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
1. Applicant’s election of Group I and species (protein; fluorophore; carbohydrate; blood; polymer) in the reply filed on 8/4/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 21-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/4/2025.
Claims 1-20 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 2/3/2023; 4/30/2023; 7/20/2023; 3/29/2024; 7/3/2024; 10/2/2024; 2/17/2025; 8/4/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
3. Claims 1-20 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.
See claims 1-20 as submitted 9/30/2022.
Claim 1 recites “detection agent solubilizes”. It is not clear if the claim means the detection agent “is solubilized upon contacting” or if the detection agent is actively doing the solubilizing or not.
Claim Rejections - 35 USC § 103
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 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.
4. Claims 1-4, 7-9, 12-17, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Babiel et al. (WO2020160472A1)(cited in applicant’s IDS submitted 2/3/2023).
See claims 1-4, 7-9, 12-17, 19, 20 as submitted 9/30/2022.
See also the 35 U.S.C. 112(b) rejection above.
Babiel et al. teaches: biological assays, screening formats, detection devices, and methods of use (abstract); methods of diagnosing and individual with a disease or condition when a target analyte associated with the disease or condition is detected (abstract); including device including: (a) a substrate comprising a surface [0014](as recited in claim 1); (b); non-fouling layer on the surface [0015](as recited in claim 1); comprising brush polymer [0012](as recited in claim 1).
Babiel et al. also teaches: detection of antibodies to infectious disease agents [0001](interpreted to read upon pathogen); a plurality of capture regions, wherein each capture region comprises at least one capture agent [0015]; wherein capture agent comprises protein [0015](wherein disease antigen is from viruses [0022](as recited in claim 4)); wherein each of the plurality of capture regions comprises a different capture agent [0015](interpreted to also read upon plurality of pathogen regions, each including a different pathogen as recited in claims 1, 7).
Babiel et al. also teaches: optionally comprising at least one detection agent and an excipient [0164](interpreted to read upon detection region and spatial separation as it is a separate or optional component (as recited in claim 1); as well as claim 8 for reciting “at least one”); detection agents comprises antibody (interpreted to comprise protein as recited in claim 9); fluorophore [0167](as recited in claim 12); excipient carbohydrate, trehalose [0168])(as recited in claims 13, 14); wherein sample comprises blood [0009](as recited in claims 1, 19).
In view of such teachings, Babiel et al. is considered to teach, suggest or render obvious the method as recited in claim 1. Babiel et al. teaches or suggests detection of antibodies to infectious disease agents, such as viruses, as well as contacting sample with device comprising substrate, non-fouling layer, plurality of capture or pathogen regions, at least one detection region comprising agent and excipient spatially separated (as recited in claim 1).
Babiel et al. also teaches: heparin [0172](as recited in claim 15); core group coupled to protein resistant head group [0148](as recited in claim 16); POEGMA [0152](as recited in claim 17); polymer substrate [0015](as recited in claim 20).
As to claims 2, 3, Babiel et al. teaches incubation times including 30 minutes [0091] and increasing efficiency and reducing time [0204]). In view of such teachings or suggestions, the parameters as recited in claims 2, 3 are considered to be routine optimization to one of ordinary skill in the art in view of Babiel et al., absent unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
5. Claims 5, 6, 10, 11, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Babiel et al. as applied to claims 1-4, 7-9, 12-17, 19, 20 above, and further in view of Xu et al. (CN112946261A)(See also the WIPO translation of CN 112946261A)(See PTO-892: Notice of References Cited).
See claims 5, 6, 10, 11, 18 as submitted 9/30/2022.
See the teachings of Babiel et al. above.
Babiel et al. above. does not teach: spike protein; ACE2; SARS-CoV-2.
