DETAILED ACTION
Examiner has received and accepted the amended claims and remarks filed on 11 December 2025. These amended claims and remarks are the claims and remarks being referred to in the instant Office Action. Examiner acknowledges Claim 6 has been cancelled.
Response to Arguments
Applicant’s arguments with respect to Claims 2, 5, 7, 10, 11, and 13 - 15 have been fully considered and are persuasive. The 112(b) Rejection of Claims 2, 5, 7, 10, 11, and 13 - 15 has been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive.
Regarding Claim 4, Applicant argues the term high is definite it is well known in the art of HPLC and SFC. Examiner respectfully disagrees.
The claim does not limit the claimed pressure to pressures used in HPLC nor SFC. As such, the claim rejection is maintained.
Regarding Claim 12, Applicant has amended the claim however, the claim still recites a method where no steps are provided. No argument has been provided. As such, the claim rejection is maintained.
Regarding Claim 1, Applicant argues Berger and Nagy’s systems and methods are materially different from one another, as such the claims are not obvious. Examiner respectfully disagrees.
A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See MPEP 2141.01(a)
Applicant’s claims have not specifically limited the claimed invention to a specific type of chromatograph. Furthermore, the problem faced by the inventor was bypassing a mixer using a switching valve which Nagy teaches. As such, the claim rejection is maintained.
Claim Objections
Claim 10 is objected to because of the following informalities:
Regarding Claim 10, “cCaim” should read “Claim”.
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.
Claims 4, 12 – 14, and 16 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.
The term “high” in Claim 4 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to at what point a pressure can be considered high, thus rendering the claim indefinite.
Regarding Claim 12, the claim recites a method however no steps are provided. As such, the scope of the claim is unclear, thus rendering the claim indefinite. See MPEP 2173.05(q).
Regarding Claim 16, the claim recites the chromatographic procedure has a solvent gradient. It is unclear as to how a procedure can have a solvent gradient, thus rendering the claim indefinite.
Claims dependent upon a rejected claim are therefore rejected as well.
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.
Claim(s) 1 – 5, 8, 12, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (US 2003/0034307), in view of Nagy et al. (US 2022/0333060).
Regarding Claim 1, Berger discloses a chromatography system, in at least Figure 2, comprising at least a first pump (18) which is connectable or connected with a liquid reservoir (14) for a first fluid, and a second pump (16) which is connectable or connected with a liquid reservoir (12) for a second fluid, wherein pump outlet lines from the first pump and the second pump are connected with at a T (Figure 2) and, viewed in a direction of flow, a chromatography column (26) is provided downstream of the T (Figure 2), wherein: viewed in the direction of flow, an addition unit (22) is provided upstream of the T (Figure 2), and a mixer (24) provided between the T and the chromatography column (Figure 2).
Berger fails to expressly disclose the T is a connection piece.
Examiner takes Official Notice it is common knowledge in the art to utilize a connection piece at a T junction to form the junction.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the applicant’s invention to modify Berger so that the T is a connection piece for the benefit of forming the connection at the T junction.
Berger further fails to expressly disclose a mixer switching valve and the mixer switchable by way of the mixer switching valve provided between the connection piece and the chromatography column, wherein the mixer switching valve has at least two switching positions, and wherein the mixer is connectable in a first position and the mixer is bypassable in a second position.
Nagy teaches a mixer switching valve (in vi) and a mixer (iii) switchable by way of the mixer switching valve provided between a connection piece (ii) and a chromatography column (iv), wherein the mixer switching valve has at least two switching positions, and wherein the mixer is connectable in a first position and the mixer is bypassable in a second position [0158] (Figure 3).
As such, it would have been obvious to modify Berger so that a mixer switching valve and the mixer switchable by way of the mixer switching valve provided between the connection piece and the chromatography column, wherein the mixer switching valve has at least two switching positions, and wherein the mixer is connectable in a first position and the mixer is bypassable in a second position for the benefit of allowing for charging of the column performing steps of ultrafiltration and/or diafiltration according to process selected for the apparatus, as taught by Nagy [0158].
Regarding Claim 2, Nagy teaches a flow path of the first fluid in the second position of the mixer switching valve, in which the mixer is bypassable, is shorter than the first position of the mixer switching valve, in which the mixer is connectable (Figure 2 illustrating the paths generally have a quadrilateral path in iii, iv however the mixer being present inherently increases the length of the path when the mixer is connected).
Regarding Claim 3, Berger discloses wherein, viewed in the direction of flow, the addition unit is provided downstream of the first pump (Figure 2).
Regarding Claim 4, Berger discloses the addition unit comprises an injection valve, wherein the injection valve has at least two sample loop ports and two high pressure ports for infeed and outfeed of high-pressure fluid [0010, 0012, 0021]
Regarding Claim 5, Nagy teaches the mixer switching valve comprises at least four ports, wherein two of said ports are connected with the mixer (Figure 2).
