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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 43 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In this case, the claims states, “at least one form of casein is expressed as a cytoplasmic, non-secreted protein, encoded by a gene lacking a signal peptide”. Wherein the applicants specification on page 22 states, “In their native hosts, caseins are synthesized at the endoplasmic reticulum (ER), packaged into Golgi derived vesicles, and secreted by exocytosis to the milk. To evaluate CSNs accumulation into plant cells, these proteins were expressed as cytoplasmic soluble proteins and for that their signal peptides (highlighted in bold on SEQ ID NO: 1 to 4) where removed.” In biochemistry, the difference between “encoded” and removed” are very different.
Claims 44-47 are rejected as depending from a rejected claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over Geistlinger et al. (herein referred to as Geistlinger, WO 2018039632 A1) in view of El-Richani et al (herein referred to as El-Richani, US 20180291392 A1) with evidence from Khan Academy (“Protein targeting”)
With regard to Claim 43, Geistlinger teaches a plant-based dairy substitute (page 2, lines 6-19) comprising engineered recombinant milk proteins with nonanimal proteins (pages 8/9 lines 31- 2) In some embodiments the milk proteins are casein (page 11 lines 10-20, Claim 29). The composition further comprises water (page 41 line 3), at least one chemical (page 39, lines 1-7, Page 51 lines 16-17), at least one food additive (page 39, lines 12-13), at least one vegetable oil (page 30/31, lines 22-5), at least one saccharide (page 34, lines 1-4), at least one vegetable protein (page 20/21 lines 10-10) and at least one strain of lactic bacteria page 34 lines 23-34). Geistlinger teaches the composition is fermented by the lactic bacteria (page 60, lines 11-19). Geistlinger teaches a plant-based dairy substitute characterized by organoleptic and physicochemical properties characteristic of dairy products of animal origin (page 41, lines 16-18).
However, Geistlinger is silent to a slurry of transgenic plant cells expressing at least one form of casein.
El-Richani teaches the production, extraction, and purification of milk proteins from transgenic plants ([0003]). Specifically, El-Richani teaches transgenic plant cells expressing at least one form of casein ([0009]). Further, depending on the need, the transgenic plants can be further processed by cutting, peeling, pulverizing, squeezing, extracting, or any other step into the form of cut vegetables, cut fruits, powders, juice, extracts, etc. ([0283]). It would have been obvious to one with ordinary skill in the art that the further processing taught by El-Richani would reasonably include a slurry as described in the instant claims. Continuing, El-Richani teaches the sustainable production of important recombinant proteins is necessary to provide abundant amounts of the high-quality proteins for commercial applications ([0007]).
Because El-Richani teaches the transgenic plants can be further processed into the form of a powder, the art reads on the limitation which states, “wherein said transgenic plant cells are configured to be spray-dried into a plant cell powder, prior to forming said slurry” because clearly if the material can be processed into a powder than one with ordinary skill in the art would recognize it would be in a state prior to further processing that would be considered “configured” to be spray dried. The examiner would like to note that the act of spray drying is not positively recited in the claim and only the act of “configured” in positively recited. Thus, El-Richani reads on the limitation of the material being “configured”.
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Geistlinger to utilize a slurry of transgenic plant cells expressing at least one form of casein as taught by El-Richani to provide an abundant amounts of the high-quality proteins [(0007]).
With regard to the casein, El-Richani teaches appropriate construction of recombinant constructs/vectors/plasmids having milk protein-coding nucleic acid sequences is critical in order to produce high-quality milk proteins ([0009]). El-Richani teaches a transgenic plant comprising a recombinant DNA construct, said construct comprising (i) a promoter, (ii) a nucleic acid sequence encoding a bovine milk protein and/or a functional fragment thereof, which is operably linked to said promoter, and (iii) a termination sequence; wherein the bovine milk protein and/or the functional fragment thereof is expressed in the transgenic plant and/or a part thereof. Wherein the bovine milk protein can be from the group consisting of α-S1 casein, α-S2 casein, β-casein, κ-casein ([0013]). El-Richani teaches embodiments where k-casein and β-casein are encoded without a signal peptide ([0216]-[0218], [0361]). El-Richani teaches when constructs are encoded with a signal peptide secretion of the target protein is desired ([0088]). Therefore, the embodiments taught by El-Richani in which the k-casein and β-casein do not contain a signal peptide would be considered non-secreted proteins because a signal protein is required is secretion is desired.
Continuing, one with ordinary skill in the art would recognize that without a signal peptide the protein would not be sent to the endoplasmic reticulum and thus stay where the protein is translated in the cytosol (i.e. the cytoplasm). This is evidence by Khan academy which teaches translation of all proteins in a eukaryotic cell begins in the cytosol (Overview of cellular shipping routes) and shortly after translation starts, the protein will either remain in the cytosol for the rest of translation, or be fed into the endoplasmic reticulum (ER) as it is translated. Proteins are fed into the ER during translation if they have an amino sequence called a signal peptide and proteins that do not have a signal peptide stay in the cytosol for the rest of translation. (Overview of cellular shipping routes). Therefore, because the El-Richani teaches an embodiment wherein casein lacks a signal protein, one with ordinary skill in the art would recognize the protein would stay in the cytoplasm.
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Geistlinger in view of El-Richani to utilize a casein that is encoded by a gene lacking a signal peptide and is non-secreted to produce high-quality milk proteins.
