DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/26/2025 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Tremolada (EP3106512B1).
Regarding Claim 1, Tremolada teaches the following:
A method for preparing tissue using a device that includes a washing and separating container (para 52, lines 15-17) (a cell separation chamber) and the cell components designed to be used for later transplantation will float, separated from the liquid component (para 52) (configured for separating at least one cell system from a culture medium and for recovering the at least one cell system). Further, the cell separation chamber being configured for separating at least one cell system from a culture medium and for recovering the at least one cell system is an intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2111.02). The separation chamber would be capable of separating and recovering the at least one cell system and therefore meets the claim.
The container has an inlet (first fluid inlet-outlet) and an outlet (second fluid inlet-outlet) (para 52, lines 19-20). The inlet and outlet being used as both an inlet and outlet and configured to allow a liquid medium to enter or leave the cell separation chamber is an intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2111.02). The inlet and outlet of Tremolada would be capable of being used as both inlets and outlets and allowing a liquid medium to enter or leave the chamber.
A filter 4 may be provided proximate to the outlet (arranged in the second fluid inlet-outlet) which allows passage of the fluid and/or solid component and retains the stirring elements (plurality of particles)(para 134).
The filter can also be replaced by a fine mesh cutting net (also considered a filter) that provides means for reducing the size of the solid component (para 139) and the size reducing means (filter) may be provided at the opposite end (the first fluid inlet-outlet) (para 140).
The size reducing means (first filter) is a net (having a plurality of pores) and is provided to reduce the size of the solid component and therefore has a pore size smaller than the size of each component of the cell system.
The filter (second filter) allows the passage of the solid component (a pore size lager than the size of each component of the cell system) and retains the stirring elements in the washing chamber (pore size smaller than the size of the microparticles)(para 134).
The stirring elements (microparticles) are of relatively small size so they can move freely in the chamber (free-flowing) (para 119). The microparticles configured to reversibly self-assemble to form a three-dimensional network under fluid flow conditions is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2111.02). The stirring elements would be capable of self-assembling into a three-dimensional network under fluid flow conditions and therefore meet the claim.
The container communicates with connection terminals and/or closing valves (para 129) and the kit may comprise one or more devices which can be connected together by sterile tubes, multi-way valves, and connectors (duct network) (para 234) (in fluid communication with a duct network of a cell separation and recovery system)
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The stirring means 104 forms a three-dimensional network with a plurality of interstices as the liquid passes from the chamber through the first filter (Fig. 9, below)
The three-dimensional network defining a plurality of interstices where components of the cell system are selectively retained by size exclusion is an intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2111.02). The three-dimensional network would be capable of selectively retaining the cell system by size exclusion and therefore meets the claim.
The cell separation chamber being configured so when a recovery medium is driven in a second flow direction inside the cell separation chamber towards the second inlet-outlet, the network of microparticles is broken up and the cell system is entrained to the second inlet-outlet for their recovery is in intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2111.02). Given the pore sizes of the filters as stated above, if a recovery medium were driven inside the cell separation chamber towards the second inlet-outlet, the network would be broken up and the cell system would be entrained to the second inlet-outlet.
Tremolada further teaches the stirring elements such as balls or the like may be of relatively small size when compared to the washing chamber (para 119, lines 1-2). Tremolada does not specifically teach the stirring members to have a specific size and therefore there are no teachings that they are specifically microparticles.
However, it would have been obvious to one of ordinary skill in the art to select a size of stirring element of a microparticle size. One would have been motivated to do this as if they were too large, they could not move freely in the chamber and they should be sufficient enough to form an emulsion of liquids without causing cell wall breaking (para 119, lines 3-7). Choosing stirring particle size would be a matter of routine experimentation to meet these uses.
Regarding Claim 2, Tremolada teaches all of the limitations of Claim 1 (see above). Tremolada does not explicitly teach the stirring members (microparticles) to occupy a volume between 10% and 50% of the chamber. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the volume of the particles and arrive at volume between 10% and 50%. One would have been motivated to do this as they need to move freely within the chamber and they should be sufficient enough to form an emulsion of liquids without causing cell wall breaking (para 119, lines 3-7).
Regarding Claim 4, Tremolada teaches all of the limitations of Claim 1 (see above). Tremolada also teaches the meshes of the net (pore size of the second filter) may have a size ranging from 1000 to 50 µm (para 137).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the pore size between 50 and 200 µm as it is within the range as taught by Tremolada. One could have selected this size with a reasonable expectation of success and it would have resulted in an effective filter for the separation chamber. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 3, 5, 6, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tremolada (EP3106512) in view of Terajima et al. (JPH1156338).
Regarding Claims 3 and 16, Tremolada teaches all of the limitations of Claim 1 (see above). Tremolada further teaches the stirring members (microparticles) to be made of a sterile material that does not interact with the biological material contained in the chamber (para 121, lines 1-4).
Tremolada does not specifically teach the stirring members to be formed by a polymeric material from the group consisting of polystyrene, polypropylene, polylactic acid, collagen, cellulose, and chitosan.
Terajima teaches materials that are preferred in terms of moldability, sterilizability, and low cytotoxicity such as synthetic polymers polyethylene, polypropylene, polystyrene, etc. that can be in granular form (lines 96-101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a polymeric material of polystyrene or polypropylene for the formation of the stirring elements as they are preferred in terms of moldability, sterilizability, and low cytotoxicity (lines 94-95).
Regarding Claims 5 and 17, Tremolada teaches all of the limitations of Claim 1 (see above).
Tremolada does not specifically teach the filter to be formed by a polymeric material from the group consisting of polystyrene, polypropylene, polylactic acid, collagen, cellulose, and chitosan.
Terajima teaches a cell separation device (lines 78-79) and a filter within the container that is made of synthetic polymers such as polyethylene, polypropylene, polystyrene, etc. (lines 93-98).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a polymeric material of polystyrene or polypropylene for the formation of the filter as they are preferred in terms of moldability, sterilizability, and low cytotoxicity (lines 94-95).
Regarding Claims 6 and 18, Tremolada teaches all the limitations of Claim 1 (see above). Tremolada does not teach the separation chamber to have a third inlet-outlet configured so the fluid is air.
Terajima teaches the device to be equipped with an air circulation adapter, which is a short tube with a clamp attached to the tip, whereby opening the clamp air can be discharged from within the device or air can be introduced into the device (lines 196-204).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the separation chamber of Tremolada with the air circulation adapter as taught by Terajima. One would have been motivated to make this modification as it allows for easy operation of storing and discharging liquid (lines 197-198).
Response to Arguments
Applicant's arguments filed 08/26/2025 have been fully considered but they are not persuasive.
Regarding applicant’s arguments on page 9 that Tremolada does not teach the dual filter configuration, Tremolada teaches a size reducing means (net) and a filter, both of which are considered types of filters.
Regarding applicant’s arguments on page 11 that Tremolada does not teach the stirring elements to be microparticles, it would have been obvious to one of ordinary skill in the art to select a size of stirring element of a microparticle size as if they were too large, they could not move freely in the chamber and they should be sufficient enough to form an emulsion of liquids without causing cell wall breaking (para 119, lines 3-7) and choosing stirring particle size would be a matter of routine experimentation to meet these uses.
Regarding applicant’s arguments on page 12 that Tremolada has a different purpose than the present invention, an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2111.02). Since the device of Tremolada would be capable of being used as the cell separation device as claimed, it meets the claim.
The remainder of Applicant’s arguments are toward the newly amended claims which have been addressed above.
Conclusion
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796