Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/27/2026 has been entered.
DETAILED ACTION
Claims 1-7, 15, 18, 20, 23 and 26-27 are canceled. Claims 28-29 are new. Claims 15-27 are new. Claims 8-14, 16-17, 19, 21-22, 24-25 and 28-29 are pending and under consideration.
Priority
The instant claims are entitled to the effective filing date of 01/18/2021.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16 and 21 and rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 16 and 21 broaden the scope of the skim milk and sodium chloride. Claim 16 depends from claim 8, and claim 21 depends from claim 10. Claims 8 and 10 recite the composition comprises the skim milk and the sodium chloride at a weight ratio of 1:0.5 to 1:10. Claims 16 and 21 recite the composition 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. Therefore, claims 16 and 21 encompass composition embodiments in which skim milk is 6 wt% to 20 wt% and sodium chloride is 6 wt% to 10 wt%. The skim milk cannot, for example, simultaneously be 14 wt% while the sodium chloride is 6 wt% because 14:6 is 1:0.43, which is less than the required 1:0.5 ratio. As such, claims 16 and 21 fail to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 8-14, 16-17, 19, 21-22, 24-25 and 28-29 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) and Barclay (US 2008/0166780), with evidence from Archer (Frontiers in Nutrition, 2022, 9, 746018).
Regarding claims 8, 10, 19, 24, and 28-29, Minami teaches long-term preservation of microorganisms by freeze-drying. Minami discloses that the term “microorganism” includes microalgae and bacteria. In example 1, Minami teaches culturing bacteria in a medium, centrifuging the culture solution and precipitating bacteria (i.e. recovering culture product). The precipitated bacteria are dispersed (i.e. mixing) in a mixture containing 3% by weight of skim milk, and the mixture is fitted into ampoule tubes for cryopreservation. See [0007]. Minami teaches adding a dispersing medium so that the organisms will not die during freeze drying. See [0002]. Minami teaches a dispersion medium comprising skim milk, sucrose, bouillon, etc. See claim 1 of Minami. Minami suggests that skim milk or sucrose can be added to a culture medium for freeze-drying. See [0004]. Minami teaches a culture medium containing 0.5% by weight of NaCl. See [0008].
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 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 p. 367 the ‘cryopreservation of selected thraustochytrids’ section 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 p. 364 second full paragraph. 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 substitute Unagul’s marine thraustochytrids for the microorganism in Minami’s cryopreservation method. One of ordinary skill in the art would have been motivated to do so 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 have been 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.
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.
Barclay, in example 3, teaches placing cells of Schizochytrium (i.e. Thraustochytriaceae) in a medium containing, on a liter basis, 25 g NaCl (i.e. 2.5% wt/v). See [0042]. In example 8, Barclay teaches harvesting, lyophilizing (i.e. freeze-drying) and storing the cells [of Schizochytrium]. See [0052]. Barclay suggests reducing chloride to thereby avoid the corrosive effects of chloride on fermentation equipment. See [0005].
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 modify Minami and Unagul’s cryopreservation method by adjusting the weight percentage of each component in Minami’s dispersion medium (i.e. skim milk, sucrose, bouillon) including the NaCl in the bouillon based on Barclay’s suggestion; and in the process adjust the weight ratio of the skim milk to the sodium chloride. One of ordinary skill in the art would have been motivated to do so because Barclay suggests that the chlorine of saline (i.e. NaCl) can be corrosive (see [0051]). There would have been a reasonable expectation of success because Minami demonstrates mixing microorganisms in 3% by weight skim milk for cryopreservation; Minami suggests that skim milk can be added to a culture medium for freeze-drying; and Barclay demonstrates culturing Thraustochytriaceae in a medium with 2.5% NaCl. Thus, one of ordinary skill in the art could reasonably adjust the NaCl to 2.5% and in the process arrive at a 3:2.5 skim milk to sodium chloride ratio, which is a ratio 1:0.83. Furthermore, this 1:0.83 ratio meets the instantly required 1:0.5 to 1:10 (relevant to instant claims 8 and 10), 1:0.5 to 1:5 (relevant to instant claim 28), and 1:0.5 to 1:3 (relevant to instant claim 29) limitations. 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).