With regard to Claim 44, Geistlinger teaches plant-based dairy substitute is selected from a group consisting of cheese, yogurt, cream, ice cream, coffee creamers and emulsifiers (Ex. Milk powder) for the food industry (page 2 lines 8-9, page 3 lines 7-22)
With regard to Claim 45, Geistlinger teaches the vegetable protein is selected from a group consisting of almonds, peanuts, walnuts, rice, wheat, oat, rye, corn, quinoa, lentil, sesame, chia, pea, chickpea, soybean, fava bean, pumpkin seeds, sunflower seeds, flaxseeds, potato, cassava, yam and any combination thereof (page 20/21 lines 15-10)
With regard to Claim 46, Geistlinger teaches the lactic bacteria are selected from the group consisting of Streptococcus thermophilus, Lactobacillus bulgaricus, Lactococcus lactis, Lactococcus cremoris, Lactococcus diacetylactis, Lactobacillus acidophilus and any combination thereof (page 22, lines 9-23, page 34/35 lines 30-3)
With regard to Claim 47, the claim recites the limitation “is storable”, this is not a positive limitation but only requires that it could be stored at this temperature for 6 month with no requirement that it retains any properties or that any properties change and as such it is the examiners assertion that the invention of modified Geistlinger would be able to be stored at 6 months at 25 degrees.
Additionally because modified Geitslinger teaches the same materials as instantly claimed it must also have the same properties as instantly claimed, including being storable without refrigeration at about 25 degrees Celsius for about 6 months. See MPEP 2112.01(II) “"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Response to Arguments
Applicant's arguments filed 06 October 2025 have been fully considered but they are not persuasive.
Applicant argues that none of the cited documents teaches a plant based dairy substitute comprising a slurry of transgenic plant cells expressing one form of casein. The applicant argues Geistlinger does not teach that the recombinant proteins are produced in a plant cell nor that the plant cells could be used directly for producing a dairy product without isolation of the recombinant proteins from the transgenic plant cells. However, Geistlinger is not replied upon to teach the slurry of transgenic plant cells expressing casein. El-Richani clearly teaches the transgenic plant material can be further processed and utilized without extracting the protein of interest ([0283]). El-Richani specifically teaches further processing into a powder which reads on the claimed limitation of the slurry being “configured” to be spray dried. One with ordinary skill in the art would recognize spray drying forms a powder and therefore because the transgenic plant cells taught by El-Richani can be processed into a powder one with ordinary skill in the art would recognize it would be considered “configured” to be spray dried. Thus, the applicants argument is not found to be persuasive. Furthermore, as applicant has not specifically pointed out how this would not equate to the slurry of the instant invention being capable of being spray dried applicants arguments have not been found persuasive at this time. It is also important to note that the combination of Geistlinger and El-Richani teaches the same composition as instantly claimed, thus the composition must necessarily have the same properties as instantly claimed, including the capability of being spray dried. See MPEP 2112.01(II) "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Applicant argues that none of the cited documents alone or in combination teach or suggest recombinant caseins expressed as cytoplasmic non-secreted proteins. This is not found to be persuasive because El-Richani teaches embodiments where k-casein and β-casein are encoded without a signal peptide ([0216]-[0218], [0361]). El-Richani teaches when constructs are encoded with a signal peptide secretion of the target protein is desired ([0088]). As a result, the embodiments taught by El-Richani in which the k-casein and β-casein do not contain a signal peptide would be considered non-secreted proteins because a signal protein is required for secretion. Furthermore, one with ordinary skill in the art would recognize that without a signal peptide the protein would not be sent to the endoplasmic reticulum and thus stay where the protein is translated in the cytosol (i.e. the cytoplasm). This is evidence by Khan academy which teaches translation of all proteins in a eukaryotic cell begins in the cytosol (Overview of cellular shipping routes) and shortly after translation starts, the protein will either remain in the cytosol for the rest of translation, or be fed into the endoplasmic reticulum (ER) as it is translated. Proteins are fed into the ER during translation if they have an amino sequence called a signal peptide and proteins that do not have a signal peptide stay in the cytosol for the rest of translation. (Overview of cellular shipping routes). Therefore, because the El-Richani teaches an embodiment wherein casein lacks a signal protein, one with ordinary skill in the art would recognize the protein would stay in the cytoplasm. Therefore, applicants argument is not found to be persuasive.
Applicant argues that none of the cited documents alone or in combination teach or suggest the transgenic plant cells are configured to be spray-dried into a plant cell powder, prior to forming said slurry. As examiner has stated in the above rejection, the act of spray drying is not positively recited in the claim and only the act of “configured” in positively recited. Thus, because El-Richani teaches the transgenic plants can be further processed into the form of a powder, the art reads on the limitation which states, “wherein said transgenic plant cells are configured to be spray-dried into a plant cell powder, prior to forming said slurry” because if the material can be processed into a powder than one with ordinary skill in the art would recognize it would be in a state prior to further processing that would be considered “configured” to be spray dried. Continuing, the combination of Geistlinger and El-Richani teaches the same composition as instantly claimed, thus the composition must necessarily have the same properties as instantly claimed, including the capability of being spray dried. See MPEP 2112.01(II) "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Therefore, the applicants argument is not found to be persuasive.
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.
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792