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 .
Priority
The instant claims herein are examined utilizing the accepted effective filing date of 11/25/2021 for the basis of any prior art rejections.
Drawings
The drawings are objected to because Fig. 5 is illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 10, and 22 are objected to because of the following informalities:
Claim 1 recites multiple instances of “a step of”. Normally, recitation of “step of” could raise 112(f) interpretation. However, as per MPEP 2181, a limitation of that claim cannot be construed as a step-plus-function limitation without a showing that the limitation contains no act. The examiner suggests that the claim should be amended to remove the “step of” language from the claims.
Claim 10 is missing “a” after “comprises” in the phrase “wherein the method further comprises sterilization process”. The examiner suggests amend the claim to read as “wherein the method further comprises a sterilization process”.
Claim 22 recites “comprising a step of”. The recitation of “step of” is redundant since Applicant has already listed the step in numerical form. However, the examiner suggests that the claim should be amended to remove the “step of” language from the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 24-27 and 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.
Claim 24 recites the limitation "the medium additive for culturing cultured meat" in line 3. There is insufficient antecedent basis for this limitation in the claim because there is no previous recitation of a culture medium additive in claim 22 of which this claim depends. Although the claim recites “produced by the method of claim 1,” claim 22 does not depend on claim 1. Thus, the claim is indefinite. Claim 25-27 are included in this rejection or their dependency on indefinite claim 24.
Claim 29 recites the limitation "the medium additive for culturing cultured meat" in line 3. There is insufficient antecedent basis for this limitation in the claim because there is no previous recitation of a culture medium additive in claim 22 of which this claim ultimately depends. Although the claim recites “produced by the method of claim 1,” claim 22 does not depend on claim 1. Thus, the claim is indefinite.
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.
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.
Claim(s) 1-6, 8, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazuo et al (JPH0330669A, 6/28/1989; published 2/8/1991) in view of Milne et al (Journal of Pharmacy and Pharmacology, 2: 831-835; 1950).
Kazuo teaches a method for producing a medium additive for animal cell culture comprising bringing mammalian plasma or serum into contact with heparin and collecting components adsorbed into the heparin (claim 1 of Kazuo).
Regarding claim 2, Kazuo teaches that the plasma or serum are collected from bovine, horse, swine, or goat (abstract).
Regarding claim 1, 6, 8, and 10, Kazuo teaches that the aqueous solution can be subjected to sterilization filtration using a membrane filter or a 0.22 μm filter (see example 1 of Kazuo).
Kazuo does not teach:
Bleaching the serum or plasma, and
the bleaching comprises mixing kaolin with the serum or plasma.
Regarding (i), Milne teaches the preparation of liquid human plasma and states that pooled plasma is normally opaque due to the presence of fat and, during storage, clots and particles of fibrin can develop (p. 831, para 2).
Regarding claim 1 in-part and claim 4, Milne continues to teach that kaolin can be used for the adsorption of fibrinogen and prothrombin and that it is less likely to produce toxic reactions than material untreated with kaolin (p. 831, para 4).
The plasma prepared with kaolin is clear (i.e., bleached) and is practically free from fibrinogen and prothrombin and will not form fibrin clots on storage for periods of 4 to 6 months (p. 832, para 3).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to produce a medium additive for cell culture from animal serum or plasma as taught by Kazuo, where the plasma is bleached with kaolin as taught by Milne, to arrive at the instantly claimed invention. Milne shows that plasma can be successfully made clear with kaolin. One of ordinary skill would have been motivated to simply substitute the heparin of Kazuo with the kaolin of Milne with a reasonable expectation of advantageously adsorption of fibrinogen and prothrombin, producing plasma with less toxic reactions, and having plasma that can maintain storage for 4 to 6 months as taught by the prior art.
Regarding claim 3, neither Kazuo or Milne state that the cattle are 30 to 48 months old, chickens are 2 to 8 weeks old, or that the pigs are 180 days old. However, one of ordinary skill in the art would have been free to use any age of cattle, pig, or chicken in the method of Kazuo and Milne in combination absent evidence to the contrary.
Regarding claims 5 and 11, neither Kazuo nor Milne describe that the bleaching is performed at 50-70℃ or that the sterilization is performed at 50-70℃. However, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05(II)(A))
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazuo and Milne as applied to claims 1-6, 8, and 10-11 above, and further in view of Oishi et al (US7087168B2, 7/24/2002, published 8/8/2022).
The teachings of Kazuo and Milne in combination were recited in the above 35 U.S.C. 103 rejection as applied to claim 1 of which claim 7 depends. The teachings will not be repeated here.
Neither Kazuo nor Milne teach:
pre-filtering process through pores sized 2 microns to 25 microns.
Oishi teaches a hollow fiber membrane for purifying blood.
