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 .
Status of the Claims
Claims 1-11 are currently pending (claim set as filed on 9/9/2026). Claim 11 is withdrawn due to a restriction/election requirement. Claims 1-10 are under examination.
Election/Restrictions
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected composition, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/9/2026.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR 10-2021-0152921, filed on 11/9/2021.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. Until the applicant provides a copy of the English translation, the effective filing date of this application is 10/9/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/6/2024 was considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-10 are objected to because of the following informalities: the use of the word “Overseas” is unnecessary and appropriate correction is required to remove the word.
Claims 2-10 are objected to for depending on claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically an Epidermidibacterium keratini bacteria deposited in the Korean Culture Center of Microorganisms. Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5
years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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 1-10 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.
Regarding claim 1, reciting “as skin flora” renders the claim indefinite as it is unclear if the skin flora is referring to the deposited microorganism itself or if the culturing of the microorganism occurs physically on the skin flora. For examination purposes, the skin flora limitation is interpreted as referring to the deposited microorganism itself. Claims 1 further recites “producing a fermented product”. However, the language recites merely the mixing of the preculture to the caviar extract medium which is not a fermentation step to produce a fermented product; thus it is unclear what the fermented product is. Claim 1 further recites the method steps of “a seed culture step of producing a seed culture” and “a preculture step of culturing the seed culture to produce a preculture”. However, the order of the steps performed are unclear as it appears as though the preculture step precedes the seed culture step, but the claim language recites that it is initiated after the seed culturing step. Therefore, it is unclear how one could carry out the preculture step after the seed culture step if the seed culture step relies on the preculture step to be carried out beforehand. Thus the claim is rendered indefinite.
Regarding claims 1, 4-6, and 9, the recitation of “a main fermentation step” renders the claims indefinite as a main step implies the existence of at least one other fermentation step, whereas the claims only recite one fermentation step.
Claims 2-10 are rejected for depending on claim 1.
Regarding claim 8, the recited limitation “the 5% culture solution” has insufficient antecedent basis in the claim as the term was not recited in the base claim. Further, the recitation of “the 5% culture solution” in regard to the termination of the preculture step is indefinite. It is unclear as to as to what the referred to “the 5% culture solution” is and therefore the termination of the preculture step, which hinges on the recited solution, is rendered indefinite as well.
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, 6-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (Pre-Grant Publication No. KR 2016/0050982 A – date of publication 5/11/2016), in view of Lee (Pre-Grant Publication No. US 2019/0040475 A1 – date of publication 2/7/2019), in further view of Lee (Pre-Grant Publication No. KR 2013/0089137 A – date of publication 8/9/2013), and as evidenced by Thermo Fisher (Thermo Fisher, “R2A Agar”, 2007 Jul 11, www.documents.thermofisher.com/TFS Assets/LSG/manuals/IFU112543.pdf, accessed 2026 Oct 8, pgs. 1-2).
Kim (KR Patent 982)’s general disclosure relates to pre-culturing a microorganism and then producing a fermented product by mixing the culture with an oil (see [0007-0008]) to form a product that can improve skin aging (see [0005]).
Regarding claim 1, Kim (KR Patent ‘982) teaches preculturing the microorganism and then a fermentation step by mixing the cultured microbe with an oil (see [0007-0008]). As noted in the 112b rejected above, it is unclear how a seed culture step can precede the preculture step if the seed culturing relies upon preculturing first, therefore rendering this step indefinite. For examination purposes, the process of first preculturing the microbe before the fermentation step reads on the seed culturing and preculturing step.
Kim (KR Patent ‘982) does not teach a microorganism with the deposit number of KCCM 11843P or a medium containing caviar extract.
Lee (US Patent ‘475)’s general disclosure relates to the culture composition of an Epidermidibacterium microorganism which is used to prevent skin aging (see abstract and [0082]).
Regarding claim 1, Lee (US Patent ‘475) teaches the culturing of the deposited microorganism KCCM 11843P, which corresponds to the strain Epidermidibacterium keratini (see [0007-0008] and [0227]).
