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 .
DETAILED ACTION
Claim 64 is newly added. Claims 1-64 are pending. Claims 27-63 are withdrawn. Claims 1-26 and 64 are examined.
Response to Amendment
The objection to the specification is withdrawn in view of the amendment.
The objection of claim 23 is withdrawn in view of the amendment.
Maintained Rejection
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.
(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.
Claims 1-6, 12, 16-19, and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauer (WO-2009/130659 A2, hereinafter “Bauer”).
Regarding claim 1, Bauer teaches plasma membrane vesicles (Abstract), teaches the vesicles are affixed to a surface (page 6 line 7), and teaches the vesicles are made from eukaryotic membrane such as chloroplast membrane (i.e. plant) (page 13 line 9). Bauer teaches the vesicles are not associated with cell (Figure 2) and are originated solely from plasma membrane (page 44 line 27, page 10 lines 11-14).
Regarding claim 2, Bauer teaches the plasma membrane possess a lipid bilayer (page 14 line 13, page 10 line 15).
Regarding claims 3 and 4, Bauer teaches the plasma membrane vesicle is affixed to the surface (i.e. adsorbed) (page 6 lines 6-8). Bauer also teaches the plasma membrane vesicle adhere to the solid surface of the flow cell (i.e., support) (page 38 lines 24-25).
Regarding claim 5, Bauer teaches the vesicles are made from eukaryotic membrane such as cytoplasmic membrane (i.e. cell plasma membrane) (page 13 lines 5-10)
Regarding claim 6, Bauer teaches the vesicles are made from eukaryotic membrane such as chloroplast membrane (page 13 line 9).
Regarding claim 12, the instant claim recites “wherein the plant plasma membrane is derived from a plant or plant part that has been modified” in the body of the claim. This is a product (“the composition of claim 11”) by process (“wherein the plant plasma membrane is derived from a plant or plant part that has been modified”) claim. Thus, any composition which reads on claim 11 would similarly read on the instant claim.
Regarding claim 16, Bauer teaches the membrane can be modified with fluorescent labelling (page 44 line 31).
Regarding claim 17, the instant claim recites “wherein the plant plasma membrane is produced by a method comprising blebbing” in the body of the claim. This is a product (“the composition of claim 1”) by process (“wherein the plant plasma membrane is produced by a method comprising blebbing”) claim. Thus, any composition which reads on claim 1 would similarly read on the instant claim.
Regarding claim 18, the instant claim recites “wherein the plant plasma membrane is produced by a method comprising bubbles” in the body of the claim. This is a product (“the composition of claim 1”) by process (“wherein the plant plasma membrane is produced by a method comprising bubbles”) claim. Thus, any composition which reads on claim 1 would similarly read on the instant claim.
Regarding claim 19, Bauer teaches the surface is a microfluidic device (claim 38)
Regarding claim 25, Bauer teaches the surface is flat (Figure 4A)
Regarding claim 26, Bauer teaches a microfluidic device which has a geometric shape such as rectangular shape.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauer, and as evidenced by Richards (Richards, Mark J., et al. "Membrane protein mobility and orientation preserved in supported bilayers created directly from cell plasma membrane blebs." Langmuir 32.12 (2016): 2963-2974, of record in IDS filed on 04/05/2024, hereinafter “Richards”).
Regarding claim 10, Bauer teaches the plasma membrane vesicles are known as blebs (page 10 line 11). Bauer teaches these blebs are used to study the lipid and proteins of the plasma membrane, their structure, dynamical and spatiotemporal behavior, and activity (page 22 lines 15-16, page 31 lines 5, page 44 line 2, page 45 lines 17-21). Evidentiary reference Richards reports the membrane protein mobility and orientation preserved in supported bilayers created directly from cell plasma membrane blebs (title, whole document). The limitation of “the plant plasma membrane has a protein and lipid orientation, mobility, and activity that is native to the plant plasma membrane” is considered a characteristic of the composition.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer as applied to claim 6 above, and further in view of Lee (WO-2015111972. Since WO-2015111972 document is published in Korean, reference is herein made to text in the corresponding English language machine translated application WO-2015111972-MT; see attached copy, hereinafter “Lee”).
