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, 6-7, 16 cancelled
Claims 2, 4-5, 8, 22-23 amended
Claims 1-2, 4-5, 8-15, 17-23 pending
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/11/2026 has been entered.
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, 8-13, 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, 8-9, 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 05/11/2026 have been fully considered but they are not persuasive.
The previously applied 112 claims rejection, in light of the amended claim are now withdrawn.
The applicant argued against the prior arts, on the ground that prior art the Sah is directed to a "prokaryotic microorganism strain" and Thoen is directed to "protein chemistry, molecular biology, neurobiology, neurology, and pain management”, where the instant application is related to the “pharmaceutical manufacturing process”.
However, although the claims preamble state “pharmaceutical manufacturing process”, the process is process is revolve around the usage of “pathway” having “weld”, “corner”, “flange” and “threaded portion” per claims 10-13, and also for the use on chromatographic device, per the instant specification [0019]. Moreover, the prior arts of Bischof, Sah, and Thoen discloses the process using chromatographic devices, such as High-Performance Liquid Chromatography (HPLC) (Bischof, [0015], Sah, [0214], Thoen, [0120]). Where the HPLC device is known to be used in pharmaceutical manufacturing process, as shown in Bischof [0008].
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
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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/Mohammad Mayy/
Art Unit 1718
/GORDON BALDWIN/Supervisory Patent Examiner, Art Unit 1718
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