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 of Claims
Claims 1-13 are currently pending
Claims 14-18 are currently withdrawn from consideration
Claims 1-13 are currently rejected
Information Disclosure Statement
The Information Disclosure Statement filed on 03/12/2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered. An initialed copy of the Form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-13 in the reply filed on 06/07/2026 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: Lines 3 and 11 (x2) each state “the other” and instead should all three state “another” for further clarity and to avoid any antecedent issues. Appropriate corrections are required.
Claim 2 is objected to because of the following informalities: Line 3 states “the first pores” and instead should state “the plurality of first pores” for further clarity and to maintain consistency. FURTHERMORE, line 5 states “the second pores” and instead should state “the plurality of second pores” for further clarity and to maintain consistency. Appropriate corrections are required.
Claim 3 is objected to because of the following informalities: Line 3 states “the average pore size change gradient” and instead should state “the change in the gradient manner of the average pore size” for further clarity and to avoid any antecedent issues. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: Lines 2 and 3 each state “the filter membrane” and instead should each state “the asymmetric PES filter membrane” for further clarity and to maintain consistency. Appropriate corrections are required.
Claim 5 is objected to because of the following informalities: Lines 3-4 state “the membrane.” and instead should state “the asymmetric PES filter membrane.” for further clarity and to maintain consistency. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Lines 2, 4, 5 and 6 each state “the PES filter membrane” and instead should each state “the asymmetric PES filter membrane” for further clarity and to maintain consistency. Appropriate corrections are required.
Claim 13 is objected to because of the following informalities: Line 2 states “the PES filter membrane” and instead should state “the asymmetric PES filter membrane” for further clarity and to maintain consistency. Appropriate correction is required.
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 1-13 are 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.
Claim 1 recites the limitation "the average pore size” on line 4, “the average pore size” on lines 4-5, and “the average pore size” on line 6. There is insufficient antecedent basis for these limitations in the claim. FURTHERMORE, claim 1 recites the limitation “a virus” on line 9. It is unclear and confusing whether Applicant is trying to refer to the same ‘a virus,’ as recited on line 1 of claim 1, or a different virus? Claims 2-13 are also rejected since these claims depend on claim 1.
Claim 2 recites the limitation "the pore area ratio” on line 3, and “the pore area ratio” on lines 4-5. There is insufficient antecedent basis for these limitations in the claim.
Claim 3 recites the limitation "the ratio” on line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the PMI average pore size…the thickness” on line 2, and “the porosity” on line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 5 recites the limitation "the PMI average pore size…the porosity” on line 2, and “the thickness” on line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 6 recites the limitation "the pore area ratio of the first pores…the second pores” on lines 3-4, and “the thickness…of the first pores” on line 5. There is insufficient antecedent basis for these limitations in the claim.
Claim 7 recites the limitation "the average pore size…the porosity…the thickness” on lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 8 recites the limitation "the ratio of the average pore size” on line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the average diameter…and the average diameter” on lines 4-5. There is insufficient antecedent basis for these limitations in the claim. Claims 10-11 are also rejected since these claims depend on claim 9.
Claim 11 recites the limitation "the average pore size…the porosity…the thickness” on lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 recites the limitation "the tensile strength…the elongation” on line 2, “the flux” on line 4, “the LRV” on line 5, and “the protein yield” on line 6. There is insufficient antecedent basis for these limitations in the claim.
Claim 13 recites the limitation "the LRV” on line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over KAYAMA et al. (U.S. 2017/0266626 A1) (hereinafter “Kaya”).
Regarding Claim 1:
Kaya teaches an asymmetric polyether sulfone (PES) filter membrane for removing a virus (see paragraphs 1, 28-33, 49, 53-54, 57-60, 62, 99-102, 105, 109-112, 121 and 127), comprising a main body having a non-directional tortuous path therein (see paragraphs 1, 28-33, 49, 53-54, 57-60, 62, 99-102, 105, 109-112, 121 and 127), one surface of the main body being a first outer surface (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure), and the other surface of the main body being a second outer surface (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure), wherein the average pore size of the first outer surface is 150-450 nm, and the average pore size of the second outer surface is 10-42 nm (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer);
the average pore size of the main body continuously changes in a gradient manner from a region on one side close to the first outer surface to a region on one side close to the second outer surface (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure); and
the main body comprises a pre-filtering layer and a separation layer for retaining a virus (see paragraphs 31-33, 57, 98-102, 105, 109-113, 121 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure), one side of the pre-filtering layer is the first outer surface, and one side of the separation layer is the second outer surface (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure); and the other side of the pre-filtering layer and the other side of the separation layer are in transition with a continuous fiber (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure).
Although Kaya teaches an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, one may broadly interpret that the average pore size of the main body continuously changes in a gradient manner, as recited in independent claim 1. However, it would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the asymmetric PES filter membrane of Kaya to be capable of having the average pore size of the main body continuously change in a gradient manner for optimization purposes (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer).
Regarding Claim 2:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein a plurality of first pores in a circular shape are arranged in the first outer surface (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer); and the pore area ratio of the first pores in the first outer surface is 0.1%-15% (see paragraphs 33, 39, 41-43, 57 and 113-116); and
a plurality of second pores in a circular shape are arranged in the second outer surface (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer); and the pore area ratio of the second pores in the second outer surface is 2%-10% (see paragraphs 33, 39, 41-43, 57 and 113-116).
