DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a national stage entry of PCT application PCT/KR2022/004745, filed 09/18/2023 under 35 USC 371. Acknowledgment is made of applicant's claim for foreign priority based on an application KR10-2021-0066419 filed in Republic of Korea on 05/24/2021.
Election/Restrictions
Applicant’s election of Group I, claims 1-8, drawn to a method for producing a cell culture medium composition, in the reply filed on 02/18/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 1-8 have been considered on the merits. Claims 9-17 are withdrawn from consideration pursuant 37 CFR 1.142(b).
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 recites “the group consisting of … or…” in the Markush group, the word “or” needs to be replaced with “and”. Claim language defined by a Markush grouping requires selection from a closed group "consisting of" the alternative members. Id. at 1280, 67 USPQ2d at 1196. See also Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1376-78, 2020 USPQ2d 3197 (Fed. Cir. 2020). Treatment of claims reciting alternatives is not governed by the particular format used (e.g., alternatives may be set forth as "a material selected from the group consisting of A, B, and C" or "wherein the material is A, B, or C"). See, e.g., the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications ("Supplementary Guidelines"), 76 Fed. Reg. 7162 (February 9, 2011). See MPEP 2117.I.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “two or more kinds of hydrolytic enzyme” renders instant claim indefinite. Herein the word “kind” is equivalent to the word “type”. The addition of the word "type" to an otherwise definite expression (e.g., Friedel-Crafts catalyst) extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). Likewise, the phrase "ZSM-5-type aluminosilicate zeolites" was held to be indefinite because it was unclear what "type" was intended to convey. The interpretation was made more difficult by the fact that the zeolites defined in the dependent claims were not within the genus of the type of zeolites defined in the independent claim. Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986). See MPEP 2173.05(b). In instant case, it is not clear what “kind/type” of hydrolytic enzyme is intended to convey. Therefore the scope of instant claim is indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raisa et al. (J. Nat. Prod. Resour. 2(2) (2016) 71-75, cited in IDS), as evidenced by Amri et al. (American Journal of Biochemistry and Biotechnology, 2012, 8 (2), 99-104).
Raisa et al. teach obtaining a peptone from S. platensis appropriate for the growth promotion of bacteria and yeast in culture media (Abstract).
Regarding claim 1, Raisa et al. developed a peptone from Spirulina platensis (SP) using enzymatic hydrolysis with papain and evaluated their suitability as microbial growth media appropriate for the culture of gramnegative, and grampositive bacteria, and yeast (p71, right column). In the method, SP mass was obtained from the Spirulina culture. The algae after culture were harvested by filtration under vacuum, washed and the remaining biomass with a 20 % of solid content was dehydrated and pasteurized. A dry product was obtained as 4 cm length and 0.8-1.6 mm thickness flakes of intense green-bluish color and with 5-7 % humidity (see p71, right column, Experimental Methods 2.1). This teaching reads on “a method for producing a cell culture medium composition, the method comprising: a first step of obtaining a Spirulina extract from Spirulina” in instant claim. Raisa et al. teach preparation of spirulina platensis hydrolysates using papain (see p71, right column, Experimental Methods 2.2), papain is an appropriate enzyme for highly nutritive hydrolysate protein preparation (see p74, right column). This teaching reads on “a second step of treating the Spirulina extract with a hydrolytic enzyme to prepare a Spirulina hydrolysate” as recited in instant claim. Raisa et al. teach the supernatants were filtered through a clarifying plate filter under negative pressure and stored at -20 °C for further experiments (p72, left column), and after the hydrolysis process, the clarified supernatant was concentrated in a rotary vacuum evaporator (IKA-Labortechnik, Germany) up to 40 % dry matter and dried at 180 °C to 90 °C in a spray dryer (p72, left column). This teaching reads on “a third step of filtering and recovering the Spirulina hydrolysate” in instant claim. In sum, Raisa et al. anticipate the method for producing a cell culture medium composition in instant claim.
Regarding claims 2 and 7, Raisa et al. teach developing peptone from Spirulina platensis using enzymatic hydrolysis with papain (p71, right column), reads on that the Spirulina is Spirulina platensis as recited in instant claim 2, and the hydrolytic enzyme is papain as recited in instant claim 7.
Regarding claim 4, as discussed above, Raisa et al. teach developing peptone from Spirulina platensis using enzymatic hydrolysis with papain (p71, right column). Papain is an enzyme has proteolysis, which is evidenced by Amri et al.. Amri et al. teach papain is an endolytic plant cysteine protease enzyme which is isolated from papaya latex. Papain enzyme belongs to the papain superfamily, as a proteolytic enzyme, papain is of crucial importance in many vital biological processes in all living organisms. Papain shows extensive proteolytic activity towards proteins, short chain peptides, amino acid esters and amide links (see p99, left column). This teaching indicates that papain is an enzyme has proteolysis, as recited in instant claim.
