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
Claims 1-7 are canceled. Claims 15-27 are new. Claims 8-27 are pending and under consideration.
In light of the claim amendment on 11/10/2025, the rejection of claims 9 and 11 under 35 U.S.C. §112(d) is withdrawn; the rejection of claims 1 and 7 under 35 U.S.C. §102(a)(1) as being anticipated by Minami with evidence from Archer is withdrawn; the rejection of claims 2-7 under 35 U.S.C. §103 over Minami is withdrawn; and the provisional double patenting rejections of claims 1-7 over Choi ‘943 (18/255,943) or Shin ‘256 (18/023,256) in view of Minami and Unagul are withdrawn.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The instant claims are entitled to the effective filing date of 01/18/2021 because a certified translation of the priority document, KR10-2021-0006814, was received on 10/09/2025.
Claim Rejections - 35 USC § 112(a)
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 15, 20 and 26-27 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 amendment filed on 11/10/2025 has introduced new matter into the claims.
Claim 15, as filed on 11/10/2025, recites the method according to claim 8, wherein the composition comprises at least 6 wt% of at least one selected from the group consisting of skim milk, sucrose, and sodium chloride based on the total weight of the composition.
Claim 20, as filed on 11/10/2025, recites the method according to claim 10, wherein the composition comprises at least 6 wt% of at least one selected from the group consisting of skim milk, sucrose, and sodium chloride based on the total weight of the composition.
Claim 26, as filed on 11/10/2025, recites the method according to claim 8, wherein the method increases viability of the microalgae compared to mixing a composition that does not include sucrose.
Claim 27, as filed on 11/10/2025, recites the method according to claim 10, wherein the method increases viability of the microalgae compared to mixing a composition that does not include sucrose.
Applicant’s amendment, filed 11/10/2025, directs to support to the original specification, as filed 02/24/2023, and asserts that no new matter has been added. See paragraph 1 on page 6 of the remarks. However, the specification and the original claims do not provide sufficient written description of the above underlined limitations.
Claims 15 and 20 contain new matter because of the limitation that requires the skim milk, sucrose, and/or sodium chloride to be in an amount that is at least 6 wt% based on the total weight of the composition. Claims 26 and 27 contain new matter because of the limitation that requires the method to increase viability of the microalgae compared to mixing a composition that does not include sucrose. In other words, the instant disclosure does not provide a comparison commensurate in scope with claims 26 and 27.
The specification and the original claims do not provide support for the full breadth encompassed by the “at least 6 wt%” limitation in claims 15 and 20. The disclosure teaches a composition that comprises 0.5 wt% to 20 wt% of skim milk, 1 wt% to 20 wt% of sucrose and 0.1 wt% to 10 wt% of sodium chloride based on the total weight of the composition. See paragraphs 3-5 on page 3 of the specification as filed 02/24/2023 and claims 2-4 as filed 02/24/2023. However, the disclosure does not support an embodiment with at least 6 wt% of skim milk, sucrose and/or sodium chloride where there is no upper weight percentage limit.
The specification and the original claims do not provide support for a method that increases the viability of microalgae compared to mixing a composition that does not include sucrose. In example 2, a biomass suspension of Schizochytrium (accession number KCTC14345) is freeze-dried with the preservative compositions disclosed in table 2. Table 2 teaches condition 2-6, which corresponds to a composition that includes skim milk, sucrose and sodium chloride. As shown in table 3, the viability of the cells freeze-dried with a preservative containing skim milk, sucrose and sodium chloride (condition 2-6) is 16.67%. See pages 12-13 of the specification. The specification does not compare the viability of cells freeze-dried in accordance with condition 2-6 to the viability of cells freeze-dried with only skim milk and sodium chloride (i.e. the composition without sucrose). Furthermore, example 2 is specific to Schizochytrium (accession number KCTC14345). Thus, the specification does not provide support for the instantly claimed viability comparison.
Such limitations recited in the instant claims 15, 20 and 26-27, which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the instant claims.
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 8-11, 15-24 and 26-27 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.
Claims 8 and 10 recite “the composition comprising skim milk, sucrose, and sodium chloride” (line 4 of claim 8 and the last two lines of claim 10). There is insufficient antecedent basis for this limitation in the claim.
Claims 9, 11, 15-24, and 26-27 depend from either claim 8 or 10 and are rejected for the reason set forth above.
