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 . 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 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.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/561,252 application filed on November 15, 2023. Claims 1-16 are pending. Claims 1-13 are examined, on the merits, in this Office action. The examined claims are directed to a method.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on March 16, 2026 is acknowledged. Claims 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 11/15/2023. Please refer to the signed copy of the PTO-1449 form attached herewith.
Claim Objections
Claim 11 is objected to because of the following informality: In claim 11, it appears the term ‘system’ is missing after ‘chromatography.’
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.
Claim 2 is 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 pre-AIA the applicant regards as the invention.
In claim 2, the phrase “the total volume” lacks antecedent basis since it is unclear which volume is intended.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vogel et al. (US20130345402, Vogel).
Regarding claims 1-3 and 5-8, Vogel discloses a method for purifying a feed comprising a concentration of at least one target product (Abstract, Fig. 3) in a chromatography system ([0014]) having at least a first adsorption purifying unit ([0039]), the at least first adsorption purifying unit has a capacity for binding the target product ([0007], [0158], [0159]) and is configured to receive the feed from a first holding tank ([0003]) and to provide the at least one target product at an outlet ([0114], [0118], [0145]),
wherein the first holding tank is configured to receive a continuous feed from a bioreactor ([0012], [0018], [0063], [0144]-[0148], where surge vessel 200, 201 is continuously fed by the output solution from the particle removal device 100; when the balance (202) detects that the surge vessel is filled to a predetermined level, it automatically triggers the adsorption/desorption cycle of the module 406 ([0164]-[0168]), while simultaneously continuously filling the surge tank), the method comprising:
a) loading the at least first adsorption purifying unit with a volume of feed provided from the first holding tank, the volume of feed comprising an amount of the at least one target product corresponding to less than, or equal to, the capacity for binding the target product in the at least first adsorption purifying unit ([0150]-[0152]);
b) when step a) is completed, washing, eluting, cleaning and regenerating the at least first adsorption purifying unit while filling the first holding tank with feed, said first holding tank having a volume of at least the amount of the feed provided by the bioreactor during this step;
c) repeating step a) and b) for a predetermined number of cycles (0148], [0172]).
Additional Disclosures Included: Claim 2: The first holding tank has a maximum volume and contains a fraction of the total volume when step a) is completed ([0096], [0109]); Claim 3: The chromatography system further comprises a weight sensor configured to measure a weight, W, of the first holding tank, wherein step a) and step b) are initiated based on the measured weight of the first holding tank ([0116], [0120]); Claim 5: In the method, step a) is performed during a time period, T, while filling the first holding tank with feed ([0148], claim 1 analysis); Claim 6: The step of determining the target product concentration, CTP, is performed by measuring the concentration in the first holding tank ([0162], [0168], where concentration is known and thus must have been be measured); Claim 7: The at least first adsorption purifying unit is a single adsorption purifying unit or multiple parallel-connected adsorption purifying units ([0047], [0071], [0159]); and Claim 8: The loading in step a) is performed at a loading flow rate, RL, and the feed from the bioreactor is introduced into the first holding tank at a feed flow rate, RF, wherein the feed flow rate is lower than the loading flow rate, RF<RL ([0150]).
Claims 1, 2 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cattaneo et al. (US 20170204446, Cattaneo)(IDS of 11-15-2023).
Regarding claims 1, 2 and 5-7, Cattaneo discloses a method for purifying a feed comprising a concentration of at least one target product (Abstract, [0001], Fig. 6) in a chromatography system ([0012]-[0015]) having at least a first adsorption purifying unit ([0011]), the at least first adsorption purifying unit has a capacity for binding the target product ([0010], [0040]) and is configured to receive the feed from a first holding tank ([0003]) and to provide the at least one target product at an outlet ([0114], [0118], [0145]),
wherein the first holding tank is configured to receive a continuous feed from a bioreactor ([0012]), the method comprising:
a) loading the at least first adsorption purifying unit with a volume of feed provided from the first holding tank, the volume of feed comprising an amount of the at least one target product corresponding to less than, or equal to, the capacity for binding the target product in the at least first adsorption purifying unit ([0017], [0040]-[0042], [0052]);
b) when step a) is completed, washing, eluting, cleaning and regenerating the at least first adsorption purifying unit while filling the first holding tank with feed, said first holding tank having a volume of at least the amount of the feed provided by the bioreactor during this step ([0017], [0049], [0051], [0053], [0063], [0065]);
c) repeating step a) and b) for a predetermined number of cycles ([0051]).
Additional Disclosures Included: Claim 2: The first holding tank has a maximum volume and contains a fraction of the total volume when step a) is completed ([0011], [0017], [0018]); Claim 5: In the method, step a) is performed during a time period, T, while filling the first holding tank with feed ([0017], [0040]; claim 1 analysis); Claim 6: The step of determining the target product concentration, CTP, is performed by measuring the concentration in the first holding tank ([0057]); and Claim 7: (Previously Presented) The method according to claim 1, wherein the at least first adsorption purifying unit is a single adsorption purifying unit or multiple parallel-connected adsorption purifying units ([0006], [0016], [0040]).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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. The inventive entity for a particular application is based on some contribution to at least one of the claims made by each of the named inventors. MPEP §2137.01.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Vogel et al. (US20130345402), as applied to claims 1 and 3 above.
