DETAILED ACTION
For this Office action, Claims 1-3, 7-10, 15, 17-19, 22-28, 31 and 33 are pending. Claims 4-6, 11-14, 16, 20, 21, 29, 30, 32 and 34-38 are canceled.
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 .
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 7-10, 15, 17-19, 22-28, 31 and 33 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. Claim 1, upon which the remaining claims are at least indirectly dependent, recites “the vesicle-forming material”; however, this limitation lacks antecedent basis. A vesicle-forming material is not inherently implied with a vesicle, or even necessarily a part of the vesicle when considering the limits of the claim, so the claim is rejected on this basis. Appropriate correction is required. For purposes of this examination, the examiner will ignore the antecedent basis issue and examine the claim and its dependents on their merits.
Claim 8-9 are further rejected under 35 U.S.C. 112(b) for additional antecedent basis issues.
Claim 8 recites “said reactive end group functionalized PDMS” and “the number of monomers”, which both lack antecedent basis. The “reactive end group functionalized PDMS” is established in Claim 7, yet Claim 8 is dependent only on Claim 1 (via preliminary amendment). The issue regarding “the number of monomers” renders the claim further indefinite, as the claim language is unclear what the number of monomers may refer to within the claim. For purposes of this examination, the examiner will assume the claim is dependent on Claim 7 and not give patentable weight (at this time) for the monomer limitation. Applicant is advised potential prior art rejections could made in a following action once this issue is rectified regarding the monomer limitation.
Claim 9 recites “the reactive group functionalized PDMS”, which lacks established antecedent basis. See that this limitation is introduced in Claim 7, yet Claim 9 has been amended to be dependent on Claim 1. For purposes of this examination, the examiner will instead assume Claim 9 is dependent on Claim 7.
Claims 22-23 are further rejected under 35 U.S.C. 112(b) for reciting “the total protein concentration of the liquid composition”, which lacks established antecedent basis. Since Claim 22 is dependent on Claim 18 (wherein Claim 18 establishes “plant-derived transmembrane proteins”; see also Claim 23’s dependency on Claim 22). The only item established within the water are the vesicles (see Claim 1), so the claim language is unclear what may be considered within the total protein concentration in the liquid to read on the claim (for instance, should the protein be the plant-derived transmembrane proteins from Claim 18 only or should the “total” protein concentration be derived from other potential sources as well?). Applicant is urged to address this issue in the response to this Office action. For purposes of this examination, the examiner will assume the total protein concentration refers to the plant-derived transmembrane proteins of Claim 18.
Claim 23 is further rejected under 35 U.S.C. 112(b) for reciting “the total water channel transmembrane protein concentration of the liquid composition”, which lacks established antecedent basis. No water channel or water channel transmembrane protein concentration has been established in either Claim 23 or the claims upon which it is dependent. This issue renders the claim further indefinite, as the language is unclear if the “total water channel transmembrane protein concentration” should be different from other protein concentrations in the liquid composition. For purposes of this examination, the examiner will not give the claim patentable weight until the issue has been resolved within the claims.
Claim 26 is further rejected under 35 U.S.C. 112(b) for reciting “a porous substrate membrane”, as the claim language is unclear whether this limitation should be considered the same as Claim 25’s (upon which Claim 26 is dependent) “porous support membrane” or a different membrane comprised within the active layer. For purposes of this examination, the examiner will assume the support membrane and the substrate membrane may be considered the same limitation.
Claim 28 is further rejected under 35 U.S.C. 112(b) for reciting preferential language regarding the suggestions for the free reactive groups. This issue renders the claim indefinite, as the claim language is unclear whether the reactive groups must be one of the suggested categories or not to read on the claim. For purposes of this examination, the examiner will assume the reactive group must be one of the suggested groups.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 10, 15, 17, 18, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lopez-Perez et al. (herein referred to as “Lopez”; “Changes in plasma membrane lipids, aquaporins and proton pump of broccoli roots, as an adaptation mechanism to salinity”, PHYTOCHEMISTRY, ELSEVIER, AMSTERDAM, NL, vol. 70, no. 4, 1 March 2009 (2009-03-01), pages 492-500, XP026029325, ISSN: 0031-9422, DOI: 10.1016/J.PHYTOCHEM.2009.01.014; found and cited in IDS filed 02/09/2024).
Regarding instant Claim 1, Lopez discloses a vesicle in a liquid composition (Abstract; Introduction, Paragraph [0001] broccoli plasma membrane vesicles placed in water), said vesicle comprising plant-derived transmembrane proteins (Abstract; pg. 4942, 2.2, Paragraph [0001]; broccoli root, proteins in cells of roots, such as PIP), wherein the vesicle-forming material comprises plant plasma membrane components (Abstract; broccoli root plasma membrane vesicles).
