DETAILED ACTION
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 .
Status
Claims(s) 1-10, is/are filed on 7/11/2023 are currently pending. Claim(s) 11-18 is/are withdrawn without traverse, 1-10 is/are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 8, 10 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by FUKADA (WO 2015099015 A1).
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Regarding claim 1, FUKADA discloses a hollow fiber membrane module comprising a hollow fiber membrane (10) accommodated in a module case (outer casing of 10), where the hollow fiber is a plurality of hollow fiber membranes (A) bundled together to form a bundle (accumulation of A), with both end faces of the hollow fiber membrane bundle being integrated with the module case by a potting material (30) that bonds the membranes at the end faces to form fixation portions; a storage liquid (H) is contained in 90% or more of the pores of the hollow fiber membrane bundle (i.e. 100%), the storage liquid (H) being water free of viable bacteria, and a space portion (10b) inside the module case is filled with a gas free of viable bacteria and the storage liquid (H), as taught in paragraph [0044] ("sterilized pure water is used as the preservation solution. The preservative solution is a liquid for maintaining the filtration performance of the hollow fiber membrane 3 a"), with FUKADA teaching partial filling implying gas spaces sterilized by steam – the same process as the application ("the filling ratio of pure water H in the sealed space including the inside of the hollow fiber membrane module 10 and the connection tube 12 is preferably 20% or more and 100% or less with respect to the entire sealed space, and 50% or more and 100% or less More preferable. 95% or more and 100% or less is more preferable. In addition, said filling rate is shown by the volume ratio in normal temperature") (p. 2-5).
Regarding claim 2, FUKADA discloses the volumes Vfirst as the primary side space, Vsecond as the secondary side space, Vpore as membrane pores, Vall as total, and corresponding W volumes, with sealing by a sealing member (13) ("the closing member 13 has a structure for pressing the connection tube 12 by means of, for example, a screw mechanism to close the connection tube 12"), and suggests the expression 0.35 ≤ Wall/Vall ≤ 0.95 through overlapping ratios ("20% or more and 100% or less... 95% or more and 100% or less"). However, the specific range is obvious as a result-effective variable for managing pressure ("an expansion member 14 which is expanded by the increase of the internal pressure... to absorb the increase in internal pressure during steam sterilization"). , FUKADA discloses filling ratios from 20% to 100% (with preferences up to 95-100%), which overlap and encompass the claimed 0.35-0.95. This overlap establishes prima facie obviousness, as per precedents like In re Peterson (315 F.3d 1325, Fed. Cir. 2003), where courts hold that broad prior art ranges invite routine narrowing to workable values. The motivation stems from the need to balance liquid volume for thermal expansion absorption without overpressurization, a predictable adjustment in filtration module design. Absent evidence of criticality (e.g., the specification doesn't demonstrate unique benefits at 0.35-0.95 versus broader ranges), optimization is obvious, as "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (In re Aller, 220 F.2d 454, CCPA 1955).
Regarding claim 3, depending from claim 1, FUKADA suggests Wfirst/Vfirst ≤ Wsecond/Vsecond for distribution ("the primary side space 10a of the hollow fiber membrane A... and the secondary side space 10b"), obvious to prevent drying. Wfirst/Vfirst ≤ Wsecond/Vsecond), obviousness arises from prior art's implicit guidance on uneven liquid distribution to prioritize secondary-side spaces, which heat first during sterilization. FUKADA differentiates primary and secondary spaces, suggesting higher secondary filling to mitigate risks like drying or pressure spikes. This is obvious as a functional adaptation, driven by common sense in the art to address uneven heating—echoing KSR Int'l Co. v. Teleflex Inc. (550 U.S. 398, 2007), where predictable variations based on design needs are non-inventive. No explicit teaching is required; the rationale is inferred from the problem (thermal gradients) and solution (biased filling), with reasonable success expected in mature fields like membrane modules.
Regarding claim 4, depending from claim 1, FUKADA teaches ratios like 0.8-1 through preferences ("95% or more and 100% or less"), obvious for full wetting " because prior art emphasizes near-complete secondary-side saturation to eliminate air pockets, reducing dryness, bubbles, and transport vibrations. FUKADA prefers 95-100% filling for stability, making 80-100% a routine extension—obvious as it achieves expected benefits like suppressed humidity drops during heating, per MPEP 2144.05's guidance on optimizing for criticality-absent ranges. Full wetting ensures reliability without innovation, as high-fill preferences invite such fine-tuning.
Regarding claim 8, depending from claim 1, FUKADA teaches the module wrapped by a wrapping film (200) having a first portion with gas permeability ("the membrane module device 1 is put into a sterile bag 200 as a package of the air permeable member and sealed").
Regarding claim 10, depending from claim 1, FUKADA teaches an aseptic connector (130) attached to the piping connection port, comprising a sterile filter or membrane, in direct contact with the internal space ("a sterile connection connector 130 is attached to the tip of the connection tube 12... the sterile connection connector 130 includes... a sealing tape 142 provided on the connection surface 141a to close the conduit... the tape 142 interposed between the connection surfaces 141a can be pulled out to connect the tubes with each other while maintaining the sterility").
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over FUKADA (WO 2015099015 A1) in view of SATOSHI (JP 2018089614 A).
Regarding claim 6, FUKADA does not the details of the claim. SATOSHI teaches TOC in the storage liquid (H) contained in the module case (5) is 1 ppm or more and 50 ppm or less, as per paragraph [0046] ("the organic matter content in the preservation solution is 1 ppm or more and less than 50 ppm as TOC (Total Organic Carbon)") to enhance thermal stability during sterilization, preventing damage while maintaining sterility—a predictable improvement addressing shared problems like expansion and microbial control.
Allowable Subject Matter
Claim(s) 5, 7, 9 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Waqaas Ali whose telephone number is (571) 270-0235. The examiner can normally be reached on M-F 9-5 PM.
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/WAQAAS ALI/Primary Examiner, Art Unit 1777