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.
Response to Amendments
Applicant’s amendments filed 03 June 2026 have been entered. Claims 1, 3, and 7-12 have been amended; Claims 11-14 are withdrawn; and Claim 2 has been canceled. Overall, Claims 1 and 3-14 are pending.
Regarding the rejections of Claims 9 and 10 under 35 U.S.C. 101, Applicant’s amendments are sufficient; these rejections have been withdrawn.
Regarding the rejections of Claims 9 and 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, Applicant’s amendments are sufficient; these rejections have been withdrawn.
Regarding the rejections of Claim(s) 1, 3, 4, and 6-10 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); Claim(s) 2 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); and Claim(s) 5 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 (EP 0913186 A1), Applicant’s amendments are persuasive; these rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made for Claim(s) 1, 3, 4, 7, and 8 under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by ISHIDA et al. (US 4,388,256 A); Claim(s) 5 under 35 U.S.C. 103 as obvious over ISHIDA et al. (US 4,388,256 A) in view of FUKUDA et al. (EP 0913186 A1); and Claim(s) 6, 9, and 10 under 35 U.S.C. 103 as obvious over ISHIDA et al. (US 4,388,256 A) in view of HAMAMOTO et al. (US 10,675,593 B2).
Please note the added objections to Claims 8 and 10.
Response to Arguments
Applicant’s arguments filed 03 June 2026 have been fully considered but are not persuasive.
Regarding “Claim Interpretation” (pg. 6-7), Applicant has disagreed with the Examiner’s interpretation of “elastic limit pressure”. Applicant argues “the ‘elastic limit pressure’ is a physical and mechanical property of the membrane itself, rather than a product-by-process limitation” (pg. 6, par. 4).
The Examiner agrees; the claim interpretation of the previous Office action has been withdrawn. The Examiner further acknowledges Applicant’s assertion that “elastic limit pressure” is a physical/mechanical property of the membrane itself.
Regarding “Rejection under 35 U.S.C. 101” (pg. 7), Applicant’s arguments are moot; the rejections of Claims 9 and 10 under 35 U.S.C. 101 have been withdrawn.
Regarding “Rejections under 35 U.S.C. 102 and 103” (pg. 8-14), Applicant argues the “claimed disclosure is structurally different from Hamamoto in that the ratio R/t of the present claimed disclosure is in a range of 4.8 or more and 8.4 or less, which is entirely outside of the ratio R/t values in Hamamoto” (pg. 9, par. 2). Applicant further explains that there is a correlation between R/t and the elastic limit pressure; because the R/t of HAMAMOTO is not within the claimed R/t range, the elastic limit pressure of the membrane of Hamamoto is also not 200 kPa or more. (§I, pg. 9, par. 3).
Applicant further argues HAMAMOTO utilizes a different method for manufacturing the membrane than the methos used in “the present claimed disclosure” (§II, pg. 10, par. 1). Applicant compares HAMAMOTO’s method with that of Comparative Example 2 of the present specification and notes their similarities—Comparative Example 2 shows an R/t of 12.2 and elastic limit pressure of 108 kPa (pg. 10, par. 2). Regarding the Office Action statement that although HAMAMOTO discloses an R/t ratio outside the claimed range, such a claimed range is optimizable, Applicant argues the relationship between R/t and elastic limit pressure would not have been recognized by one of ordinary skill in the art and “therefore would not have had reason to optimize these parameters to achieve the claimed properties” (pg. 11, par. 2).
Applicant further argues YAMAGUCHI fails to remedy the deficiencies of HAMAMOTO (§III, pg. 12-13), arguing that YAMAGUCHI fails to disclose a membrane thickness of 36.2 µm or more as claimed (pg. 12, par. 2), and that YAMAGUCHI discloses a different raw solution discharge rate than the specification-disclosed spinning dope ejection rate, i.e., “the membrane manufacturing method of Yamaguchi differs substantially from that of the present claimed disclosure. Therefore, the membrane of Yamaguchi cannot be said to inherently possess an elastic limit pressure of 200 kPa or more” (pg. 12, par. 3-4).
Finally, Applicant argues one of ordinary skill would not have a reasonable expectation of success when modifying the membranes of the prior art to achieve the presently claimed membrane of amended Claim 1 (§IV, pg. 13-14), arguing that the prior art does not recognize the relationship between R/t and elastic limit pressure nor the resultant improvement to pressure resistance (pg. 13, par. 4). Moreover, Applicant argues the prior art membranes are prepared “under very different spinning conditions from those of the present claimed disclosure” (pg. 14, par. 1).