The combination would have been obvious for the same reasons regarding the rejection of Claim 1 above.
Regarding Claim 8, Nagy teaches the mixer is configured as a static mixer [0104].
The combination would have been obvious for the same reasons regarding the rejection of Claim 1 above.
Regarding Claim 12, as best understood, the combination renders obvious a method for carrying out a chromatographic procedure comprising use of the chromatography system according to claim 1.
Regarding Claim 14, Nagy teaches wherein on application of a sample to be separated to the chromatography column, the mixer switching valve is switched into the second position and the first fluid is bypassed around the mixer [0158].
The combination would have been obvious for the same reasons regarding the rejection of Claim 1 above.
Regarding Claim 16, Berger discloses the chromatographic procedure has a solvent gradient [0019, 0020].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (US 2003/0034307), in view of Nagy et al. (US 2022/0333060), in further view of Wikfors et al. (US 2019/0184327).
Regarding Claim 7, the combination fails to expressly disclose fluid cooling is provided for the liquid reservoir for the second fluid and the second pump.
Wikfors teaches liquid cooling is provided for a reservoir [0046].
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the applicant’s invention to modify the combination by having fluid cooling be provided for the liquid reservoir for the second fluid and the second pump for the benefit of maintaining the phase of the fluid for its intended use, as taught by Wikfors [0046].
Claim(s) 9 – 11, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berger et al. (US 2003/0034307), in view of Nagy et al. (US 2022/0333060), in further view of Bozic (US 2020/0284769).
Regarding Claim 9, the combination fails to expressly disclose the chromatography system is controllable by way of a chromatography system controller.
Bozic teaches a chromatography system is controllable by way of a chromatography system controller [0055, 0146 – 0148].
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the applicant’s invention to modify the combination so that the chromatography system is controllable by way of a chromatography system controller for the benefit of controlling the parameters of the system, as taught by Bozic [0146 – 0148]
Regarding Claim 10, Berger discloses the chromatography system has the chromatography column (26).
The combination fails to expressly disclose viewed in the direction of flow, at least one downstream backpressure regulator.
Bozic teaches a chromatography system has a chromatography column (118) and, viewed in the direction of flow, at least one downstream backpressure regulator (126) [0183].
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the applicant’s invention to modify the combination so that viewed in the direction of flow, at least one downstream backpressure regulator for the benefit of a system that allows different substances to be divided, chemically analyzed, identified and quantified easily and reliably, as taught by Bozic [0002].
Regarding Claim 11, Bozic teaches wherein, viewed in the direction of flow, a gas-liquid separator (130) is provided downstream of the backpressure regulator [0180].
The combination would have been obvious for the same reasons regarding the rejection of Claim 10 above.
Regarding Claim 13, the combination fails to expressly disclose the liquid reservoir for the first fluid contains a first solvent which is liquid under standard conditions, and the liquid reservoir for the second fluid contains a second solvent which is gaseous under standard conditions.
Bozic teaches a liquid reservoir for a first fluid contains a first solvent which is liquid under standard conditions, and a liquid reservoir for a second fluid contains a second solvent which is gaseous under standard conditions [Abstract].
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the applicant’s invention to modify the combination so that the liquid reservoir for a first fluid contains a first solvent which is liquid under standard conditions, and the liquid reservoir for a second fluid contains a second solvent which is gaseous under standard conditions for the benefit of a system that allows different substances to be divided, chemically analyzed, identified and quantified easily and reliably, as taught by Bozic [0002].
Regarding Claim 15, Nagy teaches a conversion kit for converting a high-performance liquid- chromatography (HPLC) system into a chromatography system according to claim 1, wherein HPLC chromatography system as claimed is rendered obvious according to Berger as discussed in the rejection of Claim 1 above, and wherein the kit includes the mixer switching valve (in vi).
The combination would have been obvious for the same reasons regarding the rejection of Claim 1 above.
The combination fails to expressly disclose including at least one gas-liquid separator.
Bozic teaches at least one gas-liquid separator (130).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the applicant’s invention to modify the combination so it includes at least one gas-liquid separator for the benefit of a system that allows different substances to be divided, chemically analyzed, identified and quantified easily and reliably, as taught by Bozic [0002].
Conclusion
THIS ACTION IS MADE FINAL. 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 ALEXANDER MERCADO whose telephone number is (571)270-7094. The examiner can normally be reached Monday - Thursday 9am - 4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Laura Martin can be reached at (571) 272-2160. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALEXANDER A. MERCADO
Primary Examiner
Art Unit 2855
/ALEXANDER A MERCADO/ Primary Examiner, Art Unit 2855