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 .
Priority
Applicant’s claim for the benefit of a prior-filed application (371 of PCT/JP2021/044385, filed 03 December 2021) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority (JP2020-202097, filed 04 December 2020) under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group 1, Claims 1-10, and Species 2 in the reply filed on 04 December 2025 is acknowledged.
Claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 December 2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Interpretation
Claim 1 recites that the hollow-fiber membrane has “an elastic limit pressure of 200 kPa or more”. Such a limitation is considered a measured value and is dependent on a process. As described in the Specification, p0038:
The term "elastic limit pressure" is defined as a pressure at the time when expansion observed from a change in the outer diameter of a hollow-fiber membrane shows deviation from a linear change due to a pressure increase caused by the pressurization with air of the hollow-fiber membrane from the inner surface side. (start of p0038, emphasis added)
And further:
The elastic limit pressure of the porous hollow-fiber membrane of the present embodiment is measured while wetting the porous hollow-fiber membrane with water. (end of p0038, emphasis added)
From these disclosures, an elastic limit pressure is considered a testing process whereby the hollow-fiber membrane is wetted with water and pressurized with air to determine a pressure value that meets certain criteria. As such, claims with limitations directed toward an “elastic limit pressure” are considered product-by-process limitations so long as the prior art discloses or makes obvious the products set forth in the claims (see In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985); MPEP §2113). While a structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, “[t]he Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to Applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. Marosi supra.
In this instant case, while the claimed porous hollow-fiber membrane containing a regenerated cellulose is characterized by the limitation of an elastic limit pressure value, such a characterization can only be made via a process as summarized earlier. Therefore, a claim including a limitation of “an elastic limit pressure” is considered to be product-by-process language: e.g., because it describes how an elastic limit pressure is measured for the claimed product.
Rejections based on anticipation or obviousness for product-by-process claims have further been approved by the courts. "[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claim 8 recites the term “bubble point”. As described in the Specification, p0060: “The term "bubble point" as used herein is an index showing the size of a maximum pore of the porous hollow-fiber membrane”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9 and 10 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101 (MPEP § 2173.05(q)).
Regarding Claim 9, the claim only requires that the porous hollow-fiber membrane of Claim 1 is “used for virus removal” and fails to set forth any steps involved in such a process. The claim is considered a “use” claim and does not actually claim a process, machine, manufacture, or composition of matter and therefore, fails to comply with 35 U.S.C. 101. Claim 10 is also rejected due to its dependency on Claim 9.
Similarly, regarding Claim 10, the claim does not provide any steps involved in the process. The claim is considered a “use” claim and does not actually claim a process, machine, manufacture, or composition of matter and therefore, fails to comply with 35 U.S.C. 101.
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.
Claims 9 and 10 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.
Regarding Claim 9, attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Here, no steps are recited in support of the use of the porous hollow-fiber membrane of Claim 1 for virus removal. Because the claim merely recites a use without any active, positive steps delimiting how this use is actually practiced, the claim is indefinite. Claim 10 is also rejected due to its dependency on Claim 9.
Similarly, regarding Claim 10, no steps are set forth by the claim; the only limitation recites an expected/intended result. Because the claim merely recites a use without any active, positive steps delimiting how this use is actually practiced, the claim is indefinite.
Claim Rejections - 35 USC § 102/103
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 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)(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.
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) 1, 3, 4, and 6-10 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over HAMAMOTO et al. (US 10,675,593 B2).
Regarding Claim 1, HAMAMOTO discloses a virus removal membrane formed from cellulose (abstract); the membrane is a hollow fiber membrane shape (c9/34-35), and the cellulose is a regenerated cellulose (c9/25-26). HAMAMOTO fails to explicitly disclose the membrane has “an elastic limit pressure of 200 kPa or more”. However, such a limitation is considered to render the claim a product-by-process claim because the limitation of “an elastic limit pressure” has been recognized to be a limitation dependent on a process by which a pressure value is measured. Because the prior art discloses a product that appears to be the same as the product set forth in this product-by-process claim, although produced by a different process, the claim is directly read on by the prior art (see In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985); MPEP §2113). Additionally, although the immediate claim is a product-by-process claim and is limited by and defined by its process, the determination of patentability is based on the product itself, not on the method of production. Thus, these process limitations do not further limit the claimed product.
Regarding Claim 3, HAMAMOTO discloses the membrane of Claim 1. HAMAMOTO further discloses the membrane has a thickness of 24 µm or more and 40 µm or less (c9/40-42), which reads on the claimed range of 20 µm or more and 70 µm or less.
Regarding Claim 4, HAMAMOTO discloses the membrane of Claim 1. HAMAMOTO further discloses the regenerated cellulose is produced by a cuprammonium method (i.e., the regenerated cellulose is obtained by a cuprammonium process; c9/28-29).
Regarding Claim 6, HAMAMOTO discloses the membrane of Claim 1. HAMAMOTO further discloses the pore size of the pore first decreases and then increases from a primary surface (i.e., inner lumen surface) towards a secondary surface (i.e., outer surface) of the membrane (i.e., wherein the porous hollow-fiber membrane has a gradient structure in which a pore size becomes smaller from an inner surface side to an outer surface side; c9/56-59).
Further, it is noted that HAMAMOTO discloses a membrane fabrication process (i.e., coagulation) that only produces membranes having asymmetric pore structures, i.e., having a gradient in pore size from one layer of the membrane to the other layer of the membrane.
