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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-16, 18-21, and 23-33, in the reply filed on 8/19/2026 is acknowledged. The traversal is on the ground(s) that claim 34 incorporates all limitations of Claim 1. This is not found persuasive because the restriction was evaluated under Unity of Invention, and the lack of Unity of Invention was determined because the technical features of one or more incubators, one or more workstations, and a transfer device, is known in the art and the system of the instant application, which includes these technical features, does not make a contribution over the prior art. Furthermore, the Applicant did not specify how the prior art, Blanchard (US 2018/0320122 A1) (already of record), fails to teach the technical features recited in claim 1 to overcome the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 2/9/2024 and 10/9/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: i. It is also recommended that "one or more workstation" in line 6 read "one or more workstations". Appropriate correction is required.
Claim 5 is objected to because of the following informalities: it is believed that “wherein the volume of the pocket is arranged to maintain the cell culture is adjustable optionally” in lines 1-2 should read “wherein the volume of the pocket is arranged to maintain the cell culture is adjustable and optionally”. It is also recommended that “the clamp” in line 3 read “the at least one clamp”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: it is recommended that “the incubator(s) and the workstations” in lines 6-7 read “the one or more incubators and the one or more workstations”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: it is recommended that “optionally comprising” in line 2 read “optionally comprises”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: it is recommended that “the workstations” in line 3 read “the one or more workstations”. It is also recommended that the claim concludes with a period. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: it is recommended that “one or more pump or more valve” in line 15 read “one or more pumps or one or more valves”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: it is recommended that “a (peristaltic) pumps” in line 3 read “(peristaltic) pumps”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: it is recommended that “one of (1)” in line 2 and “(b)” in line 3 be cancelled. It is also recommended that “and (b)” read “or (b)”. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: it is recommended that “and (b)” in line 3 read “or (b)”. Appropriate correction is required.
Claims 34-40 are objected to because of the following informalities: the claims are directed to a non-elected invention and the status identifiers of these claims should reflect their withdrawn status.
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.
Claims 1-16, 18-21, and 23-33 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 1 recites the limitation "the incubato" in line 4 and “the incubator” in line 9. There is insufficient antecedent basis for these limitations in the claim.
Claim 4 recites the limitation "the " in line . It is unclear whether the limitations recited in the claim only describe one cell culture vessel or each cell culture vessel of the plurality of cell culture vessels.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation "disposed", and the claim also recites " which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation ", and the claim also recites " which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 recites the limitation "the incubato" in line . There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation ", and the claim also recites " which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 12 recites the limitation "the" in line . There is insufficient antecedent basis for these limitations in the claim. Claim 12 also recites “a first container” and “a second container” in lines 13-14. It is unclear if these first and second containers are the same first and second containers recited in lines 10-11 in the claim or if the first and second containers recited in lines 13-14 are different containers. Claim 12 also recites “a sterilization agent” in line 12. It is unclear if this is the same sterilization agent recited in line 9 or if it is a different sterilization agent. Claim 12 also recites “the first container” and “the second container” in line 16. It is unclear what these first and second containers are referring to as claim 12 defines more than one “first container” and “second container”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “a”, and the claim also recites “preferably” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 13 recites the limitation "the " in line . It is unclear whether there is only one peristaltic pump or more than one peristaltic pump, as it is also unclear from line 3 in claim 13 whether there is only one pump or more than one pump. Claim 13 also recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim. Claim 13 also recites “the first container” and “the second container” in line 2. It is unclear if these first and second containers are the same first and second containers recited in lines 10-11 in claim 12 or the first and second containers recited in lines 13-14 in claim 12. Claim 13 also recites the limitation "the in line 5. There is insufficient antecedent basis for these limitations in the claim. Claim 12 also recites “a peristaltic pump” and “two interlocking valves” in line 7. It is unclear if “a peristaltic pump” and “two interlocking valves” are the same pump and valves in line 3 or if it is a different peristaltic pump and different interlocking valves.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “valves... pumps”, and the claim also recites “(pinch)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14 recites “the first container” in line 1. It is unclear if this first container is the same first container recited in line 10 in claim 12 or the first container recited in line 13 in claim 12.