It would have been obvious to one of ordinary skill in the arts before the effective filing date to substitute the deposited Epidermidibacterium keratini as taught in Lee (US Patent ‘475) for the nitrate bacteria as taught in Kim (KR Patent ‘982). One would be motivated to do so because Lee (US Patent ‘475) teaches that the purpose of using the Epidermidibacterium keratini in the composition is to prevent skin aging (see Lee (US Patent ‘475) [0082]). As such, Lee (US Patent ‘475)’s Epidermidibacterium keratini-containing composition and Kim (KR Patent ‘982)’s nitrate bacteria-containing composition have the same purpose of anti-aging (see Kim (KR Patent ‘982) [0028]) and would be considered functional equivalents.
Further, it would have been obvious to one of ordinary skill in the arts before the effective filing date to add the Epidermidibacterium keratini microbe as taught in Lee (US Patent ‘475) to the culture as taught in Kim (KR Patent ‘982). One would be motivated to do so because Lee (US Patent ‘475) teaches that the microbe in the composition has the benefit of improving the skin (see Lee (US Patent ‘475) [0082]). This addition would be advantageous to Kim (KR Patent ‘982)’s disclosure which states a need for a composition to improve the skin (see Kim (KR Patent ‘982) [0005-0006]).
Lee (KR Patent ‘137)’s general disclosure relates to the production of a fermented caviar extract cosmetic improve the appearance of skin wrinkles (see [0001]).
Regarding claim 1, Lee (KR Patent ‘137) teaches the fermenting a bacterial culture and then mixing the culture with caviar to obtain a fermented caviar extract (see [0014]).
It would have been obvious to one of ordinary skill in the arts before the effective filing date to substitute the caviar extract as taught in Lee (KR Patent ‘137) for the vegetable oil as taught in Kim (KR Patent ‘982). One would be motivated to do so because Lee (KR Patent ‘137) teaches that the purpose of using the caviar extract in the composition is to prevent skin aging as it contains a large amount of omega-3 fatty acids (see Lee (KR Patent ‘137) [0007]). As such, Lee (KR Patent ‘137)’s caviar extract composition and Kim (KR Patent ‘982)’s vegetable oil composition have the same purpose of anti-aging (see Kim (KR Patent ‘982) [0028]) and would be considered functional equivalents.
Regarding claims 2-3, the combined references teach the seed culture or preculture is grown in Reasoner’s 2A (R2A) medium (see Lee (US Patent ‘475) [0117]). As evidenced by Thermo Fisher, R2A medium contains 0.5 g/L of casein hydrolysate, 0.5 g/L of yeast extract, 0.5 g/L of dextrose (which is the commercial name for glucose), 0.5 g/L of soluble starch, 0.3 g/L of K2HPO4 (also known as dipotassium phosphate), 0.3 g/L of sodium pyruvate, and 0.25 g/L of casein peptone (see Thermo Fisher pg. 1 – “Reagents”). The values for these ingredients all fall within their respective claimed ranges. The combined references also teach the medium contains 0.5 g/L of MgSO4 (see Kim (KR Patent ‘982) [0060]) which falls within the claimed range.
Regarding claims 6-7, the combined references teach the preculture medium contains 100 g/L of vegetable oil (see Kim (KR Patent ‘982) [0060]), which is within the claimed range. Since the fermentation medium is simply the preculture medium as well as caviar extract, any components in the preculture medium should also be in the fermentation medium.
Regarding claim 10, the combined references teach the fermented caviar extract composition is intended for improving skin aging and skin moisturization (see Lee (KR Patent ‘137) [0010]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (Pre-Grant Publication No. KR 2016/0050982 A – date of publication 5/11/2016), in view of Lee (Pre-Grant Publication No. US 2019/0040475 A1 – date of publication 2/7/2019), in view of Lee (Pre-Grant Publication No. KR 2013/0089137 A – date of publication 8/9/2013), in view of Kim (Patent No. US 10,188,594 B2 – date of patent 1/29/2019), in further view of Microsolv (Microsolv, “Ammonium Acetate or Triethylamine TEA Use with Cogent HPLC Columns - Tips and Suggestions”, 2020 Apr 14, www.mtc-usa.com/kb-article/using-ammonium-acetate, accessed 2026 Oct 8, pgs. 1-3), and as evidenced by Thermo Fisher (Thermo Fisher, “R2A Agar”, 2007 Jul 11, www.documents.thermofisher.com/TFS Assets/LSG/manuals/IFU112543.pdf, accessed 2026 Oct 8, pgs. 1-2).
The general disclosure of the combined references has been set forth above.
