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
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 1-15 and 22-26 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.
On line 1 of claim 1, the phrase “low pH viral inactivation” is indefinite since it is not clear what constitutes a “low pH”. See this same problem throughout the claims. On line 12 of claim 1, the phrase “the acidified pool” lacks antecedent basis. In order to correct this problem, it is suggested to change the phrase “an acid pump configured to pump acid into the first vessel after the fluid is transferred into the first vessel” on lines 8-9 of claim 1 to -- an acid pump configured to pump acid into the first vessel after the fluid is transferred into the first vessel to form an acidified pool of fluid--. On lines 13-14 of claim 1, the phrase “the threshold pH value for viral inactivation” lacks antecedent basis. This phrase should be changed to –the target pH value for viral inactivation—in order to use the same terminology as recited earlier in the claim on lines 10-11 of claim 1.
On line 11 of claim 4, the phrase “the neutralized viral inactivated pool” lacks antecedent basis. In order to correct this problem, it is suggested to insert the phrase --, wherein the base neutralizes the acidified pool to form a neutralized viral inactivated pool-- after the phrase “range of neutral pH values” on line 10 of claim 4. On line 14 of claim 4, the phrase “the entire pool” should be changed to –the entire neutralized viral inactivated pool—so as to use the same terminology as recited earlier in the claim. On lines 17-18 of claim 4, the phrase “compare a second pH value, measured by the second pH probe after the first equilibration buffer is pumped into the second vessel” should be changed to -- compare a second pH value, measured by the second pH probe after the second equilibration buffer is pumped into the second vessel—since claim 4 recites that the second equilibration buffer is pumped into the second vessel, not into the first vessel. On line 22 of claim 4, the phrase “the threshold pH value” lacks antecedent basis and should be changed to –a threshold pH value--.
Claim 22 is indefinite since it recites a method limitation. However, claim 22 is directed to a system, not a method. On line 2 of claim 22, the phrase “neutralized viral inactivated chromatography elution pool” lacks antecedent basis. In addition, claim 22 should depend from claim 4, not claim 1, since claim 4 positively recites a neutralized viral inactivated pool, not claim 1. It is suggested to amend claim 22 to read: --The automated system of low pH viral inactivation of claim 4, further comprising a holding vessel, wherein the neutralized viral inactivated pool from the second vessel is transferred to the holding vessel--.
Claim 23 is indefinite since it recites a method limitation. However, claim 23 is directed to a system, not a method. On line 2 of claim 23, the phrase “neutralized viral inactivated chromatography elution pool” lacks antecedent basis. In addition, claim 23 should depend from claim 4, not claim 1, since claim 4 positively recites a neutralized viral inactivated pool, not claim 1. It is suggested to amend claim 23 to read: --The automated system of low pH viral inactivation of claim 4, further comprising a depth filter, wherein the neutralized viral inactivated pool from the second vessel is transferred to the depth filter--.
Claim 24 is indefinite since it recites a method limitation. However, claim 24 is directed to a system, not a method. On line 2 of claim 24, the phrase “the neutralized viral inactivated eluate” lacks antecedent basis and should be changed to –the neutralized viral inactivated pool--. It is suggested to amend claim 24 to read: --The automated system of low pH viral inactivation of claim 23, further comprising a sterile filter, wherein following depth filtration, the neutralized viral inactivated pool is transferred to the sterile filter--.
Claim 25 is indefinite since it recites a method limitation. However, claim 25 is directed to a system, not a method. On line 2 of claim 22, the phrase “neutralized viral inactivated chromatography elution pool” lacks antecedent basis. In addition, claim 25 should depend from claim 4, not claim 1, since claim 4 positively recites a neutralized viral inactivated pool, not claim 1. It is suggested to amend claim 25 to read: --The automated system of low pH viral inactivation of claim 4, further comprising a first polish chromatography column, wherein the neutralized viral inactivated pool from the second vessel is transferred to the first polish chromatography column--.
On line 1 of claim 26, the phrase “low pH viral inactivation” is indefinite since it is not clear what constitutes a “low pH”. On line 3 of claim 26, the phrase “adding a pool to a first vessel” is indefinite since it is not clear what constitutes the “pool” in this phrase. Does the “pool” comprise a source of fluid known or suspected to contain at least one enveloped virus?
Inventorship
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.
Allowable Subject Matter
Claims 1 and 26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action since while the closest prior art to Bartake et al (both US 2022/0090001 and WO 2020/152509, submitted in the IDS filed on May 4, 2023) teaches of an automated continuous system and method for producing therapeutic proteins that comprises a first viral inactivation vessel 128 connected to a chromatography system 119 for collecting a protein A eluate and inactivating viruses that may be present in the eluate by adjusting a pH of the eluate, wherein the viral inactivation system comprises a vessel 201 and a pH probe 220 associated with the vessel 201 for measuring the pH of the protein A eluate during viral inactivation, Bartake et al fails to teach or fairly suggest that the system and method also comprises a first buffer pump for pumping a first equilibration buffer having a first known pH value into the first viral inactivation vessel 201 in response to the entire acidified sample of eluate in the first viral inactivation vessel 201 being pumped out of the vessel 201, and an alert generator configured to compare a second pH value, measured by the pH probe 220 after the first equilibration buffer is pumped into the first vessel, to the first known pH value of the first equilibration buffer; determine whether the second pH value measured by the pH probe 220 is different from the first known pH value of the first equilibration buffer by greater than a threshold pH value; and generate a first alert responsive to the second pH value measured by the pH probe 220 being different from the first known pH of the first equilibration buffer by greater than the threshold pH value.
Claims 2-15 and 22-25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims for the same reasons as set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Bartake et al (US 2022/0090001) who teach of an automated continuous system and method for producing therapeutic proteins including a viral inactivation vessel; Vandiver et al (US 2022/0235311) who teach of an automated biomanufacturing system; Fiadeiro et al (US 2022/0356454) who teach of a method for continuously inactivating a virus during manufacture of a protein; Xenopoulos (US 2015/0064769) who teach of methods for inactivating viruses during protein purification; Wang et al (US 2012/0264920) who teach of a process for the purification of proteins; Coffman et al (US 2017/0037381) who teach of a method and an apparatus for continuously inactivating a virus during manufacture of a biological product; Kateja et al (article from Biochemical Engineering Journal, vol. 167, 107885, December 19, 2020, pages 1-9) who teach of a reactor configuration for continuous viral inactivation; and Gillespie et al (article from Biotechnology Journal, vol. 14, 1700718, 2019, pages 1-9) who teach of a continuous in-line virus inactivation system used during the production of monoclonal antibody therapeutics.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 January 27, 2026