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 EP2020/082787, filed 20 November 2020; which has PRO 62/938,761, filed 21 November2019) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 February 2026 has been entered.
Response to Amendments
Applicant’s amendments filed 08 January 2026 have been entered.
Claims 1, 5, 8, 10, and 17 have been amended; Claims 2-4, 20, and 22-79 have been canceled; overall, Claims 1, 5-19, and 21 are pending.
Regarding the rejections of Claims 5-8, 10, and 17 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 to overcome the rejections of Claims 5-7 and 17; however, the rejections of Claims 8 and 10 have not been sufficiently addressed, and the as-amended claims have introduced new indefiniteness issues.
Regarding the rejections of Claim(s) 1-4, 9, 11, and 14 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by CUSSLER et al. (US 5,160,627) and Claim(s) 5-8, 15-17, and 21 under 35 U.S.C. 103 as being unpatentable over CUSSLER et al. (US 5,160,627) and RAGHEB et al. (US 9,962,691), Applicant’s amendments have not overcome the grounds of rejection.
Response to Arguments
Applicant’s arguments filed 08 January 2026 have been fully considered.
Regarding “Claim Objections” (pg. 7, middle), it is unclear what Applicant is referencing; there were no outstanding Claim Objections in the previous Office action.
Regarding “Rejections under 35 U.S.C. 112(b)” (pg. 7, bottom), Applicant argues the as-amended claims traverse the rejections.
The Examiner respectfully disagrees. Applicant’s amendments have failed to fully address the rejections of Claims 8 and 10, and further, the as-amended claims have introduced new indefiniteness issues.
Regarding “Rejections under 35 U.S.C. 102” (pg. 7-8), Applicant argues that as-amended independent Claim 1 now requiring further limitations regarding the “coplanar stack of coextensive sheets” (pg. 8, par. 1) and the disclosed technical problem solved by Applicant’s Claim 1 (pg. 8, par. 1-2) are not anticipated by CUSSLER especially because CUSSLER fails to teach or suggest a “coplanar stack of coextensive sheets, or a substantially spiral wound configuration” (pg. 8, par. 3).
The Examiner respectfully disagrees. First, regarding the limitations of “coplanar stack of coextensive sheets”, it is noted that the features upon which Applicant relies (i.e., coplanar stack of coextensive sheets, or a substantially spiral wound configuration) are not required in the rejected claim(s) and are instead listed in the alternative. While Applicant may have disclosed an embodiment in the Specification requiring a coplanar stack, such a requirement is not claimed. 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 claim allows for the composite material to be “arranged in a coplanar stack of coextensive sheets, said coplanar coextensive sheets being periodically separated by screens, a tubular configuration, or a spiral wound configuration, said spiral wound composite material being wound with a screen”, i.e., the elements of the coplanar coextensive sheets, tubular configuration, and spiral wound configuration are listed in the alternative. CUSSLER discloses tubular configuration and therefore, anticipates this recited arrangement of the functionalized composite material.
Second, Applicant is arguing an intended result from the practice of the claimed method, i.e., “increasing the ligand coupling to the composite materials [to improve] the binding capacity of affinity media” (Applicant citing par. 0003 of the Specification; pg. 8, par. 2). No such limitation is recited by the claim. 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).
Applicant further argues that Claims 9, 11, and 14 depend from Claim 1 and are patentable for the same reasons argued above (pg. 8, par. 4).
The Examiner respectfully disagrees. Applicant’s previous arguments have not traversed the rejection of Claim 1. Claim 1 is not patentable over the prior art as explained; therefore, dependent Claims 9, 11, and 14 are not patentable for the same reasons.
Regarding “Rejections under 35 U.S.C. 103” (pg. 9-11), Applicant argues that the secondary art RAGHEB “requires two thiol groups and 1) carbon to carbon double bond moieties or 2) carbon to carbon triple bond moieties” and further, “RAGHEB does not describe hollow fibers for filtration, as in CUSSLER”; therefore, one of ordinary skill would not find it obvious to modify CUSSLER with RAGHEB (pg. 9, par. 2).
The Examiner respectfully disagrees. Applicant has misinterpreted RAGHEB and has only cited broad disclosures of the prior art to support their argument. RAGHEB explicitly teaches in c7/19-23 that the cross-linked polymers are further functionalized by grafting with a grafting moiety wherein “the grafting moiety is a thiol or an alkene”. There is no requirement by RAGHEB to have a grafting moiety that consists of “two thiol groups and 1) carbon to carbon double bond moieties or 2) carbon to carbon triple bond moieties” as argued by Applicant. Further, Applicant is apparently arguing that their instantly claimed invention is narrower than claimed, i.e., that the molecule comprising a thiol functional group may only have thiol functional groups. No such claim language or construction has been recited. In fact, Claim 1 even allows for “a mixture thereof” of various pendant reactive functional groups, including thiols and carbon-carbon double/triple bonds.
