FINAL ACTION
Response to Arguments
Applicant's arguments filed March 20th, 2026 have been fully considered but they are not persuasive.
Applicant argues that:
Initially, neither Li nor Vollenbroich discloses or suggests a method for reducing the bioburden of a cyclic lipopeptide compound. The disclosure of Li relates specifically to cyclic lipopeptides that are analogues of daptomycin and methods of making them. Li, Abstract, para. [0006]. Meanwhile, the disclosure of Vollenbroich relates to a method of inactivating lipid-enveloped viruses. Vollenbroich, Abstract. In addition, Vollenbroich is silent regarding irradiating a cyclic lipopeptide compound, thereby reducing bioburden of the cyclic lipopeptide compound. Thus, the claimed method for reducing the bioburden of a cyclic lipopeptide compound, and a method for producing a cyclic lipopeptide compound with reduced bioburden, cannot be contemplated from the teachings of Li and Vollenbroich.
The Examiner would respectfully respond that:
The reference of Li is utilized for the teaching of a method for reducing the bioburden of a cyclic lipopeptide compound. More specifically, Li clearly discloses in paragraph 2 that, “The invention is in the field of antibacterial agents, particularly antibacterial cyclic lipopeptides.” And in paragraph 166 that, “In a preferred embodiment, the disclosed compounds…may be sterilized by, for example….by irradiating the compositions…” As such, Li clearly discloses cyclic lipopeptide compounds, and that said compounds are sterilized (i.e., reducing the bioburden) by irradiating said compound.
Therefore, this response is not persuasive.
Applicant also argues that:
In addition, a person of ordinary skill in the art would not consider sterilizing the surfactin of Vollenbroich with a radiation beam taught by Li, as the Examiner proposes. Vollenbroich only describes sterilization of the cyclic lipopeptide compound via filtration (sterilized filtered). Vollenbroich, para. [0066]. The irradiation of gamma ray described in Vollenbroich is merely an example of various prior arts for inactivating lipid-enveloped viruses. See Vollenbroich, paras. [0003]-[0008]. As noted above, the disclosures of Vollenbroich relates to utilization of cyclic lipopeptide compounds instead of the other methods such as irradiation with gamma rays, as a means for inactivating lipid-enveloped viruses. Furthermore, Vollenbroich teaches that none of the inactivation methods used up to now (which includes gamma irradiation) can safely inactivate or eliminate all viruses which may occur in biological material. Vollenbroich, para. [0013]. Thus, Vollenbroich suggests that gamma irradiation may not be a suitable method for sterilization for the cyclic lipopeptide compound. Accordingly, a person of ordinary skill in the art would not contemplate, and would likely be discouraged from, modifying the method of Vollenbroich and replacing the filtration sterilization applied to the surfactin with irradiation sterilization taught by Li.
The Examiner would respectfully respond that:
Plainly stated, the rejection is made over Li in view of Vollenbroich¸ and not Vollenbroich in view of Li. As such, one of ordinary skill, beginning with the teachings of Li, would understand from the teachings of Li that cyclic lipopeptide compounds are sterilized by irradiating the cyclic lipopeptide compound because Li teaches a method for reducing bioburden of a cyclic lipopeptide compound (paragraph 2) by irradiating a cyclic lipopeptide compound with a radiation beam (paragraph 166). Vollenbroich is only provided to show that cyclic lipopeptide surfactins (or salts thereof) are sterilized as well (i.e., reducing the bioburden). See paragraphs 1, 24-31 and 66. As such, one of ordinary skill, beginning with the teachings of Li, would turn to Vollenbroich and understand that cyclic lipopeptide surfactins are sterilized (i.e., reducing the bioburden) as well; and determine from the teachings to sterilize (i.e., reduce the bioburden) a cyclic lipopeptide surfactin by irradiating said cyclic lipopeptide surfactin because Li teaches that cyclic lipopeptide compounds are sterilized (i.e., reducing the bioburden) by irradiation, and Vollenbroich teaches that cyclic lipopeptide surfactins are in need of sterilization (i.e., reducing the bioburden).
To the Applicant’s position that, “Vollenbroich teaches that none of the inactivation methods used up to now (which includes gamma irradiation) can safely inactivate or eliminate all viruses which may occur in biological material”; such appears to be a general blanked statement by the reference of Vollenbroich in paragraph 13, in which Vollenbroich does not specifically state that irradiation cannot safely inactivate or eliminate all viruses which may occur in biological material. Vollenbroich actually specifically focuses on pasteurization heat treatment, and the use of solvents & synthetic surfactins for sterilization as methods that cannot safely inactivate or eliminate viruses that occur; and does not focus on irradiation as a method that is unsafe. As such, one of ordinary skill would not be deterred from sterilizing (i.e., reducing the bioburden) the disclosed cyclic lipopeptide surfactins via irradiation.
Because of the reasonings set forth above, it is the position of the Office that the combination is proper, and this response is not persuasive.
The Applicant continues to argue that:
Moreover, the object of the present claims is to reduce bioburden in cyclic lipopeptide compound. On the other hand, the object of Vollenbroich is to provide a means for inactivating lipid enveloped viruses as noted above. Therefore, the object of the present claims is different from that of Vollenbroich.