Oishi continues to teach that bovine serum containing heparin (heparin amount: 5,000 IU/I, protein concentration: 6.0 g/dL (deciliters)) is heated to 37° C. and passed through the inner surface side of the membrane in the module at a linear speed of 1.0 cm/second to carry out ultrafiltration for 30 minutes with the average input and output pressure of the module being 50 mmHg.
The membrane of the present invention is a dry membrane not containing a membrane pore holding agent, does not possess a polymer deficient part where the pore size of the membrane exceeds 10 μm, and has a sponge-like structure with the pore size continuously decreasing from the outer surface of the membrane toward the compact layer of the inner surface.
The membrane exhibiting excellent selective permeability and having excellent dialysis performance, and allowing little elution from the membrane and little adhesion of blood proteins and platelets (“Disclosure of the invention” para 1).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to produce a medium additive as taught by Kazuo and Milne in combination, where the blood is pre-filtered as taught by Oishi, to arrive at the instantly claimed invention. Oishi shows that bovine serum can be pre-filtered. One of ordinary skill would have been motivated to modify the method of Kazuo and Milne in combination to include pre-filtering as taught by Oishi with a reasonable expectation of advantageously having excellent dialysis performance, and allowing little elution from the membrane and little adhesion of blood proteins and platelets as taught by the prior art.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazuo and Milne as applied to claims 1-6, 8, and 10-11 above, and further in view of Khouw et al (US3984539A, 12/02/1974, published 10/5/1976).
The teachings of Kazuo and Milne in combination were recited in the above 35 U.S.C. 103 rejection as applied to claim 8 of which claim 9 depends. The teachings will not be repeated here.
Neither Kazuo nor Milne teach:
the filtering further comprises using a filter paper, syringe filter and combinations thereof.
Regarding (i), Khouw teaches bovine blood from several animals was collected from an abattoir. Clear plasma was obtained by sedimenting the blood cells by means of a centrifuge.
Khouw continues to teach that 3 liters of the plasma so obtained was added 936 gms of solid ammonium sulfate, to give 0.5 saturation of the plasma with the ammonium sulfate. Precipitation occurred. The precipitate, containing the immunoglobulins was collected on a filter paper, dissolved in about 2.4 liters of 0.9% saline at 60° C with constant stirring for about 20 minutes. The mixture was cooled, and clarified by filtration through a cheesecloth and by centrifugation.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to produce a medium additive as taught by Kazuo and Milne in combination, where plasma is filtered through filter paper as taught by Khouw, to arrive at the instantly claimed invention. Khouw shows blood plasma can be successfully filtered through filter paper. One of ordinary skill would have been motivated to modify the method of Kazuo and Milne in combination to include filtration with filter paper with a reasonable expectation of advantageously obtaining clear plasma as taught by the prior art. One of ordinary skill would recognize that the improvements taught in Khouw would improve similar filtration methods in a similar way.
Claim(s) 22-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Arye et al (US20200140810A1, 7/15/2018; published 5/7/2020).
Regarding claim 22-24, 26-28 Ben-Arye teaches an edible composition comprising bovine satellite cells (BSC), which were cultured in BSC proliferation media 43.5% DMEM/HEPES (Gibco), 43.5% F-10 Nut Mix (Gibco), 10% FBS (HyClone), 1% NEAA (Gibco), 1% GlutaMAX (Gibco) and 1% Penicillin-Streptomycin-Amphotericin B Solution (Biological Industries (Ab/Am, BI) supplemented with 50 μM ZnCl2 (Millipore), 62 ng/ml EGF (R&D Systems), 100 ng/ml IGF-1 (R&D Systems), 10 ng/ml LIF (R&D Systems) and 10 ng/ml bFGF (R&D Systems) (para 124).
Regarding claim 25 and 29, Ben-Arye teaches that an optimized SC differentiation media comprises DMEM/HEPES (97%), Donor Horse Serum (2%; replacement for FBS), AB/AM (1% 1×), IGF-1 (100 ng/ml), and EGF (62 ng/ml).
Ben-Arye does not teach the weight parts of the medium compositions. The examiner is interpreting that the ranges described in Ben-Arye fall into the claimed “weight parts” ranges. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05(II)(A)).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to culture bovine satellite cells in the presence of culture medium additive as taught by Ben-Arye to arrive at the instantly claimed invention. Ben-Arye shows bovine satellite cells can be successfully cultured in FBS or BS substitute to produce edible composition. One of ordinary skill would have been motivated to use any amount of medium additive in the culture method with a reasonable expectation of advantageously producing cultured meat products for consumption by humans, or for animal feed as taught by the prior art. Moreover, one of ordinary skill would have been motivated to combine FBS with donor horse serum to produce edible compositions from muscle satellite cells. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (see MPEP 2144.06(I)).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.R./Examiner, Art Unit 1632 /DAVID A MONTANARI/ Examiner, Art Unit 1632
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