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 .
DETAILED ACTION
Non-compliance and Status of the Claims
Receipt of Remarks/Amendments filed on 03/02/2026 is acknowledged. Claims 1-20 are cancelled. Claims 21-33 are new and pending. Applicant elected Group I, Claims 1, 3, 4, 9-14, and 19, and Group II, Claims 2, 5-8, 15, and 20 without traverse. The reply is not fully responsive to the prior Office action because Applicant was required to elect only ONE group. Furthermore, while indicating non-traversal in their response, Applicant also argued that Ummadi (US 9,253,993), which the Examiner has cited as art that breaks unity, does not defeat the unity of invention as Ummadi. However, for compact prosecution, because Applicant has cancelled Claims 1-20 and filed a new claim set, Claims 21-38 will be examined in lieu of issuing a noncompliance. Accordingly, Claims 21-38 are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
Claim Objections
Claims 21 and 24 are objected to because of the following informalities: For clarity, the Examiner recommends amending the recitation of “to a temperature of 75°C to 105°C” in these claims to “to a temperature between 75°C to 105°C” in order to avoid the possibility of interpreting the range as raising the temperature from 75°C to 105°C.
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 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 21-33, and 35-38 are rejected under 35 U.S.C. 103(a) as being unpatentable over Geistlinger et al. (CA 3116718 A1), hereinafter Geistlinger.
Geistlinger discloses compositions and methods for producing food products comprising recombinant components (Abstract).
Regarding Claim 21, Geistlinger teaches producing a food product comprising a recombinant component produced by a recombinant microbial host cell (Claim 1). Geistlinger teaches embodiments wherein the recombinant component is a recombinant casein selected from the group consisting of β-casein, [Symbol font/0x67]-casein, [Symbol font/0x6B]-casein, α-S1-casein, and α-S2-casein (Claims 75-76). The method provided comprises the steps of: a) obtaining a recombinant microbial host cell that is capable of producing a recombinant component; b) culturing the recombinant microbial host cell in a culture medium under conditions suitable for essentially eliminating or modulating an esterase activity and for production and/or secretion of the recombinant component to obtain a fermentation broth comprising the recombinant component and an essentially eliminated or modulated esterase activity; c) optionally purifying the recombinant component from the fermentation broth; and d) preparing a food product [0066]. Geistlinger teaches embodiments wherein the suitable pH is between 2 and 7.5; between 6 and 7.5; between 6.5 and 7.5 etc., thereby reading on the pH in step i), and also renders Claim 36 obvious [0067].
Regarding step ii), Geistlinger relates that the esterase activity in a fermentation broth or preparation is essentially eliminated or reduced by incubating the fermentation broth or preparation at high temperature, e.g. between 85°C and 90°C [0072].
Regarding step iii), Geistlinger teaches the purification of the recombinant component by precipitating out the esterase from the solution while the recombinant component remains intact and soluble [0085]. This can be performed by chromatography, sedimentation, centrifugation, or filtration [0086].
Geistlinger teaches the claimed step of producing a recombinant component, which reads on the casein, using microbial host cells, wherein the pH overlaps with the claimed pH. Geistlinger’s method removes esterases, which reads on the non-casein proteins, leaving the casein in the soluble fraction. The casein is recovered by chromatography etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the method of Geistlinger in obtaining a desired casein product prepared in the same manner as the instant claims.
Regarding Claim 22, Geistlinger teaches esterase which is non-casein protein, and teaches purification to remove the esterase from the soluble fraction, which necessarily enriches the fraction with casein [0085]-[0086]. As such, Claim 25 is also obvious.
Regarding Claim 23, Geistlinger teaches purifying the recombinant component from the microbial host cell [0136], [0188].
Regarding Claim 24, Geistlinger teaches an example wherein recombinant β-lactoglobulin was isolated by separation based on charge, followed by separation based on thermolability/thermostability (i.e., heating (e.g., 80-85°C for 20-60 minutes) to precipitate out the esterase activity [0256]. While Geistlinger does not teach an example for casein, one skilled in the art would take guidance from this example and start with the time and temperature exemplified for β-lactoglobulin and modify as needed to obtain the optimal conditions for casein.
