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 .
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.
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.
Claims 1,3-5,8,11,12,15,17 are rejected under 35 U.S.C. 103 as being unpatentable over Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A).
Japanese reference(JP3048652B2) in figure 1 teaches an aeration module(noting translation stating “a method for producing a membrane oxygenator”) capable of aerating a liquid(blood supplied to inlet 28) supplied to inner portions of hollow fiber membranes(hollow fiber membrane bundle 16) comprising a housing(housing 6) , and a plurality of hollow fiber membranes((membranes 2) containing polytetrafluoroethylene or a modified polytetrafluoroethylene as a main component(translation stating “specific examples of the hydrophobic membrane used in the present invention include , …, polytetrafluoroethylene”), wherein a porosity K [%], an average thickness T1 [mm], and an average outer diameter D2 [mm] of the hollow-fiber membranes satisfy a relation of a formula K/(T1 x D2 x 100) >= 2.0 (Examiner noting an example 1 stating a porosity of 38%, a thickness of 50 microns(.05mm), and an inner diameter of 200 microns(.2mm). Examiner furthermore notes that an outer diameter of a hollow fiber membrane in a mm size is 2 to 4 times an inner diameter, therefore an outer diameter is expected to be 4 X .2 mm = .8 mm. Examiner notes inserting the variables of Japanese reference(JP3048652B2) as 38/(.05 X .8 X100) results in a value of 9.5, wherein 9.5 anticipates >= 2.0 as stated in the claimed formula). Japanese reference(JP3048652B2) is silent as to wherein the housing contains a fluororesin as a main component.
Japanese reference(H06296836A) teaches a membrane module for holding hollow fiber membranes in figure 1, wherein the membrane module provides for treating water with a predetermined ozone concentration, wherein the housing of the membrane module is provided as a fluororesin as a main component(Examiner noting translation stating “from the viewpoints of ozone resistance, molding processibility, mechanical strength and the like, ETFE and PVDF are more preferable as the fluororesin for the housing of the present invention”). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to provide the housing of the membrane module of Japanese reference(JP3048652B2) as a fluororesin as a main component in order to provide ozone resistance, molding processibility, mechanical strength for the housing(main body housing 6 of Japanese reference(JP3048652B2)). Examiner also notes Japanese reference(H06296836A). stating “the size of the hollow fiber membrane has an outer diameter of 5 to 1 mm, an inner diameter of 4.5 to 0.5 …”, wherein Japanese reference(H06296836A) supports an outer diameter of a hollow fiber membrane in a mm size is 2 to 4 times an inner diameter.
Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) is silent as to wherein the hollow-fiber membranes have a heat of fusion of 30 J/g to 45 J/g. Examiner notes a heat of fusion is not a physical characteristic of the hollow fiber membranes, and is based on a function of porosity, outer diameter, and inner diameter of the membranes. Examiner notes that Japanese reference(JP3048652B2) taken together with Japanese reference teaches hollow fiber membranes including porosity and outer diameter meeting the criteria of the claimed formula, therefore it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to form the hollow fiber membranes of Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) with a heat of fusion of 30 J/g to 45 J/g in order to optimize a pore diameter for the hollow fiber membranes.
With regards to claim 3, Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) further teaches wherein the hollow-fiber membranes have an average outer diameter D2 of 0.70 mm or less(outer diameter expected to be 2 to 4 times an inner diameter, therefore an outer diameter is expected to be 3 X .2 mm = .6mm) , an average inner diameter D1 of 0.32 mm or less(an inner diameter of 200 microns(.2mm)), a water pressure resistance of 0.3 MPa or more, and a porosity K of 30% or more(porosity 38%). Examiner notes that the claims require “aerating a liquid”, therefore a “water pressure resistance of 0.3 MPa or more” is not given patentable weight, wherein the claimed water pressure resistance is not a physical characteristic of the hollow fiber membranes.
With regards to claim 4, Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) further teaches wherein when pure water with a dissolved oxygen concentration of 0.6 ppm or less is supplied to the inner portions of the hollow-fiber membranes and air is caused to permeate at a pressure of 10 kPa, a maximum flow rate per minute at which the pure water after aeration treatment is capable of maintaining a dissolved oxygen concentration of 8 ppm or more is 0.035 mL/(cm?-min) or more relative to a unit inner surface area of the hollow-fiber membranes (Examiner notes the stated claim limitations are based on a specific process of supplying pure water to the hollow fiber membranes, wherein the limitations of claim 4 are not given patentable weight for prior art analysis of the claimed “aeration module”.)
With regards to claim 5, Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) further teaches wherein the main component of the housing is a tetrafluoroethylene/perfluoroalkyl vinyl ether copolymer, polytetrafluoroethylene, a tetrafluoroethylene/hexafluoropropylene copolymer, or a combination thereof(examiner noting translation of Japanese reference(H06296836A) stating “the housing portion is made of polytetrafluoroethylene , tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer”).
With regards to claims 8, Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) further teaches wherein when pure water with a dissolved oxygen concentration of 0.6 ppm or less is supplied to the inner portions of the hollow-fiber membranes and air is caused to permeate at a pressure of 10 kPa, a maximum flow rate per minute at which the pure water after aeration treatment is capable of maintaining a dissolved oxygen concentration of 8 ppm or more is 0.035 mL/(cm?-min) or more relative to a unit inner surface area of the hollow-fiber membranes (Examiner notes the stated claim limitations are based on a specific process of supplying pure water to the hollow fiber membranes, wherein the limitations of claims 7-9 are not given patentable weight for prior art analysis of the claimed “aeration module”.).
