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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/18/26 has been entered.
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.
Claims 1, 3-13, 15-20 are 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. The phrases “prior to performing any heating steps following step d)” in claim 1, 13 are not supported by the application. Figure 1 positively discloses sterilizing at 130C before drying.
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.
Claims 1, 3-8, 13, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson Jr et al [US 11,051,532B2] in view of Suzuki et al [US 2004/0137560A1].
Henderson Jr et al teach a method for purifying protein (title) by providing a suspension of yeast cells (column 7, line 33; column 8, line 20), washing and adjusting the pH to “about” 8.5-12.0 (column 8, line 24), mechanically lysing the yeast cells at 4-15C (column 8, line 44), purification by steps such as centrifugation, clarification, precipitation, microfiltration, ultrafiltration, diafiltration, pasteurization, and/or spray drying (column 8, lines 52-56; Figure 1-2), the filtration reducing the amount of particulates with a molecular weight cutoff of 10 kDa or 30 kDa (column 9, lines 47, 64), an absence of heating between the filtration and spray drying steps (see whole document), the protein product capable of forming a gel (column 2, line 8), the suspension of yeast cells having about 10-15% dry matter (column 8, line 36), maintaining a pH of “about” 8.5-12.0 throughout the clarifying process (column 9, line 1-3), at least 99% of protein molecules being larger than 50 kDa (column 11, line 56-62), a protein content up to 250 mg/mL (column 11, line 35), at least 90% of the polypeptides being about 10-200 kDa in size (column 15, line 8), use of the protein composition as an egg replica, meat replica, or cheese replica (column 15, line 20), freeze-drying or spray drying the protein composition (column 25, line 53), a non-dairy solution made into a replica food having 20% protein (column 25, line 51; column 27, line 6-26), and creating a cheese-replica by heating and gelling the non-dairy milk at 55-65C to create a gel (column 43, lines 36-62).
For examination purposes, the pH range of “about” 8.5-12.0 of Henderson Jr et al, reads upon the claimed range of “between 6.5 and 8.5” as a value of 8.499, for example, would be considered to be “about” 8.5 in the process of Henderson Jr et al by one of ordinary skill in the art.
Henderson Jr et al do not explicitly recite performing all of steps a-d at 20C or less (claim 1, 13) or 15C or less (claim 2, 15).
Suzuki et al teach a method for preparing a yeast extract solution (title) by rupturing frozen yeast cells (paragraph 0011), mechanical rupturing/lysing with a mortar and pestle (paragraph 0013), removing intracellular components smaller than 5,000 from the solution (paragraph 0014), a pH value of 6.0-8.0 or 4-10 (paragraph 0017, 0041), centrifugation (paragraph 0044), and a reaction temperature of 10-40C (paragraph 0081).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed low temperature values into the invention of Henderson Jr et al, in view of Suzuki et al, since both are directed to methods of purifying yeast proteins, since Henderson Jr et al already disclosed mechanically lysing the yeast cells at 4-15C (column 8, line 44), the stated goal of achieving non-denatured protein (column 2, line 7), and an absence of heating during the other claimed steps a-d; since yeast purifying systems commonly operated at a reaction temperature of 10-40C (paragraph 0081) as shown by Suzuki et al, since proteins were known to become denatured at elevated temperatures, since using low temperatures throughout the process of Henderson Jr et al would have ensured that the proteins remain undenatured, and since the claimed temperature values would have been used during the course of normal experimentation and optimization procedures due to factors such as the type of yeast and/or the desired end use of the yeast.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson Jr et al, in view of Suzuki et al, as applied above, and further in view of Robbins et al [US 3,887,431].
Henderson Jr et al and Suzuki et al teach the above mentioned concepts. Henderson Jr et al also disclose at least 99% of protein molecules being larger than 50 kDa (column 11, line 56-62). Henderson Jr et al do not explicitly recite at least 55% protein (claim 9), the powder having at least 90% dry matter (claim 11).
Robbins et al teach a process for making yeast protein isolate with reduced nucleic acid content (title) by providing a suspension of yeast cells (Figure 1, 1st & 2ⁿᵈ box), water washing with dilute alkali (column 3, line 19), the suspension including 12% solids (column 5, line 66), adjusting the pH to 4.5-6.5 and a temperature of 32-122F (column 3, line 31), rupturing/lysing the cells by mechanical means (Figure 1, 3rd box; column 3, line 20-29), re-adjusting the pH to 8- 11 and a temperature of 40-140F (column 3, line 45), separating the ruptured cells by centrifugation and/or filtration into a cell wall residue and a protein extract (Figure 1, 4th box; column 3, lines 50), these mild conditions do not introduce off-flavors or destroy the nutritive quality of the protein (column 4, line 1), freeze-drying or spray-drying into a powder (column 4, line 23), the product containing 65-85% protein (column 4, lien 45), an example of the powder having 3.4% moisture (column 16, line 4), mixing the product with water at 100-140F to provide a gelled product (column 19, line 65), using the rehydrated and gelled product as a meat- substitute (column 20, lines 40-53).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed protein and moisture contents into the invention of Henderson Jr et al, in view of Suzuki et al and Robbins et al, since all are directed to methods of purifying yeast proteins, since Henderson et al already included a concentrated yeast protein but simply did not mention values for protein content and moisture content, since concentrated yeast protein systems commonly achieved the product containing 65-85% protein (column 4, lien 45) and an example of the powder having 3.4% moisture (column 16, line 4) as shown by Robbins et al, and since the claimed values would have been used during the course of normal experimentation and optimization procedures due to factors such as the desired end use of the concentrated protein and/or the intended storage conditions of the product of Henderson Jr et al, in view of Suzuki et al and Robbins et al.
Claims 12, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson Jr et al, in view of Suzuki et al, as applied above, and further in view of Drozd et al [US 4,729,958].
Henderson Jr et al and Suzuki et al teach the above mentioned concepts. Henderson Jr et al do not explicitly recite an RNAase enzyme (claim 12, 20). Drozd et al teach a method for improving the filterability of a microbial broth (title) by adding Ribonuclease and Deoxyribonuclease to broth of microbial cells to improve filterability (claim 1). It would have been obvious to one of ordinary skill in the art to incorporate the claimed RNAase into the invention of Henderson Jr et al, in view of Suzuki et al and Drozd et al, since all are directed to methods of purifying microbial proteins, since Henderson Jr et al already desired a reduced amount of cell debris by filtering, since it was commonly known that the addition of Ribonuclease and Deoxyribonuclease to a broth of microbial cells would improve filterability (claim 1) as shown by Drozd et al, and since improved filtering would have prevented clogging of the filters pf the combined system of Henderson Jr et al, in view of Suzuki et and Drozd et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-13, 15-20 have been considered but are moot because the new ground of rejection does not rely on the same references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Drozd et al used elevated temperatures. However, the temperatures used by Drozd et al were prior to the claimed steps a-d.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hwang et al also discloses mechanical lysing and filtration of microbial cells to create a concentrated protein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DREW E BECKER whose telephone number is (571)272-1396. The examiner can normally be reached 8am-5pm Monday-Friday.
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/DREW E BECKER/Primary Examiner, Art Unit 1792