Claim 16 recites “the second container” in line 1. It is unclear if this first container is the same second container recited in line 11 in claim 12 or the second container recited in line 14 in claim 12. Claim 16 also recites “a solution” in lines 1 and 3. It is unclear if this solution is the same solution recited in claim 14, line 2. Claim 16 also recites “a culture medium” in line 2. It is unclear if this culture medium is the same culture medium recited in claim 14, line 3. Claim 16 also recites “a nucleic acid” in line 3. It is unclear if this nucleic acid is the same nucleic acid recited in claim 14, line 3. Claim 16 also recites “a viral particle” in line 3. It is unclear if this viral particle is the same viral particle recited in claim 14, line 3. Claim 16 also recites “a chimeric receptor” in line 5. It is unclear if this chimeric receptor is the same chimeric receptor recited in claim 14, line 4. Claim 16 also recites “comprising such” and it is unclear as to what “such” is referring to.
Claim 21 recites “the sterilizer agent” in line 1. There is insufficient antecedent basis for this limitation in the claim. If “the sterilizer agent” was intended to be “a sterilization agent”, it is unclear if this is the same sterilization agent recited in line 9 or line 12 of claim 12 or if it is a different sterilization agent.
Claim 23 recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim. Claim 23 also recites “the second container” in line 2 and “a second container” in line 3. It is unclear whether “the second container” and “a second container” are the same structure or different structures and/or the same or different structures as those recited in claim 12. Claim 23 also recites “liquid transfer between the second container and the first container, a second container, and/or the third container”. It is unclear how liquid transfer can occur between the second container and a second container.
Claim 24 recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the " in line and “the third connector” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 28 recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the " in line . There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blanchard (US 2018/0079999 A1).
Regarding claim 1, Blanchard discloses a system for manufacturing of cells (abstract), wherein the system comprises:
(a) one or more incubators (Fig. 3 internal chamber 101) arranged to house a plurality of cell culture vessels (Fig. 3 cell culture vessel P1, P2), wherein each cell culture vessel is configured for moving in and out of the incubators independently (para. 0065 “a cell culture vessel transfer device may be used to move a cell culture vessel”);
(b) one or more workstations (Fig. 3 second internal chamber 109) configured to host each of the cell culture vessels to perform one or more manufacturing operations (Fig. 3 imager 110, manipulator 111); and
(c) a transfer device for moving the cell culture vessels between two incubators, between the incubator and the workstation, or between two workstations (para. 0065 “cell culture vessel transfer device… cell culture vessel transfer device may be used to move a cell culture vessel from a transfer chamber to an internal chamber, and/or from a storage location to an imaging location”; Fig. 6);
wherein the transfer device of (c) operates automated, manually, or a combination thereof (para. 0066).
Regarding claim 2, Blanchard discloses a system wherein the one or more manufacturing operations of (b) comprise centrifugation, mixing, media removal, media addition, feed addition, vector addition, sampling, buffer addition, buffer removal, or a combination thereof (paras. 0078, 0080).
Regarding claim 3, Blanchard discloses a system wherein the one or more workstations of (b) are configured for sterile connection and liquid transfer between the cell culture vessels and one or more bioprocess containers, wherein the one or more bioprocess containers comprise media bags, buffer bags, sample containers, waste containers, or a combination thereof (para. 0038 “culture media is aseptically transferred from a storage container to a cell culture vessel”).
Regarding claim 4, Blanchard discloses a system wherein the cell culture vessel comprises:
(A) an inner container comprising a pocket, wherein the pocket defines a volume within which a cell culture is maintained during manufacturing of cells (para. 0045 “one or more chambers for culturing cells”); and
(B) an outer shell configured to receive and support the inner container (para. 0045 “housing”), wherein the outer shell includes a shell top (para. 0045 “frame”) and a shell bottom that cooperate with one another to form a chamber within which the inner container is disposed, optionally, encapsulated (para. 0045 “lid”).
Regarding claim 6, Blanchard discloses a system further comprising a controller (para. 0022 “controller for the transfer device”), the controller includes:
(I) a processor (para. 0022 “processor”);
(II) a memory storing manufacturing operations (para. 0022 “computer”; paras. 0107-0108), sampling and instructions that, when executed by the processor, cause the processor to:
(a) schedule movements of the cell culture vessels between the incubator(s) and the workstations, wherein the movements are configured to execute automatically (para. 0066 “the automated transfer device may be a robotic arm controlled by a computer that is programmed to move cell culture vessels from a storage location within the internal chamber of the incubator to an imaging location within the internal chamber of the incubator”).
