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 .
Applicant’s response filed on 01/21/2026 is acknowledged and has been entered into the application file. Claim 1, 3, 5-9, 11-12, 16-18 were pending. Claim 41 is newly added. Claims 1, 3, 5-9, 11-12, 16-18, and 41 are pending and under examination in the instant application.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No.
PCT/US2019/066089, filed 12/12/2019, which claims the benefit under 35 U.S.C. 119(e) of prior-
filed provisional application 62/778,751, filed on 12/12/2018. Therefore, the earliest effective filing date of this
application is 12/12/2018.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claim(s) 1, 3, 5, 7, 8, 9, 11, and 12 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being
anticipated by Chancellor et al.:
Applicants have traversed the rejection asserting that Chancellor does not teach or suggest "alternating layers" of cells and polymers/scaffolds. Applicants specifically argue that paragraph 0016 refers to MDCs being cultured as described in paragraph 0011, which describes standard culture procedures where the MDCs are grown in a monolayer and then are removed from the growth container. Applicants state that “Seeding onto additional carriers or matrices” does not create alternating layers of edible fibers or scaffolds and cells. Applicants state that moving the MDCs to a different carrier or matrix is not creating multiple layers but moving a single layer to a different growth substrate.
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Although Chancellor et al. does not explicitly disclose "alternating layers" of cells and polymers/scaffolds, the teaching in paragraph 0016 that the MDCs may be further seeded onto additional matrices and/or carriers for additional growth reads on the limitation “alternating layers of edible fibers or scaffolds and cells”. Paragraph 0016 teaches this as an alternative embodiment by specifically teaching “alternatively, the MDCs may be further seeded onto additional matrices and/or carriers for additional growth and manipulation prior to being incorporated into an edible end product”. Regarding applicants’ argument that moving the MDCs to a different carrier or matrix is not creating multiple layers but moving a single layer to a different growth substrate. This is not persuasive because Chancellor et al. teaches additional matrices and/or carriers not a different carrier. The rejection is therefore maintained.
RE: Rejection of claim(s) 1, 5, and 6 under 35 U.S.C. 103 as being unpatentable over Chancellor et al., in view of Vein et al.:
Applicants have traversed the rejection asserting that Vein et al. does not teach or suggest "alternating layers" of cells and polymers/scaffolds. Vein teaches seeding myoblasts and/or adipocytes on a layer of chondrocytes. This may, at least temporarily, form two layers. However, "alternating layers" must have at least four layers, or there would be no "alternating" - just one layer, two layers, or a sandwich of layers.
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Although Vein et al. does not teach or suggest "alternating layers" of cells and polymers/scaffolds, Vein et al. was only used to cure the deficiency that the edible product further comprises a supplement that comprises a vitamin, a mineral, or both. The rejection is therefore maintained.
RE: Rejection of Claim(s) 1 and 16-18 under 35 U.S.C. 103 as being unpatentable over Chancellor et al., in view of Liu et al.:
Applicants have traversed the rejection asserting that Chancellor is missing elements recited in applicant's claim 1 ("alternating layers" of cells and polymers/scaffolds). The addition of Liu does not add the missing elements, therefore even with the addition of Liu, the combination of references is missing elements recited in applicant's claim 1.
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Although Liu et al. does not teach or suggest "alternating layers" of cells and polymers/scaffolds, Liu et al. was only used to cure the deficiency that the edible polymeric fibers or scaffolds are generated using a fiber spinning technique, wherein the fiber spinning technique is solution blow spinning. The rejection is therefore maintained.
New/Maintained Grounds of Rejection
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 7, 8, 9, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Chancellor et al. (the US Patent Application Publication US20060121006A1, filed on 09/12/2005, and published on 06/08/2006).
Regarding claim 1, Chancellor et al. teaches a method for producing nutritional and/or therapeutic cells in vitro, comprising selecting a quantity of cells for cell culture, wherein said cells are, predominantly mammalian;
seeding said cells onto a carrier; growing the cells into a monolayer wherein said monolayer is used to prepare an edible or consumable product; and harvesting the monolayer for use in the preparation of an edible, consumable substance for use as a nutritional and/or therapeutic product (claims 1 and 9 of Chancellor et al.). Chancellor et al. teaches that the cells are animal cells including muscle-derived cells (MDCs) (paragraph 0004, lines 1-2). Chancellor et al. also teaches that the carrier is a nontoxic polymer, such as collagen-containing substance. This reads on an edible polymeric fiber. Chancellor et al. further teaches that the edible meat-containing products are suitable for consumption by humans and other organisms, whether as food or as nutritional supplements (claims 5-6 of Chancellor et al.). Regarding the recitation that the edible polymeric fibers or scaffolds and the population of cells are arranged as alternating layers of edible fibers or scaffolds and cells, Chancellor et al. teaches that the MDCs may be further seeded onto additional matrices and/or carriers for additional growth and manipulation prior to being incorporated into the edible product (paragraph 0016, lines 7-9). The additional matrices and/or carriers that the cells are seeded into are comparable to alternating layers of edible fibers or scaffolds and cells.
Regarding claim 3: Following discussion of claim 1 above, Chancellor et al. teaches that the MDCs may be enhanced with flavor supplements and/or other additives and preservatives (paragraph 0015, lines 8-11).
