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 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 5-8 and 10 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 5 and 10 recite the limitation low molecular weight peptide. Claims 5 and 10 are indefinite since it is unclear what molecular weight a peptide must have to be considered a low weight. Although page 6 of the instant specification states that the low-molecular-weight peptide may have a molecular weight of 0.1-10 kDa, specifically 0.1-5 kDa, more specifically 0.1-1 kDa, the limitation of low molecular weight peptide is not defined by the specification since the specification provides examples of low molecular weight peptides but not a clearly written definition. The use of the term “may” indicates that the low-molecular-weight peptide may have the disclosed molecular weight or a different molecular weight.
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.
1. Claim 9 is rejected under 35 U.S.C. 102(a1) as being anticipated by Soon (KR 20200055518 A, May 21, 2020) (cited by applicant IDS 10/17/2023, English translation provided by examiner) (hereinafter Soon).
Soon discloses a method for preparing a cosmetic, an external preparation for skin, or a quasi-drug using an Auxenochlorella protothecoides extract as an active ingredient ([0007]). In the method of production, the Auxenochlorella protothecoides is cultured and then supercritical carbon dioxide extraction of the culture is used to provide the Auxenochlorella protothecoides strain ([0012]). The culture of Auxenochlorella protothecoides was freeze-dried to obtain a dry powder. The dry powder was placed in a supercritical extractor, and semi-continuous supercritical extraction was performed. Specifically, carbon dioxide (i.e., a solvent) was temporarily supplied to the extraction tank by using a high pressure gas pump at an internal extraction temperature of 50 to 70 ° C, and the pressure was increased to 300 bar (i.e., obtain a dispersion) to extract the crude oil from the Auxenochlorella protothecoides dry powder. After the extraction operation is completed, carbon dioxide is released into the atmosphere and the crude oil obtained in the collector is recovered ([0061]). The extract has improved skin improvement function ([0033]) such as whitening ([0034]), is applied externally in cosmetic and pharmaceutical preparations ([0041]).
Accordingly, Soon anticipates the instant claims insofar as disclosing an external preparation for skin, using an Auxenochlorella protothecoides (i.e., Chlorella protothecoides) extract as an active ingredient ([0007]) that has improved skin improvement function ([0033]) such as whitening ([0034]), is applied externally in cosmetic preparations ([0041]). Because Soon teaches that the composition comprising Auxenochlorella protothecoides (i.e., Chlorella protothecoides) extract is applied externally in cosmetic preparations for skin whitening, Soon teaches the method of claim 9.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
2. Claims 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Patinier (US 2020/0095292 A1, March 26, 2020) (hereinafter Patinier) in view of Soon (KR 20200055518 A, May 21, 2020) (cited by applicant IDS 10/17/2023, English translation provided by examiner) (hereinafter Soon).
Patinier discloses a method for preparing a protein isolate from a biomass of microalgae of the genus Chlorella comprising: supplying a microalgal biomass, washing the biomass so as to eliminate the soluble interstitial compounds and concentrating the biomass, mechanically grinding the washed and concentrated biomass to produce an emulsion, destructuring the emulsion thus produced, triple-phase separation so as to separate the soluble fraction from the fractions containing the lipids and the cell debris, and recovery of the soluble fraction thus produced in order to produce the soluble protein isolate (Abstract). The Chlorella is Chlorella protothecoides (Claim 9). The biomass is collected by solid-liquid separation or by any means known, moreover, to those skilled in the art ([0062]). The emulsion may be destabilized by enzymatic predigestion ([0077]) which is treating the protein fraction in mixture via the enzymatic route, for example by a protease ([0081]) and the emulsion is then split up by triphase separation ([0086]) to obtain a soluble fraction (i.e., meeting obtaining a reaction solution by adding a protease) ([0091]). The proteins of interest are then isolated by membrane fractionation ([0092]) in three steps including ultrafiltration of the clarified soluble fraction on a membrane with a cut-off threshold of less than 5 kDa ([0093]) resulting in a permeate containing peptides having a molecular weight of less than 5 kDa (i.e., meeting obtaining an extract comprising a low-molecular-weight peptide) ([0122-0124]). The protein fraction may be exploited as a functional agent in the cosmetic, or even pharmaceutical, industries ([0007]).
Patinier differs from the instant claims insofar as not disclosing wherein the method comprises obtaining a dispersion by dispersing in a solvent and compressing at 100-5000 psi.
However, the teachings of Soon are discussed above.
As discussed above, Patinier discloses a method for preparing a protein isolate from a biomass of microalgae of Chlorella protothecoides comprising a first step of collecting the biomass by any means known to those skilled in the art. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have collected the biomass of Patinier in the first step of the method by using supercritical extraction of Auxenochlorella protothecoides (i.e., Chlorella protothecoides) powder in carbon dioxide (i.e., a solvent) at a pressure of 300 bar (i.e., obtain a dispersion) since it is a known and effective method of collecting the Auxenochlorella protothecoides crude oil (i.e., biomass) as taught by Soon.
