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 .
Claims 1-7 are pending and under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
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 1-7 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 pre-AIA the applicant regards as the invention.
The claims recite the phrase “fermentation broth of an engineered strain of D-psicose-3-epimerase” which renders the claim vague and indefinite since the meaning of the phrase is uncertain by recitation of “engineered strain of D-psicose-3-epimerase”, the specific genetic modifications to the D-psicose-3-epimerase are not known and not recited in the claims, and it is uncertain if the claims are specifically directed to preserving the specific enzyme activity and stability of D-psicose-3-epimerase enzyme. Dependent claims 2-7 are also rejected because they do not correct the defect.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-7 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad genus of methods for preserving a fermentation broth of any genus of engineered strain of D- psicose-3-epimerases, comprising: adding any lysozyme into a fermentation broth of an engineered strain of D-psicose-3-epimerase, stirring to make the OD600 of the fermentation broth less than or equal to 1 to obtain an enzyme solution; and adjusting the enzyme solution to be weakly alkaline with an alkali liquor, and storing the weakly alkaline enzyme solution at room temperature. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The specification as originally filed does not disclose a representative number of species of the genus of engineered strain of D- psicose-3-epimerases. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures of the epimerases can be genetically engineered and still retain enzymatic activity.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed genus of methods for preserving a fermentation broth of any genus of engineered strain of D- psicose-3-epimerases, comprising: adding any lysozyme into a fermentation broth of an engineered strain of D-psicose-3-epimerase, stirring to make the OD600 of the fermentation broth less than or equal to 1 to obtain an enzyme solution; and adjusting the enzyme solution to be weakly alkaline with an alkali liquor, and storing the weakly alkaline enzyme solution at room temperature.
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 of this title, 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Shandong Fuyang Biotechnology (CN113957064, published 01/21/2022; PTO 892) in view of Suphantharika et al. (Bioprocess Engineering 12: 181-186, 1995; PTO 892), Zhu et al. (CN112852795, 05/28/2021; PTO 892), US20110269189 (2011-11-03; PTO 892)
Shandong Fuyang Biotechnology teaches a method for producing DPE (D-psicose epimerase) by high-density fermentation of recombinant Bacillus subtilis where “in the first step, the recombinant Bacillus subtilis is cultivated to obtain seed liquid; the second step is to inoculate the seed liquid obtained in the first step into a nutrient solution of a fermentation tank" (pg. 2, claim 1). Shandong Fuyang Biotechnology teaches that the primary and secondary seed media are comprised of 5 g/L yeast powder, 10 g/L peptone, 10 g/L sodium chloride (pg. 3, claim 3) and 50 mg/L kanamycin is added after sterilization (pg. 3, claim 5). Shandong Fuyang Biotechnology also teaches that the primary seed culture is obtained by inoculating 1% of recombinant Bacillus subtilis in the primary seed culture medium, Shandong Fuyang Biotechnology also teaches inoculating a fermentation tank with the obtained seed liquid, the amount being 10% by volume, ventilation is 1 vvm (air flow rate of 5 L/min) and a rotation speed of 400 rpm (pg. 3, claim 4). Shandong Fuyang Biotechnology further teaches that "the OD600 of the bacteria is 14-15, and the feeding rate is 10-11ml/L/h" (pg. 2, claim 1). Shandong Fuyang Biotechnology discloses ”the fermentation was finished, the bacterium OD600 = 100-110, and by centrifuging a crude enzyme solution was obtained, the enzyme activity being 200-210 U/mL; the resulting crude enzyme solution was slowly passed through an ion column, removing negative and positive ions to obtain a pure enzyme solution” (pg. 5, End of enzyme production”).
The teachings of the reference differ from the claims in that the reference does not teach the claimed method comprising adding the method step of adding a lysozyme into a fermentation broth.
Suphantharika et al. disclose constant control of dissolved oxygen (DOT) in B. subtilis fermentations at 15%, 20% and 40% (page 183, Table 2), wherein the maximum biomass concentration does not essentially vary between 15% and 20% (i.e., 4.4 g/L vs 4.3 g/L) and increases slightly at 40% (6.8% increase from 4.4 g/L to 4.7 g/L)(pg. 183, Table 2).
Zhu et al. discloses a recombinant Bacillus subtilis strain B-3-1, genetically engineered with a psicose 3-epimerase mutant (see entire publication and claims especially Examples 1-7, and claim 1 Specification).
US20110269189 teaches method for extracting high acyl gellan from the fermentation broth containing gellan gum with a low production cost and high quality of products (see entire publication and claims especially paragraphs [0008]-[0041] and Examples 1-2). US20110269189 teaches the following in the claims:
1. A post extraction process for preparing high acyl gellan, comprising the following steps:
(1) Treatment of the Fermentation Broth with an Enzyme;
Adding the enzyme preparation into the fermentation broth to conduct a reaction by raising the temperature;
(2) Flocculation of the Fermentation Broth with an Acid;
Cooling down the fermentation broth treated by the enzyme in step (1), adding an acid to flocculate the fermentation broth, and then conducting a solid-liquid separation;
(3) Wash of the Solid Fiber-Like Material;
Washing the solid fiber-like material obtained from the solid-liquid separation in step (2) firstly with a low polar or non-polar solvent, then conducting a solid-liquid separation, and then washing the solid fiber-like material with a lower alcohol, and then conducting a solid-liquid separation; and
(4) Drying and Disintegrating;
Drying and disintegrating the solid material obtained in step (3), to obtain the high acyl gellan product.
2. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the enzyme used in step (1) is one enzyme or a combination of more than one enzymes, wherein the enzymes are selected from the group consisting of neutral protease, alkaline protease, acidic protease, papain, and lysozyme.
3. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the enzyme used in step (1) is a combination of an alkaline protease and a lysozyme, with the two enzymes of alkaline protease and lysozyme in the combination in the weight ratio of 5:1.
4. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the amount of the enzyme preparation is used at the final concentration of 100 ppm, on the basis of the volume of the fermentation broth.
5. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the enzyme is firstly dissolved and dispersed with a small amount of water, and then added.
6. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the reaction by raising the temperature in step (1) is conducted by raising the temperature up to 50-60° C. and maintaining the temperature for 4˜6 hrs.
7. The post extraction process for preparing high acyl gellan according to claim 1, the flocculation with an acid in step (2) is to cool down the material of step (1) to a temperature below 35° C., to add the acid into the material to adjust the pH to a pH in the range of 1.5˜4, and form the fiber-like flocculates, and then to conduct a solid-liquid separation.
8. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the acid used in step 2 is at the concentration of 10%.
9. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the acid used in step 2 is one selected from the group consisting of acetic acid, citric acid, hydrochloric acid, and sulfuric acid.
10. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the acid used in step 2 is acetic acid.
11. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the device used for the solid-liquid separation in step 2 is chamber-type plate-and-frame filter press.
12. The post extraction process for preparing high acyl gellan according to claim 1, characterized in that the wash with a non-polar solvent in step (3) is: taking the material prepared in step (1), adding the non-polar solvent in the amount of 1 to 2 times of the material in weight into the material, and adjusting to pH 4.5˜8 with a base and washing 2 hrs and conducting the solid-liquid separation.
13. The post extraction process for preparing high acyl gellan according to claim 12, characterized in that the low polar or non-polar solvent used in step 3 is one selected from the group consisting of acetone, butanone, ethyl ether, and n-hexane.
14. The post extraction process for preparing high acyl gellan according to claim 12, characterized in that the low polar or non-polar solvent in step 3 is acetone.
15. The post extraction process for preparing high acyl gellan according to claim 12, characterized in that the base in step 3 is used at the concentration of 10%.
16. The post extraction process for preparing high acyl gellan according to claim 12, characterized in that the base used in step 3 is one selected from the group consisting of NaOH, KOH, Na2CO3, and K2CO3.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by fermenting in broth the recombinant Bacillus subtilis expressing D-psicose epimerase taught by Shandong Fuyang Biotechnology or recombinant Bacillus subtilis strain B-3-1 genetically engineered with a psicose 3-epimerase mutant of Zhu et al. as taught by Shandong Fuyang Biotechnology under conditions including the recited amounts of dissolved oxygen as taught by Suphantharika et al.; adding lysozyme and adjusting the pH of the broth by addition of sodium hydroxide as taught by US20110269189; and storing the solution at room temperature. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain a simple method for preserving the stability and activity of the D-psicose epimerase. It would have been obvious to adjust the amounts of the enzymes and proportions of the enzymes, adjust to desired alkaline pH 8.0, and room temperature levels recited in the claims as routine optimization and/or as desired in view of the above teachings for preserving the stability and activity of the D-psicose epimerase. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success in view of the reference teachings showing addition of lysozyme to fermentation broth. Hence, the claimed invention as a whole is prima facie obvious.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US Patent No. 12012627. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims are broad and widely varying and encompass any method for preserving a fermentation broth of any engineered strain of D- psicose-3-epimerase, comprising: adding a lysozyme into a fermentation broth of an engineered strain of D-psicose-3-epimerase, stirring to make the OD600 of the fermentation broth less than or equal to 1 to obtain an enzyme solution; and adjusting the enzyme solution to be weakly alkaline with an alkali liquor, and storing the weakly alkaline enzyme solution at room temperature.
The claims and/or specification of the patents teach the claimed method for preserving a fermentation broth of an engineered strain of D- psicose-3-epimerase, comprising: adding a lysozyme into a fermentation broth of an engineered strain of D-psicose-3-epimerase, stirring to make the OD600 of the fermentation broth less than or equal to 1 to obtain an enzyme solution; and adjusting the enzyme solution to be weakly alkaline with an alkali liquor, and storing the weakly alkaline enzyme solution at room temperature. Thus, the teachings anticipate the claimed invention.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of Application Serial No. 19041885, claims 1-12 of Application Serial No. 19041945. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims are broad and widely varying and encompass any method for preserving a fermentation broth of any engineered strain of D- psicose-3-epimerase, comprising: adding a lysozyme into a fermentation broth of an engineered strain of D-psicose-3-epimerase, stirring to make the OD600 of the fermentation broth less than or equal to 1 to obtain an enzyme solution; and adjusting the enzyme solution to be weakly alkaline with an alkali liquor, and storing the weakly alkaline enzyme solution at room temperature.
The claims and/or specification of the copending applications teach the claimed method for preserving a fermentation broth of an engineered strain of D- psicose-3-epimerase, comprising: adding a lysozyme into a fermentation broth of an engineered strain of D-psicose-3-epimerase, stirring to make the OD600 of the fermentation broth less than or equal to 1 to obtain an enzyme solution; and adjusting the enzyme solution to be weakly alkaline with an alkali liquor, and storing the weakly alkaline enzyme solution at room temperature. Thus, the teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652