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 .
Claims 1-40, of record 11/17/2025, are pending.
Election/Restrictions
Applicant’s election without traverse of group IV, claims 22-29, in the reply filed on 11/17/2025 is acknowledged. Claims 22-29 are subject to prosecution.
Claims 1-21 and 30-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected elections, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Priority
The instant application is a national stage entry of PCT/EP2021/073078 (filed 8/19/2021), which claims benefit of provisional application 63/068397 (filed 8/21/2020).
Specification
The use of the term MilliQ, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claim 22 recites the limitation “myocyte-like cells”, which is interpreted as cells substantially resembling myocytes in structure and appearance, consistent with ¶0061 of the application’s PG Pub.
Claim 27 recites the limitations “adipocyte-like cells” and “fibroblast-like cells”, which are not expressly defined in the instant specification. These limitations are interpreted as requiring cells that substantially resemble adipocytes and fibroblasts, respectively, in structure and appearance, to be consistent with the interpretation of myocyte-like cells above.
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 22-29 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.
Claims 22-26 and 28-29 recite the limitation "the cells or “said cells”. Claim 22 also recites the limitation “the void space”. There is insufficient antecedent basis for these limitations in the claims. Dependent claim 27 is included in the rejection.
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.
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.
Claims 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over Nahmias et al. (US 20210395690 A1) in view of Whitford et al. (BioProcess International, 2009), Gramer (US 6001585 A), Kallury et al. (US 20040171169 A1), Yamamoto et al. (Journal of Chemical Engineering of Japan, 2012), and Miller (US 20110091604 A1).
Regarding claims 22-23 and 25-28: Nahmias et al. teach methods of culturing adherent connective tissue cells (See ¶0005). The methods can be used to produce a cultured meat (See v0025 and ¶0060-0061). The cells can be fibroblasts, adipocytes, myofibroblasts, and myocytes (See ¶0046). The cells can be cultured on a matrix, that can comprise collagen, soy or pea protein, or hydroxypropyl cellulose (which reads on “hydrocolloid”), and the matrix can be an edible hollow fiber cartridge with fibers can be made from edible natural or synthetic polymers (See ¶0063-0066). The cells form a mass surrounding the hollow fibers (which reads on “seeding the void space between the hollow fibers”) (See ¶0066). Nahmias et al. do not expressly teach the cartridge and reactor setup, the dimensions of the hollow fibers, the seeded cell density, or the final cell confluency.
Whitford et al. teach that hollow fiber perfusion bioreactors comprise semipermeable hollow fibers set in parallel array within a tubular housing or cartridge and attached to each end of the cartridge so that any liquid entering the cartridge will flow through the interior of the fibers (which reads on “hollow fibers having a first end and a second end wherein said first end and said second end are positionally opposed to each other and, wherein said hollow fibers are arranged in parallel to each other” and “the first ends of said hollow fibers are secured in a first holding device and the second ends of said hollow fibers are secured in a second holding device, the first and second holding devices being oriented essentially perpendicular to the longitudinal orientation of the hollow fibers and being orientated essentially parallel to each other, wherein the at least one holding device allows for the flow of fluids to the interior of the hollow fibers” (See page 54, col. 2, full ¶2 and col. 3, v1 and fig. 1-2 and 5). The cartridge housing comprises inlet and outlet ports for connecting medium and waste reservoirs using a pump system (See fig. 2 and 5). The medium supplied through the hollow fiber lumens perfuses into the extracapillary space holding the cells (See fig. 1).
Gramer teaches hollow fiber bioreactors and components for growing cells (See Abstract). Commercially available hollow fibers are suitable for use in the bioreactor (See col. 7, line 57-60). Preferred hollow fibers have a wall thickness of between about 2-200 microns (which reads on “a wall thickness of about 0.05 mm to about 0.4 mm”) and an inner diameter of between about 20-1000 microns (which, in view of the preferred wall thickness, reads on “an outer diameter of about 0.2 mm to about 2.0 mm”) (See col. 8, line 18-27).
Kallury et al. teach that typical commercially-available hollow fibers have a porosity of about 30-80% (See ¶0047).
Yamamoto et al. teach the seeding of skeletal muscle cells in a hollow fiber bioreactor at 8.7 × 107 cells/ml (which reads on “a density of about 105 cells/ml to about 108 cells/ml”) for forming muscle tissue constructs (See page 6, full ¶1).
Miller teaches methods for producing synthetic meat (See Abstract). Miller teaches that, generally, completion of the growth process may be considered when a sheet of meat has been formed and that the substrate on which the cells are grown may exit the bioreactor (which reads on “removing said hollow fiber cartridge from the hollow fiber cell culture reactor”) after cell growth has formed a uniform and mechanically integral film of meat (which reads on “cells are cultured until achieving about… 99% confluency”) (See ¶0016).
It would have been obvious to one having ordinary skill in the at prior to the effective filing date of the claimed invention to modify the method of Nahmias et al. to comprise the hollow fiber cartridge and bioreactor setup taught by Whitford et al. One would be motivated to make this modification because Whitford et al. teach these setups as typical for culturing cells in hollow fiber cartridges (See fig. 2 and 5). There would be a reasonable expectation of success in doing so because Nahmias et al. teach that culturing cells to form a meat product can be performed using an edible hollow fiber cartridge (See ¶0066).
It would have also been obvious to modify the method of Nahmias et al. to comprise the dimensions and porosity ranges taught by Gramer and Kallury et al. for the hollow fibers. One would be motivated to make this modification because Gramer teaches these physical properties as suitable for hollow fibers in bioreactors wherein membranes separate cells and medium channels (See col. 7, line 57-60 and col. 8, line 18-27). There would be a reasonable expectation of success in making this modification because the edible hollow fiber cartridges of Nahmias could be readily modified to have these properties.
It would have been further obvious to modify the method of Nahmias et al. to comprise the seeding density of 8.7 × 107 cells/ml taught by Yamamoto et al. One would be motivated to make this modification because the use of such a density by Yamamoto et al. suggests that it is appropriate for generating skeletal muscle constructs in a hollow fiber bioreactor, and such a modification could be readily made.
Finally, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Nahmias et al. to comprise culturing the cells to approximately 99% confluency to form a uniform and mechanically integral sample. One would be motivated to make this modification because Miller suggests that ending the culturing process when the cells have formed a uniform sheet of meat is appropriate (See ¶0016). Such a modification could be readily made.
Regarding claim 24: Following the discussion of claims 22-23 and 25-28, Nahmias et al. do not expressly teach removing the hollow fibers from being held by the cartridge. However, because Nahmias et al. expressly teach that the fibers of the cartridge are edible (See ¶0066) without teaching that other parts of the cartridge are edible, one of ordinary skill in the art would find it obvious to remove the myocyte-laden hollow fibers from their holders upon harvesting.
Regarding claim 29: Following the discussion of claims 22-23 and 25-28, Nahmias et al. teach that coloring agents, flavoring agents, and preservatives may be present (See ¶0081) but do not expressly teach infusion of the hollow fiber interior or void space. However, it would have been obvious to one of ordinary skill in the art that addition of coloring or flavoring agents or preservatives to the cells after confluency is reached and prior to harvesting could be performed using the inlet port of the cartridge. This would readily enable agents to efficiently perfuse any void space via the lumens of the hollow fibers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M Babic, can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633