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 without traverse of Group I, claims 1-7 and 9-11 in the reply filed on 12/03/2025 is acknowledged.
Claims 30-34, 36, and 38-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/03/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/10/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3-4 are objected to because of the following informalities:
In each of claims 3 and 4, please change “biologic processing units” to “automated biologic processing units” for consistency with independent claim 1.
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.
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 11 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 11 recites the limitation "the automated biologic processing unit" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 11 depends, recites a plurality of automated biologic processing units and it is unclear which one of these is being referred to in claim 11.
Claim Rejections - 35 USC § 102
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, 3-6, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US Patent Application Publication 2020/0200781) (already of record).
Regarding claim 1, Smith et al. discloses an automated selection and support system (Abstract, para. 76) comprising:
a plurality of automated biologic processing units (16) (para. 58, 229), each of the plurality of automated biologic processing units being translatable (para. 229-230) between at least a first position for storage and maintaining the plurality of automated biologic processing units (e.g., a position away from a user access point such as the rear of the carousel) (para. 229-230, 236) (Figs. 1-2, sheets 1-2 of 11), and a second position (called position for access, or access point) for presenting at least one or more of the plurality of automated biologic processing units (para. 9, 229-230) (Figs. 1-2, sheets 1-2 of 11);
a movable support structure (called carousel) (10) for transitioning each of the plurality of automated biologic processing units between the first position and the second position (para. 229-230);
an electrical system including a power supply and an interface device (para. 226, 249), both the power supply and the interface device being operatively connected to each of the plurality of automated biologic processing units and the movable support structure (para. 58, 226, 229, 249); and
a gas supply system including a gas line fluidly coupled to each of the plurality of automated biologic processing units (para. 230, claim 11).
Regarding claim 3, Smith et al. discloses wherein the plurality of biologic processing units are translatable to a plurality of positions between the first position for storage and maintaining, and the second position for presenting the at least one or more of the plurality of automated biologic processing units (para. 229-230, 247) (Fig. 2, sheet 2 of 11).
Regarding claim 4, Smith et al. discloses wherein the plurality of biologic processing units are autonomous such that each of the plurality of biologic processing units individually regulate and adjust various functions and controls to maintain a desired environment within each of the plurality of automated biologic processing units in real time (Abstract, para. 11, 231).
Regarding claim 5, Smith et al. discloses wherein the various functions and controls include tilt control (para. 231).
Regarding claim 6, Smith et al. discloses wherein translating at least one of the plurality of automated biologic processing units does not impact expanding of cell cultures within the remaining plurality of automated biologic processing units (para. 89, 212-213).
Regarding claim 9, Smith et al. discloses wherein the interface device is a separate unit allowing for remote access/connection (para. 226).
Regarding claim 11, Smith et al. discloses wherein the electrical system operably controls the movable support structure such that an automated biologic processing unit is maintained in a level position while transitioning between the first position and second position (para. 197, 240-246).
Claim Rejections - 35 USC § 103
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US Patent Application Publication 2020/0200781) (already of record) in view of Recker et al. (US Patent Application Publication 2021/0095239) and Runyon (US Patent Application Publication 2010/0316446).
Regarding claim 2, Smith et al. discloses wherein the electrical system and the gas supply system, discussed in the rejection of claim 1, above, are both operatively connected to each of the automated biologic processing units “from a central location” (para. 230).
Smith et al. does not expressly teach via a single axis of connection.
However, Recker et al. discloses a system comprising a plurality of modular bioprocess assemblies (Abstract) and an electrical system including a power supply operatively connected to each modular bioprocess assembly via a single axis of connection (para. 36-37) (Fig. 1, sheet 1 of 3).
Additionally, Runyon discloses a system comprising a plurality of bioreactor chambers (para. 82) and a gas supply system operatively connected to each of the bioreactor chambers via a single axis of connection (para. 82, 87-88) (Fig. 1, sheet 1 of 14).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the system disclosed by Smith et al. such that each of the electrical system and the gas supply system are operatively connected to each of the automated biologic processing units via a single axis of connection, based on the teachings of Recker et al. and Runyon, respectively, as the skilled artisan would have been motivated to adopt a known configuration for supplying an electrical connection and gas to individual biologic processing units from a central location.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US Patent Application Publication 2020/0200781) (already of record) in view of Runyon (US Patent Application Publication 2010/0316446).
Regarding claim 7, Smith et al. discloses wherein the plurality of automated biologic processing units are disposed within a regulated environment (para. 254).
Smith et al. is silent as to the system further comprising a heat management system configured to circulate a fluid to heat or cool each of the plurality of automated biologic processing units.
Runyon discloses a system comprising a plurality of bioreactor chambers (para. 82) housed within a housing (para. 111, 119), the system further comprising a heat management system (comprising a temperature regulator) configured to circulate a fluid to heat or cool each of the plurality of bioreactor chambers (para. 116).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the system disclosed by Smith et al. to further comprise a heat management system configured to circulate a fluid to heat or cool each of the plurality of automated biologic processing units, based on the teachings of Runyon, in order to maintain biologic processing units at a temperature conducive to a desired biologic process using a known configuration.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US Patent Application Publication 2020/0200781) (already of record).
Regarding claim 10, Smith et al. discloses the interface device, as set forth above, wherein it may comprise a device such as a touchpad screen (para. 226).
Smith et al. does not expressly teach wherein the interface device is physically coupled to the system.
Nonetheless, it has been held that making parts of a prior art device integral is a prima facie obvious modification (MPEP 2144.04).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the system disclosed by Smith et al. such that the interface device is physically coupled (i.e., integrated) to the system, as the skilled artisan would recognize that such a modification would advantageously prevent misalignment and/or misplacement of the interface device with respect to the system.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Roberts et al. (US Patent Application Publication 2021/0246406) is directed to a cell culture device comprising a conveyor for translating each of a plurality of cell culture plates to different positions vertically while maintaining a horizontal orientation of each plate.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799