Regarding claims 4-5, the combined references teach the seed culture or preculture is grown in Reasoner’s 2A (R2A) medium (see Lee (US Patent ‘475) [0117]). As evidenced by Thermo Fisher, R2A medium contains 0.5 g/L of yeast extract and 0.25 g/L of casein peptone (see Thermo Fisher pg. 1 – “Reagents”). The values for these ingredients both fall within their respective claimed ranges. The combined references teach the preculture media contains 1 g/L of KH2PO4 (see Kim (KR Patent ‘982) [0060]), which is within the claimed range. Since the fermentation medium is simply the preculture medium as well as caviar extract, any components in the preculture medium should also be in the fermentation medium. The combined references disclose the fermentation media contains 0.001-95% by weight of caviar extract (see Lee (KR Patent ‘137) [0016]), which calculates to 0.1-950 g/L and fully compasses the claimed range.
The combined references do not teach that the fermentation medium contains glycerol, K2HPO4, and ammonium acetate.
Kim (US Patent ‘594)’s general disclosure relates to a method for preparing a fermented oil using a fermentation medium comprising K2HPO4 and glycerol carrier to provide stabilization for the composition (see abstract and col. 6, ¶ 1 and Table 1).
Regarding claims 4-5, Kim (US Patent ‘594) teaches a fermentation medium comprising 2.5 g/L of K2HPO4 (see col. 6, Table 1),which is within the claimed range. Kim (US Patent ‘594) further discloses the fermentation medium contains a glycerol carrier (see col. 6, ¶ 1) that constitutes 1% of the overall composition (see col. 13, Table 9). As the concentration of the composition is 122.6 g/L (see col. 13, Table 9), 1% of the total would calculate to 1.2 g/L which is within the claimed range.
It would be obvious to one of ordinary skill in the art at the time of the effective filing date to add glycerol at its specified concentration as taught in Kim (US Patent ‘594) to the fermentation medium as taught in the combined references. One would be motivated to do so because Kim (US Patent ‘594) suggests glycerol as a carrier for the formulation of the microbial composition (see Kim (US Patent ‘594) col. 6, ¶ 1). This addition would be an advantage to the combined references which also describe a need for the microbial composition to be stabilized by a carrier (see Lee (US Patent ‘475) [0084]).
Further, It would be obvious to one of ordinary skill in the art at the time of the effective filing date to add K2HPO4 at the specified concentration as taught in Kim (US Patent ‘594) to the fermentation medium as taught in the combined references. One would be motivated to do so because Kim (US Patent ‘594) teaches that the fermentation media containing this ingredient at its specific concentration was effective at growing the microbe (see Kim (US Patent ‘594) col. 7, ¶ 1). Therefore, using this additional component at the specified concentration would have offered the ordinary artisan a reasonable expectation of success in culturing the microbe in the combined references and would have improved upon their microbial culturing method as well.
Microsolv’s general disclosure relates to the use of ammonium acetate as a common additive in high liquid performance chromatography (HLPC) (see pg. 1, ¶ 1).
Regarding claims 4-5, Microsolv teaches the addition of ammonium acetate as a buffer in high liquid performance chromatography (HLPC) (see pg. 1, ¶ 1). Microsolv further discloses the ideal concentration for ammonium acetate during this application is 10 mM or less (see pg. 2, ¶ 2), which calculates to 0.77 g/L or less, and thus any values such as the claimed range of 0.005-0.1 g/L would fall under this threshold.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the ammonium acetate as taught in Microsolv to the fermentation medium as taught in the combined references. One would be motivated to do so because Microsolv teaches ammonium acetate is a commonly used reagent for high liquid performance chromatography (HLPC) (see Microsolv pg. 1, ¶ 1). Thus the addition of such an ingredient to the fermentation medium would be an advantage to the disclosure of the combined references which teach that the DNA of the microbes were analyzed for structural stability using HLPC post-culturing (see Lee (US Patent ‘475) [0163]). By adding ammonium acetate to the fermentation medium, one would have a preferred chromatography reagent already present for intended downstream HLPC applications.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (Pre-Grant Publication No. KR 2016/0050982 A – date of publication 5/11/2016), in view of Lee (Pre-Grant Publication No. US 2019/0040475 A1 – date of publication 2/7/2019), in view of Lee (Pre-Grant Publication No. KR 2013/0089137 A – date of publication 8/9/2013), in view of Kim (Patent No. US 10,188,594 B2 – date of patent 1/29/2019), in view of SBT Instruments (SBT Instruments, “Understanding OD600”, 2017 Sep, www.sbtinstruments.com/knowledge/understanding-od600, accessed 2026 Oct 8, pgs. 1-2), in further view of Kim (Pre-Grant Publication No. KR 2020/0093839 A1 – date of publication 8/6/2020), and as evidenced by Thermo Fisher (Thermo Fisher, “R2A Agar”, 2007 Jul 11, www.documents.thermofisher.com/TFS Assets/LSG/manuals/IFU112543.pdf, accessed 2026 Oct 8, pgs. 1-2).
