DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The status of the claims stands as follows:
Pending claims: 1-7, 10-11, 13, 15-16, 18-19, 22, 26, 28, 30, 32, 34
Withdrawn claims: None
Cancelled claims: 8-9, 12, 14, 17, 20-21, 23-25, 27, 29, 31, 33
Claims currently under consideration: 1-7, 10-11, 13, 15-16, 18-19, 22, 26, 28, 30, 32, 34
Currently rejected claims: 1-7, 10-11, 13, 15-16, 18-19, 22, 26, 28, 32
Allowed claims: None
Claim Interpretation
For the purpose of this examination, the term “upstream process” in claim 7 will be interpreted as meaning a bioreaction that occurred prior to the formation of the edible bioreactor. The term “downstream process” in claim 7 will be interpreted as meaning a bioreaction that occurs after the formation of the edible bioreactor.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5-6, 11, 13, 16, 26, and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. Claims 1, 3, 5-6, 11, 13, 16, 26, and 32 are directed to a naturally-occurring product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 1, 3, 5, and 6 recite an edible bioreactor comprising an edible core and an edible membrane encapsulating the core, wherein a bioreaction occurs within the edible core; and wherein the edible membrane comprises more than one edible polymer. Claim 11 recites that the edible membrane is substantially impermeable or selectively permeable. Claims 13 and 16 recite that the bioreaction occurs at a temperature between about 15°C to about 50°C; and that the bioreaction is fermentation. Claim 26 recites that the product of the bioreaction is an edible product. Claim 32 recites that the edible core comprises an edible barrier. A cell of Saccharomyces cerevisiae yeast comprises all of these features as the cell comprises an inner core surrounded by a cell wall and plasma membrane (corresponding to the presently claimed edible membrane and barrier around the edible core), wherein fermentation occurs within the core of the cell and fermentation produces the edible products CO2 and ethanol. The cell wall of the yeast cell comprises a plurality of edible polymers; and the cell wall is substantially impermeable or selectively permeable.
For these reasons, the claimed product is not markedly different from its closest naturally-occurring counterpart because there is no indication that the claimed product has any characteristics that are markedly different from the closest naturally-occurring product; and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Furthermore, there is no evidence of record of a structural or functional difference between the claimed product and that of its naturally-occurring counterpart. To show a marked difference, the characteristic(s) of the claimed invention must be changed as compared to its naturally-occurring counterpart. For example, an assertion of changed functionality must be accompanied with evidence of a comparison of the claimed composition with its closest naturally-occurring counterpart and should apply to the full scope of the claim. Furthermore, inherent or innate characteristics of the naturally-occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently or any effect or influence by Applicant cannot show a marked difference.
Thus, there is no evidence of record to indicate that the claimed product is markedly different, structurally, chemically, or functionally, than its naturally-occurring counterpart and is not eligible subject matter under current 35 U.S.C. 101 standards.
Claim Objections
Claims 30 and 34 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 30 and 34 have not been further treated on the 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.
Claims 1-7, 10-11, 13, 15-16, 18-19, 22, 26, 28, and 32 are rejected under 35 U.S.C. 112(b) 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.
Regarding claims 1-2, 10, 15, 26, and 28, the parentheses render the claims indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention. For the purpose of this examination, the limitation(s) written within the parentheses will not be considered as part of the claims.
Regarding claims 11, 13, 15, and 16, the term "e.g." renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of this examination, the limitation(s) written after “e.g.” will not be considered as part of the claim.
Claims 3-7, 11, 19, and 28 recite the limitation: “first edible membrane, and/or second edible membrane”; or "the first edible membrane, and/or the second edible membrane". There is insufficient antecedent basis for this limitation in the claims. For the purpose of this examination, the claims will be interpreted as meaning “the edible membrane”.
Claims 13, 18, 22, and 32 are rejected by reason of dependency from at least claim 1.
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, 3-7, 10-11, 15-16, 18-19, 22, 26, 28, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horn (US 2016/0192689; IDS citation).
