DETAILED ACTION
Pending Claims
Claims 1-20 are pending.
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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 28, 2026 has been entered.
Election/Restrictions
Claims 18-20 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 19, 2024.
Claims 12-17 (Species II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 19, 2024.
Response to Amendment
The rejection of claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph (indefinite), has been overcome by amendment.
The rejection of claim 2 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description requirement), has been overcome by amendment.
Claim Objections
Claims 1-11 are objected to because of the following informalities:
For improved clarity, claim 1 should state: wherein the substrate is a porous membrane (see paragraph 0027 of the specification and pre-publication). Claims 2-11 are objected to because they are dependent from claim 1.
For improved clarity, claim 2 should state: wherein the porous membrane is a supported membrane (see paragraph 0029 of the specification and pre-publication).
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Takatsuma (JP 2004-242522 A) in view of Zhou et al. (US 2020/0188859 A1).
Regarding claims 1, 5-8, and 10, Takatsuma discloses: (1) a method for forming an activated substrate comprising contacting a substrate with an activation solution (paragraph 0029; see also paragraph 0030), wherein the activation solution comprises an activation agent (paragraph 0029: epichlorohydrin), a base (paragraph 0029: sodium hydroxide), and an organic solvent (paragraph 0029: dimethyl sulfoxide), the activation agent including a reactive functionality configured to react with a surface of the substrate to form a linking group on the surface, the activation agent further including an epoxy group, the linking group comprising the epoxy group (paragraph 0029: epichlorohydrin);
(5) wherein the activation agent comprises an epichlorohydrin, a diglycidyl ether, a triglycidyl ether, a tetraglycidyl ether, or any combination thereof (paragraph 0029: epichlorohydrin);
(6) wherein the organic solvent comprises a protic organic solvent or an aprotic organic solvent, or a combination thereof (paragraph 0029: dimethyl sulfoxide);
(7) wherein the organic solvent comprises an alcohol, nitromethane, dimethyl sulfoxide, dimethyl formamide, N-methylpyrrolidinone, or any combination thereof (paragraph 0029: dimethyl sulfoxide);
(8) wherein the base comprising an alkanamine, a pyridine, an imidazole, a benzimidazole, a histidine, a guanidine, a phosphazene base, N,N-dimethylbenzyl amine, 3-dimethylaminopropyl amine, N,N-diisopropylethylamine, N,N-dimethylene diamine, diethylamine, sodium amide, sodium hydroxide, lithium bis(trimethylsilyl)amide, lithium tert-butoxide, or any combination thereof (paragraph 0029: sodium hydroxide); and
(10) wherein the substrate is contacted with the activation solution at a temperature of from about 0oC to about 100oC (paragraph 0029: 30 oC).
The materials of Takatsuma are used for biological testing (see Abstract). The exemplary embodiment of Takatsuma features a granular substrate of polyvinyl alcohol resin (see paragraph 0029). The general teachings of Takatsuma embrace a solid phase substrate in various forms, including those having a granular shape, a film shape or sheet shape (see paragraph 0010). They fail to explicitly disclose: (1) wherein the substrate is a porous membrane.
Zhou et al. also disclose a material used for biological testing (see Abstract). These materials feature substrates that undergo a similar activation process (see paragraphs 0126-0127). They demonstrate that porous membranes are recognized in the art as suitable film-shaped or sheet-shaped substrates for this type of testing material. This includes polyvinyl alcohol membranes (see paragraph 0017). In light of this, it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination – see MPEP 2144.07.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the biological testing material of Takatsuma with a porous membrane substrate because: (a) the exemplary embodiment of Takatsuma features a granular substrate of polyvinyl alcohol resin; (b) the general teachings of Takatsuma embrace a solid phase substrate in various forms, including those having a granular shape, a film shape or sheet shape; (c) Zhou et al. also disclose materials used for biological testing, which feature substrates that undergo a similar activation process; (d) Zhou et al. demonstrate that porous membranes are recognized in the art as suitable film-shaped or sheet-shaped substrates for this type of testing material, including polyvinyl alcohol membranes; and (e) it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Regarding claim 2, the combined teachings of {Takatsuma and Zhou et al.} are as set forth above and incorporated herein. They fail to explicitly disclose: (2) wherein the porous membrane is a supported membrane. However, the scope of the claim embraces multiple porous membranes (where one supports the other). In light of this, it has been found that a mere duplication of parts does not have patentable significance unless a new and unexpected result is produced – see MPEP 2144.04 VI. B.