The general disclosure of the combined references has been set forth above.
Regarding claim 8, the combined references teach a preculturing or seed culturing step (see Kim (KR Patent ‘982) [0007]) and that the seed culture was shaken under aerobic conditions at 25[Symbol font/0xB0]C (see (see Kim (US Patent ‘594) col. 7, ¶ 5), which falls within the claimed range. The combined references teach that the components of the preculture culture step equals to 130.2 g/L (see Kim (US Patent ‘594) col. 7, ¶ 5) which is then added to the seed culture and is within the claimed range. The combined references disclose the preculture step is done under aerobic conditions at 25°C which is within the claimed range (see Kim (US Patent ‘594) col. 7, ¶ 5). As noted in the 112b rejection above, the term “the 5% culture solution” recited is indefinite and therefore the termination of the preculture step is rendered indefinite too as it is based off this limiting term. However, the combined references do read on the termination step limitation in that the preculture ends when the spectrophotometric absorbance of the solution is 0.8, which is within the claimed absorbance reading (see Kim (US Patent ‘594) col. 7, Table 2) and has a wavelength reading.
The combined references do not teach that in the preculture step the shaking was 10-100 rpm, the wavelength was 600 nm, and the volumetric flow rate was 5-20 NL/min.
It would be obvious to one of ordinary skill in the art at the time of the effective filing date to optimize the shaking speed as taught in combined references to the claimed range of 10-100 rpm. One would be motivated to do so because the combined references teach that the shaking speed is increased when the culture volume is increased as well (see Kim (US Patent ‘594) col. 8, ¶ 2). Therefore, it would only be a matter of routine experimentation to decrease the shaking speed to a lower range if modifying the preculture step to a lower volume.
SBT Instrument’s general disclosure relates to the optimal density range of 540-660 nm for tracking bacterial cell concentrations (see pg. 1, ¶ 1 and pg. 2, ¶ 1).
Regarding claim 8, SBT Instruments teaches measure the optical density of a bacterial culture at a range of 540-660 nm (see pg. 2, ¶ 1), of which 600 nm as claimed is fully encompassed.
It would be obvious to one of ordinary skill in the art at the time of the effective filing date to substitute the wavelength to 600 nm as taught in SBT Instruments from the 660 nm wavelength as taught in the combined references. One would be motivated to do so because SBT Instruments teaches that a wavelength range of 540 to 660 nm can be used to measure microbial growth and concentration (see SBT Instruments pg. 2, ¶ 1). Therefore, the 660 nm wavelength as disclosed by the combined references would be considered a functional equivalent as it has the same purpose as the 600 nm wavelength. See MPEP 2144.06.
Kim (KR Patent ‘839)’s general disclosure relates to a fermented oil composition which can be used cosmetically as a skin lotion (see [0001], [0044], and [0049]) and wherein the fermentation occurs under specified volumetric flow rates (see [0055]).
Regarding claim 8, Kim (KR Patent ‘839) teaches a preculture step at 10 NL/min which is within the claimed range (see [0055]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the NL/min conditions as taught in Kim (KR Patent ‘839) to the culturing of the deposited strain as taught in the combined references. One would have been motivated to do so because Kim (KR Patent ‘839) teaches that culturing was successfully performed under aerobic conditions with defined gas flow rates measured in normal liters per minute (see Kim (KR Patent ‘839) [0055]). By adding a specific gas flow rate, the ordinary artisan would have been able to improve upon the disclosure of the combined references which also attempt to culture the microbes under similar aerobic conditions (see Kim (US Patent ‘594) col. 7, ¶ 5).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (Pre-Grant Publication No. KR 2016/0050982 A – date of publication 5/11/2016), in view of Lee (Pre-Grant Publication No. US 2019/0040475 A1 – date of publication 2/7/2019), in view of Lee (Pre-Grant Publication No. KR 2013/0089137 A – date of publication 8/9/2013), in view of Kim (Patent No. US 10,188,594 B2 – date of patent 1/29/2019), in further view of Kim (Pre-Grant Publication No. KR 2020/0093839 A1 – date of publication 8/6/2020), and as evidenced by Thermo Fisher (Thermo Fisher, “R2A Agar”, 2007 Jul 11, www.documents.thermofisher.com/TFS Assets/LSG/manuals/IFU112543.pdf, accessed 2026 Oct 8, pgs. 1-2).