Claims 15-18 and 20-23 recite “the composition”, which is indefinite because it is unclear which composition is being referenced. Claims 15-18 depend from claim 8, which includes multiple compositions. Consequently, it is unclear whether “the composition” is referring to (1) the medium comprising the composition comprising skim milk, sucrose and sodium chloride, (2) the mixed product, which comprises Thraustochytriaceae microalgae with a medium composition comprising skim milk, sucrose, and sodium chloride, or (3) the freeze-dried biomass. Claims 20 and 21 depend from claim 10, which includes multiple compositions. Consequently, it is unclear whether “the composition” is referring to (1) the freeze-dried recovered culture product with the composition comprising skim milk, sucrose, and sodium chloride, or (2) the skim milk, sucrose, and sodium chloride before the freeze-drying step.
Claims 26 and 27 recite “the method increases viability of the microalgae compared to mixing a composition that does not include sucrose”, which is indefinite because there are multiple reasonable interpretations for this limitation. In the first interpretation, the claim requires the method to increase the viability of the microalgae compared to the viability of the microalgae when mixed with any composition that does not include sucrose. In the second interpretation, the claim requires the method to increase the viability of the microalgae compared to the viability of the microalgae when mixed with a composition comprising only skim milk and sodium chloride, without sucrose. In the third interpretation, the claim is incomplete because it is unclear how a microalgae’s viability can be compared to the active method step of “mixing a composition that does not include sucrose”. Furthermore, claims 26 and 27 recite “the microalgae” and it is unclear whether the claims are referring to the Thraustochytriaceae microalgae before or after the freeze-drying step of claims 8 and 10, from which claims 26 and 27 depend respectively.
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 8-17, 19-22 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Minami (JPH10243781A) in view of Unagul (Botanica Marina, 2017, 60(4), 363-379; as filed with the IDS on 02/24/2023), with evidence from Archer (Frontiers in Nutrition, 2022, 9, 746018).
Regarding claims 8, 10, 19 and 24, Minami teaches a method for long-term preservation of microorganisms, which comprises centrifuging the microorganisms to be preserved (recovering culture product), discarding the culture liquid, suspending the microorganisms in a dispersion medium comprising skim milk, sucrose, bouillon, etc., dispensing the suspended microbial liquid into storage ampule tubes, rapidly freezing the liquid, and drying the microorganisms together with the medium by evaporating the frozen water produced by the freezing under reduced pressure in a sterile environment, and then preserving the liquid in a sealed state. See Minami claim 1 and [0007] for the culture step prior to centrifugation. Evidentiary reference Archer discloses that bouillon typically includes salt in the form of sodium chloride. See the first two paragraphs of the ‘sodium levels in bouillon’ section of Archer. Minami indicates that the term “microorganisms” includes microalgae. See [0001].
Minami does not teach Thraustochytriaceae microalgae.
Unagul teaches the cryopreservation of four marine thraustochytrids: Parietichytrium sakarianum (JS510), Aurantiochytrium sp. (JS702), Thraustochytrium sp. (JS974), and Thraustochytrium sp. (JS1085). See the ‘cryopreservation of selected thraustochytrids’ section on page 367 and table 1. Unagul suggests that the long-term preservation of these microorganisms [in reference to thraustochytrids] is of importance for reducing contamination and preserving genetic change. See the second full paragraph on page 364. Thus, Unagul teaches Thraustochytriaceae species, and suggests that there is a need for long-term preservation of such thraustochytrids.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use any one of the marine thraustochytrids of Unagul as the microorganism in the method for long-term preservation of microorganisms of Minami. One would be motivated to use the thraustochytrids of Unagul because Unagul suggests that there is a need to preserve these microorganisms for a long-time in order to reduce contamination and preserve genetic change. There would be a reasonable expectation of success because Minami discloses that microalgae may be used as the microorganism in the method for long-term preservation. Moreover, Minami and Unagul are in the same field of freeze-drying microorganisms with skim milk.
Regarding claims 9 and 11, neither Minami nor Unagul teaches frozen microorganism or microalgae before freeze-drying. Therefore, both Minami and Unagul meet claims 9 and 11.
Regarding claim 12, Minami teaches a dispersion medium comprising a composition comprising skim milk, sucrose, bouillon (a sodium chloride source as evidenced by Archer). Minami teaches suspending microorganisms in the dispersion medium, freezing the liquid and drying the microorganisms together with the medium. See Minami claim 1.
Minami does not teach Thraustochytriaceae microalgae.