Regarding claim 3, the combined teachings of {Takatsuma and Zhou et al.} are as set forth above and incorporated herein. The primary teachings of Takatsuma fail to explicitly disclose: (3) wherein the substrate comprises a porosity having a pore size of from about 0.1 micrometers to about 10 micrometers. However, the supporting teachings of Zhou et al. demonstrate that the instantly claimed pore size is recognized in the art as a suitable pore size of a membrane used in this type of testing material. In light of this, it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination – see MPEP 2144.07.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the testing material resulting from the combined teachings of {Takatsuma and Zhou et al.} with a membrane substrate having the instantly claimed porosity (a pore size of from about 0.1 micrometers to about 10 micrometers) because: (a) the supporting teachings of Zhou et al. demonstrate that the instantly claimed pore size is recognized in the art as a suitable pore size of a membrane used in this type of testing material; and (b) it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Regarding claim 4, the combined teachings of {Takatsuma and Zhou et al.} are as set forth above and incorporated herein. The exemplary embodiment in the primary teachings of Takatsuma features a polyvinyl alcohol substrate (see paragraph 0029). Accordingly, this embodiment fails to disclose: (4) wherein the substrate comprises cellulose, regenerated cellulose, a cellulose derivative, a nylon, a polysulfone, a polyether sulfone, a polyvinylidene fluoride, a polyacrylonitrile, a polyetherimide, a polypropylene, a polyethylene, a polyether terephthalate, or any combination thereof. However, the general teachings of Takatsuma are open to other materials, including cellulose and various polymers (including acrylonitrile) (see paragraph 0010). Furthermore, the supporting teachings of Zhou et al. demonstrate that these materials are recognized in the art as suitable membrane substrate materials for this type of testing material (see paragraph 0017). In light of this, it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination – see MPEP 2144.07.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the testing material resulting from the combined teachings of {Takatsuma and Zhou et al.} with the instantly claimed membrane substrate materials because: (a) the exemplary embodiment in the primary teachings of Takatsuma features a polyvinyl alcohol substrate; and (b) the general teachings of Takatsuma are open to other materials, including cellulose and various polymers (including acrylonitrile). Furthermore: (c) the supporting teachings of Zhou et al. demonstrate that these materials are recognized in the art as suitable membrane substrate materials for this type of testing material; and (d) it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Takatsuma (JP 2004-242522 A) in view of Zhou et al. (US 2020/0188859 A1) and Zhao (CN 101003017 A).
Regarding claim 9, the combined teachings of {Takatsuma and Zhou et al.} are as set forth above and incorporated herein. They fail to explicitly disclose: (9) wherein the activation solution comprises the activation agent in an amount of from about 0.1% (V/V) to about 60% (V/V) by volume of the organic solvent; the organic solvent in an amount of from about 1 % (V/V) to about 99% (V/V) by volume of the activation solution; and the base in an amount of from about 0.1% (V/V) to about 50% (V/V) by volume of the activation solution. Rather, the exemplary embodiment in the primary teachings of Takatsuma features 50 meq/g of epichlorohydrin, 5 meq/g of sodium hydroxide and 10 ml/g of dimethyl sulfoxide (see paragraph 0029). It is not immediately clear how this translates to relative volume amounts.