The general disclosure of the combined references has been set forth above.
Regarding claim 9, the combined references teach the fermentation step (see Kim (KR Patent ‘982) [0008]) and that the weight of the fermentation medium is 2-40 wt%, which falls into the claimed range (see Kim (US Patent ‘594) col. 5, ¶ 1). As the fermentation media is simply the preculture media plus vegetable oil, it would be reasonable to interpret the preculture makes up the majority of the culture weight once added to the fermentation vegetable oil. The combined references teach that the fermentation step occurred for 3-120 hours which falls into the claimed range and that is was done under aerobic conditions (see Kim (US Patent ‘594) col. 8, ¶ 2). The combined references also teach the fermentation occurred under shaking conditions of 500 rpm (see Kim (US Patent ‘594) col. 8, ¶ 2).
The combined references do not teach that in the fermentation step the shaking was 100-300 rpm and the volumetric gas flow was 100-500 NL/min.
It would be obvious to one of ordinary skill in the art at the time of the effective filing date to optimize the shaking speed as taught in combined references to the claimed range of 100-300 rpm. One would be motivated to do so because the combined references teach that the shaking speed is increased when the culture volume is increased as well (see Kim (US Patent ‘594) col. 8, ¶ 2). Therefore, it would only be a matter of routine experimentation to increase the shaking speed to a higher range if modifying the fermentation step to a higher volume.
Kim (KR Patent ‘839)’s general disclosure has been set forth above.
Regarding claim 9, Kim (KR Patent ‘839) teaches a fermentation step at 100 NL/min which is within the claimed range (see [0059]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the NL/min conditions as taught in Kim (KR Patent ‘839) to the culturing of the deposited strain as taught in the combined references. One would have been motivated to do so because Kim (KR Patent ‘839) teaches that culturing was successfully performed under aerobic conditions with defined gas flow rates measured in normal liters per minute (see Kim (KR Patent ‘839) [0059]). By adding a specific gas flow rate, the ordinary artisan would have been able to improve upon the disclosure of the combined references which also attempt to culture the microbes under similar aerobic conditions (see Kim (US Patent ‘594) col. 7, ¶ 5).
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/707,873 in view of Kim (Pre-Grant Publication No. KR 2016/0050982 A – date of publication 5/11/2016).
This is a provisional nonstatutory double patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
Method for producing a cosmetic including a seed culture step by culturing the deposited
microbe KCCM 11843P, a preculture step, and a fermentation step of adding the preculture
to a oil medium (claims 1-9)
Wherein the seed culture or preculture medium contains casein hydrolyzate, yeast extract,
glucose, soluble starch, K2HPO4, sodium pyruvate, casein peptone, and MgSO4 and their
concentrations (claims 2-3)
Wherein the fermentation media contains glycerol, yeast extract, casein peptone, K2HPO4,
KH2PO4, and vegetable oil and their concentrations (claims 4-7)
Preculture conditions including adding seed culture, while shaking, in an aerobic
environment, at a set temperature and gas flow rate (NL/min), and wherein the culture is
terminated at a set absorbance and wavelength (claim 8)
Fermentation conditions including adding seeding with preculture, fermenting for a time
period, within an aerobic environment, at set temperature and gas flow rate (in NL/min),
and while shaking (claim 9)
Copending Application No. 18/707,873 claims are directed towards:
Method for producing a cosmetic including a seed culture step by culturing the deposited
microbe KCCM 11843P, a preculture step, and a fermentation step of adding the preculture
to a oil medium (claim 1-7)
Wherein the seed culture or preculture medium contains casein hydrolyzate, yeast extract,
glucose, soluble starch, K2HPO4, sodium pyruvate, casein peptone, and MgSO4 and their
concentrations (claims 2-3)
Wherein the fermentation medium contains glycerol, yeast extract, casein peptone, K2HPO4,
KH2PO4, MgSO4.7H20, FeSO4, and vegetable oil and their concentrations
(claims 4-5)
Seed culturing conditions including shaking, within an aerobic environment, and at a set
temperature (claim 6)
Preculture conditions including adding seed culture, while shaking, in an aerobic
environment, at a set temperature and gas flow rate (NL/min), and wherein the culture is
terminated at a set absorbance and wavelength (claim 6)
Fermentation conditions including adding seeding with preculture, fermenting for a time
period, within an aerobic environment, at set temperature and gas flow (in NL/min), and
while shaking (claim 7)
Although the preambles are different, both sets of claims are directed to a method for producing cosmetic composition including a seeding, preculture, and fermentation step. As such, both the instant application and the copending application no. 18/707,873 are directed to overlapping subject matter.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-10 of Application No. 17/926,162 in view of Kim (KR 2020/093839A – date of publication 8/6/2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
Method for producing a cosmetic including a seed culture step by culturing the deposited
microbe KCCM 11843P, a preculture step, and a fermentation step of adding the preculture
to a oil medium (claims 1-9)
Wherein the seed culture or preculture medium contains casein hydrolyzate, yeast extract,
glucose, soluble starch, K2HPO4, sodium pyruvate, casein peptone, and MgSO4 and their
concentrations (claims 2-3)
Wherein the fermentation media contains glycerol, yeast extract, casein peptone, K2HPO4,
KH2PO4, and vegetable oil and their concentrations (claims 4-7)
Preculture conditions including adding seed culture, while shaking, in an aerobic
environment, at a set temperature and gas flow rate (NL/min), and wherein the culture is
terminated at a set absorbance and wavelength (claim 8)
Fermentation conditions including adding seeding with preculture, fermenting for a time
period, within an aerobic environment, at set temperature and gas flow rate (in NL/min),
and while shaking (claim 9)
Copending Application No. 17/926,162 claims are directed towards:
Method for producing a cosmetic including a seed culture step by culturing the deposited
microbe KCCM 11843P, a preculture step, and a fermentation step of adding the preculture
to a medium containing vegetable oil, K2HPO4, KH2PO4, and MgSO4 (claims 1-3 and 5-10)
Wherein the seed culture or preculture medium contains casein acid hydrolysate, a yeast
extract, a glucose, a soluble starch, K2HPO4, sodium pyruvate, casein peptone, and MgCl2
(claims 2 and 5)
Wherein the fermentation medium contains glycerol, yeast extract, casein peptone,
vegetable oil, K2HPO4, KH2PO4, and MgSO4 and their concentrations (claims 1 and 6)
Seed culturing conditions including shaking, aerobic environment, and at a set temperature
(claim 8)
Preculture conditions including adding seed culture in an aerobic
environment, at a set temperature, and wherein the culture is terminated at a set
absorbance and wavelength (claim 9)
Fermentation conditions including adding seeding with preculture, fermenting for a time
period, and at set temperature (claim 10)
Although the preambles are different, both sets of claims are directed to a method for producing cosmetic composition including a seeding, preculture, and fermentation step.
Co-pending Application No. 17/926,162 does not claim:
Preculture conditions including at a set gas flow rate (NL/min)
Fermentation conditions including within an aerobic environment, at a set gas flow rate (NL/min)
Kim (KR Patent ‘839) teaches preculture step at a gas flow rate of 10 NL/min (see [0057]). And a fermentation step with a gas flow rate of at 100 NL/min (see [0059]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing
date to add the gas flow rate (NL/min) conditions as taught in Kim (KR Patent ‘839) to the culturing of
the deposited strain as taught in modified-Kim (KR Patent ‘982)-‘162. One would have been motivated
to do so because Kim (KR Patent ‘839) teaches that culturing was successfully performed under aerobic
conditions with defined gas flow rates measured in normal liters per minute (see Kim (KR Patent ‘839)
pg. 5, ¶ 7-8). By adding a specific gas flow rate, the ordinary artisan would have been able to improve upon ‘162’s disclosure which also attempts to culture the microbe under similar aerobic conditions (see ‘162 [0060]).
Conclusion
No claims are allowed.
Correspondence Information
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/EMMALEE R WILLIAMS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