Regarding claims 1, 6, and 16, Horn teaches a functional food composition comprising an edible core (corresponding to edible or potable substance) and an edible membrane encapsulating the core (corresponding to a cross-linked edible matrix) (abstract). Horn teaches that the core may comprise a prebiotic or a probiotic; and that the edible membrane may comprise a prebiotic or a probiotic (abstract), wherein the bacterial probiotic may be in a physiologically active state [0455]; and wherein the prebiotic may be fermented to allow specific changes in the composition [0181]. Horn teaches that the prebiotic or probiotic in the core interacts with the prebiotic or probiotic in the matrix by the probiotic consuming the prebiotic [0194]. Since probiotics are known in the art to consume prebiotics by fermentation and Horn discloses the prebiotic as being fermented [0181], a skilled practitioner consulting Horn would immediately recognize that the interaction between the probiotic and prebiotic inside the composition of Horn is a bioreaction involving fermentation so that the edible membrane of the composition supports a bioreaction in the edible core as recited in present claims 1 and 16. Therefore, the composition of Horn is an edible bioreactor as recited by present claim 1; and the edible membrane forms a bioreactor vessel as recited by present claim 6.
Regarding claims 3, 4, 5, 11, and 28, Horn teaches the invention as described above in claim 1, including the edible membrane may comprise a plurality of edible polymers (corresponding to a combination of polysaccharides); and that an edible polymer is alginate [0444], [0449] as recited in present clams 3, 5, and 28. Horn teaches that the edible membrane may comprise edible particles [0443]-[0444] as recited in present claim 4. Horn also teaches that the edible membrane may be substantially impermeable or selectively permeable [0195], [0447] as recited by present claim 11.
Regarding claim 7, Horn teaches the invention as described above in any one of the preceding claims, including that the core may comprise yogurt, which is a substance which undergoes fermentation during production [0199], [0457]. In disclosing that the core may comprise yogurt, Horn discloses that the bioreactor supports an upstream process as recited by present claim 7. Horn also teaches that the prebiotic or probiotic in the core undergoes fermentation with the prebiotic or probiotic in the edible membrane within the bioreactor [0194]. Therefore, Horn discloses that the edible membrane supports a downstream process of a bioreaction in the edible core as recite din present claim 7.
Regarding claims 10, 18, 19, and 22, Horn teaches the invention as described above in claim 1, including the edible membrane or the edible core or the edible membrane comprises an active culture (corresponding to probiotic) [0194] as recited by present claims 18 and 19. Horn also teaches that the edible core or the edible membrane comprises a substrate that can be fermented by the active culture (corresponding to prebiotic) [0194] as recited by present claim 22. Horn also teaches the probiotic in the edible membrane may inoculate the edible core or a component within the edible core [0194] as recited by present claim 10.
Regarding claim 15, Horn teaches the invention as described above in claim 1, including that the core may comprise yogurt, which is a substance which undergoes lactic acid fermentation during production [0199], [0457] and is known in the art to be an acidic food. As an acidic food, the yogurt in the edible core has a pH of less than 7.0, which falls within the pH range of less than 7.0 recited in present claim 15.
Regarding claim 26, Horn teaches the invention as described above in claim 1, including the product of the bioreaction is an edible product (corresponding to by-product that affect the mouthfeel or user experience of the edible composition) [0194] as recited by present claim 26.
Regarding claim 32, Horn teaches the invention as described above in claim 1, including the edible bioreactor may comprise a particulate layer between two or more membrane layers [0447]. The inner membrane layer and/or the particulate layer is/are considered to be an edible barrier around the edible core as recited in present claim 32.
Claims 1 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lip (Lip et al., “Selection and subsequent physiological characterization of industrial Saccharomyces cerevisiae strains during continuous growth at sub- and supra optimal temperatures”, 2020, Biotechnology Reports, 26, https://doi.org/10.1016/j.btre.2020.e00462).