Regarding claim 7, Bauer teaches the plasma membrane vesicles can be from eukaryotic cell membranes and gives several examples including chloroplast (page 13 line 9). Bauer does not teach plasma membrane from thylakoid membrane. However, Lee teaches plasma membrane vesicles from thylakoid membrane (claim 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasma membrane taught by Bauer by adding the membrane from thylakoid as suggested by Lee. One of ordinary skill in the art would be motivated to do so in order to study the lipid and proteome of the thylakoid membrane as suggested by Bauer.
Claims 8-9, 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer as applied to claim 1 above.
Regarding claim 8, Bauer teaches plasma membrane vesicles are from eukaryotic membrane such as a membrane from a plant (page 13 lines 1-5), and teaches these vesicles are used for membrane proteome and lipidome analysis of a cell (page 5 lines 8-9, page 6 lines 12-13). Bauer does not teach the plant plasma membrane is derived from a leaf, stem, or root of a plant. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasma membrane composition taught by Bauer by adding plasma membrane derived from different parts of the plant as suggested by Bauer. One of ordinary skill in the art would be motivated to do so in order to analyze the proteome of the membranes derived from different parts of the plant.
Regarding claim 9, Bauer teaches plasma membrane vesicles are from eukaryotic membrane such as a membrane from a plant (page 13 lines 1-5), and teaches these vesicles are used for membrane proteome and lipidome analysis of a cell (page 5 lines 8-9, page 6 lines 12-13). Bauer does not teach the plant plasma membrane is derived from maize plant, an Arabidopsis plant, or a tobacco plant. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasma membrane composition taught by Bauer by adding plasma membrane derived from different plants such as maize or tobacco as suggested by Bauer. One of ordinary skill in the art would be motivated to do so in order to analyze and compare the proteome of the membranes derived from plants.
Regarding claims 11, 13, and 15, Bauer teaches identifying a modulator of a transmembrane protein by transforming a cell with a nucleic acid molecule encoding a protein of interest and producing plasma membrane vesicles (i.e., plant plasma membrane is modified) (page 5 lines 17-22). Bauer teaches the cells are transformed or transfected to yield a protein of interest, and the protein of interest is one or several membrane proteins, e.g., transmembrane proteins, or lipid-anchored proteins (page 12 line 11-13) and teaches the nucleic acid encodes exogenous proteins (page 12 line 23). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasma membrane taught by Bauer by adding a plasma membrane formed from a cell transformed with a nucleic acid molecule encoding a protein of interest such as a transmembrane protein as suggested by Bauer. One of ordinary skill in the art would be motivated to do so in order to study and analyze an exogenous protein in the membrane.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer as applied to claim 13 above, and further in view of Richards.
Regarding claim 14, Bauer does not teach adding a lipid to the plasma membrane. However, Richards teaches adding PEGylated lipid to the plasma membrane (Figure 1) and teaches the PEGylated lipid generates a cushioned bleb bilayer which increases the distance between the bilayer and glass surface (page 2964 left column last paragraph). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasma membrane taught by Bauer by adding the lipid to the membrane as taught by Richards. One of ordinary skill in the art would be motivated to do so in order generate a cushioned bleb bilayer which increases the distance between the bilayer and surface as taught by Richards.
Claims 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer as applied to claim 1 above, and further in view of Qiu (Qiu, Yuan, et al. "Cell uptake, intracellular distribution, fate and reactive oxygen species generation of polymer brush engineered CeO 2− x NPs." Nanoscale 7.15 (2015): 6588-6598, hereinafter “Qiu”), as evidenced by Liu (Liu, Han-Yuan, et al. "Biologically complex planar cell plasma membranes supported on polyelectrolyte cushions enhance transmembrane protein mobility and retain native orientation." Langmuir 34.3 (2018): 1061-1072, hereinafter “Liu).