Xu et al. teaches: detection kit for coronavirus neutralizing antibody based on trimeric S protein RBD-ACE2 binding competition (description, n0001)(as recited in claim 18); for SARS-CoV-2 [n0002](as recited in claim 6); wherein spike protein can interact with human ACE2 [n0002](as recited in claims 5, 10, 11);
One of ordinary skill in the art would have been motivated to use proteins and binding partners as taught by Xu et al. with the assay and method as taught by Babiel et al. Babiel et al. teaches using viral antigens for detecting neutralizing antibodies, and Xu et al., which also teaches using viral antigens for detecting neutralizing antibodies, teaches such a binding relationship (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using proteins and binding partners as taught by Xu et al. with the assay and method as taught by Babiel et al. There would have been a reasonable expectation of success given the underlying materials and methods (binding assays as taught by Babiel et al. and Xu et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
6. Claims 1-4, 7-9, 12-17, 19, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. (cited above).
See claims 1-4, 7-9, 12-17, 19, 20 as submitted 9/30/2022.
Claims 1-14, 19 of U.S. Patent No. 9482664 recite a device comprising: a. a substrate comprising a surface; b. a non-fouling polymer layer on the surface, wherein the non-fouling polymer layer comprises a plurality of brush molecules; c. at least one capture region on the polymer layer, comprising at least one capture agent non-covalently bound to the polymer layer, wherein the at least one capture agent binds a target in a sample and the at least one capture agent remains bound to the polymer layer when exposed to the sample; and d. at least one labile region on the polymer layer, comprising at least one detection agent and an excipient, wherein the at least one detection agent solubilizes upon contact with the sample and labels the target in the sample; wherein the capture region and the labile region are spatially separated.
Claims 1-14, 19 of U.S. Patent No. 9482664 do not recite the method for detecting antibody as claimed.
See the teachings of Babiel et al. above.
One of ordinary skill in the art would have been motivated to use device as recited in claims 1-14, 19 of U.S. Patent No. 9482664 with the method as taught by Babiel et al. Babiel et al. teaches detecting antibodies using device comprising substrate, non-fouling layer, at least one capture region and at least one detection agent, and claims 1-14, 19 of U.S. Patent No. 9482664 teach such a device comprising substrate, non-fouling layer, at least one capture region and at least one detection agent (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using device as recited in claims 1-14, 19 of U.S. Patent No. 9482664 with the method as taught by Babiel et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
7. Claims 5, 6, 10, 11, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. as applied to claims 1-4, 7-9, 12-17, 19, 20 above, and further in view of Xu et al. (cited above).
See claims 5, 6, 10, 11, 18 as submitted 9/30/2022.
See the teachings of claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. above.
Claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. do not recite: spike protein; ACE2; SARS-CoV-2.
See the teachings of Xu et al. above.
One of ordinary skill in the art would have been motivated to use proteins and binding partners as taught by Xu et al. with the assay and method as taught by claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. Claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. teach using viral antigens for detecting neutralizing antibodies, and Xu et al., which also teaches using viral antigens for detecting neutralizing antibodies, teaches such a binding relationship (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using proteins and binding partners as taught by Xu et al. with the assay and method as taught by claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. There would have been a reasonable expectation of success given the underlying materials and methods (binding assays as taught by claims 1-14, 19 of U.S. Patent No. 9482664 in view of Babiel et al. and Xu et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
8. Claims 1-4, 7-9, 12-17, 19, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. (cited above).
See claims 1-4, 7-9, 12-17, 19, 20 as submitted 9/30/2022.
Claims 1-14, 20 of U.S. Patent No. 10302636 recite a device comprising: a. a substrate comprising a surface; b. a non-fouling polymer layer on the surface, wherein the non-fouling polymer layer comprises a film of functionalized poly(oligo(ethylene glycol)methyl methacrylate) brush molecules, the brush molecules comprising a monomeric core group and a protein-resistant head group; c. at least one capture region on the polymer layer, comprising at least one capture agent, wherein the at least one capture agent binds a target in a sample and the at least one capture agent remains bound to the polymer layer when exposed to the sample; and d. at least one labile region on the polymer layer, comprising at least one detection agent and an excipient, wherein the at least one detection agent solubilizes upon contact with the sample and binds to and labels the target in the sample; wherein the capture region and the labile region are spatially separated.
