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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-7 and 9-11 in the reply filed on 09/04/2026 is acknowledged.
Claims 8 and 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/04/2026.
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 (i.e., changing from AIA to pre-AIA ) 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 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)(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, 3-5, and 9-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osabe et al. (US 2015/0053609A1).
Regarding claim 1 and 5, Osabe teaches a polysulfone based hollow fiber membrane (refer abstract), wherein an average pore size of an inner surface of the hollow fiber membrane is 0.50 µm (refer [0160]).
The limitation “particles having a particle size of 0.15 µm have a permeability of 50% or more and 100% or less” is reciting how permeability property of the hollow fiber membrane is calculated without imparting additional structure. Membrane having an average pore size of 0.50 µm inherently allows permeation of 0.15 µm particles.
Regarding claim 3, Osabe teaches limitations of claim 1 as set forth above. Osabe further teaches that average pore diameter of outer surface is 0.7 µm (refer [0165]).
Regarding claim 4, Osabe teaches limitations of claim 1 as set forth above. Osabe further teaches that the membrane has inner diameter of 300 µm and membrane thickness of 80 µm (refer [0149]).
Regarding claims 9-11, Osabe teaches limitations of claim 1 as set forth above. Osabe further teaches a membrane module comprising the hollow fibers and that the module is used for blood purification (Refer abstract, [0001]).
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osabe et al. (US 2015/0053609A1), in view of Kayama et al. (US 2017/0348650A1).
Regarding claim 2, Osabe teaches limitations of claim 1 as set forth above. Osabe further teaches providing a dense layer (refer [0069], [0184]). Osabe does not teach thickness of the dense layer, however, Kayama teaches hollow fiber membrane having a dense layer having a thickness of 2 to 10 μm (refer [0028], [0052], [0078], [0079]). It would have been obvious to one of ordinary skill in the art to modify the hollow fiber membrane of Osabe to provide a dense layer in a range of 2 to 10 μm to control permeability as taught by Kayama.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osabe et al. (US 2015/0053609A1), in view of Hayashi et al. (JP 2018-057852, refer attached English language machine translation for claim mapping).
Regarding claims 6-7, Osabe teaches limitations of claim 1 as set forth above. Osabe further teaches that the membrane comprises a hydrophilic polymer comprising vinyl ester (refer [0036]). Osabe does not disclose that the hydrophilic polymer comprises monocarboxylic acid and that content of hydrophilic polymer is 5.0 mass% to 15.0 mass%. However, hollow fiber membrane having hydrophilic polymer having monocarboxylic acid vinyl ester units is known in the art and disclosed by Hayashi (refer abstract). Hayashi also teaches that copolymer composed of the above hydrophilic unit and hydrophobic unit, and when the monocarboxylic acid vinyl ester unit is contained as the hydrophobic unit, the hydrophilic unit and the hydrophobic unit in the entire hydrophobic unit Is preferably 10% to 90%, more preferably 20% to 80%. Setting the molar fraction to the above upper limit is preferable for suppressing the increase in hydrophobicity of the entire copolymer and avoiding the adhesion of proteins and platelets. Further, setting the molar fraction to the above lower limit is preferable for suppressing the increase in hydrophilicity of the entire copolymer, avoiding structural instability / denaturation of platelets and proteins, and thus preventing adhesion (refer page 8).
Selection of a known hydrophilic polymer comprising monocarboxylic acid vinyl ester units would have been an obvious matter of choice to one of ordinary skill in the art. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Carlos Echaide-Gorriz et al., Nanofiltration thin-film composite membrane on either the internal or the external surface of a polysulfone hollow fiber, AIChE J. 2020; 66:16970 teaches filtration membrane having gradient pore structure.
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/PRANAV N PATEL/Primary Examiner, Art Unit 1779
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