Regarding the limitation of claim 7 reciting wherein 10-150 parts by weight of the protease is added based on 100 parts by weight of the Chlorella protothecoides, as discussed above, Patinier teaches that the emulsion is destabilized by treating the protein fraction with a protease. Accordingly, one of ordinary skill in the art would have arrived at the claimed amount of protease through routine experimentation based on the amount of protease necessary to effectively destabilize the emulsion. 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. See MPEP 144.05(II)(A).
Regarding the limitation of claim 9 reciting a method for skin whitening, it would have been obvious to one of ordinary skill in the art to use the Auxenochlorella protothecoides (i.e., Chlorella protothecoides) extract produced by Patinier in a method for skin whitening since Auxenochlorella protothecoides (i.e., Chlorella protothecoides) extract is an active ingredient in compositions that have improved skin improvement function such as whitening as taught by Soon.
3. Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Soon (KR 20200055518 A, May 21, 2020) (cited by applicant IDS 10/17/2023, English translation provided by examiner) (hereinafter Soon) in view of Patinier (US 2020/0095292 A1, March 26, 2020) (hereinafter Patinier).
As discussed above, Soon makes obvious the limitations of claim 9 but does not teach wherein the Chlorella protothecoides extract comprises a low-molecular-weight peptide obtained using a protease.
The teachings of Patinier are discussed above.
Regarding claims 10-11, as discussed above, Patinier discloses a method for preparing a protein isolate from a biomass of Chlorella protothecoides that comprises treating a protein fraction of the biomass by a protease to obtain a soluble fraction that is subjected to ultrafiltration resulting in a protein isolate containing peptides having a molecular weight of less than 5 kDa, which may be exploited as a functional agent in the cosmetic industry.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to formulated the composition of Soon to further comprise the protein isolates of Patinier (i.e., low-molecular-weight peptide obtained using a protease) since such protein isolates are exploited as a functional agent in cosmetics, as taught by Patiner.
4. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Soon (KR 20200055518 A, May 21, 2020) (cited by applicant IDS 10/17/2023, English translation provided by examiner) (hereinafter Soon) in view of Patinier (US 2020/0095292 A1, March 26, 2020) (hereinafter Patinier), and further in view of Wang et al., (Separation, antitumor activities, and encapsulation of polypeptide from Chlorella pyrenoidosa, April 18, 2013) (hereinafter Wang).
As discussed above, Soon and Patinier make obvious the limitations of claim 11 but do not teach wherein the protease is derived from papaya.
However, Wang discloses that a polypeptide was separated from Chlorella pyrenoidosa that may be a useful ingredient in food, nutraceutical, and pharmaceutical applications (Abstract). Chlorella, a type of unicellular green algae, has been reported to have certain beneficial physiological effects in animal and human studies (page 681, Introduction). In the discloses method of separation, ten grams of Chlorella pyrenoidosa powder was dissolved in 200 mL of distilled water and was subjected to protein extraction using a Low-Temperature High-Pressure Continuous Flow Cell Breakage machine at 6°C and 170 MPa (page 682, Extraction of proteins). The extracted proteins were hydrolyzed with the protease papain (i.e., derived from papaya) under optimal conditions (page 682, Hydrolysis of proteins).
As discussed above, Patinier discloses wherein the protein fraction is enzymatically predigested with a protease. Accordingly, it would have been obvious to one of ordinary skill in the art to have used the protease papain (i.e., derived from papaya) to treat the protein fraction of Patinier since it is a known and effective protease for hydrolyzing proteins (i.e., enzymatic predigestion) extracted from Chlorella compositions as taught by Wang.
5. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable Patinier (US 2020/0095292 A1, March 26, 2020) (hereinafter Patinier) and Soon (KR 20200055518 A, May 21, 2020) (cited by applicant IDS 10/17/2023, English translation provided by examiner) (hereinafter Soon), further in view of Wang et al., (Separation, antitumor activities, and encapsulation of polypeptide from Chlorella pyrenoidosa, April 18, 2013) (hereinafter Wang).
As discussed above, Soon and Patinier make obvious the limitations of claim 11 but do not teach wherein the protease is derived from papaya.
However, Wang discloses that a polypeptide was separated from Chlorella pyrenoidosa that may be a useful ingredient in food, nutraceutical, and pharmaceutical applications (Abstract). Chlorella, a type of unicellular green algae, has been reported to have certain beneficial physiological effects in animal and human studies (page 681, Introduction). In the discloses method of separation, ten grams of Chlorella pyrenoidosa powder was dissolved in 200 mL of distilled water and was subjected to protein extraction using a Low-Temperature High-Pressure Continuous Flow Cell Breakage machine at 6°C and 170 MPa (page 682, Extraction of proteins). The extracted proteins were hydrolyzed with the protease papain (i.e., derived from papaya) under optimal conditions (page 682, Hydrolysis of proteins).
As discussed above, Patinier discloses wherein the protein fraction is enzymatically predigested with a protease. Accordingly, it would have been obvious to one of ordinary skill in the art to have used the protease papain (i.e., derived from papaya) to treat the protein fraction of Patinier since it is a known and effective protease for hydrolyzing proteins (i.e., enzymatic predigestion) extracted from Chlorella compositions as taught by Wang.
Conclusion
Claims 5-12 are rejected.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.J.K./Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614