DETAILED ACTION
For this Office action, Claims 16-35 are pending. Claims 1-15 have been canceled.
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 25 and 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. Claims 25 and 26 both recite “media”, which lacks established antecedent basis. For purposes of this examination, the examiner will assume “media” means “the diafiltration medium”.
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.
Claims 16-19, 25 and 27-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leuthold et al. (herein referred to as “Leuthold”, US Pat Pub. 2019/0030486; found in IDS filed 09/27/2024).
Regarding instant Claims 16 and 28, Leuthold discloses a separation system to process a first fluid containing a plurality of components, wherein at least one component for the plurality of components is a target component, wherein the target component is selected from at least viruses (Abstract; Paragraph [0016]; crossflow filtration unit for treatment of feed/first fluid; component to be separated may be a virus; see Claim 28) and wherein the separation system comprises:
a first and a second chromatography device and a single-pass crossflow diafiltration unit integrally integrated between the first and second chromatography (Figure 5B; Paragraph [0104]; Paragraph [0111]; chromatography steps 44 and crossflow diafiltration unit 1 in the configuration of Figure 5B),
wherein the first chromatography device is configured to receive and process the first fluid and to provide a second fluid containing the target compound (Figure 5B; Paragraph [0016]; Paragraph [0081]; Paragraph [0082]; Paragraph [0082]; Paragraph [0111]; first chromatography step 44 provides second fluid with separation),
the single-pass crossflow diafiltration unit is configured to continuously diafiltrate the second fluid with a diafiltration medium for obtaining a permeate and a third fluid containing the target component as retentate (Figure 2; Figure 5B; Paragraph [0106]; diafiltration process with diafiltration medium 3 supplied to filtration cassette 1, see permeate 2 and third fluid retentate 7 comprising target molecules [retentate retaining the rejected particles]), and
the second chromatography device is configured to receive and process the third fluid and to provide a fourth fluid containing the target compound (Figure 5B; Paragraph [0016]; Paragraph [0081]; Paragraph [0082]; Paragraph [0082]; Paragraph [0111]; second chromatography step 44 would further separate and arrive at target particle such as viruses).
Regarding instant Claim 17, Claim 16, upon which Claim 17 is dependent, has been rejected above. Leuthold further discloses wherein the single-pass crossflow diafiltration unit at least comprises a diafiltration channel, a first filter material, a retentate channel, a second filter material and a permeate collection channel, arranged in such a way that the first filter material delimits the diafiltration channel and the retentate channel from one another, and the second filter material delimits the retentate channel and the permeate collection channel from one another (Abstract; Figure 2; Paragraph [0046]; crossflow diafiltration unit comprises diafiltration channel, first filter material, retentate channel, a second filter material and a permeate collection; see Abstract description),
wherein the diafiltration channel is connected in a fluid conducting manner to at least one inlet for diafiltration medium (Figure 2; Figure 5B; Paragraph [0046]; Paragraph [0106]; Paragraph [0108]; diafiltration medium 3 introduced to diafiltration channel via pump 12),
the retentate channel is connected in a fluid conducting manner to at least one inlet for the second fluid and to at least one outlet for the third fluid (Figure 2; Paragraph [0005]; retentate channel is connected from feed fluid inlet to retentate outlet), and
the permeate collection channel is connected in a fluid conducting manner to at least one outlet for permeate (Figure 2; Paragraph [0010]; permeate channel is connected to permeate outlet).
Regarding instant Claim 18, Claim 17, upon which Claim 18 is dependent, has been rejected above. Leuthold further discloses wherein the second filter has a pore diameter being smaller than the target component and being larger than at least one of the other components of the second fluid (Paragraph [0010]; Paragraph [0012]; Paragraph [0022]; molecular weight cutoff is adjusted to allow particles of certain diameters to get through, smaller particles beyond the range of ultrafiltration will pass through while what is desired to be contained in the retentate will not).
Regarding instant Claim 19, Claim 16, upon which Claim 19 is dependent, has been rejected above. Leuthold further discloses wherein the second and third fluid differ in at least conductivity (Figure 2; Figure 5B; Paragraph [0106]; conductometer 19s indicate differences in conductivity and need to monitor said differences).
Regarding instant Claim 25, Claim 16, upon which Claim 25 is dependent, has been rejected above. Leuthold further discloses wherein the system comprises at least three means for providing the fluids and media selected from the group consisting of pumps and valves (Figure 2; Paragraph [0106]; Paragraph [0107]; pumps 12 and 14 and valve 17).
Regarding instant Claim 27, Claim 16, upon which Claim 27 is dependent, has been rejected above. Leuthold further discloses wherein the single-pass crossflow diafiltration unit is configured such that a volume flow rate of the supplied diafiltration medium is 0.5 to 20 times a volume flow rate of the supplied second fluid (Paragraph [0058]; range can be 0.5 to 15).