Unagul teaches the cryopreservation of four marine thraustochytrids: Parietichytrium sakarianum (JS510), Aurantiochytrium sp. (JS702), Thraustochytrium sp. (JS974), and Thraustochytrium sp. (JS1085). See the ‘cryopreservation of selected thraustochytrids’ section on page 367 and table 1. Unagul suggests that the long-term preservation of these microorganisms [in reference to thraustochytrids] is of importance for reducing contamination and preserving genetic change. See the second full paragraph on page 364. Thus, Unagul teaches freeze-drying Thraustochytriaceae species, and suggests that there is a need for long-term preservation of such thraustochytrids.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use any one of the marine thraustochytrids of Unagul as the microorganism in Minami’s method for long-term preservation. In the process, one would arrive at freeze-dried biomass of Thraustochytriaceae comprising skim milk, sucrose and sodium chloride. One would be motivated to use the thraustochytrids of Unagul because Unagul suggests that there is a need to preserve these microorganisms for a long-time in order to reduce contamination and preserve genetic change. There would be a reasonable expectation of success because Minami discloses that microalgae may be used as the microorganism in the method for long-term preservation. Moreover, Minami and Unagul are in the same field of freeze-drying microorganisms with skim milk.
Regarding claims 14 and 25, Minami teaches that microorganisms can be cultured under well-known conditions suitable for the growth of each microorganism. Freeze-drying for long-term storage of microorganisms can be carried out according to conventional freeze-drying methods. Specifically, for example, after centrifuging the culture solution, sterilized main solution, e.g. 5% glucose, 5% skim milk, 1% biopolymer, is aseptically added to the centrifuged product and the mixture is thoroughly mixed and suspended to a bacterial count of 108 [sic. 108] to 1010 [sic. 1010] cells/ml. The suspension is poured into storage ampoules, which are immersed in a dry ice-methanol solution to freeze the water, which are then placed in a vacuum system of a freeze-dryer. See [0005]. The microorganisms placed in the storage ampoule tube and freeze-dried are kept in a sealed state and are stored for a long period of time under conditions such as refrigerator controlled at 2 to 5˚C or a low-temperature room controlled at 10˚C or below. See [0006]. Thus, Minami indicates that the freeze-dried biomass that is able to be stored and Minami teaches a freeze-dried biomass that comprises between 108 [sic. 108] to 1010 [sic. 1010], which overlaps with the instantly claimed 1x107 to 1x108 live cells per 1 mL of the freeze-dried biomass range (relevant to instant claim 14) and the instantly claimed 1x1010 to 1x10-12 live cells per 1 mL of freeze-dried biomass range (relevant to instant claim 25).
Regarding claim 13, Minami does not disclose whether the freeze-dried biomass is “able to be stored for at least 12 weeks at 15 ºC to 25 ºC”. However, the instant product claims do not require the active step of storing the freeze-dried biomass, and all freeze-dried biomass is considered to be capable of being stored for any duration of time at any temperature.
Unagul teaches adding concentrated cells of marine thraustochytrids JS510, JS702, JS974 and JS1085 to a cryotube containing (iii) 17% skim milk (Difco) combined with 20% glycerol (SG). Unagul teaches freezing the cryotubes at 1ºC min-1 before storing at -80ºC for 6 months (i.e. approximately 24 weeks). See the ‘cryopreservation of selected thraustochytrids’ section’.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the storage time and temperature taught by Minami in view of Unagul. A person of ordinary skill in the art has good reason to pursue the known options within his/her technical grasp. There would be a reasonable expectation of success because Minami teaches that the freeze-dried microorganisms can be stored for a long period of time at 10˚C, and Unagul demonstrates storing marine thraustochytrids for 6 months. Moreover, MPEP 2144.05(II) indicates that “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).
Regarding claims 15-16 and 20-21, Minami teaches a medium for preserving a microorganism that contains one or more of sucrose, bouillon, skim milk, horse serum, glucose, sodium glutamate, cysteine, and gelatin as a dispersion and osmotic pressure adjusting agent. These additives are usually added to the microbial storage medium in an amount of 0.01 to 5.0% by weight. See [0005].
Minami does not teach a composition that comprises at least 6 wt% of at least one selected from the group consisting of skim milk, sucrose, and sodium chloride based on the total weight of the composition (relevant to instant claims 15 and 20).
Minami does not teach a composition that comprises at least one selected from the group consisting of skim milk in an amount of 6 wt% to 20 wt% based on the total weight of the composition, sucrose in an amount of 6 wt% to 20 wt% based on the total weight of the composition, and sodium chloride in an amount of 6 wt% to 10 wt% based on the total weight of the composition (relevant to instant claims 16 and 21).