Overall, based on these arguments, Applicant argues that independent Claim 1 is in condition for allowance and dependent Claims 3-10 are allowable (pg. 14, par. 4).
The Examiner respectfully disagrees. Applicant’s arguments have been considered but are not persuasive because they are directed to grounds of rejection that have been withdrawn. Therefore, the arguments are not commensurate in scope with the presently pending claims.
Claim Objections
Claim 8 is objected to because of the following informalities:
“…wherein a bubble point is in a range of 1.2 MPa or more”.
Claim 10 is objected to because of the following informalities:
The added limitation “as the virus removal” renders the claim grammatically awkward.
Appropriate correction is required.
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)(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.
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, 7, and 8 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by ISHIDA et al. (US 4,388,256 A).
Regarding Claim 1, ISHIDA discloses regenerated cellulose hollow fiber permeable membranes (i.e., [a] porous hollow-fiber membrane containing a regenerated cellulose; c1/7-9, c1/49-53); e.g., having outer and inner diameters of about 290 and about 250 µm (c9/41-42), 300 and 250 µm (c10/13-14), and 340 and 300 µm (c11/50-51), which have membrane thicknesses of 40, 50, and 40 µm, respectively, which read on the claimed membrane thickness (t) range of 36.2 µm or more. Such membranes have ratios (R/t) of inner diameters to membrane thicknesses of 6.25, 5.00, and 7.50, respectively, which read on the claimed ratio (R/t) range of 4.8 or more to 8.4 or less.
ISHIDA is deficient in explicitly disclosing an elastic limit pressure of 200 kPa or more; however, as noted in the disclosure of the present invention (FIG. 7), for (R/t) ratios of 6.25, 5.00, and 7.50, the membranes have elastic limit pressures of approximately 350, 450, and 325 kPa, respectively, which read on the claimed range of an elastic limit pressure of 200 kPa or more.
Regarding Claim 3, ISHIDA discloses the porous hollow-fiber membrane of Claim 1. As noted, the ISHIDA disclosed membranes have thicknesses ranging from 40 to 50 µm, which read on the claimed membrane thickness upper limit of 70 µm.
Regarding Claim 4, ISHIDA discloses the porous hollow-fiber membrane of Claim 1. The instant limitation “wherein the regenerated cellulose is obtained by a cuprammonium process” renders the claim a product-by-process claim. 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 7, ISHIDA discloses the porous hollow-fiber membrane of Claim 1. The instant limitation requiring “a water permeability at a filtration pressure of 27 kPa and 37°C is in a range of 10 L/(m2·hr) or more to 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, ISHIDA discloses the porous hollow-fiber membrane of Claim 1. The instant limitation requiring “a bubble point is in [a] range of 1.2 MPa or more” is directed toward an inherent property of the claimed porous hollow-fiber membrane. The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)).
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) 5 is/are rejected under 35 U.S.C. 103 as obvious over ISHIDA et al. (US 4,388,256 A) in view of FUKUDA et al. (EP 0913186 A1).
Regarding Claim 5, ISHIDA discloses the porous hollow-fiber membrane of Claim 1. ISHIDA is deficient in disclosing 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 (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. 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 porous hollow-fiber membrane disclosed by ISHIDA.
Claim(s) 6, 9, and 10 is/are rejected under 35 U.S.C. 103 as obvious over ISHIDA et al. (US 4,388,256 A) in view of HAMAMOTO et al. (US 10,675,593 B2).
Regarding Claim 6, ISHIDA discloses the porous hollow-fiber membrane of Claim 1. ISHIDA is deficient in disclosing 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.
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 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). Advantageously, such a gradient structure has a high permeation efficiency (c1/39-44). 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 a pore gradient structure as taught by HAMAMOTO for the porous hollow-fiber membrane of ISHIDA.
Regarding Claim 9, ISHIDA discloses the porous hollow-fiber membrane of Claim 1. ISHIDA is deficient in disclosing the porous hollow-fiber membrane has a porosity configured for virus removal.
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 further discloses virus removal (i.e., used for virus removal; abstract), specifically parvovirus (c1/18-30; c2/22-24; c4/31-34). The nature of the problem to be solved would have led one of ordinary skill in the art to combine 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). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to use the regenerated cellulose hollow-fiber membrane of ISHIDA for virus removal as suggested by HAMAMOTO.
Regarding Claim 10, modified ISHIDA makes obvious the porous hollow-fiber 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.
Conclusion
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 RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, In Suk Bullock can be reached at (571)272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ryan B Huang/Primary Examiner, Art Unit 1772
Prosecution Insights