Regarding instant Claim 2, Claim 1, upon which Claim 2 is dependent, has been rejected above. Lopez further discloses wherein the vesicle forming material consists of plasma membrane components (Abstract; broccoli root plasma membrane vesicles).
Regarding instant Claim 3, Claim 1, upon which Claim 3 is dependent, has been rejected above. Lopez further discloses wherein the plant plasma membrane components originate from the same plant as the plant-derived transmembrane proteins (Abstract; pg. 496, 4., 4.1; single plant material used for procedure).
Regarding instant Claim 10, Claim 1, upon which Claim 10 is dependent, has been rejected above. Lopez further discloses wherein the plant-derived components comprise plant plasma membrane phospholipids (Abstract; pp. 493-494, I. Paragraph [0002]; see aquaporins, which are phospholipids).
Regarding instant Claim 15, Claim 1, upon which Claim 15 is dependent, has been rejected above. Lopez further discloses wherein the liquid composition does not comprise a detergent or a surfactant (Pg. 496, 4.,4.1; no detergent or surfactant is added in preparation).
Regarding instant Claim 17, Claim 1, upon which Claim 17 is dependent, has been rejected above. Lopez further discloses the vesicle is for use in a separation membrane (Abstract; pp. 493-494; I. Paragraph [0002]; aquaporins in the vesicles serve to permeate water).
Regarding instant Claim 18, Claim 1, upon which Claim 18 is dependent, has been rejected above. Lopez further discloses a method of preparing the vesicles in a liquid composition comprising extracting the plant plasma membrane components and the plant-derived transmembrane proteins from a plant using ultracentrifugation and/or two-phase partitioning (pg. 498, 4.9, see centrifugation at 100000g for 45 min).
Regarding instant Claim 22, Claim 18, upon which Claim 22 is dependent, has been rejected above. Lopez further discloses wherein the total protein concentration of the liquid composition is below 10 mg/ml (pg. 498, 4.9, see concentration of 1 mg/ml).
Regarding instant Claim 24, Claim 1, upon which Claim 24 is dependent, has been rejected above. Lopez further discloses a separation membrane comprising the vesicle (Abstract; pp. 493-494; I. Paragraph [0002]; aquaporins in the vesicles serve to permeate water).
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.
Claims 7-9, 25-28, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez-Perez et al. (herein referred to as “Lopez”; “Changes in plasma membrane lipids, aquaporins and proton pump of broccoli roots, as an adaptation mechanism to salinity”, PHYTOCHEMISTRY, ELSEVIER, AMSTERDAM, NL, vol. 70, no. 4, 1 March 2009 (2009-03-01), pages 492-500, XP026029325, ISSN: 0031-9422, DOI: 10.1016/J.PHYTOCHEM.2009.01.014; found and cited in IDS filed 02/09/2024) in view of Spulber et al. (herein referred to as “Spulber”, US Pat Pub. 2019/0076789; found in IDS filed 12/01/2023).
Regarding instant Claim 7, Claim 1, upon which Claim 3 is dependent, has been rejected above. However, Lopez is silent on the liquid composition comprising a reactive end group functionalized PDMS (polydimethylsilane).
Spulber discloses self-assembled nanostructures and separation membranes comprising aquaporin water channels and methods of making and using them in the same field of endeavor as the instant application, as it solves the mutual problem of providing vesicles comprising transmembrane proteins (Abstract; Paragraphs [0152]-[0154]). Spulber further discloses a liquid composition comprising a PDMS, as such a copolymer is often used to assemble vesicles (Abstract; Paragraphs [0152]-[0154]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liquid composition of Lopez to further comprise a reactive end group functionalized PDMS as taught by Spulber because Spulber discloses this compound is often used in the formation of self-assembling vesicles (Spulber, Abstract; Paragraphs [0152]-[0154]).
Regarding instant Claim 8, Claim 1, upon which Claim 8 is dependent, has been rejected above. The combined references further disclose wherein said reactive end group wherein said reactive group functionalized PDMS is functionalized with amine (Spulber, Paragraph [0153]; see poly(dimethylsiloxane),bis(3-aminopropyl)).
Regarding instant Claim 9, Claim 7, upon which Claim 9 is assumed to be dependent, has been rejected above. The combined references further disclose wherein the reactive end group functionalized PDMS is poly(dimethylsiloxane),bis(3-aminopropyl) (Spulber, Paragraph [0153]).
Regarding instant Claim 25, Claim 24, upon which Claim 25 is dependent, has been rejected above. However, Lopez is silent on the separation membrane comprising an active layer incorporating the vesicle and a porous support membrane.