Regarding Claim 7, HAMAMOTO discloses the membrane of Claim 1. The instant limitation requiring “a water permeability at a filtration pressure of 27 kPa and 37°C is 10 L/(m2·hr) or more and 50 L/(m2·hr) or less” is directed toward a manner or method by which the apparatus is used, i.e., measuring a permeability at certain filtration pressures and temperatures, and is not subject to patentability of the apparatus itself (In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); MPEP §2115).
Regarding Claim 8, HAMAMOTO discloses the membrane of Claim 1. HAMAMOTO further discloses a bubble point of 1.2 MPa or more (c10/19-20), which reads upon the claimed range of 1.2 MPa or more.
Regarding Claim 9, HAMAMOTO discloses the membrane of Claim 1. HAMAMOTO further discloses virus removal (i.e., used for virus removal; abstract), specifically parvovirus (c1/18-30; c2/22-24; c4/31-34).
Regarding Claim 10, HAMAMOTO discloses the membrane of Claim 9. HAMAMOTO further discloses a logarithmic removal rate (LRV) of virus being 4.00 or more (c9/63-65), e.g., parvovirus (c4/31-34), which reads on the claimed range of a parvovirus removal ratio (LRV) is 4.0 or more.
Claim Rejections - 35 USC § 103
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as obvious over HAMAMOTO et al. (US 10,675,593 B2) or, in the alternative, further in view of YAMAGUCHI et al. (US 8,741,600 B2).
Regarding Claim 2, HAMAMOTO discloses the membrane of Claim 1. HAMAMOTO is deficient in disclosing a ratio (R/t) of an inner diameter (R) to a membrane thickness (t) of the porous hollow-fiber membrane is 8.4 or less.
However, HAMAMOTO does disclose an inner diameter range of 332.4 µm to 395.2 µm and a membrane thickness range of 25.7 µm to 39.2 µm (FIG. 5); while the calculated R/t ratio for these ranges exceeds the claimed range of 8.4 or less, such geometries are readily controlled and optimizable by one of ordinary skill in the art of membrane spinning and phase inversion in coagulation baths. The claimed inventive membrane and the disclosed membrane are both made by the same process, i.e., non-solvent coagulation; it would be expected that one of ordinary skill in the art would be capable of achieving the desired inner diameter and membrane thickness through routine experimentation. 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 absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05). Thus, the claimed range of 8.4 or less would have been optimizable by one of ordinary skill in the art through simple routine experimentation.
Alternatively, YAMAGUCHI discloses a similar membrane but having the claimed R/t ratio: YAMAGUCHI discloses a membrane for purifying immunoglobulin solutions (abstract), wherein the solutions further contain parvovirus (c5/48-51; c13/28-31). The membrane is a hollow fiber membrane (c17/57) and is formed of regenerated cellulose (c61/31-44; see also c81-c82 for an exemplary cellulose HFM). YAMAGUCHI further discloses the hollow fiber membrane has an inner diameter of 181 µm and thickness of 33 µm (c82/25-28), which reads upon the claimed range ratio of inner diameter to membrane thickness of 8.4 or less. All claimed elements were known in the prior art and one of ordinary skill in the art could have combined the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as obvious over HAMAMOTO et al. (US 10,675,593 B2) in view of FUKUDA et al. (EP 0913186 A1).
Regarding Claim 5, HAMAMOTO discloses the membrane of Claim 1. HAMAMOTO further discloses the pore size of the pore first decreases and then increases from a primary surface (i.e., inner lumen surface) towards a secondary surface (i.e., outer surface) of the membrane (c9/56-59); however, HAMAMOTO is deficient in disclosing wherein a pore size on an inner surface of the porous hollow-fiber membrane is larger than a pore size on an outer surface.
FUKUDA teaches a hollow fiber membrane prepared via non-solvent coagulating bath (abstract, p0013); the membrane comprises regenerated cellulose prepared via cuprammonium process (p0013). The hollow fiber membrane is characterized with a fine porous structure with a pore size D1 on the inner wall surface being from 10 nm to 300 nm (p0018) and a pore size D2 on the outer wall surface satisfying the range 0.6 D1 ≤ D2 ≤ 1.2 D1 (p0019). FUKUDA further discloses that values of D1 and D2 outside such ranges may negatively affect membrane performance (p0018-0019). FUKUDA further discloses a pore size D3 encompassing the interior of the membrane, satisfying D3 ≥ 1.2 D1 (p0020). Thus, FUKUDA discloses a membrane pore gradient that initially increases from inner wall then decreases to the outer wall, much like HAMAMOTO. As further shown by the relative ranges of D1 and D2, D2 is primarily smaller than D1 at least for the inequality of 0.6 D1 ≤ D2 ≤ 1.0 D1, i.e., a pore size on an inner surface of the porous hollow-fiber membrane is larger than a pore size on an outer surface, which establishes a case of prima facie obviousness (MPEP 2144.05). Advantageously, by maintaining D2 in the range of 0.6 D1 ≤ D2 ≤ 1.2 D1, excellent performance for removal of globulins and prevention of toxins from penetrating the membrane are achieved (p0019). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to provide relative pore sizes of the inner and outer surfaces as claimed and made obvious by FUKUDA for the membrane disclosed by HAMAMOTO.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
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/Ryan B Huang/Primary Examiner, Art Unit 1777