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 .
Status of Claims
Claims 1-6 and 16-18 are objected to.
Claim 19 is rejected.
Claims 7-15 are withdrawn. Examiner recommends the cancellation of Claims 7-15 as rejoinder requires the withdrawn claims to be in condition for allowance (to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 112).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 6, states “a liquid medium”. This should read “the liquid medium” to correct antecedent basis.
Claim 1, line 6, states “a cell system”. This should read “the at least one cell system”.
Claim 1, line 7, states “the cell system”. This should read “the at least one cell system”.
Claim 1, line 15, states “the cell systems”. This should read “the at least one cell system”.
Claim 1, line 19, states “the cell systems”. This should read “the at least one cell system”.
Claim 1, line 24, states “a liquid medium”. This should read “the liquid medium” to correct antecedent basis.
Claim 1, line 27, states “the cell system”. This should read “the at least one cell system”.
Claim 1, line 31, states “the cell system”. This should read “the at least one cell system”.
Claim 1, lines 33-34, states “the cell system”. This should read “the at least one cell system”.
Claim 1, line 35, states “the cell system”. This should read “the at least one cell system”.
Appropriate correction is required.
Claims 2-6 and 16-18 are objected as they depend from Claim 1.
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 19 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.
Claim 19 recites the limitation "the at least one cell system" in line 2. There is insufficient antecedent basis for this limitation in the claim. Correction is required.
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tremolada (EP3106512B1).
Regarding Claim 19, 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.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter (assuming the above objections are corrected):
Regarding Claim 1, Tremolada (EP3106512B1) 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.
Tremolada also does not teach the microparticles to have a characteristic size comparable to a size of the cells of the cell system, being such that the interstices formed between adjacent microparticles are dimensioned to retain the cell of the cell system by cell exclusion. Rather, there is no teaching of the interstices formed between microparticles to be able to retain the cells of the cell system by exclusion in combination with the size of the microparticles being comparable to the size of the cells.
Further examiner found no other art that teaches or would have been obvious to combine to arrive at the claimed invention.
Claims 2-6 and 16-18 are further allowable for the same reasons above as they depend from Claim 1.
Response to Arguments
Applicant's arguments filed 04/15/2026 have been fully considered and the reasons for indicating allowable subject matter are stated above.
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.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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