With regards to claims 11,12,15, Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) further teaches wherein the main component of the housing is a tetrafluoroethylene/perfluoroalkyl vinyl ether copolymer, polytetrafluoroethylene, a tetrafluoroethylene/hexafluoropropylene copolymer, or a combination thereof(examiner noting translation of Japanese reference(H06296836A) stating “the housing portion is made of polytetrafluoroethylene , tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer”).
With regards to claim 17, Japanese reference(JP3048652B2) taken together with Japanese reference(H06296836A) is silent as to wherein the hollow-fiber membranes have an average pore size of 5.2 nm to 9.4 nm. Japanese reference(JP3048652B2) in the translation states that a pore size can include a lower limit of 0.1 microns, which is 10 nm. Examiner respectfully submits that someone of ordinary skill in the art before the effective filing date of the claimed invention , through routine experimentation, would have been motivated to modify an average pore size from 10nm to, at a minimum, the upper claimed limit of 9.4 nm, in order to provide for an aeration module including hollow fiber membranes that include polytetrafluoroethylene having an average pore size of 5.2 to 9.4 nm. Examiner notes that a change from 10nm to 9.4nm includes a change of 6%, and wherein examiner respectfully submits that a modification of average pore size of 6% does not effectively change an efficiency percentage of separation for a hollow fiber membrane, wherein the hollow fiber membranes of Japanese reference(JP3048652B2) meet the required functional relationship for porosity of claim 1.
Response to Arguments
Applicant's arguments filed 1-7-2026 have been fully considered but they are not persuasive.
Applicant argues the present application specifically describes “heat of fusion” as measured material property, not a value based on porosity of diameters. Applicant argues neither JP3048652B2 nor H06296836A teaches or suggests selecting or controlling “differential scanning calorimeter” measured heat of fusion(“an endothermic amount between 296C and 343C in a third step”) in the claimed 30J/g to 45J/g range as a structural property of the membrane.
Examiner respectfully submits the claim requires amendment to differentiate over a structural component of the hollow fiber membranes, wherein the claimed heat of fusion is not a property that is a physical characteristic of the hollow fiber membranes. Examiner respectfully submits that JP3048652B2 taken together H06296836A teaches polytetrafluoroethylene hollow fiber membranes including porosity meeting the claimed formula of claim 1, therefore the hollow fiber membranes are expected to include a heat of fusion which falls within the claimed range of 30J/g to 45J/g. Examiner respectfully submits that providing a differential scanning calorimeter to determine a heat of fusion represents a method limitation, wherein a differential scanning calorimeter that measures a heat of fusion does not provide a specific physical characteristic of the claimed hollow fiber membranes. Examiner notes para 0045 of the current specification which connect critical characteristics of the hollow fiber membrane to the claimed heat of fusion.
Applicant argues that experimental data in Tables 1 and 2 demonstrates the criticality and unexpected results of the heat of fusion range 30 J/g to 45 J/g, and that MPEP 2145 requires that evidence of unexpected results must be weighed against a prima facie case of obviousness.
Examiner notes the hollow fiber membrane of test 1 and test 2, having a heat of fusion of 35 and 45 respectfully, are based on physical characteristics of the hollow fiber membranes including average outer diameter D2 0.70 mm or less, average inner diameter D1 0.32 mm or less, average thickness T1, porosity K greater than 30%, functional relationship K(T1 X D2 X 100) >=2.0, and average pore size 5.2 nm to 9.4nm. Examiner respectfully submits claim 1 only includes a required functional relationship K(T1 X D2 X 100) >=2.0, but does not include the remainder of the stated characteristics, wherein unexpected results based on heat of fusion of 30 J/g to 45 J/g are based on a combination of all the stated characteristics. Examiner respectfully submits that claim 1 is required to differentiate over the prior art based on physical characteristics of the claimed hollow fiber membranes only, and inclusion of a range of heat of fusion without the corresponding stated physical characteristics of table 2 does not provide for unexpected results over the prior art.
Examiner notes claim 3 includes claimed characteristics of including average outer diameter D2 0.70 mm or less, average inner diameter D1 0.32 mm or less, porosity K greater than 30%, and claim 17 includes claimed characteristics of average pore size of 5.2 nm to 9.4 nm. Examiner also notes that para 0045 of the current specification mentions “the heat of fusion from 296C to 343C in the third step is 30.0 J/g to 45.0 J/G, so that the hollow fiber membrane can have characteristics suitable for stretching”. Examiner also notes table 1 provides an axial stretching ratio of 5.00, wherein an axial stretching ratio seems to provide an additional physical characteristic, which if incorporated into claim 1 along with the limitations of claims 3 and 17, would provide evidence of unexpected results against a prima facie case of obviousness. Examiner respectfully submits that choosing selected characteristics of the hollow fiber membranes(such as only the functional relationship for porosity in claim 1) does not provide evidence of unexpected results against a prima facie case of obviousness.
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 ROBERT A HOPKINS whose telephone number is (571)272-1159. The examiner can normally be reached Mon-Thurs 6am-4pm.
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/ROBERT A HOPKINS/Primary Examiner, Art Unit 1776
January 28, 2026