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 the species, transfected cells, in the reply filed on 26 January 2026 is acknowledged.
The elected species, transfected cells, are directed to eukaryotic cells. The specification does not provide a definition of transfected cells, however, transfected cells are generally considered eukaryotic cells as evidenced by Chong et al. (PeerJ 9:e11165, published 21 April 2021). Chong discloses transfection is a process by which foreign nucleic acids are delivered into a eukaryotic cell to modify the host cell’s genetic makeup (Abstract). The specification at paragraph 25, Applicant suggests a population of transfected cells are mammalian cells.
Therefore, the definition of transfected cells has been considered in light of the art and the specification to mean eukaryotic cells. As such, all claims directed to non-eukaryotic cells have been withdrawn. Claim 3 is directed to transformed cells, claim 7 is directed to a disaggregation solution comprising microbial grown medium, and claims 11-20 are directed to a method comprising spore forming cells.
Claims 3, 7, and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 January 2026.
Claim Status
Claims 3, 7, and 11-20 have been withdrawn and claims 1-2, 4-6, and 8-10 have been considered on their merits.
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 6 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 6 contains the trademark/trade names Pluronic™ F-68, Accumax™, and Accutase™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe dissociation solutions, and accordingly, the identification/description is indefinite.
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 1-2, 4-6, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paull et al. (Nature Methods, Vol.12 N0.9, September 2015, IDS ref.).
Regarding claim 1, Paull teaches cells were resuspended into Matrix tubes and refrozen, said cells were thawed before being placed on a robotic deck (p. e2, Online Methods, Automated fibroblast thawing). The thawed cells in the Matrix tubes read as providing a suspension comprising a population of cells. Paull teaches fibroblast growth medium was added to the tubes, centrifuged, supernatant removed, and the cells resuspended in fresh media before being transferred to 12-well plates (p. e2, Online Methods, Automated fibroblast thawing). The 12-well plates read as reservoir plates. Paull teaches each 12-well plate was fed every 3 days over a ten-day growth period (p. e2, Online Methods, Automated fibroblast thawing). The ten-day growth period reads as incubating the reservoir plate. Paull teaches cells grown in 12-well plates were washed and dissociated (disaggregation) with TrypLE Select CTS (p. e2, Online Methods, Automated cell seeding). Paull teaches the cell suspension was transferred into a 96-well imaging plate, centrifuged for 2 min (mechanical force), then counted (p. e2, Online Methods, Automated cell seeding). Paull teaches the cell counts were auto-exported with the liquid-handling software automatically calculated the exact volume of cell suspension required for transfer into daughter wells of a 24-well plate (collecting resuspended cells) to reach user-selected seeding density (p. e2, Online Methods, Automated cell seeding). The disaggregation, application of mechanical force, and collecting resuspended cells read as automatic steps, as Paull teaches these steps as part of an automated cell seeding method.
Regarding claim 2, Paull teaches the automated fibroblast production, wherein the automated reprogramming occurs via automated delivery of modified mRNAs encoding reprogramming transcription factors (p. 886, Automated reprogramming). The reprogrammed fibroblasts read as transfected cells.
Regarding claim 4, Paull does not specifically identify the temperature which the cells were centrifuged, however, it is understood that these steps were performed in a laboratory with appropriate temperature controls in place. Therefore, absent evidence to the contrary, the cells are considered to have been centrifuged at room temperature which is approximately 20-25°C. This falls in the range of between 4 and 40°C.
Regarding claim 5, Paull teaches the cell suspension was automatically transferred into daughter wells of a 24-well plate (multi-well plate) to reach user-selected seeding density (p. e2, Online Methods, Automated cell seeding). The cells in suspension taught by Paull were grown in 12-well plates, prior to the automatic transfer into the multi-well plate (p. e2, Online Methods, Automated cell seeding).
Regarding claim 6, Paull teaches the cells are dissociated with TrypLE select CTS, which is a disaggregation solution comprising a protease.
Regarding claim 8, Paull teaches the cells were centrifuged for two minutes (p. e2, Online Methods, Automated cell seeding).
Regarding claim 9, Paull teaches fibroblast growth medium was added to the tubes, centrifuged, supernatant removed, and the cells resuspended in fresh media (liquid growth medium) before being transferred to 12-well plates (p. e2, Online Methods, Automated fibroblast thawing).
Regarding claim 10, Paull teaches the cell counts were auto-exported with the liquid-handling software automatically calculated the exact volume (predetermined volume of growth medium) of cell suspension required for transfer into daughter wells of a 24-well plate to reach user-selected seeding density (p. e2, Online Methods, Automated cell seeding).
Thus, the reference anticipates the subject matter of claims 1-2, 4-6, and 8-10.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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