Unagul teaches adding concentrated cells of marine thraustochytrids JS510, JS702, JS974 and JS1085 to a cryotube containing (iii) 17% skim milk (Difco) combined with 20% glycerol (SG). Unagul teaches freezing the cryotubes at 1ºC min-1 before storing. See the ‘cryopreservation of selected thraustochytrids’ section. Unagul suggests that SG is one of three cryoprotective agents that provides high survival rates for JS510 [Parietichytrium sarkarianum] after 6 months. See the sentence spanning the left and right columns on page 372.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the skim milk weight percentage of Minami in view of Unagul. One would be motivated to optimize the skim milk weight percentage, because Unagul teaches a cryoprotective agent with 17% skim milk that provides high survival rates for the marine thraustochytrid P. sarkarianum. There would be a reasonable expectation of success because Minami teaches using skim milk as an additive for preserving a microorganism, and Unagul demonstrates preserving the marine thraustochytrid microorganism P. sarkarianum for 6 months in a composition comprising 17% skim milk. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “Where 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).
Regarding claims 17 and 22, Minami teaches a medium for preserving a microorganism that contains one or more of sucrose, bouillon, skim milk, horse serum, glucose, sodium glutamate, cysteine, and gelatin as a dispersion and osmotic pressure adjusting agent. These additives are usually added to the microbial storage medium in an amount of 0.01 to 5.0% by weight. See [0005]. Thus, Minami indicates that the skim milk and sucrose can be at equivalent weight percentages between 0.01 to 5.0%, i.e. a 1:1 ratio.
Regarding claims 26 and 27, Minami teaches adding sucrose to the medium in which the microorganisms are cultured, so that the preserved organisms will not die (i.e. remain viable) during freeze-drying or when water is added to the preservation ampule tube to revive the preserved organisms. See [0002]. Thus, Minami suggests that sucrose affects the viability of microorganisms during freeze-drying.
Claims 18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Minami (JPH10243781A) and Unagul (Botanica Marina, 2017, 60(4), 363-379; as filed with the IDS on 02/24/2023), as applied to claims 8-17, 19-22 and 24-27, and further in view of Barclay (US 2008/0166780).
The teachings of Minami and Unagul with respect to instant claims 8 and 10 are discussed above.
Regarding claims 18 and 23, Minami teaches a medium generally used for culturing and preserving microorganisms. This medium for preserving microorganisms contains one or more of sucrose, bouillon (sodium chloride source), skim milk, horse serum, glucose, sodium glutamate, cysteine, and gelatin as a dispersion and osmotic pressure adjusting agent. These additives are usually added to the microbial storage medium in an amount of 0.01 to 5.0% by weight. See [0005]. Minami suggests adding skim milk or sucrose to the culture medium for conventional long-term preservation. See [0004].
Unagul suggests that the long-term preservation of these microorganisms [in reference to thraustochytrids] is of importance for reducing contamination and preserving genetic change. See the second full paragraph on page 364. Unagul discloses that Schizochytrium is an example of a thraustochytrid strain. See table 1.
Minami and Unagul do not teach a composition that comprises skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10 (relevant to instant claims 18 and 23).
Barclay teaches a process comprising: culturing the microorganism of the order Thraustochytriales in a culture medium that comprises a chloride concentration of less than 3 grams of chloride per liter of said culture medium. See claim 74. The microorganism is Thraustochytrium, Schizochytrium or mixtures thereof. See claim 86. Barclay suggests that by reducing the chloride content in the medium the corrosive effects of chloride on fermentation equipment can be avoided. See [0005] and [0020]. In example 8, Barclay teaches inoculating a culture medium comprising 2.5 g of NaCl with a colony of Schizochytrium sp S31. The cells are harvested by centrifugation, lyophilized and stored under N-2. See [0052].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to apply the long-term preservation technique of Minami and Unagul discussed above to the culture medium inoculated with Schizochytrium as taught by Barclay, and to further adjust the amount ratios of each component including the skim milk and sodium chloride. One would be motivated to apply the long-term preservation technique to the culture medium inoculated with Schizochytrium, because Minami suggests that additives including skim milk can be added directly to a culture medium prior to freeze-drying for long-term preservation, and Barclay teaches lyophilizing and storing the Schizochytrium. There would be a reasonable expectation of success because Minami discloses that microalgae may be used as the microorganism in the method for long-term preservation. One would be further motivated to adjust the ratio of the components including skim milk and sodium chloride because a person of ordinary skill in the art has good reason to pursue the known options within their technical grasp. One would be particularly motivated to adjust the sodium chloride concentration because Barclay suggests that the chlorine of NaCl can be corrosive. There would be a reasonable expectation of success because Minami teaches a skim milk weight percentage range of 0.01 to 5% from which one could optimize, and Barclay provides a NaCl amount, i.e. less than 3g, from which one could optimize. In the process, one could reasonably expect the ratio of the skim milk to sodium chloride to be adjusted as well. MPEP 2144.05(II) states that “[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).
