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 .
DETAILED ACTION
Applicant’s response filed January 23, 2026 is acknowledged. Claim 1 is amended and claims 2-3 and 14-24 are canceled. Claims 1 and 4-13 are pending and further considered on the merits.
Response to Amendment
In light of applicant’s amendment, the examiner modifies the grounds of rejection set forth in the office action filed November 5, 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Currently, claims 10-11 recite elements already provided in the independent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-9, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodrich et al., US 2021/0170336 (Goodrich, of record) in view of Rolinger et al., “Multi-attribute PAT for UF/DF of Proteins-Monitoring Concentration, particle sizes and Exchange” Analytical and bioanalytical chemistry, vol. 412, issue 9 (2020), pgs. 2123-2136 (Rolinger, IDS).
Regarding claim 1, Goodrich discloses a system for filtration of a feedstock (abstract, figs. 1-2, ¶ 0004) comprising:
A feed vessel (REF 102) containing a solution comprising a target biomolecule (see “bioproduction sample”, ¶ 0002, 0004);
A filter membrane (REF 124, ¶ 0032-0036, 0066) coupled to the feed vessel via a feed line (REF 126a), the filter membrane further coupled to the feed vessel via a retentate line (REF 128a);
A feed pump (REF 122, ¶ 0070) disposed in the feed line between the feed vessel and the filter membrane, the feed pump for moving solution from the feed vessel to the filter membrane;
A permeate line (see “PERMEATE” and fluidic coupling to REF 124) coupled to the filter membrane for delivering permeate to a permeate vessel;
A buffer vessel (REF 154, ¶ 0067) coupled to the feed vessel via a buffer supply line (REF 156a);
A diafiltration pump (REF 152, ¶ 0067) disposed in the buffer supply line for adding buffer from the buffer vessel to the feed vessel;
An ultraviolet sensor coupled to the feed line between the feed vessel and the feed pump (see “concentration readings of the sample”, ¶ 0070) configured to correlate in real time transmitted light with a concentration of a target biomolecule (¶ 0096); and
A controller (REF 160, ¶ 0070) coupled to the ultraviolet sensor, the feed pump, and the diafiltration pump (¶ 0070) to receive information therefrom and to execute instructions for;
Adjusting a speed of the diafiltration pump during a diafiltration step to maintain a concentration of the target biomolecule in the solution within a predetermined range (¶ 0070, 0096);
Stopping the diafiltration pump once a user-selected diafiltration volume is determined (¶ 0070, 0096-0097); and
When a concentration of the target biomolecule in the solution reaches a user-selected final concentration, operating the system in a recirculation mode to maintain the solution at the selected final concentration (¶ 0095-0096).
Goodrich does not disclose the ultraviolet sensor as a variable path-length instrument. However, Rolinger discloses a diafiltration system for filtration of biomolecule containing feedstocks (abstract, fig. 2) comprising a variable path-length instrument (see “variable pathlength (VP) ultraviolet and visible (UV/Vis) spectrometer, abstract, and “FlowVPE VP UV/Vis spectrometer”, Experimental setup, pg. 2124), the variable path-length instrument configured to transmit light through the solution and to correlate in realtime the transmitted light with a concentration of the target biomolecule in the solution (abstract, fig. 1).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the system of Goodrich to utilize the variable path-length instrument described in Rolinger since it has been shown that alternate UV spectroscopy techniques are effective in diafiltration methods and that in-line variable path-length sensors are comparable to off-line HPLC analysis of product recovery streams with the added benefit of more reliable data acquisition (Rolinger, Results and discussion, pg. 2128)
Regarding claim 4, Goodrich (in view of Rolinger) discloses a system wherein the controller is programmed to execute instructions for receiving, from a user, input values for target concentration and/or diafiltration volume for the system to perform a combination of concentration and diafiltration steps (see “endpoint control”, ¶ 0096-0097).
Regarding claim 5, Goodrich (in view of Rolinger) discloses a system wherein the controller is programmed to execute instructions for periodically determining, based on information received from the variable path-length instrument, whether the concentration of the target biomolecule is within a predetermined range of the user input concentration (¶ 0094-0095).
Regarding claim 6, Goodrich (in view of Rolinger) discloses a system wherein the controller is programmed to execute instructions for periodically determining, based on information received from the variable path-length instrument, whether the concentration of the target biomolecule is equal to the user input final concentration (¶ 0094, 0096).
Regarding claims 7-8, Goodrich (in view of Rolinger) discloses a system wherein the filter membrane is a tangential flow filtration membrane comprising a TFF hollow-fiber cassette (¶ 0086-0087).
Regarding claim 9, Goodrich does not disclose a system wherein the controller provides a user-alert if the concentration departs from a user-specified range or user-specified predetermined amount. However, Rolinger discloses a system wherein a controller (see “custom made application”, Data acquisition and analysis, pg. 2126) is configured to provide a user-alert if the concentration of the target biomolecule, based on information provided by the variable path-length instrument, is determined to have departed from a user-specified range or user-specified value by a predetermined amount (see “small absolute deviations”, “most pronounced deviations”, In-line concentration measurements by VP UV/Vis spectroscopy, pg. 2128).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the system of Goodrich to include the user-alert described in Rolinger in order to indicate sub-optimal or deviating process conditions to a user.
Regarding claim 12, Goodrich (in view of Rolinger) discloses a system further comprising a backpressure control valve (REF 139, ¶ 0070) disposed in the retentate line.
Regarding claim 13, Goodrich (in view of Rolinger) discloses a system further comprising pressure sensors in the feed line, the retentate line, and the permeate line (¶ 0070).
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Goodrich in view of Rolinger as outlined above.
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 DIRK R BASS whose telephone number is (571)270-7370. The examiner can normally be reached 8-4:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie 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.
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DIRK R. BASS
Primary Examiner
Art Unit 1779
/DIRK R BASS/Primary Examiner, Art Unit 1779
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