The Examiner would respectfully respond that:
Vollenbroich is not utilized for disclosure of reducing the bioburden in cyclic lipopeptide compound. Li is provided for this disclosure as set forth above and below. Vollenbroich is merely provided to show that cyclic lipopeptide surfactins are sterilized as well, in which Vollenbroich discloses exactly that the surfactin was sterilized filtered in paragraph 66.
Thus, this response is not persuasive.
The Applicant further argues that:
Applicant notes that Song's disclosure relates to a method for producing homocyclic peptide Cyclo-[(Asp)5-Gly]. Song, p. 1 Song's disclosure does not relate to a cyclic lipopeptide compound which is a surfactin or a salt thereof, an iturin or a salt thereof, or a fengycin or a salt thereof.
Song describes that, in the production of homocyclic peptide, after the cyclization reaction is completed, the obtained product is placed in a container, sealed, and then placed in a 2.5 MeV and 40 mA electron accelerator for irradiation and stirring treatment under the condition that the irradiation dose rate of 50-100 Gy/min, the irradiation dose of 10-20 kGy, and the stirring speed is 100-150 rpm. Song, p. 7, Examples 6 and 7. However, Song does not describe the cyclic lipopeptides required by amended claims 1 and 2 (surfactin, iturin or fengycin) in general.
Furthermore, Song is silent regarding radiating a cyclic lipopeptide compound, thereby reducing the bioburden of the cyclic lipopeptide compound.
The Examiner would respectfully respond that:
Song is not relied upon for the disclosure of radiating a cyclic lipopeptide compound, thereby reducing the bioburden of the cyclic lipopeptide compound. Li in view of Vollenbroich is relied upon for this disclosure. Song is merely relied upon for the disclosure that cyclic peptide compounds are irradiated with electron beams with an absorbed radiation dose of said radiation beam being 100 kGy or less to produce a purity of the cyclic peptide compound of 50% or more in order to create a substantially pure drug carrier with more polarity and greater in vivo stability (page 7, Examples 6-8; page 1, first paragraph of “Background Technique).
Thus, this response is not persuasive as well.
Claim Rejections - 35 USC § 103
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, 2, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (U.S. Publication No. 2020/0010506) in view of Vollenbroich et al. (U.S. Publication No. 2002/0187929).
Concerning claims 1, 2, 11 and 12, Li discloses a method for reducing bioburden of a cyclic lipopeptide compound (paragraph 2), characterized by/comprising irradiating a cyclic lipopeptide compound with a radiation beam (paragraph 166). Li does not appear to disclose that the cyclic lipopeptide is a surfactin sodium salt. Vollenbroich discloses a method for reducing the bioburden of a cyclic lipopeptide compound utilized in inactivating viruses in pharmaceutical products and cell cultures (paragraph 1), wherein said cyclic lipopeptide compound is sterilized via filtration (paragraph 66). The reference continues to disclose that the cyclic lipopeptide is a surfactin sodium salt (abstract; paragraphs 24-31), as a surfactin salt is nearly almost always a surfactin sodium salt. Because both Li and Vollenbroich disclose sterilizing a cyclic lipopeptide utilized in inactivating viruses in pharmaceutical products and cell cultures, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to sterilize the surfactin of Vollenbroich with a radiation beam because Li discloses that radiation beam sterilization is a suitable and successful method for sterilizing a cyclic lipopeptide utilized in inactivating viruses in pharmaceutical products and cell cultures.
For further prosecution to claims 11 & 12, because Vollenbroich discloses surfactin salts, and does not specify the specific surfactin salt; and because surfactin salts are nearly almost always surfactin sodium salts, then it would have been obvious to one of ordinary skill to utilize a surfactin sodium salt as the surfactin salt in Vollenbroich, as nearly every surfactin salt is a surfactin sodium salt, which is readily available and common to one of ordinary skill. As such, one of ordinary skill, reading from the teachings of Vollenbroich, would utilize a surfactin sodium salt in the method of Li in view of Vollenbroich.
Therefore, claims 11 & 12 are not patentable over Li in view of Vollenbroich as well.
Claims 4-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (U.S. Publication No. 2020/0010506) in view of Vollenbroich et al. (U.S. Publication No. 2002/0187929) as applied to claims 1 & 2 above, and further in view of Song (Document Identification No. CN 107400161 A).
Li is relied upon as set forth above. Li does not appear to disclose that the radiation beam is an electron beam with an absorbed radiation dose of said radiation beam is 100 kGy or less to produce a purity of the lipopeptide compound of 50% or more. Song discloses a method of producing a cyclic peptide compound (page 1, “technical field”) for the use of producing a pure drug carrier (page 3, lines 24-30). The reference continues to disclose that the cyclic peptide compound is irradiated with an electron beam with an absorbed radiation dose of said radiation beam is 100 kGy or less to produce a purity of the cyclic peptide compound of 50% or more in order to create a substantially pure drug carrier with more polarity and greater in vivo stability (page 7, Examples 6-8; page 1, first paragraph of “Background Technique). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the lipopeptide compound of Li with electron beam radiation having an absorbed radiation dose of said radiation beam at 100 kGy or less to produce a purity of the lipopeptide compound of 50% or more in order to create a substantially pure drug carrier with more polarity and greater in vivo stability as exemplified by Song.
Thus, claims 4-6 and 8-10 are not patentable over Li in view of Song.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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