Regarding instant Claim 29, Leuthold discloses a method of purifying a target component included in a first fluid (Abstract; Paragraph [0016]; crossflow filtration method for treatment of feed/first fluid), wherein the method comprises the steps of:
providing the first fluid to a first chromatography device (Figure 5B; Paragraph [0016]; Paragraph [0081]; Paragraph [0082]; Paragraph [0082]; Paragraph [0111]; first chromatography step 44 provided with first fluid);
processing the first fluid in the first chromatography device to obtain a second fluid containing the target component (Figure 5B; Paragraph [0016]; Paragraph [0081]; Paragraph [0082]; Paragraph [0082]; Paragraph [0111]; first chromatography step 44 provides second fluid with separation);
providing the second fluid to a single-pass crossflow diafiltration unit (Figure 2; Figure 5B; Paragraph [0106]; Paragraph [0111]; unit 1 receives fluid from first step 44);
processing the second fluid with a diafiltration medium in the single-pass crossflow diafiltration unit to obtain a third fluid containing the target particle (Figure 2; Figure 5B; Paragraph [0106]; diafiltration process with diafiltration medium 3 supplied to filtration cassette 1, see permeate 2 and third fluid retentate 7 comprising target molecules [retentate retaining the rejected particles]);
providing the third fluid to a second chromatography device; and
processing the third fluid in the second chromatography device to obtain a fourth fluid containing the target particle (Figure 5B; Paragraph [0016]; Paragraph [0081]; Paragraph [0082]; Paragraph [0082]; Paragraph [0111]; second chromatography step 44 would further separate and arrive at target particle such as viruses),
wherein the single-pass crossflow diafiltration unit is integrally integrated between the first and second chromatography device (Figure 5B; Paragraph [0111]).
Regarding instant Claim 30, Claim 29, upon which Claim 30 is dependent, has been rejected above. Leuthold further discloses wherein the single-pass crossflow diafiltration unit at least comprises a diafiltration channel, a first filter material, a retentate channel, a second filter material and a permeate collection channel, arranged in such a way that the first filter material delimits the diafiltration channel and the retentate channel from one another, and the second filter material delimits the retentate channel and the permeate collection channel from one another (Abstract; Figure 2; Paragraph [0046]; crossflow diafiltration unit comprises diafiltration channel, first filter material, retentate channel, a second filter material and a permeate collection; see Abstract description),
wherein the diafiltration channel is connected in a fluid conducting manner to at least one inlet for diafiltration medium (Figure 2; Figure 5B; Paragraph [0046]; Paragraph [0106]; Paragraph [0108]; diafiltration medium 3 introduced to diafiltration channel via pump 12),
the retentate channel is connected in a fluid conducting manner to at least one inlet for the second fluid and to at least one outlet for the third fluid (Figure 2; Paragraph [0005]; retentate channel is connected from feed fluid inlet to retentate outlet), and
the permeate collection channel is connected in a fluid conducting manner to at least one outlet for permeate (Figure 2; Paragraph [0010]; permeate channel is connected to permeate outlet).
Regarding instant Claim 31, Claim 30, upon which Claim 31 is dependent, has been rejected above. Leuthold further discloses wherein the second filter has a pore diameter being smaller than the target component and being larger than at least one of the other components of the second fluid (Paragraph [0010]; Paragraph [0012]; Paragraph [0022]; molecular weight cutoff is adjusted to allow particles of certain diameters to get through, smaller particles beyond the range of ultrafiltration will pass through while what is desired to be contained in the retentate will not).
Regarding instant Claim 32, Claim 29, upon which Claim 32 is dependent, has been rejected above. Leuthold further discloses wherein the second and third fluid differ in at least conductivity (Figure 2; Figure 5B; Paragraph [0106]; conductometer 19s indicate differences in conductivity and need to monitor said differences).
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 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.
Claims 20-23 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Leuthold et al. (herein referred to as “Leuthold”, US Pat Pub. 2019/0030486; found in IDS filed 09/27/2024) in view of Falkenstein et al. (herein referred to as “Falkenstein”, US Pat Pub. 2018/0009878).
Regarding instant Claims 20, 21 and 23, Claim 16, upon which each of Claims 20, 21 and 23 are dependent, has been rejected above. However, Leuthold is silent on the first and second chromatography device each being a plurality of chromatography devices.
