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 with traverse of Group III (i.e., claims 6-12, 14, 16, 18-22, 24-25, and 27 drawn to a method for purifying an echinocandin drug impurity of a structure represented by Formula I) in the reply filed on December 1, 2025, is acknowledged. Additionally, Applicant's election with traverse of Species B (i.e., a single and specific macroporous adsorptive resin purification as HP20SS for the macroporous adsorptive resin and methyl alcohol for the organic solvent; and a single and specific silica gel purification as Click Xion silica gel for the silica gel, acetic acid for the acidic solution, and acetonitrile for the organic solvent) in the reply filed on December 1, 2025, is acknowledged. The traversal is on the grounds that the Groups have the same or corresponding technical feature over the prior arts, and thus relate to a single general inventive concept under PCT Rule 13.1 (See Applicant’s Response received on 12/1/25, pg. 6). Furthermore, Applicants assert that any prior art searched for the elected Group III would be applicable to the non-elected Groups (See Applicant’s Response received on 12/1/25, pg. 6).
This is not found persuasive because the shared technical feature between Groups I-III lacks unity of invention as stated in the Restriction mailed on 10/2/25. As stated in the Restriction, the shared technical feature is an echinocandin drug impurity of a structure represented by Formula I (See Restriction, pg. 5). This technical feature does not make a contribution over the prior art, as asserted by Applicant, in light of the teachings of Liu et al. US 2015/0065417 A1 (See Restriction, pg. 5). Thus, contrary to Applicant’s argument, the shared technical feature between Groups I-III lacks unity of invention for the reasons set forth in the Restriction.
Furthermore, in response to Applicant’s argument that there is no search burden in examining the Groups together, it is noted that undue search burden is not a criteria for election/restriction purposes under 35 USC §121 and 35 USC § 372. As stated in the Restriction, according to PCT Rule 13.1, unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. PCT Rule 13.2 has clearly stated that ‘Where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art’. Please refer MPEP 1850 for details. In the instant case, as stated in supra, the shared technical feature does not make a contribution over the prior art in light of the teachings of Liu et al. Thus, Groups I-III lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Please note that the single and specific acidic solution in Species B is hereby withdrawn. However, please note that the remaining elements of Species B are maintained.
Status of Claims
Claims 1-28 were originally filed on January 19, 2023.
The amendment received on January 19, 2023, canceled claims 13, 15, 17, 23, and 26; and amended claims 12, 14, 16, 22, 25, and 28. The amendment received on December 1, 2025, amended claim 6. The amendment received on May 28, 2026, canceled claims 7-8, 11-12, 14, 16, 18-22, and 25; amended claims 6, 9, 24, and 27; and added new claims 29-33.
Claims 1-6, 9-10, 24, and 27-33 are currently pending and claims 6, 9-10, 24, 27, and 29-33 are under consideration as claims 1-5 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 1, 2025.
Priority
The present application claims status as a 371 (National Stage) of PCT/CN2022/099564 filed June 17, 2022, and claims priority under 119(a)-(d) to Chinese Application No. 202111057760.2 filed on September 9, 2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Chinese Application No. 202111057760.2, which papers have been placed of record in the file. Please note that the Chinese application is not in English and therefore cannot be verified.
Response to Arguments
Applicant’s arguments, see Response, filed 5/28/26, with respect to claim objection have been fully considered and are persuasive. The objection of claim 27 has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 112(a), written description, rejection have been fully considered and are persuasive. The rejection of claims 6-12, 14, 16, 18-22, and 24-25 as failing to comply with the written description requirement has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claims 6-12, 14, 16, 18-22, 24-25, and 27 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 has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claims 12, 14, 16, 22, and 25 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 has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 112(b) rejection have been fully considered and are persuasive. The rejection of claims 20 and 27 as being indefinite for containing the trademarks/trade names “UniSil®”, “Chromatorex”, “Click “XIon” and “Inertsil” has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 102/103 rejection have been fully considered and are persuasive. The rejection of claims 6-7 as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Liu et al. US 2015/0065417 A1 published on March 5, 2015 has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 6-12, 14, 18, 21-22, and 24-25 as being unpatentable over Liu et al. US 2015/0065417 A1 published on March 5, 2015 and further in view of Aassveen et al. US Publication No. 2014/0371423 A1 published on December 18, 2014, alone or as evidenced by, Dolan, J., “A Guide to HPLC and LC-MS Buffer Selection,” available online at https://www.hplc.eu/Downloads/ACE_Guide_BufferSelection.pdf, 20 pages (first available 2014) has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 6-8 and 16 as being unpatentable over Liu et al. US 2015/0065417 A1 published on March 5, 2015, in view of Aassveen et al. US Publication No. 2014/0371423 A1 published on December 18, 2014, and further in view of Zou et al., J. Chromatography B 978-979:111-117 (2015) has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 6-8 and 18-19 as being unpatentable over Liu et al. US 2015/0065417 A1 published on March 5, 2015, in view of Aassveen et al. US Publication No. 2014/0371423 A1 published on December 18, 2014, and further in view of Agilent, “Hydrophilic Interaction Chromatography Method Development and Troubleshooting, available online at https://www.agilent.com/cs/library/technicaloverviews/public/5991-9271EN_HILIC_method_development_TechOverview.pdf?srsltid=AfmBOopaDvF2Xgko5EN-xBvRatmRgp9fCqTVc3yyeSokVbzvYBdrHw5i, 14 pages (2018) has been withdrawn.
