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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 19-46, in the reply filed on 3/20/2026 is acknowledged.
Claims 1-18 and 47-88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/20/2026.
Information Disclosure Statement
The information disclosure statements dated 7/28/2023 (previously considered in the office communication dated 1/28/2026) and 3/20/2026 have been considered and made of record.
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 19-44 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maguire et al. (WO 2018/115973)(Attached PTO-892).
With respect to claim 19, the reference of Maguire et al. discloses:
A system (Figs. 128 and 134 (reproduced below)) comprising:
a housing including a pod holder (Figs. 128 and 134) configured to receive a pod, the pod including a filter plate and an upper portion forming a well;
a delivery solution applicator (nebulizer assembly)(9801) configured to deliver atomized delivery solution to the well;
a display (Fig. 134 and page 108); and
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a controller (Fig. 134 and pages 106-107) including circuitry configured to display at least one process parameter.
With respect to claim 20, the pod holder is configured to tilt or vibrate the pod (pages 4 and 117).
With respect to claim 21, the delivery solution applicator includes a spray head (nebulizer assembly) (9801).
With respect to claim 22, in the absence of further positively recited structure, the pod holder of Maguire et al. is considered to be structurally capable of holding the number of cells required of claim 22.
With respect to claim 23, the system is configured to automatically apply an atomized delivery solution to a cellular monolayer formed on a filter within the pod (pages 107-108).
With respect to claim 24, the delivery solution applicator includes nebulizer (nebulizer assembly) (9801).
With respect to claim 25, the delivery solution applicator further includes a mass flow controller or a volumetric flow controller to regulate a gas flow to operate the nebulizer (pages 44-45).
With respect to claim 26, the delivery solution applicator is configured to deliver 10-300 micro liters of the delivery solution (pages 3 and 43).
With respect to claim 27, the system includes a reservoir containing the delivery solution (reservoir)(3, 9810) (Figs. 23 and 126 and pages 9, 43, 98).
With respect to claims 28-30, the reference discloses the use of ethanol in the concentrations required of claims 28-30 (page 4).
With respect to claims 31-33, the reference discloses the use of KCL in the amounts required of claims 31-33.
With respect to claims 34-37 and 42, in the absence of further positively recited structure, the system is structurally capable of being used with the cells required of claims 34-37 and 42 (pages 2 and 4).
With respect to claims 38-41, the reference discloses the use mRNA payloads required of claims 38-41 (page 4).
With respect to claim 43, the system is structurally capable of being used a monolayer of non-adherent cells (pages 4 and 7).
With respect to claims 44 and 46, the system is structurally capable of being used with or holding a pod with a memory storing data. Note: The pod has not been positively recited as part of the claimed system.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (WO 2018/115973)(Attached PTO-892) in view of Connolly et al. (US 2014/0099646)(Attached PTO-892).
The reference of Maguire et al. has been discussed above with respect to claims 19 and 44.
Claim 45 differs by reciting: the controller is further configured to read, via the circuitry, the data characterizing the at least one process parameter from the memory, and perform, via the circuitry, at least one processing step utilizing the at least one processing parameter.
While the system of the reference of Maguire et al. employ a controller for automation of the operation of the system (Fig. 134 and pages 106-107), the reference does not disclose that the controller is configured as required of claim 45.
The reference of Connolly et al. discloses that it is known in the art to provide a sample processing system with a barcode scanner to read a barcode on a cartridge used within the system wherein the barcode information is used by the controller to perform a specific processing step (¶[0115]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the controller of the primary reference with the required circuitry to read, a data characterizing the at least one process parameter from a memory provided on a pod, and perform, via the circuitry, at least one processing step utilizing the at least one processing parameter for the known and expected result of providing an art recognized means for automation of a manual process which would reduce the amount of human interaction required to perform a specific processing operation within the processing system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights