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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 and 13 in the reply filed on 07/10/2026 is acknowledged.
Priority
The instant application filed on 09/18/2024 is a 371 of PCT/KR2023/013355 filed on 09/06/2023 and claims priority to KR10-2022-0120506 filed on 09/06/2023. The certified copy of KR10-2022-0120506 filed on 09/18/2024 is not in English; therefore, the effective filing date of the instant application is 09/06/2023.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/18/2024 and 12/12/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102, Anticipation
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.
Claims 1-2, 5-6, 8, 10-11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (KR-20070115580; Date of Publication: December 6, 2007 – cited in the IDS filed on 09/18/2024).
Wang’s general disclosure relates to “animal product free (APF) media and processes for the culturing and fermentation of botulinum toxin producing Clostridium botulinum bacteria. The botulinum toxin obtained can be used to formulate or formulate a botulinum toxin pharmaceutical composition” (see, e.g., Wang, English Translation, Abstract).
Regarding claim 1 pertaining to culturing a strain producing botulinum toxin, Wang teaches culturing a lyophilized culture of Clostridium botulinum in seed medium (see, e.g., Wang, English Translation, Example 1), followed by obtaining the seed medium culture and inoculating it into fermentation medium (see, e.g., Wang, English Translation, Example 4). Wang teaches that the fermentation medium has a pH between 5.0 and 5.5 (see, e.g., Wang, English Translation, pg. 6, paragraph 23).
Regarding claim 2 pertaining to culturing the seed culture, Wang teaches that the seed culture is cultured in an anaerobic chamber (see, e.g., Wang, English Translation, Example 2).
Regarding claim 5 pertaining to the culturing in operation (a), Wang teaches that the culturing is performed for 24 hours at a temperature of 33oC ± 1oC (see, e.g., Wang, English Translation, Example 2).
Regarding claim 6 pertaining to culturing the fermentation culture, Wang teaches growing Clostridium botulinum in fermentation medium in an anaerobic chamber (see, e.g., Wang, English Translation, Example 4).
Regarding claim 8 pertaining to the pH of the main culture medium, Wang teaches that the pH of the Clostridium botulinum culture in fermentation medium grown in the anaerobic chamber is 6.8 (see, e.g., Wang, English Translation, Example 4).
Regarding claim 10 pertaining to culturing in operation (b), Wang teaches that the Clostridium botulinum was grown in fermentation medium at 33oC ± 1oC for 24 hours (see, e.g., Wang, English Translation, Example 4).
Regarding claim 11 pertaining to the type of botulinum toxin, Wang teaches that the botulinum toxin can include serotypes A, B, C, D, E, F, and G, as well as recombinant, hybrid, and chimeric botulinum toxins (see, e.g., Wang, English Translation, pg. 5, paragraph 3).
Regarding claim 13 pertaining to producing a botulinum toxin, Wang teaches culturing a lyophilized culture of Clostridium botulinum in seed medium (see, e.g., Wang, English Translation, Example 1), followed by obtaining the seed medium culture and inoculating it into fermentation medium (see, e.g., Wang, English Translation, Example 4). Wang teaches that the fermentation medium has a pH between 5.0 and 5.5 (see, e.g., Wang, English Translation, pg. 6, paragraph 23). Moreover, Wang teaches harvesting the botulinum toxin by microfiltration followed by sulfuric acid precipitation followed by diafiltration (see, e.g., Wang, English Translation, Example 7).
Claim Rejections - 35 USC § 103, Obviousness
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.
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claims 1-2, 5-6, 8, 10-11, and 13 above, and further in view of Young (KR-20200114722; Date of Publication: October 7, 2020 – cited in the IDS filed on 09/18/2024).
Wang’s general disclosure is discussed above.
Regarding claims 3 and 7 pertaining to the seed culture medium and fermentation culture medium, Wang teaches that the medium for culturing and fermenting Clostridium botulinum contains about 0-3% by weight yeast extract and about 1-2% by weight glucose (see, e.g., Wang, English Translation, pg. 6, paragraph 25).
However, Wang does not teach: wherein the seed culture medium in operation (a) includes 3.0 to 4.0% (w/v) of potato peptone (claim 3); or wherein the main culture medium in operation (b) includes 3.0 to 4.0% (w/v) of potato peptone (claim 7).
Young’s general disclosure relates to “a medium composition for a medium for culturing Clostridium botulinum containing potato peptone, yeast extract, and glucose”, wherein the “the medium is a medium from which animal-derived components and major allergens are excluded, and by inducing the botulinum toxin producing strain to reach the maximum growth amount within a short time, the production time in the botulinum toxin production process is shortened and the production cost is reduced” (see, e.g., Young, English Translation, Abstract).
Regarding claims 3 and 7 pertaining to potato peptone in the medium, Young teaches a medium composition for growth of Clostridium botulinum comprising 3% (w/v) potato peptone (see, e.g., Young, English Translation, pg. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to culture Clostridium botulinum in culture medium, as taught by Wang, wherein the culture medium comprises potato peptone, as taught by Young. One would have been motivated to do so because Young teaches “when potato peptone is used to exclude animal-derived ingredients and major allergens, it induces the botulinum toxin producing strain to reach the maximum growth amount within a short time, thereby shortening the production time in the botulinum toxin production process” (see, e.g., Young, English Translation, pg. 2, paragraph 8). Furthermore, Young teaches “when the Clostridium botulinum strain is cultured in a medium containing potato peptone, yeast extract, and glucose as a culture medium in which animal-derived components and allergens are excluded, then it was confirmed that the strain reached the maximum growth amount within a very short time, and the culture rate was remarkably improved” (see, e.g., Young, English Translation, pg. 2, paragraph 11). Moreover, Wang teaches growth of Clostridium botulinum in medium free of animal-derived ingredients, wherein the medium contains soybean derivatives, yeast extract, and glucose (see, e.g., Wang, English Translation, pg. 6, paragraph 25). Therefore, based on the teachings of Wang and Young, it would have been obvious to include potato peptone in Clostridium botulinum growth medium containing yeast extract and glucose, in order to induce the botulinum toxin producing strain to reach the maximum growth amount within a short time, thereby shortening the production time in the botulinum toxin production process. One would have expected success because Wang and Young both teach growth of Clostridium botulinum in medium containing yeast extract and glucose that is free of animal-derived ingredients.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claims 1-2, 5-6, 8, 10-11, and 13 above, and further in view of Foegeding (Effect of Carbon Dioxide, Nitrogen and Hydrogen Gases on Germination of Clostridium botulinum Spores; 1983).
Wang’s general disclosure is discussed above.
However, Wang does not teach: wherein the seed culture medium in operation (a) is subjected to gas replacement through a mixed gas including two or more gases selected from the group consisting of N2, CO2, and H2 (claim 4); or wherein the main culture medium in operation (b) is subjected to gas replacement through a mixed gas including two or more gases selected from the group consisting of N2, CO2, and H2 (claim 9).
Foegeding’s general disclosure relates to monitoring the germination of Clostridium botulinum spores “in modified peptone yeast extract broth flushed with CO2, N2, CO2 + H2 and N2 + H2” (see, e.g., Foegeding, abstract). Moreover, Foegeding discloses that hydrogen gas in combination with CO2 or N2 did not substantially alter germination compared to germination in CO2 or N2 alone (see, e.g., Foegeding, abstract).
Regarding claims 4 and 9 pertaining to gas replacement, Foegeding teaches flushing media for growing Clostridium botulinum with CO2, N2, CO2 + H2 and N2 + H2 (see, e.g., Foegeding, “Medium and gassing”, pg. 987).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to culture Clostridium botulinum in culture medium, as taught by Wang, wherein the culture medium is flushed with CO2, N2, CO2 + H2 and N2 + H2, was taught by Foegeding. One would have been motivated to do so because Foegeding teaches that “Enumeration procedures for anaerobic organisms including Clostridium botulinum often dictate flushing with anaerobic-grade gases (9). Typically, combinations of CO2, N2 and H2 gases are used. Carbon dioxide has been shown to enhance germination and growth of Clostridium species and growth of other anaerobic organisms” (see, e.g., Foegeding, Introduction, pg. 987). Moreover, Wang teaches that Clostridium botulinum is an anaerobic bacterium (see, e.g., Wang, English Translation, pg. 2, paragraph 5), that is grown under anaerobic conditions (see, e.g., Wang, English Translation, Examples 2 & 4). Therefore, based on the teachings of Wang and Foegeding, gas replacement with CO2, N2, H2 maintains an anerobic atmosphere for Clostridium botulinum growth since these are anaerobic gases, and CO2 enhances germination and growth of Clostridium species. One would have expected success because Wang and Foegeding both teach growth for Clostridium botulinum under anaerobic conditions.
Conclusion
Claims 1-11 and 13 are rejected.
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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