich discloses a fluid-treatment system for treating a biological fluid in which two inlet lines are joined using a Y-connector (Matkovich col. 7 lines 24-29).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to connect the inlets and/or outlets of two of Susienka’s plurality of filtration pods using a Y-connector as taught by Matkovich in order to split, combine, or route biological/parenteral fluid streams between multiple filtration paths. Both Susienka and Matkovich concern fluid treatment of biological/parenteral fluids, and Matkovich provides a known, predictable fluid junction arrangement for connecting multiple fluid paths.
Regarding claim 28, Susienka in view of Matkovich discloses the apparatus of claim 26, wherein each of the plurality of filtration devices further comprises a vent (Susienka p. 12 par. 2 describes that one or more outlet ports may be a vent port).
Regarding claim 29, Susienka in view of Matkovich discloses the apparatus of claim 28, wherein vents of two of the plurality of filtration devices are fluidly connected by a third Y-connector (Matkovich col. 7 lines 24-29 expressly teaches using Y-connectors to join two fluid pathways which would be understood by a person of ordinary skill in the art to also apply to other inlets/feeds or outlets shared by the plurality of processing units that include a vent).
Regarding claim 30, Susienka in view of Matkovich discloses the apparatus of claim 26, wherein the first Y-connector is fluidly connectable to a manifold (Susienka Figs 2 and 4 and p. 16 teaches embodiments which incorporate manifold endcaps and fluid communication between multiple filtration devices via manifolds, and Matkovich teaches Y-connector fluid junctions).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM ADDISON GEISBERT whose telephone number is (703)756-5497. The examiner can normally be reached Mon-Fri 7:30-5:00 EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby RAMDHANIE can be reached at (571)270-3240. The fax phone 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 Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/W.A.G./Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779
Prosecution Insights