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
§ 103 rejection over Minami in view of Unagul with evidence from Archer
Applicant argues that there is no reason to combine the cited references. Applicant argues that Unagul shows that the addition of skim milk decreases viability of thraustochytrids. Applicant references G and SG of figure 5 of Unagul. See the last three paragraphs on page 7 of the remarks. Accordingly, Applicant asserts that there is no reason to combine Unagul’s thraustochytrids to Minami’s cryopreservation method, which includes skim milk. See the first paragraph on page 8 of the remarks.
This argument is not persuasive because MPEP 2123 states that “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments”. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). In the instant case, Unagul discloses that three cryoprotective agents D (DMSO), G (glycerol), and SG (skim milk combined with glycerol) provided the highest survival rates for JS510 (Parietichytrium sarkarianum) after preservation for 6 months. See the sentence spanning the left and right columns on page 372 of Unagul. Thus, Unagul does not teach away from using skim milk as a cryoprotective agent for microalgae. Rather, Unagul provides motivation for the long-term preservation of [thraustochytrid] microorganism. See the first full paragraph on page 364 of Unagul. As such, Applicants argument that there is no reason to combine the cited references is not persuasive.
Applicant argues that Hubalek teaches that sucrose and milk are known to be less effective cryoprotective additives. In addition, species and strains of microorganisms also affect the effectiveness of cryopreservation. For example, sucrose has a cryoprotective effect in E. coli but is not effective in many other microorganisms, or even toxin in some strains. See page 211 of Hubalek. Therefore, one would have no reason to add sucrose in a composition for cryopreservation as set forth in the present claims. See the second paragraph on page 8 of the remarks.
This argument is not persuasive because a reference is presumed to be operable until applicant provides facts rebutting the presumption of operability. See MPEP 2121. Minami suggests that sucrose can be used as an additive for freeze-drying and for the long-term storage of microorganisms, which encompasses microalgae. See [0001] and [0002] of Minami. Hubalek, as cited by Applicant, teaches sucrose, and skimmed milk as cryoprotectants used in microbiology. See table 1. However, Hubalek is silent regarding the cryoprotective effect of sucrose on thraustochytrids and is not germane to the rejection at issue. As such, Applicant’s argument that one would have no reason to add sucrose in a composition for cryopreservation is not persuasive.
Applicant argues that one of ordinary skill in the art would not have reasonably expected viability to increase as set forth in new claims 26 and 27. Hubalek discloses that adding sucrose as a cryoprotective additive would not have cryoprotective effect other than E. coli. See the last paragraph on page 8 of the remarks.
This argument is not persuasive because the viability required in claims 26 and 27 is indefinite, as discussed above. Minami teaches adding a dispersing medium such as sucrose to the medium in which the microorganisms are cultured, so that the preserved organisms will not die (i.e. remain viable) during freeze-drying. See [0002]. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 8-17, 19-22 and 24-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/255,943 (hereafter Choi ‘943) in view of Minami (JPH10243781A) in view of Unagul (Botanica Marina, 2017, 60(4), 363-379; as filed with the IDS on 02/24/2023), with evidence from Archer (Frontiers in Nutrition, 2022, 9, 746018). The underlined text below is relevant to the instant claims.
This is a provisional nonstatutory double patenting rejection.
Copending claim 1 recites microalgae of the genus Schizochytrium (Schizochytrium sp.), deposited under an accession number of KCTC14345BP or KCTC14345BP, and having an ability to produce docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and palmitic acid (PA).
Copending claim 7 recites biomass derived from microalgae of the genus Schizochytrium, comprising: the microalgae of the genus Schizochytrium of claim 1, cultures of the microalgae, dried products of the cultures, or lysates of the dried products.
Copending claim 9 recites a method of preparing biomass derived from microalgae of the genus Schizochytrium, comprising:
culturing microalgae of the genus Schizochytrium, which are deposited under an accession number of KCTC14345BP, and have an ability to produce docosahexaenoic acid, eicosapentaenoic acid, and palmitic acid; and
recovering biomass from the microalgae, cultures of the microalgae, dried products of the cultures, or lysates of the dried products.
Copending claim 11 recites the method of claim 9, wherein the culturing is performed by using a medium comprising a carbon source and a nitrogen source.
Copending claim 12 recites the method of claim 11, wherein the carbon source is at least one selected from the group consisting of glucose, fructose, maltose, galactose, mannose, sucrose, arabinose, xylose, and glycerol.