Applicant further argues that neither CUSSLER nor RAGHEB disclose or suggest “one or more flow distributing layers, the flow distributing layers are non-porous sheets containing a hole” (pg. 10, par. 2) and therefore, Claim 1 is patentable and Claims 5-8, 15-17, and 21 are similarly patentable for the same reasons (pg. 10, par. 3).
The Examiner respectfully disagrees. The instantly recited limitation is directed toward the “coplanar stack of coextensive sheets” which as noted earlier is only required in the alternative to a tubular configuration and a spiral wound configuration. Therefore, this instant limitation is also considered optional, and the prior art reads upon or makes obvious the claimed invention so long as the prior art discloses or makes obvious one of the claimed arrangements of the functionalized composite material.
Applicant further argues that for Claims 9-13, 18, and 19, the prior art of CUSSLER and CIHLDS similarly fail to disclose the additional limitation regarding the coplanar stack of coextensive sheets (pg. 10-11); therefore, Claims 1, 9-13, 18, and 19 are also patentable (pg. 11, par. 1).
The Examiner respectfully disagrees. As noted earlier, such a recitation is optional. The prior art reads upon or makes obvious the claimed invention so long as the prior art discloses or makes obvious one of the claimed arrangements of the functionalized composite material.
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 5-8, 10, 14-19, and 21 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 5, there is a lack of antecedent basis for “the molecule comprising a thiol group”. Claim 1 has introduced “a molecule comprising… thiols” but no “molecule comprising a thiol functional group”. Furthermore, Claim 1 has introduced “thiols” in the plurality. It is unclear which “thiol group” Applicant is referencing from the claimed “thiols” (if indeed Applicant is equating “thiol” with “thiol group”). Claims 6 and 7 are also rejected due to their dependence on Claim 5.
Regarding Claim 8, there is a lack of antecedent basis for “the molecule comprising an unsaturated carbon-carbon bond”. Claim 1 has introduced “a molecule comprising unsaturated carbon-carbon double bonds” and “a molecule comprising unsaturated carbon-carbon triple bonds” but no “molecule comprising an unsaturated carbon-carbon bond”.
Regarding Claim 10, regarding the recited limitation “the one or more polymerizable monomers comprising a pendant reactive functional group”, it is unclear which “pendant reactive functional group” is being referenced because Claim 1 has introduced “a plurality of pendant reactive functional groups” (i.e., “groups” is recited in the plurality). Claim 10 has only referenced an individual “pendant reactive functional group”.
Regarding Claim 14, regarding the recited limitation “the first ligand”, it is unclear which “first ligand” is being referenced because Claim 1 has introduced “a plurality of first ligands”. Claim 14 has only referenced an individual “first ligand”. Claims 15-19 and 21 are also rejected due to their dependence on Claim 14.
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.
Claim(s) 1, 9, 11, and 14 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by CUSSLER et al. (US 5,160,627).
Regarding Claim 1, CUSSLER discloses a process for modifying a hydrophobic microporous hollow fiber membrane (i.e., a tubular configuration; c3/32-38). Briefly, a hydrophobic hollow fiber membrane is made water-wettable by treating with a surfactant (c6/8-10) and subsequently coating with a polymer solution to yield a gel layer in the pores of the treated hollow fiber membrane (i.e., a macroporous… gel; c6/55-c7/2; c8/11-13)—because the gel layer is in the pores of the hollow fiber membrane, the pores of the gel layer are inherently smaller than the pores of the hollow fiber membrane (i.e., said macropores of the macroporous… gel are smaller than the pores of the support member). The hollow fiber membrane itself is porous having interconnected paths from one exterior surface to the other (i.e., a support member, comprising a plurality of pores extending through the support member; c4/4-11). The polymer solution consists of polyvinyl alcohol (PVA), divinyl sulfone (DVS), and water (i.e., a polymer formed from a reaction of one or more polymerizable monomers with one or more cross-linkers; c6/28-31), cross-linked (i.e., a… cross-linked gel; c7/49-50; c7/60-2). Finally, CUSSLER discloses that various ligands can be attached to the obtained PVA gel stationary phase, e.g., Example 4 discloses preparing a ligand solution comprising Reactive Blue 4 (i.e., 1-amino-4-[3-(4,6-dichlorotriazin-2-ylamino)-4-sulfophenylamino]anthraquinone-2-sulfonic acid) and flowing said solution through the hollow fiber membranes at a flow rate of 0.3 mL/min such that the dye is bound to the gel (i.e., flowing at a first flow rate a first solution substantially through or substantially across the functionalized composite material, wherein the first solution comprises a plurality of first ligands; c10/37-64). The disclosure of Reactive Blue 4 (Example 4, c10/37-64), which is a pendant reactive functional group categorized as an amine, reactive halogen, and includes unsaturated carbon-carbon double bonds, reads on the recited limitation “wherein the pendant reactive functional groups are selected from aldehydes, amines, a molecule comprising unsaturated carbon-carbon double bonds, a molecule comprising unsaturated carbon-carbon triple bonds, epoxides, hydroxyls, thiols, anhydrides, azides, reactive halogens, acid chlorides, and a mixture thereof”.