Regarding Claim 3:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein
the average pore size change gradient of the filter membrane is 1.5-6 nm/1 µm (see paragraphs 33, 39, 41-43, 57, 113-116 and 131); and
the ratio of the average pore size of the first outer surface to that of the second outer surface is 7-23 (see paragraphs 33, 39, 41-43, 57, 113-116 and 131).
Regarding Claim 4:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the PMI average pore size of the filter membrane is 15-25 nm (see paragraphs 33, 39, 41-43, 57, 113-116 and 131), the thickness of the filter membrane is 40-150 µm (see paragraphs 48 and 103), and the porosity is 70%-85% (see paragraphs 44 and 117-118).
Regarding Claim 5:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the PMI average pore size of the pre-filtering layer is 50-200 nm (see paragraphs 33, 39, 41-43, 57, 113-116 and 131), the porosity is 75%-93% (see paragraphs 44 and 117-118), and the thickness of the pre-filtering layer accounts for 70%-90% of that of the membrane (see paragraphs 48 and 103).
Regarding Claim 6:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the pre-filtering layer comprises a skin layer region and a pre-filtering region (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer);
one side of the skin layer region comprises the first outer surface, the pore area ratio of the first pores in the first outer surface is smaller than that of the second pores in the second outer surface (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer), and the thickness of the skin layer region is 0.3-3.2 µm (see paragraphs 48 and 103); and
the pore area ratio of the first pores in the first outer surface is 0.15%-1.5% (see paragraphs 33, 39, 41-43, 57, 113-116 and 131).
Regarding Claim 7:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the average pore size of the separation layer is 15-25 nm (see paragraphs 33, 39, 41-43, 57, 113-116 and 131), the porosity is 60%- 80% (see paragraphs 44 and 117-118), and the thickness of the separation layer is 2-20 µm (see paragraphs 48 and 103).
Regarding Claim 8:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the ratio of the average pore size of the pre-filtering layer to that of the separation layer is (4-13):1 (see paragraphs 33, 39, 41-43, 57, 113-116 and 131).
Regarding Claim 9:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the pre-filtering layer comprises a first fiber forming a porous structure, and the first fiber is in a sheet structure; the separation layer comprises a second fiber forming a porous structure, and the second fiber is in a strip structure (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer); and the average diameter of the first fiber is greater than that of the second fiber, and the average diameter of the second fiber is 30-75 nm (see paragraphs 33, 39, 41-43, 57, 113-116 and 131).
Regarding Claim 10:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 9, wherein the pre-filtering layer further comprises a transition region, the transition region is positioned at one side, close to the separation layer, of the pre-filtering layer, and the continuous fiber forms a porous structure of the transition region and gradually changes from the sheet structure to the strip structure; and one side, close to the separation layer, of the continuous fiber is continuous with one side, close to the pre-filtering layer, of the second fiber (see paragraphs 31-33, 57, 98-102, 105, 109-113 and 126-127 further describing an asymmetric structure with multiple inner and outer surfaces/portions including a dense layer/structure and a coarse layer/structure, wherein an average pore diameter of 50 nm or smaller is defined as a dense layer, and an average pore diameter of larger than 50 nm is defined as a coarse layer).
Regarding Claim 11:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 10, wherein the average pore size of the transition region is 60-170 nm (see paragraphs 33, 39, 41-43, 57, 113-116 and 131), the porosity is 75%-82% (see paragraphs 44 and 117-118), and the thickness of the transition region is 4-20 µm (see paragraphs 48 and 103).
Regarding Claim 12:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the tensile strength of the PES filter membrane is 5-10 MPa and the elongation at break is 8%-30% (see paragraphs 39-40, 46-47, 71, 112-119, 122 127 and 131) (see Examples);
the flux of the PES filter membrane is greater than 600 L*h⁻¹*m⁻²@30psi (see paragraphs 39-40, 46-47, 71, 112-119, 122 127 and 131) (see Examples);
the LRV of a virus impurity by the PES filter membrane is greater than or equal to 4 (see paragraphs 39-40, 46-47, 71, 112-119, 122 127 and 131) (see Examples); and
the protein yield of the PES filter membrane is greater than or equal to 98% (see paragraphs 39-40, 46-47, 71, 112-119, 122 127 and 131) (see Examples).
Regarding Claim 13:
Kaya teaches the asymmetric PES filter membrane for removing a virus according to claim 1, wherein the LRV of a virus impurity by the PES filter membrane is greater than or equal to 2.5 and smaller than 4 (see paragraphs 39-40, 46-47, 71, 112-119, 122 127 and 131) (see Examples).
Other References Considered
KAYAMA et al. (U.S. 2017/0348650 A1) (hereinafter “Kaya2”) teaches a porous hollow fiber filtration membrane.
KAYAMA et al. (U.S. 2021/0197133 A1) (hereinafter “Kaya3”) teaches a porous membrane.
Tkacik et al. (U.S. 2012/0076934 A1) (hereinafter “Tkacik”) teaches an ultrafiltration membrane system and method.
Tkacik et al. (U.S. 2002/0175124 A1) (hereinafter “Tkacik2”) teaches a high-resolution virus removal methodology and filtration capsule.
Kas et al. (U.S. 2013/0092622 A1) (hereinafter “Kas”) teaches a nanofiber containing composite membrane structure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AKASH K. VARMA whose telephone number is (571)272-9627. The examiner can normally be reached Monday-Friday 9-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L. Lebron can be reached at (571)-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AKASH K VARMA/Primary Examiner, Art Unit 1773
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