Regarding claim 5: Following discussion of claim 1 above, Chancellor et al. teaches that the MDCs may be enhanced with flavor supplements (paragraph 0015, lines 8-11).
Regarding claim 7: Following discussion of claim 1 above, Chancellor et al. teaches the use of other tissues, organs, parts, secretions, or bioproducts derived thereof—as components of the end product. Chancellor et al. further teaches animal cells are derived from rare, exotic, extinct, or endangered species. Examples of species contemplated for use include any and all species whether or not endangered, such as tiger, bear, musk deer, turtle, tortoise, snake, bird (paragraph 0030). This reads on a population of non-cultured cells, wherein the population of non-cultured cells is derived or obtained from an animal, or bird.
Regarding claim 8: Following discussion of claim 1 above, Chancellor et al. teaches that MDCs or other cellular phenotypes (e.g. fibroblasts and/or adipocytes) from multiple species may be seeded onto the same monolayer (paragraph 0015, lines 33-35).
Regarding claim 9: Following discussion of claim 8 above, Chancellor et al. teaches that the muscle-derived cells may be further seeded onto additional matrices and/or carriers for additional growth and manipulation prior to being incorporated into an edible end product This reads on that the edible fibers incorporating the myocytes and arranged so as to mimic the variegated pattern of muscle tissue.
Regarding claim 11: Following discussion of claim 9 above, Chancellor et al. further teaches other cellular phenotypes, such as adipocytes from multiple species may be seeded onto the same carrier (paragraph 0015, lines 33-35). Different monolayers containing the cells from different species may be alternately stacked, or otherwise combined into the end product (paragraph 0015, last 4 lines).
Regarding claim 12: Following discussion of claim 1 above, Chancellor et al. teaches that the cells may be further seeded onto additional matrices and/or carriers for additional growth and manipulation prior to being incorporated into an edible end product (paragraph 0016, lines 7-9). This reads on the limitation that the population of cells is deposited at least one of: onto and within the edible polymeric fibers.
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(s) 1, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Chancellor et al. (the US Patent Application Publication US20060121006A1, filed on 09/12/2005, and published on 06/08/2006), in view of
Vein et al. (the US Patent Application Publication US20050010965A1, filed on 11/16/2001, and published on 01/13/2005).
Regarding claims 1 and 5, the teachings of Chancellor et al. are set forth in detail above.
Regarding claim 6: Following discussion of claim 5 above, Chancellor et al. fails to teach that the edible product further comprises a supplement that comprises a vitamin, a mineral, or both.
However, Vein et al. teaches a non-human tissue engineered meat product and a method for producing such meat product, wherein the method comprises the step of seeding non-human fat cells onto said support structure, wherein said non-human fat cells grow in conjunction with said non-human muscle cells
to produce said non-human meat product (Abstract and claims 14, 26). Vein et al. further teaches that other nutrients such as vitamins that are normally lacking in meat products from whole animals may be added to increase the nutritional value of the meat (paragraph 0020, lines 1-3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added other nutrients such as vitamins to the edible product of Chancellor et al. with a reasonable expectation of success. One would have been motivated to have done so to increase the nutritional value of the edible product as taught by Vein et al.
Claim(s) 1, 16-18, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Chancellor et al. (the US Patent Application Publication US20060121006A1, filed on 09/12/2005, and published on 06/08/2006), in view of Liu et al. (Liu et al., "Solution Blow Spinning of Food-Grade Gelatin Nanofibers". Journal of Food Science. 04 May 2017. Vol. 82. Pages 1402-1411).
Regarding claim 1, the teachings of Chancellor et al. are set forth in detail above.
Regarding claims 16-18, Chancellor et al. fails to teach that the edible polymeric fibers or scaffolds are generated using a fiber spinning technique, wherein the fiber spinning technique is solution blow spinning.
However, Liu et al. teaches using solution blow spinning (SBS) for obtaining food-grade gelatin fibers
from fishery byproducts, such as high molecular weight fish skin gelatin (HMWFG) (Abstract). This reads on the limitations edible polymeric fibers or scaffolds are generated using a fiber spinning technique wherein the fiber spinning technique is solution blow spinning. Liu et al. further teaches that SBS is a technology that combines concepts from ES, solution, and melt spinning, where gas flow is used as the driving force to form fibers from polymer solutions, such that the fibers can be produced at a high rate and the collectors are not
limited to conducting surfaces using SBS (page 1402, column 2, paragraph 2, lines 11-23 and page 1403, column 1,
paragraph 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have used solution blow spinning to form edible fibers to seed cultured cells
of Chancellor et al. onto to form synthetic muscle tissue with a reasonable expectation of success. One would have been motivated to have done so because solution blow spinning technique allows for the fibers to be produced at a high rate and the collectors not be limited to conducting surfaces of the solution blow spinning apparatus.
Regarding claim 41: Following discussion of claim 1 above, Liu et al. teaches that the gelatin film was prepared by casting the 20% (w/v) solution (page 1404, column 2, paragraph 2).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANAN ISAM ABUZEINEH whose telephone number is (571)272-9596. The examiner can normally be reached Mon- Fri 8:30-5:00.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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