Regarding claim 7, Blanchard discloses a system wherein the controller schedules the movements based on threshold of analytical in-process data, which optionally comprising: cell count, cell viability, level of transduction, growth medium properties, contaminants, or a combination thereof (paras. 0053, 0113).
Regarding claim 8, Blanchard discloses a system wherein one or more of the cell culture vessels of the plurality of cell culture vessels host a cell culture (para. 0005 “introducing a mammalian cell sample into a cell culture vessel”), and wherein the one or more manufacturing operations on the cell cultures in the plurality of cell culture vessels are performed simultaneously (para. 0030 “simultaneous production”; para. 0101 “operate together”).
Regarding claim 9, Blanchard discloses a system wherein the processor is further configured to execute one or more of the following:
manage a plurality of cell cultures simultaneously (para. 0030 “simultaneous production”; para. 0053; para. 0101 “operate together”; para. 0113); and
create a custom schedule for the cell culture in each of the cell culture vessels to manage process performance (para. 0113).
Regarding claim 10, Blanchard discloses a system wherein the creating the custom schedule for the cell culture is based on pre-programmed instructions, in-process data, scheduling of sequential use of the workstations, or a combination thereof (paras. 0110, 0112).
Regarding claim 11, Blanchard discloses a system wherein one or more of the workstations comprise a connection interface for sterile connection and liquid transfer (para. 0037).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 2018/0079999 A1) in view of Mason et al. (US 2018/0142200 A1) and Mondy (US 2018/0139953 A1).
Regarding claim 5, Blanchard discloses a system comprising a pocket arranged to maintain the cell culture (see claim 4 above), but does not disclose wherein the volume of the pocket is adjustable optionally, wherein the outer shell comprises the at least one clamp and the volume of the pocket is adjustable via the clamp, which optionally is a sliding clamp. However, Mason et al. teaches a compressible cell culture container (abstract) that is compressed by a clamp (para. 0095) which allows the container to either have a maximum available volume for culturing cells or a minimum available volume more suitable for storage or container transport (para. 0014). It would have been obvious to a person of ordinary skill in the art to use the Mason et al. configuration of a compressible cell culture container that is compressed by a clamp in Blanchard’s device with a reasonable expectation that it would allow the container to either have a maximum available volume for culturing cells or a minimum available volume more suitable for storage or container transport. This method for improving Blanchard’s device was within the ability of one of ordinary skill in the art based on the teachings of Mason et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Blanchard and Mason et al. to obtain the invention as specified in claim 5.
Neither Blanchard nor Mason et al. explicitly disclose a sliding clamp; however, Mondy discloses that a sliding clamp is a known clamp that allows modifiable adjustment (para. 0222). It would have been obvious to a person of ordinary skill in the art to use a sliding clamp because the substitution of one known element for another would have predictably resulted in a cell culture device with an adjustable volume, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Blanchard and Mason et al. with the teachings of Mondy to obtain the invention as specified in claim 5.
Allowable Subject Matter
Claims 12-16, 18-21, and 23-3 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 12, Blanchard provides the closest prior art (see claims 1 and 3 above, as claim 12 depends on these claims). However, Blanchard does not fairly teach a connection interface comprising “a first connector; a second connector; wherein the first connector and the second connector define a sterilization chamber comprising a gap between the first connection surface and the second connection surface; preferably, wherein the gap is an enclosed space accessible through at least one opening, preferably optionally a port; wherein the gap optionally comprises a sterilization agent; wherein the first connector is fluidically coupled with a first container and the second connector is fluidically coupled with a second container; and (iii) a first sterilizable space, which optionally comprises a sterilization agent, wherein the first connector is fluidically coupled with a first container and the second connector is fluidically coupled with a second container in the first sterilizable space; and (iv) a liquid transfer device including one or more pump or more valve, configured to facilitate liquid transfer between the first container and the second container to avoid back contamination” in combination with the limitations recited in claims 1 and 3. Furthermore, no prior art could be found to teach an obvious combination of these limitations. The prior art of record, alone or in combination, does not disclose, teach, or suggest the noted features within the claim environment.
Claims 13-16, 18-21, and 23-33 would be allowable for the same reason(s) as the base claim (claim 12) upon which they depend.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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