Regarding claims 20-24, Bauer does not teach the surface is hydrophilic, chemically modified, or comprises a coating with a polymer such as PMETAC. However, Qiu teaches a support, cerium oxide nanoparticles, chemically modified by coating them with a polymer poly (2-(methacryloyloxy)ethyl-trimethylammonium chloride) (i.e., PMETA) (Abstract). Evidentiary reference Liu reports PMETA is hydrophilic (page 1063 left column last para.). Qiu teaches particles coated with PMETA show higher co-localization with lipid bodies (Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasma membrane taught by Bauer by adding a surface comprising PMETA as suggested by Qiu. One of ordinary skill in the art would be motivated to do so since Bauer teaches the plasma membrane comprises lipids and Qiu teaches the surface comprising PMETA co-localizes with lipids.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-6, 8-15, 17-19, and 25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-10, and 14 of copending Application No. 17/526,327 (reference application, PGPUB No. US20220153778). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 1 and 2, reference claim 1 teaches a supported lipid bilayer comprising solid surface.
Regarding instant claims 5-6, 8-9, 12, 17-18, the recited limitations are product-by-process. Thus, any composition which reads on claim 1 would similarly read on the instant claim. “Determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113)".
Regarding instant claim 10, reference claim 1 recites the membrane protein is functional, properly oriented within the lipid bilayer, and mobile within the lipid bilayer. Reference claim 9 recites wherein the membrane protein is properly oriented within the lipid bilayer when it is oriented in a native physiological orientation. Reference claim 10 wherein the HSLB comprises a plurality of copies of the membrane protein and wherein at least 90% of the plurality of copies of the membrane protein have a native physiological orientation.
Regarding instant claims 11, 13-15, reference claim 2 recites wherein the phospholipids comprise one or more phospholipids selected from the group consisting of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC) and poly(ethylene oxide)-b-polybutadiene (PEO14-b-PBD22). Reference claim 8 recites wherein the membrane protein comprises mechanosensitive channel of large conductance (MscL).
Regarding instant claims 19 and 25, reference claim 14 recites wherein the solid surface is a glass slide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3-4 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 17/526,327 in view of Bauer.
Regarding instant claims 3-4, reference claim 1 does not recite “wherein the plant plasma membrane is adsorbed to the surface of the object” or “wherein the plant plasma membrane adheres to the surface of the object”. However, Bauer teaches a plasma membrane and teaches it is affixed to the surface (i.e. adsorbed) (page 6 lines 6-8). Bauer also teaches the plasma membrane vesicle adhere to the solid surface of the flow cell (i.e., support) (page 38 lines 24-25). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lipid bilayer recited in reference claim 1 by affixing or adhering the composition to the support as suggested by Bauer. One of ordinary skill in the art would be motivated to do so in order to immobilize the structure for easier manipulation or visualization.
Regarding instant claim 16, reference claims 1 and 8 do not recite the exogenous protein comprises a fluorescent marker. However, Bauer teaches the membrane can be modified with fluorescent labelling (page 44 line 31). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lipid bilayer recited in reference claim 1 by adding a fluorescent marker as suggested by Bauer. One of ordinary skill in the art would be motivated to do so in order to localize or track the protein.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/526,327 in view of Lee.
Regarding instant claim 7, reference claim 1 does not recite the membrane is a thylakoid membrane. Lee teaches plasma membrane vesicles from thylakoid membrane (claim 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lipid bilayer taught by recited in reference claim 1 by adding the membrane from thylakoid as suggested by Lee. One of ordinary skill in the art would be motivated to do so in order to study the lipid and proteome of the thylakoid membrane.
Claims 20-24 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/526,327 in view of Qiu and as evidenced by Liu.
