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 .
Claim Status
Applicant’s amendment filed 06/25/2026 has been received and entered. Claims 4-7 have been cancelled, claim 1 has been amended. Claims 9-17 remain withdrawn as being directed to non-elected inventions. Accordingly, claims 1-3 and 8 are pending and under current examination.
Status of Prior Rejection/ Response to Arguments
The objection to claim 7 is withdrawn:
The cancellation of claim 7 renders the objection thereto moot. The objection is withdrawn.
The rejection to claim 6 is withdrawn:
The cancellation of claim 6 renders the rejection thereto moot. The rejection is withdrawn.
The rejection to claims 1-2, 4-5 and 7 under 35 USC 102(a)(1) over Raisa et al., evidenced by Amri et al. is withdrawn:
The cancellation of claims 4-5 and 7 renders the rejection thereto moot.
Applicant’s amendment to claim 1 adds limitations “wherein the Spirulina extract is obtained by disrupting or lysing a cell membrane of Spirulina prior to or during the first step”, “wherein the hydrolytic enzyme is a combination of: (i) pepsin and pancreatin, or (ii) pepsin, pancreatin, and papain”, and “wherein the method further comprises mixing the Spirulina hydrolysate with serum at a volume ratio of 5:5 to 1:9”. Raisa et al. do not teach, i.e., using a hydrolytic enzyme which is a combination of: (i) pepsin and pancreatin, or (ii) pepsin, pancreatin, and papain. Therefore the amendment obviates the rejection on record. The rejection is withdrawn.
The rejection to claims 1-5 and 7 under 35 USC 103 over Raisa et al., evidenced by Amri et al., in view of Kang et al. is withdrawn:
The rejection to claims 1-2, 4-6 and 7 under 35 USC 103 over Raisa et al., evidenced by Amri et al., in view of Chen et al. is withdrawn:
The rejection to claims 1-2, 4-5 and 7-8 under 35 USC 103 over Raisa et al., evidenced by Amri et al., in view of Ham et al. is withdrawn:
The cancellation of claims 4-7 renders the rejection thereto moot.
Applicant’s amendment to claim 1 adds limitations “wherein the Spirulina extract is obtained by disrupting or lysing a cell membrane of Spirulina prior to or during the first step”, “wherein the hydrolytic enzyme is a combination of: (i) pepsin and pancreatin, or (ii) pepsin, pancreatin, and papain”, and “wherein the method further comprises mixing the Spirulina hydrolysate with serum at a volume ratio of 5:5 to 1:9”. Kang et al. teach the amended limitation “wherein the Spirulina extract is obtained by disrupting or lysing a cell membrane of Spirulina prior to or during the first step” and “wherein the method further comprises mixing the Spirulina hydrolysate with serum at a volume ratio of 5:5 to 1:9”, however, none of Raisa et al., Kang et al., Chen et al. and Ham et al. teach using a hydrolytic enzyme which is a combination of: (i) pepsin and pancreatin, or (ii) pepsin, pancreatin, and papain. Therefore the amendment obviates the rejection on record. The rejection is withdrawn.
New grounds of rejection are set forth as necessitated by applicant’s amendment.
New 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.
Claims 1 and 3 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. The rejection is necessitated by applicant’s amendment.
Claim 1 recites the limitation “wherein the Spirulina extract is obtained by disrupting or lysing a cell membrane of Spirulina prior to or during the first step” renders instant claim indefinite. Claim 1 limits the first step is “obtaining a Spirulina extract from Spirulina powder”, then further limits that the Spirulina extract is obtained by disrupting or lysing a cell membrane of Spirulina prior to or during the first step, it is not clear what is the first step if the Spirulina extract is obtained prior to the first step. The scope of the claim is therefore not clear.
Claim 3 recites the limitation "homogenizing the Spirulina solution" in line 2. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 3, which depends upon claim 1, recites “homogenizing the Spirulina solution”. Given that claim 1 is limited that the first step is obtaining a Spirulina extract from Spirulina powder, it is not clear what the term “Spirulina solution” is referring to, and how the solution is obtained.
Claim interpretation
Claims 1 and 3 are indefinite. In the interest of compact prosecution, claim 1 is interpreted as “the Spirulina extract is obtained by disrupting or lysing a cell membrane of Spirulina during the first step”. Claim 3 is interpreted as ”wherein the first step is, after (dissolve the Spirulina powder in a liquid to obtain a Spirulina solution), homogenizing the Spirulina solution”.
New 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 1-3 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) in view of Kang et al. (KR1020170140762, published in 2017) and Wojcieszek et al. (Anal Bioanal Chem 408, 785–795 (2016)). The rejection is necessitated by applicant’s amendment.
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 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.