Regarding claims 1 and 13, Lip teaches Saccharomyces cerevisiae yeast (page 1, column 1, 1st paragraph). It is well-known in the art that Saccharomyces cerevisiae yeast exist as cells with a core comprising organelles and cytoplasm; and with a cell membrane and a cell wall which surround the core. It is also well-known in the art that Saccharomyces cerevisiae yeast cells perform fermentation bioreactions in the core of the cell; and that these cells are edible as they are used in producing consumables such as alcoholic beverages. These statements are supported by Lip (page 1, column 1, 1st-2nd paragraphs). For these reasons, a Saccharomyces cerevisiae yeast cell is an edible bioreactor comprising an edible core (i.e., organelles and cytoplasm) and an edible membrane (i.e., cell membrane and/or cell wall) encapsulating the core, wherein the edible membrane supports a bioreaction (i.e., fermentation) in the edible core as recited in present claim 1.
Lip also teaches that the optimal growth temperature, and thus a fermentation temperature, of Saccharomyces cerevisiae yeast is 28-33°C (page 1, column 1, 2nd paragraph – page 1, column 2, 1st paragraph), which falls within the bioreaction temperature recited in present claim 13.
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.
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Horn (US 2016/0192689; IDS citation) as applied to claim 1 above.
Regarding claim 2, Horn teaches a functional food composition comprising an edible core (corresponding to edible or potable substance), a first edible membrane encapsulating the edible core (corresponding to a membrane layer); and a second edible membrane encapsulating the first edible membrane (corresponding to an outer strength improving particulate layer) (abstract, [0447]). Horn teaches that the core may comprise a prebiotic or a probiotic; and that the edible membrane may comprise a prebiotic or a probiotic (abstract), wherein the bacterial probiotic may be in a physiologically active state [0455]; and wherein the prebiotic may be fermented to allow specific changes in the composition [0181]. Horn teaches that the prebiotic or probiotic in the core interacts with the prebiotic or probiotic in the matrix by the probiotic consuming the prebiotic [0194]. Since probiotics are known in the art to consume prebiotics by fermentation and Horn discloses the prebiotic as being fermented [0181], a skilled practitioner consulting Horn would immediately recognize that the interaction between the probiotic and prebiotic inside the composition of Horn is a bioreaction involving fermentation. Therefore, the composition of Horn is an edible bioreactor wherein: (i) the first edible membrane comprising the prebiotic may inoculate the prebiotic in the edible core and the second edible membrane supports the bioreaction; or (ii) the edible core comprising the probiotic may inoculate the prebiotic in the first edible membrane and the second edible membrane supports the bioreaction as recited by present claim 2.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Horn (US 2016/0192689; IDS citation) as applied to claim 1 above, in view of Lip (Lip et al., “Selection and subsequent physiological characterization of industrial Saccharomyces cerevisiae strains during continuous growth at sub- and supra optimal temperatures”, 2020, Biotechnology Reports, 26, https://doi.org/10.1016/j.btre.2020.e00462).
Regarding claim 13, Horn teaches the invention as described above in claim 1, including that the prebiotic or probiotic in the core interacts with the prebiotic or probiotic in the matrix by the probiotic consuming the prebiotic [0194]. Since probiotics are known in the art to consume prebiotics by fermentation and Horn discloses the prebiotic as being fermented [0181], a skilled practitioner consulting Horn would immediately recognize that the interaction between the probiotic and prebiotic inside the bioreactor of Horn is a bioreaction involving fermentation. Horn also discloses the probiotic may be Saccharomyces cerevisiae [0429]. Horn does not teach that the bioreaction temperature is between about 15°C and about 50° C.
However, Lip teaches that Saccharomyces cerevisiae has an optimal growth temperature, and thus a fermentation temperature, of 28-33°C (page 1, column 1, 2nd paragraph – page 1, column 2, 1st paragraph), which falls within the claimed temperature range.
It would have been obvious for a person of ordinary skill in the art to have performed the bioreaction of Horn at a temperature of 28-33°C as taught by Lip. Since Horn discloses that the prebiotic or probiotic in the core interacts with the prebiotic or probiotic in the matrix by the probiotic consuming the prebiotic [0194], that the prebiotic is fermented [0181], that the probiotic is Saccharomyces cerevisiae [0429], and it is known in the art that probiotics consume prebiotics by fermentation, a skilled practitioner would have been motivated to consult an additional reference such as Lip in order to determine a suitable temperature at which Saccharomyces cerevisiae may perform a fermentation bioreaction. Therefore, the claimed temperature is rendered obvious.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791