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
Claims 3, 6, 16 cancelled
Claims 1, 20-21 and 23 amended
Claims 1-2, 4-5, 7-15, 17-23 pending
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 2, 4-5, 7-8 and 22-23 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 2, 4-5, 7-8 states “the liquid”, where those claims depends on claim 1, and claim 1 state “first liquid” and “second liquid”. Therefore, it is not clear which “liquid” those claims refers to.
Claims 22-23 states “the liquid”, where those claims depends on claim 21, and claim 21 state “first liquid” and “second liquid”. Therefore, it is not clear which “liquid” those claims refers to.
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.
Claim(s) 1-2, 4-5, 7-13, 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bischof (PG Pub 2019/0262745) in view of Sah (EP 2246362), and in further view of Thoen (PG Pub 2014/0342399 A1).
Consider Claims 1-2, 4-5, 7-9, 17-23, Bischof discloses a pharmaceutical manufacturing process [0008] comprising flowing a liquid through a pathway [0016] wherein the liquid contacts a non-polymeric coating on a substrate within the pathway [0039], wherein the substrate is metallic [0017]. The liquid includes active pharmaceutical ingredients, water for injection [0016] (Fig. 1), an acid, or phosphoric acid [0040]. The liquid may include nitric acid [0014]. The substrate is susceptible to corrosion from the liquid wherein the non-polymeric coating does not corrode [0040]. The substrate is stainless steel [0020], and the non-polymeric coating includes silicon, oxygen, carbon, and/or nitrogen [0039].
Bischof does not disclose that the liquid includes guanidine hydrochloride.
Sah discloses proteins solubilized in a liquid, such as guanidine hydrochloride, which flow through a pathway of a chromatography column [0226].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to flow the liquid of Sah through a column coated with the non-polymeric coating of Bischof since the non-polymeric coating protects against HCl [0004].
The combine Bischof (with Sah) does not teach the cleaning with a second liquid by flowing though the pathway.
However, Thoen is in the prior art of processing analyte using HPLC [0120], teaches the step of rinsing the column clean after each run (testing the analyte) [0125].
A person having ordinary skill in the art before the effective date of the claimed invention would combine Bischof (with Sah) with Thoen to flow a second liquid to rinse and clean the pathway (of the column) with a second cleaning solution, to remove a new test sample contamination from previous test samples, as to prevent cross contamination from previous run.
Consider Claims 10-13 and 20, the combined Bischof (with Sah and Thoen) does not explicitly disclose the pathway includes a weld, a corner, a flange, or threaded portions.
However, Bischof discloses other components of the system which come in contact with the fluid can similarly be coated, such as fittings, valves, tubings, etc. [0016].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to coat any portion of the pathway, including components such as a weld, corner, etc. of Bischof since additional components of the system can be coated.
Claim(s) 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bischof (PG Pub 2019/0262745) in view of Sah (EP 2246362), and in further view of Thoen (PG Pub 2014/0342399 A1) and in further view of Carr (PG Pub 2015/0122365).
Consider Claims 21-23, Bischof does not disclose the surface roughness of the substrate.
Carr discloses coating an interior surface of a metallic pathway with a protective coating [0052]; [0060]-[0061] since metal structures, such as tubing, may have a significant amount of surface roughness [0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention that the protective coatings of Bischof and Carr to be applied to substrates having surface roughness within the claimed ranges because the coatings are suitable for protecting metallic substrates with significant amount of surface roughness.
Response to Arguments
Applicant’s arguments, filed 12/29/2025, with respect to the rejection(s) of claim(s) 1-2, 4-5, 7-15, 17-23 under 102/103a 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 Bischof with Sah and Thoen.
The applicant argued based on the newly amended claims, on the ground that Bischof with Sah does not disclose the use of a second liquid of cleaning solution though the pathway.
However, the newly applied prior art of Thoen discloses the process of running the HPLC with samples (first liquid) through the column/pathway, then cleaning using cleaning solution with a second liquid [0125] through the column/pathway, to prevent cross contamination between samples.
All other applicant arguments not specifically addressed above are deemed unpersuasive as either not commensurate in scope with the broadly drafted claims or are unsupported by factual evidence and are deemed mere attorney speculation.
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 Mohammad Mayy whose telephone number is (571)272-9983. The examiner can normally be reached Monday to Friday, 11:00AM-7:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gordon Baldwin can be reached at 571-272-5166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mohammad Mayy/
Art Unit 1718
/GORDON BALDWIN/Supervisory Patent Examiner, Art Unit 1718