The limitation “such that a plurality of covalent bonds forms between the reactive functional groups and the first ligands” is directed toward an intended result from the practice of the claimed method. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency.
Regarding Claims 9 and 11, CUSSLER discloses the method of Claim 1. CUSSLER further discloses Reactive Blue 4 (i.e., wherein the pendant reactive functional groups are selected from the group consisting of… amines…. Reactive halogens (Claim 9); wherein the pendant reactive functional groups are amines (Claim 11); Example 4).
Regarding Claim 14, CUSSLER discloses the method of Claim 1. CUSSLER further discloses that the ligands are particularly effective in purifying enzymes and various proteins (i.e., wherein the first ligand comprises a first functionality; c10/4-41).
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.
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) 5-8, 15-17, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over CUSSLER et al. (US 5,160,627) and further in view of RAGHEB et al. (US 9,962,691).
Regarding Claims 5-8, CUSSLER discloses the method of Claim 1. CUSSLER is deficient in disclosing the pendant reactive functional groups are derived from a molecule comprising a thiol functional group selected from various specific groups (Claims 5-7); or a molecule comprising an unsaturated carbon-carbon bond selected from a specific group (Claim 8).
RAGHEB discloses a composite membrane comprising a support membrane comprising a plurality of pores extending through the support member, a cross-linked gel wherein the cross-linked gel comprises a polymer derived from a first monomer and a first cross-linker (c1/58-64). The cross-linked gels are macroporous, and the macropores of the gel are smaller than the pores of the support member (c11/1-5). The first monomer comprises two thiol functional groups (c2/1-2); the first cross-linker comprises carbon-carbon double bonds or carbon-carbon triple bonds (c2/3-6), e.g., the cross-linked polymers are formed by the reaction between a dithiol monomer and a tri-vinyl monomer (c6/17-26)—polymerization reactions (c12/36-45).
The cross-linked polymers are then further functionalized by grafting with a grafting moiety, e.g., a thiol or an alkene with additional chemical functionalities (c7/19-23). Various grafting moieties include: mercaptosuccinic acid having a carboxylic acid functionality (c7/25-27); cysteamine having an amine functionality (i.e., wherein the pendant reactive functional groups are derived from a molecule comprising a thiol functional group… 1-mercaptosuccinic acid… cysteamine (Claim 5); c7/27-29); mercaptoethanesulfonic acid with sulfonic acid groups and negative charges (c7/28-31); biomoleucles for bio-affinity chromatography, including cysteine (i.e., wherein the molecule comprising a thiol functional group is… a protein comprising a cysteine residue (Claims 6 and 7); c8/49-51); molecules having hydrophobic interaction moieties, including 1-octene (i.e., wherein the pendant reactive functional groups are derived from a molecule comprising an unsaturated carbon-carbon bond… 1-octene (Claim 8); c8/45-48); other biomolecules with free thiol functionality (c9/30-43). It would have been obvious to utilize the functional groups disclosed by RAGHEB for the method of preparing a functionalized composite material disclosed by CUSSLER because 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).
Regarding Claims 15-17 and 21, CUSSLER discloses the method of Claim 14. CUSSLER is deficient in disclosing the first ligand further comprises at least one grafting end-group or that the first functionality is selected from a group of various interaction mechanisms, a biological molecule, and a biological ion.
RAGHEB discloses a composite membrane comprising a support membrane comprising a plurality of pores extending through the support member, a cross-linked gel wherein the cross-linked gel comprises a polymer derived from a first monomer and a first cross-linker (c1/58-64). The cross-linked gels are macroporous, and the macropores of the gel are smaller than the pores of the support member (c11/1-5). The first monomer comprises two thiol functional groups (c2/1-2); the first cross-linker comprises carbon-carbon double bonds or carbon-carbon triple bonds (c2/3-6), e.g., the cross-linked polymers are formed by the reaction between a dithiol monomer and a tri-vinyl monomer (c6/17-26)—polymerization reactions (c12/36-45).