Spulber discloses self-assembled nanostructures and separation membranes comprising aquaporin water channels and methods of making and using them in the same field of endeavor as the instant application, as it solves the mutual problem of providing vesicles comprising transmembrane proteins (Abstract; Paragraphs [0152]-[0154]). Spubler further discloses a semipermeable porous support in a liquid composition that aids in the formation of an active membrane layer via self-assembly of protein nanostructures (Paragraph [0006]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the separation membrane and vesicles of Lopez to further comprise the active layer and porous support membrane as taught by Spulber because Spulber discloses the porous support aids in the formation of an active membrane layer via self-assembly of the vesicles (Spulber, Paragraph [0006]).
Regarding instant Claim 26, Claim 25, upon which Claim 26 is dependent, has been rejected above. The combined references further disclose wherein the active layer comprises the vesicle incorporated in a thin film composite (TFC) layer formed on a porous substrate membrane (Spulber, Paragraph [0006]; see thin film composite and membrane).
Regarding instant Claim 27, Claim 26, upon which Claim 27 is dependent, has been rejected above. The combined references further disclose wherein the TFC layer is formed by interfacial polymerization between a di-amine or tri-amine monomer compound and an acyl halide monomer compound (Spulber, Paragraph [0042]; acyl halide reactant; 1, 3-diaminobenzene).
Regarding instant Claim 28, Claim 27, upon which Claim 28 is dependent, has been rejected above. the combined references further disclose wherein the vesicles are immobilized and/or chemically bound to the TFC layer by naturally occurring free reactive groups, such as amino groups, on the surface of the vesicles (Spulber, Paragraph [0042]; see amino reactive groups).
Regarding instant Claim 31, Claim 8, upon which Claim 31 can be dependent, has been rejected above. The combined references further disclose a method of preparing a thin film composite layer immobilizing vesicles incorporating a transmembrane protein on a porous substrate membrane (Spulber, Paragraph [0006]; Paragraph [0042]; see formation of nanostructures on membrane), comprising:
a. providing a mixture of vesicles in a liquid composition according to Claim 8 and a di-amine or tri-amine compound (see Claim 1/Claim 8 rejections above; Spulber, Paragraph [0006]; Paragraph [0042]; see di-amine/tri-amine compound),
b. covering the surface of a porous support membrane with the mixture of a (Spulber, Paragraph [0006]; see semipermeable support),
c. applying a hydrophobic solution comprising an acyl halide compound (Spulber, Paragraph [0046]; see acyl halide), and
d. allowing the aqueous solution and the hydrophobic solution to perform an interfacial polymerization reaction to form the thin film composite layer (Spulber, Paragraph [0006]; Paragraph [0042]; Lopez, Abstract; formation of polymerization occurs).
Regarding instant Claim 33, Claim 31, upon which Claim 33 is dependent, has been rejected above. The combined references further disclose wherein the proportion of the di-amine or tri-amine compound to acyl halide compound is from 0:1 to 30:1 by weight (Spulber, Paragraph [0106]; see weight percentages of 0.15% for TMC/acyl halide and 2.5% of MPD/amine compound with compared to water, between 10:1 and 20:1 ratio).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez-Perez et al. (herein referred to as “Lopez”; “Changes in plasma membrane lipids, aquaporins and proton pump of broccoli roots, as an adaptation mechanism to salinity”, PHYTOCHEMISTRY, ELSEVIER, AMSTERDAM, NL, vol. 70, no. 4, 1 March 2009 (2009-03-01), pages 492-500, XP026029325, ISSN: 0031-9422, DOI: 10.1016/J.PHYTOCHEM.2009.01.014; found and cited in IDS filed 02/09/2024) in view of Flemming et al. (herein referred to as “Flemming”, US 6117436).
Regarding instant Claim 19, Claim 18, upon which Claim 19 is dependent, has been rejected above. Lopez further discloses mixing the extracted plant-derived transmembrane proteins with a basic formulation obtained with a phosphate-buffered saline solution (pg. 498, 4.9; see potassium phosphate solution at pH of 7.8).
However, Lopez is silent on the basic formulation also including dissolved polyethylene glycol-hydroxystearate.
Flemming discloses a cosmetic care product with two components in the same field of endeavor, as it solves the mutual problem of extracting plant material using a solution (Abstract; Col. 10, Lines 18-40). Flemming further discloses polyethylene glycol hydroxystearate as a viable solubilizer for the extraction of plant matter (Col. 10, Lines 18-40).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the basic formulation of Lopez by further including dissolved polyethylene glycol-hydroxystearate as taught by Flemming because Flemming discloses such a compound is a viable solubilizer for the extraction of plant matter (Flemming, Col. 10, Lines 18-40).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Diallo et al. (US Pat Pub. 2013/0112618) and Tang et al. (US Pat Pub. 2014/0332468) were cited as pertinent prior art in co-owned application 16/076402 (now US 12059654) and are also considered pertinent for the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD C GURTOWSKI whose telephone number is (571)272-3189. The examiner can normally be reached 9:00 am-5:30pm MT.
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/RICHARD C GURTOWSKI/Primary Examiner, Art Unit 1773 01/24/2026