Regarding claim 5, as discussed above, Raisa et al. teach developing peptone from Spirulina platensis using enzymatic hydrolysis with papain (p71, right column), reads on the hydrolytic enzyme (papain) of the second step is used alone.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Raisa et al. (J. Nat. Prod. Resour. 2(2) (2016) 71-75, cited in IDS), as evidenced by Amri et al. (American Journal of Biochemistry and Biotechnology, 2012, 8 (2), 99-104), in view of Kang et al. (KR 10-1950245 B1, published in 2017, cited in IDS).
Raisa et al. teach obtaining a peptone from S. platensis appropriate for the growth promotion of bacteria and yeast in culture media (Abstract).
Regarding claim 1, Raisa et al. developed a peptone from Spirulina platensis (SP) using enzymatic hydrolysis with papain and evaluated their suitability as microbial growth media appropriate for the culture of gramnegative, and grampositive bacteria, and yeast (p71, right column). In the method, SP mass was obtained from the Spirulina culture. The algae after culture were harvested by filtration under vacuum, washed and the remaining biomass with a 20 % of solid content was dehydrated and pasteurized. A dry product was obtained as 4 cm length and 0.8-1.6 mm thickness flakes of intense green-bluish color and with 5-7 % humidity (see p71, right column, Experimental Methods 2.1). This teaching reads on “a method for producing a cell culture medium composition, the method comprising: a first step of obtaining a Spirulina extract from Spirulina” in instant claim. Raisa et al. teach preparation of spirulina platensis hydrolysates using papain (see p71, right column, Experimental Methods 2.2), papain is an appropriate enzyme for highly nutritive hydrolysate protein preparation (see p74, right column). This teaching reads on “a second step of treating the Spirulina extract with a hydrolytic enzyme to prepare a Spirulina hydrolysate” as recited in instant claim. Raisa et al. teach the supernatants were filtered through a clarifying plate filter under negative pressure and stored at -20 °C for further experiments (p72, left column), and after the hydrolysis process, the clarified supernatant was concentrated in a rotary vacuum evaporator (IKA-Labortechnik, Germany) up to 40 % dry matter and dried at 180 °C to 90 °C in a spray dryer (p72, left column). This teaching reads on “a third step of filtering and recovering the Spirulina hydrolysate” in instant claim. In sum, Raisa et al.’s teaching reads on the method for producing a cell culture medium composition in instant claim.
Regarding claims 2 and 7, Raisa et al. teach developing peptone from Spirulina platensis using enzymatic hydrolysis with papain (p71, right column), reads on that the Spirulina is Spirulina platensis as recited in instant claim 2, and the hydrolytic enzyme is papain as recited in instant claim 7.
Regarding claim 4, Raisa et al. teach developing peptone from Spirulina platensis using enzymatic hydrolysis with papain (p71, right column). Papain is an enzyme has proteolysis, which is evidenced by Amri et al.. Amri et al. teach papain is an endolytic plant cysteine protease enzyme which is isolated from papaya latex. Papain enzyme belongs to the papain superfamily, as a proteolytic enzyme, papain is of crucial importance in many vital biological processes in all living organisms. Papain shows extensive proteolytic activity towards proteins, short chain peptides, amino acid esters and amide links (see p99, left column). This teaching indicates that papain is an enzyme has proteolysis, as recited in instant claim.
Regarding claim 5, Raisa et al. teach developing peptone from Spirulina platensis using enzymatic hydrolysis with papain (p71, right column), reads on the hydrolytic enzyme (papain) of the second step is used alone.
Regarding claim 3, Raisa et al. do not teach the first step is after homogenizing the Spirulina solution, (a) sonicating, followed by extracting at a high temperature and a high pressure, or (b) freeze-thaw dissolving, followed by extracting by sonication. However, this was disclosed by Kang et al. at the time of instant invention.
Kang et al. teach cell culture solution containing an extract, a method for preparing the same, and a method for culturing cells using the same (p3, parag 8).
Regarding claim 3, Kang et al. teach for the preparation of a cell culture broth (Sacrula Animal Cell Culture Solution, SACS) containing an extract, the Spirulina sp. (s sp.) dried powder was subjected to an enzyme and sonication treatment, followed by high-temperature and high-pressure treatment to crush Spirulina sp. cells (p7, Example 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raisa et al.’s method of obtaining a peptone from S. platensis, and in the step of obtaining a Spirulina extract from Spirulina, after homogenizing the Spirulina solution, sonicating, followed by extracting at a high temperature and a high pressure as taught by Kang et al.. The skilled artisan would have been motivated to sonicate and extract at a high temperature and a high pressure since Kang et al. teach because the cell walls of the spirulina are physically weak through ultrasonic treatment, and the cell active ingredients can be effectively extracted through high-temperature and high-pressure treatment (p7, Example 1). There would be a reasonable expectation of success of sonicating and extracting at a high temperature and a high pressure for Spirulina extract since Kang et al. teach the Example of preparation of a cell culture broth (Sacrula Animal Cell Culture Solution, SACS) containing an extract (p7, Example 1).