Zhao discloses a similar material that is activated with a solution containing epichlorohydrin and sodium hydroxide (see Examples 1, 5 & 7-10 in paragraphs 0044, 0052 & 0056-0062). Zhao demonstrates that the instantly claimed relative volumes of epichlorohydrin, sodium hydroxide, and solvent are recognized in the art as suitable relative volume amounts for this type of activation solution. In light of this, it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination – see MPEP 2144.07.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention use the instantly claimed relative volume amounts in the method resulting from the combined teachings of {Takatsuma and Zhou et al.} because: (a) the exemplary embodiment in the primary teachings of Takatsuma features 50 meq/g of epichlorohydrin, 5 meq/g of sodium hydroxide and 10 ml/g of dimethyl sulfoxide, but it is not immediately clear how this translates to relative volume amounts; (b) Zhao discloses a similar material that is activated with a solution containing epichlorohydrin and sodium hydroxide and demonstrates that the instantly claimed relative volumes of epichlorohydrin, sodium hydroxide, and solvent are recognized in the art as suitable relative volume amounts for this type of activation solution; and (c) it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Regarding claim 11, the combined teachings of {Takatsuma and Zhou et al.} are as set forth above and incorporated herein. They fail to disclose a method: (11) further comprising pretreating the substrate prior to the contact. As discussed above, Zhao discloses a similar material that is activated with a solution containing epichlorohydrin and sodium hydroxide (see Examples 1, 5 & 7-10 in paragraphs 0044, 0052 & 0056-0062). Zhao also demonstrates that it is recognized in the art to wash the substrate before activation.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to pretreat the substrate in the method resulting from the combined teachings of {Takatsuma and Zhou et al.} because: (a) Zhao discloses a similar material that is activated with a solution containing epichlorohydrin and sodium hydroxide; and (b) Zhao also demonstrates that it is recognized in the art to wash the substrate before activation.
Response to Arguments
Applicant's arguments filed January 28, 2026 have been fully considered but they are not persuasive.
Argument 1 (see pages 6-7 of the response): Applicant submits that the epoxy group in Takatsuma is used only as a “transient intermediate” and is fully consumed to form diethylamino ion-exchange groups, rather than being retained as a surface-bound epoxy linking group.
The Office respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., epoxy groups being retained as a surface-bound epoxy linking group) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instantly claimed method for forming an activated substrate requires a step of contacting a substrate with an activation solution (and is open to additional steps: see “comprising”). The method of Takatsuma includes a step of activating a resin substrate with an activation solution that satisfies the material/chemical limitations of the activation solution presented in claim 1 (see paragraph 0029). It is understood that the epoxy-activated resin substrate of Takatsuma is further reacted/derivatized (see paragraph 0029; see also paragraph 0030); however, the step of obtaining the epoxy-activated resin substrate satisfies the instantly claimed method regardless of any further reactions or derivatizations. Furthermore, it should be noted that Applicant’s activated substrate is also used as a “transient intermediate” that is further reacted/derivatized (see paragraphs 0047-0061 of the specification and pre-publication; see also withdrawn claims 12-17).
Argument 2 (see pages 7-8 of the response): there is no motivation to combined the teachings of Takatsuma and Zhou.
The Office respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case:
the materials of Takatsuma are used for biological testing;
the exemplary embodiment of Takatsuma features a granular substrate of polyvinyl alcohol resin;
the general teachings of Takatsuma embrace a solid phase substrate in various forms, including those having a granular shape, a film shape or sheet shape;
Zhou et al. also disclose materials used for biological testing, which feature substrates that undergo a similar activation process;
Zhou et al. demonstrate that porous membranes are recognized in the art as suitable film-shaped or sheet-shaped substrates for this type of testing material, including polyvinyl alcohol membranes; and
it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J FEELY whose telephone number is (571)272-1086. The examiner can normally be reached Monday-Friday 8am-5pm.
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/MICHAEL J FEELY/Primary Examiner, Art Unit 1766
February 21, 2026