The copending claims lack mixing Thraustochytiaceae microalgae with a medium comprising the composition comprising skim milk, sucrose and sodium chloride and freeze-drying the mixed product to prepare biomass (relevant to instant claim 8); wherein the microalgae is not frozen before or after the freeze-drying (relevant to instant claim 9). The copending claims lack freeze-drying the recovered cultured product with the composition comprising skim milk, sucrose, and sodium chloride to prepare biomass (relevant to instant claim 10); the microalgae is not frozen before or after the freeze-drying (relevant to instant claim 11). The copending claims lack: a composition for cryopreservation comprising skim milk, sucrose and sodium chloride (relevant to instant claim 12); a freeze-dried biomass that is able to be stored for at least 12 weeks at 15 to 25ºC (relevant to instant claim 13), and comprises 1x107 to 1x108 live cells per 1 mL of freeze-dried biomass (relevant to instant claim 14); or 1x1010 to 1x1012 live cells per 1 mL of freeze-dried biomass (relevant to instant claim 25). The copending claims lack a composition comprising: at least 6 wt% of at least one selected from the group consisting of skim milk, sucrose, and sodium chloride based on the total weight of the composition (relevant to instant claim 15 and 20); at least one selected from the group consisting of skim milk in an amount of 6 wt% to 20 wt%, sucrose in an amount of 6 wt% to 20 wt%, and sodium chloride in an amount of 6 wt% to 10 wt% (relevant to instant claim 16 and 21); a skim milk and sucrose at a weight ratio of 1:0.5 to 1:10 (relevant to instant claim 17 and 22). The copending claims lack a method that increases viability compared to mixing a composition that does not include sucrose (relevant to instant claims 26 and 27).
Minami teaches culturing microorganisms, centrifuging microorganisms to be preserved, and suspending the microorganisms in a dispersion medium comprising skim milk, sucrose, bouillon (sodium chloride source evidenced by Archer), etc., dispensing the suspended microbial liquid into storage ampule tubes, rapidly freezing the liquid, and drying the microorganisms together with the medium by evaporating the frozen water produced by the freezing. See Minami claim 1 and [0007] and the first two paragraphs of the ‘sodium levels in bouillon’ section of Archer. Minami indicates that the term “microorganisms” includes microalgae. See [0001]. Unagul suggests that the long-term preservation of thraustochytrids is of importance for preserving genetic change. See the second full paragraph on page 364 (relevant to instant claims 8 and 10). Neither Minami nor Unagul teach freezing a microorganism or microalgae before the freeze-drying (relevant to instant claims 9 and 11). Minami teaches a bacterial count of 108 [sic. 108] to 1010 [sic. 1010] cells/ml [0005]. The microorganisms placed in the storage ampoule tube, freeze-dried and stored for a long period of time under a low-temperature of 10˚C or below. See [0006]. Unagul teaches a 6-month storage period (relevant to instant claims 13-14 and 25). Minami teaches additives including sucrose, bouillon and skim milk in an amount of 0.01 to 5% by weight [0005]. Unagul teaches a cryoprotective agent that comprise 17% skim milk. See the ‘cryopreservation of selected thraustochytrids’ section (relevant to 15-17 and 20-22). Minami teaches that adding a dispersing medium such as sucrose to the medium in which the microorganisms are cultured preserves them during freeze-drying (relevant to instant claims 26 and 27).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use the Schizochytrium microalgae of Choi ‘943 as the microorganism in the preservation method of Minami because Unagul suggests that it is important to preserve thraustochytrids (e.g. Schizochytrium) in order to reduce contamination and prevent genetic damage; and to further optimize the concentration and ratio of each component within the freeze-dried product obtained from the method of Choi ‘943, Minami and Unagul. There would be a reasonable expectation of success because Minami discloses that the microorganism may be microalgae, and Minami teaches starting concentrations from which one could optimize.
Claims 18 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/255,943 (hereafter Choi ‘943) in view of Minami (JPH10243781A), Unagul (Botanica Marina, 2017, 60(4), 363-379; as filed with the IDS on 02/24/2023), and Barclay (US 2008/0166780).
This is a provisional nonstatutory double patenting rejection.
Copending claim 9 recites a method of preparing biomass derived from microalgae of the genus Schizochytrium, comprising:
culturing microalgae of the genus Schizochytrium, which are deposited under an accession number of KCTC14345BP, and have an ability to produce docosahexaenoic acid, eicosapentaenoic acid, and palmitic acid; and
recovering biomass from the microalgae, cultures of the microalgae, dried products of the cultures, or lysates of the dried products.
The copending claims lack a composition that comprises skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10 (relevant to instant claims 18 and 23).