Regarding instant claims 20-24, reference claim 1 does not recite the surface is hydrophilic, chemically modified, or comprises a coating with a polymer such as PMETAC. However, Qiu teaches a support, cerium oxide nanoparticles, chemically modified by coating them with a polymer poly (2-(methacryloyloxy)ethyl-trimethylammonium chloride) (i.e., PMETA) (Abstract). Evidentiary reference Liu reports PMETA is hydrophilic (page 1063 left column last para.). Qiu teaches particles coated with PMETA show higher co-localization with lipid bodies (Abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lipid bilayer recited in reference claim 1 by adding a surface comprising PMETA as suggested by Qiu. One of ordinary skill in the art would be motivated to do so since Qiu teaches the surface comprising PMETA co-localizes with lipids.
Regarding claim 26, Qiu teaches the surface is spherical (scheme 1).
This is a provisional nonstatutory double patenting rejection.
New Rejection Necessitated by the Amendment
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.
Claim 64 is 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 64 recites the limitation “continuously” which renders the metes and bound of the claim unclear. It is not clear if the limitation is reciting time limitation or structure limitation. “Lipid bilayer is continuously adhered” can be understood as adhered for a period of time, or the continuity of the assembly of the bilayer is adhered.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer in view of Richards.
The teachings of Bauer are discussed above and applied herein.
Regarding claim 64, Bauer does not teach the plant lipid bilayer is continuously adhered to the surface of the object. However, Richards teaches a cell plasma membrane bilayer continuously adhered on an object (figure 1 D). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Bauer by continuously adhering it to the surface as suggested by Richards. One of ordinary skill in the art would be motivated to do so in order to enable modular on-chip assays for membrane proteins as suggested by Richards (page 2972 left column first para.)
Response to Arguments
Applicant argues the affixed vesicles taught by Bauer are destroyed by proteases and the resultant peptides analyzed (e.g., LC-MS/MS), and argues the rejection involves picking and choosing select portions of the passage to arrive at the claimed invention. Applicant argues Bauer does not anticipate the limitation of claim 10 because it requires picking and choosing from among Bauer's list of "powerful tools" such as proteomic analyses, membrane purification, and comparing varying protein expression profiles of a specific cell line.
In response to the argument, Bauer teaches adhering the membrane to the surface followed by injection of trypsin to digest the proteins (page 38 lines 24-25) (i.e., the plant plasma membrane is supported on a surface). In addition, the claim does not exclude the presence of other components such as proteases. MPEP 2131.02 states a reference that clearly names the claimed species anticipates the claim no matter how many other species are names, and states a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be at one envisaged from the disclosure. Applicant argues Bauer teaches proteomic analysis, membrane purification and comparing protein expression profiles, and these are distinct teachings. One skilled in the art would immediately envision using the 3 individual or combinations of tools taught by Bauer. Claim 1 requires the membrane is supported. Only claim 4 requires the membrane to be “adhered”. Proteases break down proteins to analyze peptides, but the lipid would remain intact. Looking at page 32 of Bauer, the reference says” A subset of proteins in a protein sample are retained on the surface, reducing the complexity of the mixture. Subsequent time -of- flight mass spectrometry generates a "fingerprint" of the retained proteins.” This seems to suggests even during the analysis, a portion of the vesicles would still be retained on the surface. Since the instant claims do not require a particular amount of the membrane to be affixed or supported on the surface, any amount is going to read on the claims. In addition, the limitation of claim 10 recite structural characteristics of the membrane such as protein and lipid orientation, mobility, and activity that is native to the plant plasma membrane. Bauer teaches supported plant plasma membrane. Evidentiary reference Richard shows these characteristics of protein and lipid orientation, mobility, and activity that is native to the plant plasma membrane are preserved in supported bilayers created directly from cell plasma membrane. It is thus understood, these characteristics will be present in the membranes taught by Bauer.
Applicant requests that the double patenting rejection over co-pending application 17/526,327 be held in abeyance (Remarks p. 3). A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filled by applicant at this time.
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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/ Examiner, Art Unit 1657
/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636