DETAILED ACTION
Status of Claims:
Claims 31, 33-40 and 43-55 are pending.
Claim 41 is canceled.
Claims 46-48 are withdrawn from consideration.
Claim 55 is New.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/13/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 33, 33-40, 43-45 and 49-55 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The previous prior art rejection is withdrawn in view of the amendments, however a new rejection is made.
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 31, 33-40, 43-45 and 49-55 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 33 has been amended to use “consisting of” as the transitional phrase, however there is no support for a process consisting of only the steps claimed. The original disclosure does not disclose at least a process “consisting of…(d) performing a viral inactivation…applying the protein mixture obtained from step (d) onto a depth filtration system…”. The original disclosure requires viral inactivation and neutralization before a depth filtration step (“after neutralization, protein has been filtered by 0.2µm filter” see at least para. 0503 and 0465 or the published specification). There is no disclosure of depth filtration without a prior neutralization step. The remaining claims are rejected as they depend from a claim containing new mater.
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 43-45 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 Claims 43 and 44:
Claims 43 and 44 depend from claim 41. Claim 41 has been canceled, it is therefore not clear what claims 43 and 44 depend from.
Claim 45 is indefinite as it depends from an indefinite claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Blaisdell (WO 2009/058769) teaches a process for purifying an IgG1 antibody comprising the steps of affinity (protein A) chromatography (see para. 0111-0112), viral inactivation, depth filtration (see para. 0113) and ion exchange chromatography (see para. 0115-0117).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAIRE A NORRIS whose telephone number is (571)272-5133. The examiner can normally be reached M-Th 7:30-5 F: 8-12.
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, Ramdhanie Bobby can be reached at 571-270-3240. 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.
/CLAIRE A NORRIS/Primary Examiner, Art Unit 1779 4/28/2026
Prosecution Insights