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 and Barclay’s cryopreservation; and in the process arrive at freeze-dried biomass of Thraustochytriaceae comprising skim milk, sucrose and sodium chloride. One of ordinary skill in the art would have been 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 have been a reasonable expectation of success because Minami discloses that microalgae may be used as the microorganism in the method for long-term preservation.
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 based on the teachings 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 have been 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 teaches storing marine thraustochytrids for 6 months. 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. “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 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 claims 16 and 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 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.
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 based on Unagul’s suggestion. One of ordinary skill in the art would have been 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 have been 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.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered to the extent that they apply to the new grounds of rejection, but they are not persuasive.
Rejection of claims 8-14, 16-17, 19, 21-22, 24-25 and 28-29 under 35 U.S.C. § 103 over Minami in view of Unagul and Barclay with evidence from Archer
Applicant argues that Archer is not prior art because of its 2022 publication date, which is later than the effective filing date of the instant application. See the remarks p. 5 paragraph 6.
This argument is not persuasive because evidentiary reference Archer is not relied upon as prior art. Rather, Archer is merely relied upon for disclosing that bouillon includes sodium chloride. MPEP §2112 (II) states “the fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”.
Applicant argues that the cited references [Minami, Unagul and Barclay] do not teach or suggest the skim milk to sodium chloride weight ratios in the composition set forth in the present claims. As the office action admits, neither Minami nor Unagul teaches the composition comprises skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10. Applicant argues that Barclay only discloses the use of sodium chloride in a culture medium, and thus fails to teach or suggest all the claim limitations. See the remarks p. 9 first full paragraph (ii-a).
This argument is not persuasive because Minami teaches the skim milk and sodium chloride elements, and Barclay provides motivation for optimizing the amount of sodium chloride, which in turn affects the skim milk to sodium chloride ratio. Minami suggests that skim milk or sucrose can be added to a culture medium for freeze-drying (see Minami [0004]) and Barclay teaches a Thraustochytriaceae culture medium that includes, on a per liter basis, 25 g NaCl (i.e. 2.5%) (see Barclay [0042]). The test for obvious is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues that the recited ratio of skim milk and sodium chloride is not a result effective variable known to change the result of the cryopreservation, and thus one of ordinary skill in the art would have no reason to modify the ratio. Applicant asserts that one of ordinary skill in the art would have [no] reason to recognize the ratio as a result-effective variable and optimize the ratio. See the remarks the paragraph spanning p. 6-7.
This argument is not persuasive because the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). In the instant case, Barclay provides motivation to optimize the NaCl concentration because Barclay suggests that chloride in saline is corrosive (see [0005]). Furthermore, Barclay teaches culturing Thraustochytriaceae microalgae and lyophilizing (i.e. freeze-drying) the cells (see [0052]). Minami suggests that the cryopreservation method is applicable to microalgae (see [0001]). As such, Barclay and Minami are in the same field of endeavor.
Applicant argues that the claimed method shows unexpectedly superior storage stability. As shown in figure 4 of the instant specification, condition 3-1 (i.e. 1:0.64 weight ratio of skim milk to sodium chloride) and condition 3-3(i.e. 1:2 weight ratio of skim milk to sodium chloride) show a higher cell growth compared to condition 3-2, which does not include skim milk, which thawed and grown after cryopreservation. See the remarks p. 7 paragraph 3.
This argument is not persuasive because the results relied upon are not commensurate in scope with the instant claims. Condition 3-1 includes 6% skim milk, 8% sucrose and 4% sodium chloride; and resulted in 30 colonies. Condition 3-2 includes 10% sucrose and 5% sodium chloride; and resulted in 32 colonies, which is more colonies compared to condition 3-1. Condition 3-3 includes 4% skim milk, 8% sucrose and 8% sodium chloride. See table 4. The instant claims do not limit the skim milk, sucrose and sodium chloride composition to the specific embodiment of condition 3-1 or 3-3. Rather, independent claims 8 and 10 encompass any sucrose weight percentage. Furthermore, independent claims 8 and 10 to not limit the skim milk to sodium chloride ratio to the 1:0.64 ratio of condition 3-1, nor does it limit the ratio to the 1:2 ratio of condition 3-3.
