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
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-9, drawn to a sensor, classified in B01L 2300/0627.
II. Claim 10-18, drawn to method of detecting highly specific protein, classified in G01N 33/6803.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, sensor can be used by a materially different method. The sensor can be used in a method to separate analytes from a sample.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification;
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with David Nocilly on 03/09/2026 a provisional election was made without traverse to prosecute the invention of the apparatus, Group I: Claims 1-9. Affirmation of this election must be made by applicant in replying to this Office action. Claim 10-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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, 3, 4, 5, 6, 7, and 9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, and 4 of U.S. Patent No. 10921309 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the patented claims encompass a similar sensor which require similar components and accomplish identical results.
Claim 1 recites all the same components of Claim 1 of the patented invention. Claim 1 recites a “lipid membrane”, however, it would be obvious to one of ordinary skill in the art that the “membrane” in the patented invention includes a lipid membrane because it can be used to capture specific biological components. Claim 1 recites a “protein pore”, however, it would be obvious to one of ordinary skill in the art that the “transducer” in the patented invention can be modified to be a protein pore to allow the selected biological molecules across the membrane. Claim 1 recites a “binding scaffold”, however, it would be obvious to one of ordinary skill in the art that “protein receptor” in the patented invention can be modified to be a binding scaffold to be able to bind to multiple sites simultaneously. Claim 1 recites “tether”, however, it would be obvious to one of ordinary skill in the art that “flexible linker” in the patented invention to be modified with a tether as both perform the same function of linking proteins. Claim 1 recites an “antibody-mimetic binder”, however, it would be obvious to one of ordinary skill in the art that “charged polypeptide adaptor” in the patented invention can be modified to be an antibody-mimetic binder to selectively bind to target analytes.
Claim 2 dependent on Claim 1 recites a “protein pore”, however, it would be obvious to one of ordinary skill in the art that the “transducer” in the patented invention can be modified to be a protein pore such as a monomeric β-barrel scaffold to allow the selected biological molecules across the membrane.
Claim 3 dependent on Claim 2 recites a “protein pore”, however, it would be obvious to one of ordinary skill in the art that the “transducer” in the patented invention can be modified to be a protein pore such as a monomeric β-barrel scaffold of a tFhuA protein to allow the selected biological molecules across the membrane.
Claim 4 dependent on Claim 1 recites a “FN3 monobody”, however, it would be obvious to one of ordinary skill in the art that “protein receptor” in the patented invention can be modified to be a binding scaffold such as FN3 monobody to be able to bind to multiple sites simultaneously.
Claim 5 dependent on Claim 1 recites “(GGS)2 tether”, however, it would be obvious to one of ordinary skill in the art that “flexible linker” in the patented invention to be modified with a (GGS)2 tether as both perform the same function of linking proteins.
Claim 6 dependent on Claim 5 recites a tether coupled to the N terminus of the protein pore, however, it would be obvious to one of ordinary skill in the art that claim 3 in the patented invention because a tether coupled to the N terminus of the protein pore allows for a uniform single-channel current with a unitary conductance.
Claim 7 dependent on Claim 1 recites a “affibody”, however, it would be obvious to one of ordinary skill in the art that “protein receptor” in the patented invention can be modified to be a binding scaffold such as an affibody to be able to bind to multiple sites simultaneously.
Claim 9 dependent on Claim 1 recites a sequence which is a combination of the protein pore, tether, and antibody-mimetic binder, however, claim 4 in the patented invention includes a sequence for the "transducer" that has a 82% query match with the sequence in claim 9. Thus, it would have been obvious to one of ordinary skill in the art to slightly alter the sequence taught by the patented invention to include the tether and antibody-mimetic to perform the function of detecting a highly specific protein.
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.
Claims 1, 2, 3, 5, and 6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Movileanu et al. (U.S. Pub No. 20190128867 A1).
Regarding Claim 1, Movileanu teaches a sensor (para 0005) with a lipid membrane (para 0005); a protein pore embedded in the membrane (para 0005); and a binding scaffold coupled to the protein pore by a tether (para 0005) and including an antibody-mimetic binder having a binding affinity for a target analyte (para 0005-0006); wherein the lipid membrane has a first membrane potential when the target analyte is not bound to the antibody-mimetic binder and a second, different membrane potential when the target analyte is bound to the antibody-mimetic binder (para 0005-0006).
Regarding Claim 2, Movileanu teaches a protein pore comprises a monomeric p-barrel scaffold (para 0005).
Regarding Claim 3, Movileanu teaches a monomeric p-barrel scaffold is a monomeric p-barrel scaffold of a t-FhuA protein (para 0005).
Regarding Claim 5, Movileanu teaches a tether comprises a (GGS)2 tether (para 0033).
Regarding Claim 6, Movileanu teaches the (GGS)2 tether is coupled to an N-terminus of the monomeric p-barrel scaffold of the t-FhuA protein (para 0033).
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:
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.
Claims 4, 7, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Movileanu et al. (U.S. Pub No. 20190128867 A1) in view of Gill (U.S. Pub No. 20110009323 A1).
Regarding Claim 4, Movileanu teaches a protein sensor with a binding scaffold. Movileanu does not teaches the binding scaffold is an FN3 monobody.
However, Gill teaches the binding scaffold being an FN3 monobody (para 0035) for the benefit that FN3 scaffolds exhibit better and thermostability compared to antibody fragments (para 0035). Gill teaches various binding scaffold composition that can be used in the same field on endeavor of developing therapeutic agents for disease. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Movileanu with a binding scaffold being a FN3 monobody as taught by Gill for the benefit that FN3 scaffolds exhibit better and thermostability compared to antibody fragments.
Regarding Claim 7, Movileanu teaches a protein sensor with a binding scaffold. Movileanu does not teach a binding scaffold being an affibody.
However, Gill teaches a binding scaffold being an affibody (para 0022) for the benefit of substituting another amino acid without substantial loss of basic structure and stability from original protein (para 0074). Gill teaches various binding scaffold composition that can be used in the same field on endeavor of developing therapeutic agents for disease. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Movileanu with binding scaffold being an affibody as taught by Gill for the benefit of substituting another amino acid without substantial loss of basic structure and stability.
Regarding Claim 8, Movileanu teaches a protein sensor with a binding scaffold. Movileanu does not teach the binding scaffold is a peptide having less than 150 residues.
However, Gill teaches the binding scaffold is a peptide having less than 150 residues for the benefit of using the binding scaffold for target selection (para 0105). Gill teaches various binding scaffold composition that can be used in the same field on endeavor of developing therapeutic agents for disease. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Movileanu with the binding scaffold being a peptide having less than 150 residues as taught by Gill for the benefit of using the binding scaffold for target selection.
With respect to Claim 9, Movileanu modified with Gill teaches the claim invention above. Movileanu teaches a protein pore sequence (SEQ ID No. 1) with an 82% query match to SEQ ID NO:1 which includes the protein pore, tether, and anti-body-mimetic binder. Although, the sequence id of Movileanu only have about 82% similarity, it still performs the same function as the instant invention of detecting a highly specific protein. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to slightly alter the sequence id taught by Movileanu to perform the function of detecting a highly specific protein. See MPEP 2141(I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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