Claims 1-2, 4-6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Raisa et al. (J. Nat. Prod. Resour. 2(2) (2016) 71-75, cited in IDS), as evidenced by Amri et al. (American Journal of Biochemistry and Biotechnology, 2012, 8 (2), 99-104), in view of Chen et al. (CN101095458A, published in 2008).
The teaching of Raisa et al. is set forth above.
Regarding claim 6, Raisa et al. do not teach two or more kinds of the hydrolytic enzyme is used sequentially in the step of treating the Spirulina extract with a hydrolytic enzyme. However, this was disclosed by Chen et al. at the time of instant invention.
Chen et al. teach a deep processing technology of a raw material of spirulina dry powder, in particular to a preparation method of a spirulina polypeptide (p1, technical field).
Regarding claim 6, Chen et al. teach the preparation method of the spirulina polypeptide, in the step of enzymatic hydrolysis, pectinase was continuously stirred and hydrolyzed at 50 ° C for 2 h, then papain which accounted for 1.0% by weight of spirulina dry powder was added, stirring was continued, and hydrolysis was carried out at 60 ° C for 3 h to obtain a solution of spirulina enzymatic hydrolysis (p3, Example 1, step 4). Pectinase and papain are two hydrolytic enzymes used sequentially.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raisa et al.’s method of obtaining a peptone from S. platensis, and use two hydrolytic enzymes pectinase and papain sequentially for enzymatic hydrolysis.
The only difference between instant claim and Raisa et al.’s method of obtaining a peptone from S. platensis is instant claim uses two hydrolytic enzymes sequentially. Given that Chen et al. teach enzymatic hydrolysis spirulina by two hydrolytic enzymes pectinase and papain sequentially, and successfully obtain spirulina polypeptide, one of ordinary skill in the art would have substituted papain, and use two hydrolytic enzymes pectinase and papain sequentially for spirulina hydrolysis. This simple substitution of one known element (use two hydrolytic enzymes pectinase and papain sequentially in spirulina hydrolysis) for another known element (use papain alone in spirulina hydrolysis) is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, B.).
Claims 1-2, 4-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Raisa et al. (J. Nat. Prod. Resour. 2(2) (2016) 71-75, cited in IDS), as evidenced by Amri et al. (American Journal of Biochemistry and Biotechnology, 2012, 8 (2), 99-104), in view of Ham et al. (Food Sci. Anim. Resour. 2020 November 40(6):1033~1043).
The teaching of Raisa et al. is set forth above.
Regarding claim 8, Raisa et al. teach after enzyme hydrolysis, the hydrolysate mixtures were centrifuged, then the supernatants were filtered through a clarifying plate filter under negative pressure (p72, left column), reads on “the third step is centrifuging the Spirulina hydrolysate, filtering the supernatant” in instant claim. The limitation “centrifuging the filtrate, separating the supernatant” is repeat the centrifuging step again for further purification. Raisa et al. do not teach the step of lyophilizing. However, lyophilizing is a common step for hydrolysate storage which, for instance, was disclosed by Ham et al. at the time of instant invention.
Ham et al. teach the impacts of gelatin hydrolysate addition on the technological properties and lipid oxidation stability of cooked sausage (Abstract).
Regarding claim 8, Ham et al. teach enzymatic hydrolysis of gelatin (p1023, parag 2-3): after enzyme hydrolysis, the gelatin hydrolysates was centrifuged, and the supernatant was freeze-dried and
pulverized to obtain gelatin hydrolysate powder.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raisa et al.’s method of obtaining a peptone from S. platensis, and lyophilize (freeze-dry) the hydrolysates as taught by Ham et al.. The only difference between instant claim and Raisa et al.’s method is instant claims repeats centrifuging and lyophilizes the hydrolysates. Given that Ham et al. teach that hydrolysates can be freeze-dried, one of ordinary skill in the art would have substituted for Raisa et al.’s hydrolysates storage in -20°C, and lyophilize (freeze-dry) the hydrolysates for storage, depends on their preference. This simple substitution of one known element (lyophilize the hydrolysates) for another known element (hydrolysates storage in -20°C without freeze-dry) is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, B.). Besides, the repeat of the centrifuge is common in the purification process, and it is not inventive to find optimal workable ranges by routine experimentation. "[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." See Jn re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699