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 8-14, 16-17, 19, 21-22, 24-25 and 28-29 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), Barclay (US 2008/0166780) with evidence from Archer (Frontiers in Nutrition, 2022, 9, 746018).
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 do not recite: 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, wherein skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10 (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, wherein skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10 (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 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 skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:5 (relevant to instant claim 28). The copending claims lack a skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:3 (relevant to instant claim 29).
However, Minami teaches culturing bacteria in a medium, centrifuging the culture solution and precipitating bacteria (i.e. recovering culture product). The precipitated bacteria are dispersed (i.e. mixing) in a mixture containing 3% by weight of skim milk, and the mixture is fitted into ampoule tubes for cryopreservation. See [0007]. Minami teaches a dispersion medium comprising skim milk, sucrose, bouillon, etc. See claim 1 of Minami. 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. Unagul teaches the cryopreservation of four marine thraustochytrids including Parietichytrium sakarianum. See table 1. Barclay teaches Thraustochytriaceae in a medium containing, on a liter basis, 25 g NaCl, i.e. 2.5% wt/v. See [0042]. (relevant to instant claims 8, 10, 12, 19, 24, and 28-29). 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 16-17 and 21-22).
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 substitute the Schizochytrium microalgae recited in copending claim 1 for the microorganism in the cryopreservation method of Minami, and to further optimize the ratios and percentages of the skim milk, sucrose and sodium chloride in order to cryopreserve a Thraustochytriaceae microalgae.
This is a provisional nonstatutory double patenting rejection.
Claims 8-14, 16-17, 19, 21-22, 24-25 and 28-29 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), and Barclay (US 2008/0166780) with evidence from Archer (Frontiers in Nutrition, 2022, 9, 746018).
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 do not recite: 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, wherein skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10 (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, wherein skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:10 (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 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 skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:5 (relevant to instant claim 28). The copending claims lack a skim milk and sodium chloride at a weight ratio of 1:0.5 to 1:3 (relevant to instant claim 29).
However, Minami teaches culturing bacteria in a medium, centrifuging the culture solution and precipitating bacteria (i.e. recovering culture product). The precipitated bacteria are dispersed (i.e. mixing) in a mixture containing 3% by weight of skim milk, and the mixture is fitted into ampoule tubes for cryopreservation. See [0007]. Minami teaches a dispersion medium comprising skim milk, sucrose, bouillon, etc. See claim 1 of Minami. 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. Unagul teaches the cryopreservation of four marine thraustochytrids including Parietichytrium sakarianum. See table 1. Barclay teaches Thraustochytriaceae in a medium containing, on a liter basis, 25 g NaCl, i.e. 2.5% wt/v. See [0042]. (relevant to instant claims 8, 10, 12, 19, 24, and 28-29). 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 16-17 and 21-22).
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 substitute the Thraustochytrid microalgae recited in copending claim 7 for the microorganism in the cryopreservation method of Minami, and to further optimize the ratios and percentages of the skim milk, sucrose and sodium chloride in order to cryopreserve a Thraustochytriaceae microalgae.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered to the extent that it applies to the new grounds for rejection, but they are not persuasive.
Double Patenting
Applicant argues that the rejection is provisional in nature and will be addressed upon indication that the claims are otherwise allowable. See the remarks p. 8 last full paragraph.
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.
Applicant argues that the claims of Shin ‘256 differ from the present claims. The claims of Shin ‘256 are directed to a method of preparing biomass which includes culturing a single strain of microalgae in a medium containing a carbon and nitrogen source, wherein the nitrogen is continuously supplied. Therefore, the claims of Shin ‘356 are silent regarding a composition comprising skim milk and sodium chloride in a ratio that is 1:0.5 to 1:10. The remaining references fail to cure the deficiency.
This argument is not persuasive because the copending claims of Shin ‘256 (18/023,256) are not relied upon for teaching the composition of skim milk, sodium chloride and sucrose, nor are they relied upon for teaching the skim milk to sodium weight ratio that is 1:0.5 to 1:10.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
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