RAGHEB further discloses utilizing a Protein A ligand containing a cysteine residue to couple to the membrane via click chemistry (i.e., wherein the first ligand further comprises at least one grafting end-group (Claim 15); c31/53-62); said Protein A ligand a biological molecule (i.e., the first functionality is selected from the group consisting of… a biological molecule (Claim 15); wherein the first functionality comprises a biological molecule or a biological ion functionality selected from the group consisting of… Protein A (Claim 21)). RAGHEB also discloses utilizing hydrophobic ligands to generate hydrophobic interaction chromatography membranes (i.e., wherein the first functionality is selected from the group consisting of… hydrophobic [interaction] (Claim 16); c33/27-41). RAGHEB also discloses the use of various acrylamides as monomers in preparing the composite membrane (i.e., wherein a molecule comprises a first functionality, and the molecule is selected from the group consisting of… acrylamide (Claim 17); c17/44-53). It would have been obvious to utilize the first ligands having first functionality as disclosed by RAGHEB for the method of preparing a functionalized composite material disclosed by CUSSLER because 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).
Claim(s) 9-13, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over CUSSLER et al. (US 5,160,627) and further in view of CHILDS et al. (US 8,206,982).
Regarding Claims 9-13, CUSSLER discloses the method of Claim 1. CUSSLER is deficient in disclosing wherein the pendant reactive functional groups are selected from the group consisting of aldehydes, amines, epoxides, hydroxyls, anhydrides, azides, reactive halogens, and acid chlorides (Claim 9); one or more polymerizable monomers comprising a pendant reactive functional group are selected from the group consisting of glycidyl methacrylate, acrylamidoxime, acrylic anhydride, azelaic anhydride, maleic anhydride, hydrazide, acryloyl chloride, 2-bromoethyl methacrylate, and vinyl methyl ketone (Claim 10); wherein the pendant reactive functional groups are amines (Claim 11); wherein the pendant reactive functional groups are epoxides (Claim 12); or wherein the pendant reactive functional groups are hydroxyls (Claim 13).
CHILDS discloses a composite membrane comprising a support member and a macroporous cross-linked gel filling the pores of the support; said composite membrane is useful for separating substances by functionalizing the membrane with various moieties and ligands (abstract; c11/46-c12/10). The macroporous gels are formed from the in situ reaction of one or more polymerizable monomers with one or more cross-linkers (c8/6-9); said monomers include glycidyl methacrylate, acrylamidoxime, acrylic anhydride, azelaic anhydride, maleic anhydride, hydrazide, acryloyl chloride, 2-bromoethyl methacrylate, and vinyl methyl ketone (i.e., wherein the pendant reactive functional groups are selected from the group consisting of aldehydes, amines, epoxides, hydroxyls, anhydrides, azides, reactive halogens, and acid chlorides (Claim 9); wherein the pendant reactive functional groups are amines (Claim 11); wherein the pendant reactive functional groups are epoxides (Claim 12); wherein the pendant reactive functional groups are hydroxyls (Claim 13); c11/46-57). Such monomers advantageously provide reactive functional groups that allow for the attachment of other ligands or other specific binding sites (c11/46-48). 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 the disclosed monomers comprising a pendant reactive functional group as taught by CHILDS for the method disclosed by CUSSLER. Further, 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).
Regarding Claims 18 and 19, CUSSLER discloses the method of Claim 15. CUSSLER is deficient in disclosing wherein the first functionality is a metal chelating functionality (Claim 18); or that wherein the first functionality comprises a metal chelating functionality selected from the group consisting of octadentate, hexadentate, tetradentate, tridentate, bidentate, iminodicarboxylic acid, and iminodiacetic acid (Claim 19).
CHILDS discloses a composite membrane comprising a support member and a macroporous cross-linked gel filling the pores of the support; said composite membrane is useful for separating substances by functionalizing the membrane with various moieties and ligands (abstract; c11/46-c12/10). Some of the functionality that is introduced include affinity ligands that are selective for certain target analytes (c11/57-c12/10); such ligands include metal affinity ligands such as complexes of iminodiacetic acid (i.e., the first functionality is a metal chelating functionality (Claim 18); wherein the first functionality comprises a metal chelating functionality selected from the group consisting of octadentate, hexadentate, tetradentate, tridentate, bidentate, iminodicarboxylic acid, and iminodiacetic acid (Claim 19); c12/6-8). It would have been obvious to utilize first ligands having such first functionality as disclosed by CHILDS for the method of preparing a functionalized composite material disclosed by CUSSLER because 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).
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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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.
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/Ryan B Huang/Primary Examiner, Art Unit 1777
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