Falkenstein discloses multistep final filtration in the same field of endeavor in the same field of endeavor as the instant application, as it solves the mutual problem of providing chromatography in combination with filtration (Abstract; Paragraphs [0039]-[0040]). Falkenstein further discloses wherein the chromatography involved in the process may be a plurality of chromatography devices that provide different types of chromatography for the solution, wherein the different types of chromatography can be anion exchange chromatography resin, cation exchange chromatography resin and hydrophobic interaction chromatography resin (Paragraph [0021]; Paragraph [0039]; Paragraph [0040]; see Claim 21 and 23 with resin and type of chromatography).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the first and second chromatography devices of Leuthold to be a plurality of chromatography devices as taught by Falkenstein because Falkenstein discloses doing so provides the process a plurality of different chromatography process such as anion exchange chromatography, cation exchange chromatography and hydrophobic interaction chromatography (Falkenstein, Paragraph [0021]; Paragraph [0039]; Paragraph [0040]).
Regarding instant Claim 22, Claim 21, upon which Claim 22 is dependent, has been rejected above. The combined references disclose wherein the chromatography is selected from AEX and CEX, and CEX and AEX (Falkenstein, Paragraph [0021]; Paragraph [0039]; Paragraph [0040]; steps can be combination of CEX and AEX or vice versa).
Regarding instant Claims 33 and 34, Claim 29, upon which each of Claims 33 and 34 are dependent, has been rejected above. However, Leuthold is silent on the first and second chromatography device each being a plurality of chromatography devices.
Falkenstein discloses multistep final filtration in the same field of endeavor in the same field of endeavor as the instant application, as it solves the mutual problem of providing chromatography in combination with filtration (Abstract; Paragraphs [0039]-[0040]). Falkenstein further discloses wherein the chromatography involved in the process may be a plurality of chromatography devices that provide different types of chromatography for the solution, wherein the different types of chromatography can be anion exchange chromatography resin, cation exchange chromatography resin and hydrophobic interaction chromatography resin (Paragraph [0021]; Paragraph [0039]; Paragraph [0040]; see Claim 34 with type of chromatography).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the first and second chromatography devices of Leuthold to be a plurality of chromatography devices as taught by Falkenstein because Falkenstein discloses doing so provides the process a plurality of different chromatography process such as anion exchange chromatography, cation exchange chromatography and hydrophobic interaction chromatography (Falkenstein, Paragraph [0021]; Paragraph [0039]; Paragraph [0040]).
Regarding instant Claim 35, Claim 34, upon which Claim 35 is dependent, has been rejected above. The combined references disclose wherein the chromatography is selected from AEX and CEX, and CEX and AEX (Falkenstein, Paragraph [0021]; Paragraph [0039]; Paragraph [0040]; steps can be combination of CEX and AEX or vice versa).
Claims 24 is rejected under 35 U.S.C. 103 as being unpatentable over Leuthold et al. (herein referred to as “Leuthold”, US Pat Pub. 2019/0030486; found in IDS filed 09/27/2024) in view of Falkenstein et al. (herein referred to as “Falkenstein”, US Pat Pub. 2018/0009878) as applied to claim 23 above, and further in view of Natarajan et al. (herein referred to as “Natarajan”, US Pat Pub. 2015/0361129).
Regarding instant Claim 24, Claim 23, upon which Claim 24 is dependent, has been rejected above. The combined references are silent on AEX/CEX membrane adsorbers.
Natarajan discloses methods for increasing the capacity of flow-through processes in the same field of endeavor as the instant application, as it solves the mutual problem of providing anion exchange chromatography (Paragraph [0003]; Paragraph [0022]). Natarajan further discloses that AEX membrane adsorbers are traditional and common in the field of anion exchange chromatography (Paragraph [0003]; Paragraph [0022]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the AEX of Leuthold by making said AEX an AEX membrane adsorber as taught by Natarajan because Natarajan discloses AEX membrane adsorbers are traditional and known in the art of anion exchange chromatography (Natarajan, Paragraph [0003]; Paragraph [0022]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Leuthold et al. (herein referred to as “Leuthold”, US Pat Pub. 2019/0030486; found in IDS filed 09/27/2024) in view of Schick (US Pat Pub. 2002/0043487).
Regarding instant Claim 26, Claim 25, upon which Claim 26 is dependent, has been rejected above. Leuthold discloses two pumps used for providing the second fluid and the diafiltration medium (Figures 2-4; pumps 12 and 14).
However, the reference is silent on a pump for the retentate/third fluid.
Schick discloses a method and apparatus for enhancing filtration yields in tangential flow filtration in the same field of endeavor as the instant application, as it solves the mutual problem of providing diafiltration (Abstract; Paragraph [0049]). Schick further discloses a pump in the retentate outlet to allow for a constant retentate volume (Paragraph [0024]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the means for the third fluid of Leuthold to be a pump as taught by Schick because Schick discloses such a pump would allow the retentate volume to remain constant (Schick, Paragraph [0024]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD C GURTOWSKI whose telephone number is (571)272-3189. The examiner can normally be reached 9:00 am-5:30pm MT.
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, Benjamin Lebron can be reached at (571) 272-0475. 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.
/RICHARD C GURTOWSKI/Primary Examiner, Art Unit 1773 09/04/2026
Prosecution Insights