Claims 1-14, 20 of U.S. Patent No. 10302636 do not recite the method for detecting antibody as claimed.
See the teachings of Babiel et al. above.
One of ordinary skill in the art would have been motivated to use device as recited in claims 1-14, 20 of U.S. Patent No. 10302636 with the method as taught by Babiel et al. Babiel et al. teaches detecting antibodies using device comprising substrate, non-fouling layer, at least one capture region and at least one detection agent, and claims 1-14, 20 of U.S. Patent No. 10302636 teach such a comprising substrate, non-fouling layer, at least one capture region and at least one detection agent (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using device as recited in claims 1-14, 20 of U.S. Patent No. 10302636 with the method as taught by Babiel et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
9. Claims 5, 6, 10, 11, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. as applied to claims 1-4, 7-9, 12-17, 19, 20 above, and further in view of Xu et al. (cited above).
See claims 5, 6, 10, 11, 18 as submitted 9/30/2022.
See the teachings of claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. above.
Claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. do not recite: spike protein; ACE2; SARS-CoV-2.
See the teachings of Xu et al. above.
One of ordinary skill in the art would have been motivated to use proteins and binding partners as taught by Xu et al. with the assay and method as taught by claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. Claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. teach using viral antigens for detecting neutralizing antibodies, and Xu et al., which also teaches using viral antigens for detecting neutralizing antibodies, teaches such a binding relationship (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using proteins and binding partners as taught by Xu et al. with the assay and method as taught by claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. There would have been a reasonable expectation of success given the underlying materials and methods (binding assays as taught by claims 1-14, 20 of U.S. Patent No. 10302636 in view of Babiel et al. and Xu et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
10. Claims 1-4, 7-9, 12-17, 19, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. (cited above).
See claims 1-4, 7-9, 12-17, 19, 20 as submitted 9/30/2022.
Claims 1-14, 19, 20 of U.S. Patent No. 11249079 recited a device comprising: a. a substrate comprising a surface; b. a non-fouling polymer layer on the surface; c. a plurality of capture regions on the non-fouling polymer layer, each comprising at least one capture agent; and d. a plurality of labile regions on the non-fouling polymer layer, each comprising at least one detection agent and an excipient; wherein the plurality of capture regions and the plurality of labile regions are spatially separated, and wherein the non-fouling polymer layer allows a biological fluid to move across the surface by diffusion.
Claims 1-14, 19, 20 of U.S. Patent No. 11249079 do not recite the method for detecting antibody as claimed.
See the teachings of Babiel et al. above.
One of ordinary skill in the art would have been motivated to use device as recited in claims 1-14, 19, 20 of U.S. Patent No. 11249079 with the method as taught by Babiel et al. Babiel et al. teaches detecting antibodies using device comprising substrate, non-fouling layer, at least one capture region and at least one detection agent, and claims 1-14, 19, 20 of U.S. Patent No. 11249079 teach such a comprising substrate, non-fouling layer, at least one capture region and at least one detection agent (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using device as recited in claims 1-14, 19, 20 of U.S. Patent No. 11249079 with the method as taught by Babiel et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
11. Claims 5, 6, 10, 11, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. as applied to claims 1-4, 7-9, 12-17, 19, 20 above, and further in view of Xu et al. (cited above).
See claims 5, 6, 10, 11, 18 as submitted 9/30/2022.
See the teachings of claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. above.
Claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. do not recite: spike protein; ACE2; SARS-CoV-2.
See the teachings of Xu et al. above.
One of ordinary skill in the art would have been motivated to use proteins and binding partners as taught by Xu et al. with the assay and method as taught by claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. Claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. teach using viral antigens for detecting neutralizing antibodies, and Xu et al., which also teaches using viral antigens for detecting neutralizing antibodies, teaches such a binding relationship (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using proteins and binding partners as taught by Xu et al. with the assay and method as taught by claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. There would have been a reasonable expectation of success given the underlying materials and methods (binding assays as taught by claims 1-14, 19, 20 of U.S. Patent No. 11249079 in view of Babiel et al. and Xu et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1671