Minami, in example 2, teaches culturing a microorganism in a medium, centrifuging (recovering) the culture, and using the precipitated bacteria to prepare a medium. The medium prepared is then thoroughly stirred (mixed) and dispensed into ampoule tubes for freeze-drying. See [0008]. Minami teaches a medium for culturing and preserving microorganisms that contains, for example, skim milk, sucrose and bouillon additives. These additives are usually added in an amount of 0.01 to 5% by weight. See claim 1 of Minami, and [0001] and [0005]. Unagul suggests that the long-term preservation of these microorganisms [in reference to thraustochytrids] is of importance for reducing contamination and preserving genetic change. See the second full paragraph on page 364. Barclay teaches a process comprising: culturing the microorganism of the order Thraustochytriales in a culture medium. See claim 74. The microorganism is Thraustochytrium, Schizochytrium or mixtures thereof. See claim 86. Barclay suggests that by reducing the chloride content in the medium the corrosive effects of chloride on fermentation equipment can be avoided. See [0005] and [0020] (relevant to instant claims 18 and 23).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use the Schizochytrium microalgae of Choi ‘943 as the microorganism in the preservation method of Minami because Unagul suggests that it is important to preserve thraustochytrids, and to further adjust the ratio of sodium chloride in view of Barclay in order to freeze-dry a biomass that includes a Schizochytrium sp. (i.e. a Thraustochytriaceae).
Claims 8-17, 19-22 and 24-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/023,256 (hereafter Shin ‘256) in view of Minami (JPH10243781A) in view of Unagul (Botanica Marina, 2017, 60(4), 363-379), with evidence from Archer (Frontiers in Nutrition, 2022, 9, 746018).
This is a provisional nonstatutory double patenting rejection.
Copending claim 1 recites a method of preparing a biomass derived from Thraustochytrid microalgae, wherein the method comprises:
culturing, a single strain of the Thraustochytrid microalgae in a medium; and
continuously supplying a nitrogen source into the medium during the culturing such that the total nitrogen concentration in the culture medium is 300 ppm or more, wherein the nitrogen source is supplied from immediately after inoculating the microalgae into a medium to the end of the culture.
Copending claim 7 of Shin ‘256 recites a method according to claim 1, wherein the Thraustochytrid microalgae of Thraustochytrium sp., Schizochytrium sp., Aurantiochytrium sp., or Thraustochytriidae sp.
The copending claims lack mixing Thraustochytiaceae microalgae with a medium comprising the composition comprising skim milk, sucrose and sodium chloride and freeze-drying the mixed product to prepare biomass (relevant to instant claim 8); wherein the microalgae is not frozen before or after the freeze-drying (relevant to instant claim 9). The copending claims lack freeze-drying the recovered cultured product with the composition comprising skim milk, sucrose, and sodium chloride to prepare biomass (relevant to instant claim 10); the microalgae is not frozen before or after the freeze-drying (relevant to instant claim 11). The copending claims lack: a composition for cryopreservation comprising skim milk, sucrose and sodium chloride (relevant to instant claim 12); a freeze-dried biomass that is able to be stored for at least 12 weeks at 15 to 25ºC (relevant to instant claim 13), and comprises 1x107 to 1x108 live cells per 1 mL of freeze-dried biomass (relevant to instant claim 14); or 1x1010 to 1x1012 live cells per 1 mL of freeze-dried biomass (relevant to instant claim 25). The copending claims lack a composition comprising: at least 6 wt% of at least one selected from the group consisting of skim milk, sucrose, and sodium chloride based on the total weight of the composition (relevant to instant claim 15 and 20); at least one selected from the group consisting of skim milk in an amount of 6 wt% to 20 wt%, sucrose in an amount of 6 wt% to 20 wt%, and sodium chloride in an amount of 6 wt% to 10 wt% (relevant to instant claim 16 and 21); a skim milk and sucrose at a weight ratio of 1:0.5 to 1:10 (relevant to instant claim 17 and 22). The copending claims lack a method that increases viability compared to mixing a composition that does not include sucrose (relevant to instant claims 26 and 27).