Regarding claims 4 and 13, Vogel discloses or suggests the method according to claim 3, except wherein the method further comprises:
initiating step a) when the measured weight of the first holding tank is above a first weight threshold, W>W1; and
initiating step b) when the measured weight of the first holding tank is below a second weight threshold, W<W2.
However Vogel uses weight signals along with a computerized system to decide on certain steps ([0116], [0120], [0146], [0148], [01666]).
When the claimed invention was effectively filed, it would have been an obvious matter of engineering choice to one of ordinary skill in the art to experiment with different weight triggers and to optimize the process accordingly, including initiating steps a) and b) based on the recited weight triggers.
Additional Disclosures Included: Claim 13: The predetermined number of cycles is based on the performance of the at least first adsorption purifying unit (claim 4 analysis and engineering choice).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vogel et al. (US20130345402), as applied to claim 1 above, in view of Hall et al. (US2013248451, Hall).
Regarding claims 9-12, Vogel discloses or suggests the method according to claim 1, except further comprising:
d) redirecting the feed from the bioreactor to at least a second adsorption purifying unit after repeating steps a)-c) using the at least first adsorption purifying unit the predetermined number of cycles; and
e) repeating steps a)-c) while providing feed from the bioreactor to the at least second adsorption purifying unit.
Adding a second adsorption purifying unit is a matter of duplicating known structure which is expected to produce enhanced purification, which is not patentably significant unless Applicant can show new and unexpected results.
Additionally, Hall discloses a chromatography system for separation of a biopolymer, comprising at least one feed tank, at least one hold tank, at least one elution buffer tank, at least one eluate tank, at least two packed bed chromatography columns and for each packed bed chromatography column at least one pump and at least one outlet detector both connected to said each packed bed chromatography column, wherein the feed tank, the hold tank(s), the elution buffer tank and the eluate tank are each connected to the packed bed chromatography columns via a system of valves (Abstract, Figs. 2-6). Hall also discloses multiple holding tanks (4, 4a, 4b, 4c) associated with different chromatography columns (7, 8, 9)([0010], [0030], Figs. 5 & 6). A hold tank can be connected to the column(s) via one or more valves, pumps, detectors and/or manifolds ([0025], [0030]). In some embodiments the at least one hold tank 4; 4a, 4b, 4c is adapted to receive a fluid from an outlet end 14 of a column 7, 8 and to convey fluid to the inlet end 13 of another column 8, 7 ([0032]).
At the time when the claimed invention was effectively filed, it would have been obvious to an ordinarily skilled artisan to experiment with appropriately connected additional purification structures and their associated accessories in an attempt at optimizing the purification process, including redirecting the feed from the bioreactor to at least a second adsorption purifying unit, since Hall discloses the use and structural connection of multiple adsorptions units, holding tanks and chromatography columns, working effectively together, for improved efficiency.
Additional Disclosures Included: Claim 10: The chromatography system is further provided with a first valve having an inlet for receiving feed from the bioreactor, a first outlet connected to the first holding tank and a second outlet connected to a second holding tank which is configured to provide feed to the at least second adsorption purifying unit, wherein step d) further comprises:
d1) redirecting the feed flow from the bioreactor to the second holding tank using the first valve after the predetermined number of cycles (claim 9 analysis, where this is an obvious process based on the additional structures suggested in Hall); Claim 11: The chromatography is further provided with a second valve having at least one inlet for receiving feed from the first holding tank, a first outlet connected to the at least first adsorption purifying unit and a second outlet connected to the at least second adsorption purifying unit,
wherein step d) further comprises: d2) redirecting the feed flow from the bioreactor to the at least second adsorption purifying unit using the second valve after the predetermined number of cycles (claim 9 and 10 analyses); and Claim 12: The method further comprises:
e1) redirecting the feed from the bioreactor from the first holding tank to a second holding tank; and
e2) loading the first adsorption purifying unit with feed from the second holding tank (claims 9-11 analyses).
Conclusion
Examiner recommends that Applicant carefully review each identified reference and all objections/rejections before responding to this office action to properly advance the case in light of the pertinent objections/rejections and the prior art. With respect to the patentability analysis, Examiner has attempted to claim map to one or more of the most suitable structures or portions of a reference. However, with respect to all OAs, Examiner notes that citations to specific pages, columns, paragraphs, lines, figures or reference numerals, in any prior art or evidentiary reference, and any interpretation of such references, should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably disclosed and/or suggested to one having ordinary skill in the art. The use of publications and patents as references is not limited to what one or more applicant/inventor/patentee describes as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. MPEP §2123.
Examiner further recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via 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) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central 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.
/HAYDEN BREWSTER/Examiner, AU 1779
Prosecution Insights