DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-9 in the reply filed on 7/15/26 is acknowledged.
The restriction is made FINAL.
Double Patenting
Applicant’s arguments, filed 7/15/26, with respect to Non-Statutory Double Patenting have been fully considered and are not persuasive.
Response to Arguments
Applicant's arguments filed 7/15/26 have been fully considered but they are not persuasive.
The applicant argues that Movileanu reference does not disclose “anti-body mimetic binder”, thus cannot anticipate it.
Examiner respectfully disagrees with the applicants’ arguments. Movileanu recites there are no fundamental limitation in replacing the protein recognition sensing element with another (Specification, para 0085). Further, Movileanu writes that the nanostructure can be a precursor for kinetic analysis of new non-antibody recognition proteins (Specification, para 0085). The claimed invention recites in the specifications that the anti-body mimetic binder includes a tenth fibronectin type-III domain (Specification, para 0007). Tenth fibronectin type-III domain is a non-antibody recognition protein known to have binding capabilities. Although, the term ‘antibody mimetic binder’ was not explicitly written in the Movileanu reference, the examiner interpreted the antibody mimetic binder as a protein with the capability to act as a receptor. Thus, the Movileanu reference does anticipate the “anti-body mimetic binder” disclosed in the claimed invention.
The applicant argues that the Movileanu reference is not generalizable in that different protein receptors cannot be swapped in and out with any expectation that pore will function properly.
The examiner respectfully disagrees with the applicants’ arguments. In response to applicant's argument that the Movileanu reference is not generalizable in that different protein receptors cannot be swapped in and out with any expectation that pore will function properly, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Movileanu recites there are no fundamental limitation in replacing the protein recognition sensing element with another (Specification, para 0085). The argument is not found persuasive.
Applicant argues that Gil does not encourage replacing binding enzymes with anti-body mimetics, nor that they are preferable.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Gill reference teaches antibody mimics may be used in any techniques for evolving new or improved binding proteins (para 0104). Furthermore, the Gill reference teaches FN3 scaffold as an example to be used for selection target (para 0104). Thus, the argument is not found persuasive.
The applicant argues that Gill reference is not analogous art and thus cannot be used int proposed obviousness combination.
In response to applicant's argument that the Gill reference is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the Gill reference teaches antibody mimics may be used in any techniques for evolving new or improved binding proteins (para 0104).
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
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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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