Minami teaches culturing microorganisms, centrifuging microorganisms to be preserved, and suspending the microorganisms in a dispersion medium comprising skim milk, sucrose, bouillon (sodium chloride source evidenced by Archer), etc., dispensing the suspended microbial liquid into storage ampule tubes, rapidly freezing the liquid, and drying the microorganisms together with the medium by evaporating the frozen water produced by the freezing. See Minami claim 1 and [0007] and the first two paragraphs of the ‘sodium levels in bouillon’ section of Archer. Minami indicates that the term “microorganisms” includes microalgae. See [0001]. Unagul suggests that the long-term preservation of thraustochytrids is of importance for preserving genetic change. See the second full paragraph on page 364 (relevant to instant claims 8 and 10). Neither Minami nor Unagul teach freezing a microorganism or microalgae before the freeze-drying (relevant to instant claims 9 and 11). Minami teaches a bacterial count of 108 [sic. 108] to 1010 [sic. 1010] cells/ml [0005]. The microorganisms placed in the storage ampoule tube and freeze-dried are stored for a long period of time under conditions such as a low-temperature room controlled at 10˚C or below. See [0006]. Unagul teaches a 6-month storage period (relevant to instant claims 13-14 and 25). Minami teaches additives including sucrose, bouillon and skim milk in an amount of 0.01 to 5% by weight [0005]. Unagul teaches a cryoprotective agent that comprise 17% skim milk. See the ‘cryopreservation of selected thraustochytrids’ section (relevant to 15-17 and 20-22). Minami teaches that adding a dispersing medium such as sucrose to the medium in which the microorganisms are cultured preserves them during freeze-drying (relevant to instant claims 26 and 27).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use one of the Thraustochytrid of Shin ‘256 as the microorganism in the preservation method of Minami because Unagul suggests that it is important to preserve thraustochytrids in order to reduce contamination and prevent genetic damage; and to further optimize the concentration and ratio of each component within the freeze-dried product obtained from the method of Shin ‘256, Minami and Unagul. There would be a reasonable expectation of success because Minami discloses that the microorganism may be microalgae, and Minami teaches starting concentrations from which one could optimize.
Claims 18 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/023,256 (hereafter Shin ‘256) in view of Minami (JPH10243781A), Unagul (Botanica Marina, 2017, 60(4), 363-379; as filed with the IDS on 02/24/2023), and Barclay (US 2008/0166780).
This is a provisional nonstatutory double patenting rejection.
Copending claim 1 recites a method of preparing a biomass derived from Thraustochytrid microalgae, wherein the method comprises:
culturing, a single strain of the Thraustochytrid microalgae in a medium; and
continuously supplying a nitrogen source into the medium during the culturing such that the total nitrogen concentration in the culture medium is 300 ppm or more, wherein the nitrogen source is supplied from immediately after inoculating the microalgae into a medium to the end of the culture.
Copending claim 7 of Shin ‘256 recites a method according to claim 1, wherein the Thraustochytrid microalgae of Thraustochytrium sp., Schizochytrium sp., Aurantiochytrium sp., or Thraustochytriidae sp.
The copending claims lack a composition that comprises skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10 (relevant to instant claims 18 and 23).
Minami, in example 2, teaches culturing a microorganism in a medium, centrifuging (recovering) the culture, and using the precipitated bacteria to prepare a medium. The medium prepared is then thoroughly stirred (mixed) and dispensed into ampoule tubes for freeze-drying. See [0008]. Minami teaches a medium for culturing and preserving microorganisms that contains, for example, skim milk, sucrose and bouillon additives. These additives are usually added in an amount of 0.01 to 5% by weight. See claim 1 of Minami, and [0001] and [0005]. Unagul suggests that the long-term preservation of these microorganisms [in reference to thraustochytrids] is of importance for reducing contamination and preserving genetic change. See the second full paragraph on page 364. Barclay teaches a process comprising: culturing the microorganism of the order Thraustochytriales in a culture medium. See claim 74. The microorganism is Thraustochytrium, Schizochytrium or mixtures thereof. See claim 86. Barclay suggests that by reducing the chloride content in the medium the corrosive effects of chloride on fermentation equipment can be avoided. See [0005] and [0020] (relevant to instant claims 18 and 23).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use the Thraustochytrid microalgae of Shin ‘256 as the microorganism in the preservation method of Minami because Unagul suggests that it is important to preserve thraustochytrids, and to further adjust the ratio of sodium chloride in view of Barclay in order to freeze-dry a biomass that includes a Schizochytrium sp. (i.e. a Thraustochytriaceae).
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Provisional double patenting rejection over Choi ‘943 in view of Minami and Unagul with evidence from Archer
Applicant argues that the rejection is provisional in nature and will be addressed upon indication that the claims are otherwise allowable. See the second paragraph on page 9 of the remarks.
To an extent, Applicant is requesting that the double patenting rejection over co-pending application 18/255,943 be held in abeyance (remarks page 9). A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the rejection is maintained as no has been filled by applicant at this time.
Provisional double patenting rejection over Shin ‘256 in view of Minami and Unagul with evidence from Archer
Applicant argues that there is no reason to utilize Unagul’s thraustochytrids to Minami’s cryopreservation method to reach the composition of the present claims. See the fourth paragraph on page 9 of the remarks.
This argument is not persuasive because the copending claims of Shin ‘256 are relied upon for teaching the instantly claimed Thraustochytriaceae microalgae, not Unagul. Rather, Unagul provides motivation for applying the preservation method of Minami to the Thraustochytrid microalgae of Shin ‘256.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657