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 .
StatusClaims(s) 8-14, is/are filed on 04/09/2026 are currently pending. Claim(s) 8-14 is/are rejected.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over YAMASHITA (CA 3156253 A).
Regarding claim 8, YAMASHITA discloses a blood treatment material (claim 1) comprising a hollow fiber (Fig. 2 and par.[0129]) used from adsorption and removal of activated leukocytes and/or inflammatory cytokines (claim 7) with a ligand containing an amino group is bounded to the surface of the membrane (claim 4). The maximum value (RaA) of the arithmetic average roughness (Ra) of the surface is preferably 0.50 μm (par.[0046]). There are specific examples in Table 1 with RaA values between 0.10 μm to 0.80 μm (0.71 μm, 0.65 μm, 0.23 μm). It is well settled that where the prior art describes the components of a claimed compound or compositions in concentrations within or overlapping the claimed concentrations a prima facie case of obviousness is established. See In re Harris, 409 F.3d 1339, 1343, 74 USPQ2d 1951, 1953 (Fed. Cir 2005); In re Peterson, 315 F.3d 1325, 1329, 65 USPQ 2d 1379, 1382 (Fed. Cir. 1997); In re Woodruff, 919 F.2d 1575, 1578 16 USPQ2d 1934, 1936-37 (CCPA 1990); In re Malagari, 499 F.2d 1297, 1303, 182 USPQ 549, 553 (CCPA 1974).
Regarding claim 9, YAMASHITA teaches wherein the arithmetic mean roughness (RaA) is 0.30 μm to 0.60 μm. The maximum value (RaA) of the arithmetic average roughness (Ra) of the surface is preferably 0.50 μm (par.[0046]). There are specific examples in Table 1 with RaA values between 0.10 μm to 0.80 μm (0.71 μm, 0.65 μm, 0.23 μm). It is well settled that where the prior art describes the components of a claimed compound or compositions in concentrations within or overlapping the claimed concentrations a prima facie case of obviousness is established. See In re Harris, 409 F.3d 1339, 1343, 74 USPQ2d 1951, 1953 (Fed. Cir 2005); In re Peterson, 315 F.3d 1325, 1329, 65 USPQ 2d 1379, 1382 (Fed. Cir. 1997); In re Woodruff, 919 F.2d 1575, 1578 16 USPQ2d 1934, 1936-37 (CCPA 1990); In re Malagari, 499 F.2d 1297, 1303, 182 USPQ 549, 553 (CCPA 1974).
Regarding claim 10, YAMASHITA teaches wherein the blood-contacting surface is an inner surface of the hollow fiber membrane. (discloses in Fig. 2 the fiber and in par.[0028] explained the adsorption, it is implicitly disclosed that the solution to be treated has to circulate inside the fiber))
Regarding claim 11, YAMASHITA teaches wherein the inner diameter of the hollow fiber membrane is 150 μm to 400 μm. In par.[0036] that the fiber diameter is preferably from 3 μm to 200 μm). It is well settled that where the prior art describes the components of a claimed compound or compositions in concentrations within or overlapping the claimed concentrations a prima facie case of obviousness is established. See In re Harris, 409 F.3d 1339, 1343, 74 USPQ2d 1951, 1953 (Fed. Cir 2005); In re Peterson, 315 F.3d 1325, 1329, 65 USPQ 2d 1379, 1382 (Fed. Cir. 1997); In re Woodruff, 919 F.2d 1575, 1578 16 USPQ2d 1934, 1936-37 (CCPA 1990); In re Malagari, 499 F.2d 1297, 1303, 182 USPQ 549, 553 (CCPA 1974).
Regarding claim 12, YAMASHITA teaches wherein the material of the hollow fiber membrane is a copolymer of: a hydrophobic polymer selected from the group consisting of polyacrylonitrile, poly(methyl methacrylate), polystyrene, polysulfone, poly(ether-sulfone), polyester, copolymers thereof, and combinations thereof; and a hydrophilic polymer selected from the group consisting of poly(methallylsulfonic acid), poly(methallyl sulfonate), poly(styrenesulfonic acid), poly(styrene sulfonate), sulfonated polysulfone, sulfonated poly(ether-sulfone), copolymers thereof, and combinations thereof and cellulose acetate. (YAMASHITA discloses in par.[0029] the possible combination of hydrophilic polymers (cellulose acetate for example) and hydrophobic polymers (polyacrylonitrile for example) to synthesize.
Regarding claim 13, YAMASHITA teaches adapted to adsorb and remove activated leukocytes and inflammatory cytokines (see claim 7; intended use).
Regarding claim 14, YAMASHITA teaches a blood purification column comprising the blood treatment material of claim 8 (blood purification column see par.[0083]).
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It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
Response to Arguments
Applicant’s arguments have been considered as filed but are not persuasive. Applicant argue the cited references cannot be used under § 102(a)(1) because the underlying disclosure was made by the inventors themselves. Applicant further argue WO reference cannot be used under § 102(a)(2) because both the cited reference and the present application were owned by the same entity when the current invention was made.
Firstly, the 102(b)(2)(C) common-ownership argument does not apply to the reference of record. CA 3156253 A1 is a Canadian patent document available only as a printed publication under 102(a)(1). The common-ownership exception removes only 102(a)(2) art (MPEP 717.02) and has no application to a 102(a)(1) reference. Applicant's showing of common ownership by Toray Industries does not remove CA 3156253 A1. WO 2021/066152 A1 is not the reference relied upon, and argument directed to it is moot.
The Declaration is insufficient to invoke that exception. Falling within the grace period is necessary but not sufficient; the exception applies only where the relied-upon disclosure was made "by the inventor or a joint inventor." CA 3156253 A1 names three inventors — Yamashita, Kanda, and Takahashi — while the present application names only Yamashita and Takahashi. The reference thus names an additional inventor and is, on its face, partly the disclosure of another. Under MPEP 2155.01, where a reference names an inventor together with an additional person, the declaration must unequivocally attribute the relied-upon subject matter to the inventor(s) and reasonably explain the presence of the additional person. Paragraph IV.2 does neither, is merely conclusory states that the "common subject matter... was disclosed by" Yamashita and Takahashi. It does not attribute the specific features relied upon — the surface-roughness values (par. [0046]; Table 1), the fiber-diameter range (par. [0036]), the polyacrylonitrile/cellulose-acetate combination (par. [0029]), the amino-group ligand, and the column (par. [0083]) — to Yamashita and Takahashi, and nowhere addresses Kanda's role or his absence from the present application. To the extent any relied-upon feature originated with Kanda, that disclosure is the work of another and cannot be brought within 102(b)(1)(A) by a declaration executed by Yamashita and Takahashi, whatever its form.
Finally, Applicant has not traversed the substance of the rejection. The overlapping-range rationale therefore stands unrebutted.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Waqaas Ali whose telephone number is (571) 270-0235. The examiner can normally be reached on M-F 9-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached on 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WAQAAS ALI/Primary Examiner, Art Unit 1777
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