Raisa et al. do not teach: (1) the Spirulina extract is obtained from Spirulina powder by disrupting or lysing a cell membrane of Spirulina prior to or during the first step; (2) the hydrolytic enzyme is a combination of: (i) pepsin and pancreatin, or (ii) pepsin, pancreatin, and papain; (3) the method further comprises mixing the Spirulina hydrolysate with serum at a volume ratio of 5:5 to 1:9. However, such were disclosed by Kang et al. and Wojcieszek et al..
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).
Wojcieszek et al. teach estimation of zinc and copper bioaccessibility in Spirulina tablets by in vitro simulation of gastrointestinal digestion compared to that from a synthetic diet supplement containing copper and zinc gluconate (p786, left column).
Regarding (1) the Spirulina extract is obtained from Spirulina powder by disrupting or lysing a cell membrane of Spirulina prior to or during the first step, 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). Herein “crush cells” by high-temperature and high-pressure treatment indicates the disrupting a cell membrane of Spirulina.
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 obtain the Spirulina extract from Spirulina powder by disrupting (crushing) the cell membrane of Spirulina at a high temperature and a high pressure as taught by Kang et al.. The skilled artisan would have been motivated to disrupt (crush) the cell membrane of Spirulina at a high temperature and a high pressure since Kang et al. teach the cell active ingredients can be effectively extracted through disrupting (crushing) the cell membrane by high-temperature and high-pressure treatment (p7, Example 1). There would be a reasonable expectation of success of disrupting (crushing) the cell membrane of Spirulina at a high temperature and a high pressure 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).
Regarding (2) the hydrolytic enzyme is a combination of: (i) pepsin and pancreatin, or (ii) pepsin, pancreatin, and papain, Wojcieszek et al. teach enzymatic digestion with pepsin (gastric digestion) and pancreatin cocktail (gastrointestinal digestion) of Spirulina extracts (see p786, left column; p790, left column).
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 both pepsin and pancreatin as the hydrolytic enzyme as taught by Wojcieszek et al..
The only difference between instant claim and Raisa et al.’s method of obtaining a peptone from S. platensis is instant claim use a combination of pepsin and pancreatin as hydrolytic enzyme to prepare a Spirulina hydrolysate. Given that Wojcieszek et al. teach using pepsin (gastic digestion enzyme) and pancreatin (gastrointestinal digestion enzyme) for obtaining Spirulina hydrolysate, one of ordinary skill in the art would have substituted Raisa et al.’s hydrolytic enzyme papain, and use a combination of pepsin and pancreatin, for the interest that, i.e., obtaining both gastric and gastrointestinal peptides in the Spirulina hydrolysate. This simple substitution of one known element (use pepsin and pancreatin as hydrolytic enzyme to prepare a Spirulina hydrolysate) for another known element (use papain as hydrolytic enzyme to prepare a Spirulina hydrolysate) 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.).
Regarding (3) mixing the Spirulina hydrolysate with serum at a volume ratio of 5:5 to 1:9, Kang et al. teach a medium containing a cell culture solution (SACCS) containing an extract was confirmed whether the medium is suitable for HCT116 cell culture. As a result, [FBS 70%: SACCS 30%] medium containing FBS and SACCS and [FBS50%: SACCS 50%] medium showed about 10% increased survival compared to the [FBS 100%] control medium (see Example 7). The ratio of Spirulina hydrolysate to serum of 5:5 and 3:7 is in the range of 5:5 to 1:9.
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 used as peptone in culture medium, and mixing the Spirulina hydrolysate with serum at a volume ratio of 5:5 or 3:7 in the culture medium as taught by Kang et al.. The skilled artisan would have been motivated to add Spirulina hydrolysate and serum with a ratio of 5:5 or 3:7 to the culture medium since Kang et al. teach the adding of Spirulina hydrolysate and serum with a ratio of 5:5 or 3:7 in the culture medium shows about 10% increased survival compared to the [FBS 100%] control medium (see Example 7). There would be a reasonable expectation of success of adding Spirulina hydrolysate and serum in the culture medium since it is routine operation in the art to add two substances in a culture medium and Kang et al. teach the ratio (i.e., 5:5 or 3:7).
Regarding claim 2, Raisa et al. teach developing peptone from Spirulina platensis (p71, right column), reads on that the Spirulina is Spirulina platensis as recited in instant claim 2.
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, 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 1-3 and 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) in view of Kang et al. (KR1020170140762, published in 2017) and Wojcieszek et al. (Anal Bioanal Chem 408, 785–795 (2016)), as applied to claims 1-3 above, further in view of Ham et al. (Food Sci. Anim. Resour. 2020 November 40(6):1033~1043). The rejection is necessitated by applicant’s amendment.
The teaching of Raisa et al., Kang et al. and Wojcieszek 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.
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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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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