Applicant’s arguments, see Response, filed 5/28/26, with respect to 103(a) rejection have been fully considered and are persuasive. The rejection of claims 6-7 and 27 as being unpatentable over Liu et al. US 2015/0065417 A1 published on March 5, 2015, in view of Aassveen et al. US Publication No. 2014/0371423 A1 published on December 18, 2014, and further in view of Bionity, “Vacuum distillation,” Bionity.com, available online at https://www.bionity.com/en/encyclopedia/Vacuum_distillation.html, 3 pages (first available 2013), and Dolan, J., “A Guide to HPLC and LC-MS Buffer Selection,” available online at https://www.hplc.eu/Downloads/ACE_Guide_BufferSelection.pdf, 20 pages (first available 2014) has been withdrawn.
New Objections
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 recites, “HPLC purity of 90% or more…” in line 3. Although, the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is respectfully requested that claim 6 recites, “High-Performance Liquid Chromatography (HPLC) purity of 90% or more…” for the first recitation, thereafter HPLC may be utilized. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: claim 6 recites with respect to the silica gel purification steps, “the organic solvent is selected from the group consisting of methyl alcohol, ethyl alcohol, propyl alcohol, butanol, acetone, acetonitrile and any mixtures thereof, the organic solvent is selected from the group consisting of methyl alcohol, ethyl alcohol, propyl alcohol, butanol, acetone, acetonitrile and any mixtures thereof,…” In other words, the same Markush group is recited in duplicate. It is respectfully requested that claim 6 only recites the Markush group in the silica gel purification steps once in order to be grammatically correct. Appropriate correction is required.
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 6, 9-10, 24, 27, and 29-33 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. Claim 6 is directed to a purification method of an echinocandin drug impurity of a structure represented by Formula I by producing an echinocandin drug impurity having an HPLC purity of 90% or more through column chromatography purification…wherein the column chromatography purification comprises macroporous adsorptive resin purification and silica gel purification…. As such, there is a lack of nexus between the purity level being based on HPLC and the column chromatography purification method in the manipulative steps. In other words, it is unclear how the purity level is based on HPLC, but the column chromatography purification does not correlate the column chromatography to HPLC. Although macroporous adsorptive resin, silica gel purification, and hydrophobic interaction chromatography can all be utilized in HPLC, the manipulative steps fail to correlate these individual purification processes to obtain an HPLC purity level. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to a lack of nexus between the purity level being based on HPLC and the column chromatography purification method in the manipulative steps.
Please note that claims 9-10, 24, 27, and 29-33 are rejected by virtue of their dependency.
Allowable Subject Matter
Notwithstanding the claim objections and 112(b) rejection supra, claims 6, 9-10, 24, 27, and 29-33 are free of the prior art. It is noted that the claimed invention is free of the prior art because there is no teaching or suggestion in the art to purify the echinocandin drug impurity of Formula I via the macroporous adsorptive resin and silica gel purification processes such that the impurity has an HPLC purity of at least 90%. The closest prior art, Liu et al. US 2015/0065417 A1 (cited in the Action mailed on 3/2/26), teaches utilizing macroporous adsorptive resin and silica gel purification processes in general, but to obtain sodium micafungin (i.e., FK463), i.e., the active compound instant Formula I is an impurity of (See Liu, [0004], [0006], [0019], [0027], [0029], [0031]). Liu et al. fails to evaluate and/or determine the purity level of any micafungin impurity compounds. Therefore, there is no teaching or suggestion in the art to purify a micafungin sample in order to obtain the impurity of instant Formula I having at least 90% HPLC purity. Thus, the claimed purification method is free of the prior art.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
Prosecution Insights