Regarding Claim 26, Geistlinger teaches embodiments where the fermentation broth is clarified, i.e. a fermentation broth from which cells and cell debris were removed, or preparation comprising the recombinant component is heated to a temperature at which an esterase is denatured and precipitates out of solution but at which the recombinant component remains structurally intact and soluble. Geistlinger therefore implies that the second option, i.e. preparation comprising the recombinant component is heated to a temperature, does not involve lysis prior to heating [0085]. As such, Claim 37 is also obvious.
Regarding Claims 27 and 38, Geistlinger teaches a temperature between 85°C and 90°C, which is close to the claimed “about 95°C” [0072]. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Regarding Claims 28-30, Geistlinger teaches embodiments in which the recombinant polynucleotide comprises two or more expression cassettes [0169]. The recombinant protein that is typically encoded by the recombinant polynucleotide can be any recombinant e, g, recombinant β-lactoglobulin, recombinant α-lactalbumin, recombinant [Symbol font/0x6B]-casein, recombinant β-casein etc.
Regarding Claims 31-32, Geistlinger teaches its recombinant components can be purified on the basis of its molecular weight, e.g. size exclusion/exchange chromatography, ultrafiltration, gel permeation chromatography, or density centrifugation [0184].
Regarding Claim 33, Geistlinger teaches its recombinant component also can be purified on the basis of its surface charge or hydrophobicity/hydrophilicity, by, for example, isoelectric precipitation [0185].
Regarding Claim 35, Geistlinger teaches bacteria as the recombinant microbial host cell [0136].
Claim 34 is rejected under 35 U.S.C. 103(a) as being unpatentable over Geistlinger, as applied to Claims 21 and 31-33, and in view of Broyard et al. (Dairy Sci. & Technol. (2015) 95:831–862), hereinafter Broyard.
Geistlinger does not expressly teach the soluble fraction recovered in step (iii) is acidified to a pH of about 4.
Broyard recognizes the use of casein in the food industry (Abstract). Broyard teaches the effect of different physicochemical conditions, including acidification, on casein molecules (Fig. 1). Broyard discloses that decrease in pH induces changes on intra- and intermolecular interactions of casein molecules, wherein the phosphoseryl residues and carboxyl groups change their ionization state (Section 2.1.5). During acidification, casein molecules are aggregated and their solubilities are minimal; At pH 4.6, the charge of caseins is equal to zero and precipitation or gelation is observed (Section 2.1.5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Broyard with that of Geistlinger, and acidify the soluble fraction of Geistlinger, starting at pH 4.6 and lowering as needed, to precipitate the casein if the artisan desires to isolate the casein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3, 12-16, 18, 20, and 23-24 of Application 19/503,556, hereinafter ‘556, in view of Geistlinger and Broyard.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter and composition components.
Both the instant claims and ‘556 are drawn to a method providing a composition comprising microorganisms transformed with at least one nucleic acid encoding a casein, the microorganisms having been cultured under conditions that induce expression of the nucleic acid and production of the casein, wherein the microorganism composition has a pH of at least 6.5; heating the composition, and recovering the soluble fraction comprising casein.
The differences are cured by Geistlinger and Broyard, the teachings of which have been set forth in the 103 rejection supra.
Therefore, the claims are drawn to the same subject matter and are not patentably distinct from the instant claims.
Claims 21-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 40, 49-60 and 64 of Application 19/503,565, hereinafter ‘556, in view of Geistlinger and Broyard.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter and composition components.
Both the instant claims and ‘565 are drawn to a method providing a composition comprising microorganisms transformed with at least one nucleic acid encoding a casein, the microorganisms having been cultured under conditions that induce expression of the nucleic acid and production of the casein, wherein the microorganism composition has a pH of at least 6.5; heating the composition, and recovering the soluble fraction comprising casein.
The differences are cured by Geistlinger and Broyard, the teachings of which have been set forth in the 103 rejection supra.
Therefore, the claims are drawn to the same subject matter and are not patentably distinct from the instant claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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