Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 35-54 are pending. Claims 1-34 have been cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 35-54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 is vague. In line 12, the recitation of “the two-dimensional array” lacks antecedent support.
Claims 37-41, 44, and 45 are vague. The recitation of “the beads” in each claim lacks antecedent support. It is suggested that these claims be amended to recite “the magnetically susceptible beads” for proper antecedent support.
Claims 48-52 are vague. The recitation of “the magnet” in each claim lacks antecedent support. It is suggested that these claims be amended to recite “the permanent high-field magnet” for proper antecedent support.
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 35-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,402,375. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘375 claims a point-of-care magnetic immunosensing device that anticipates the instant invention.
Patent ‘375 claims:
1. A point-of-care magnetic immunosensing device, comprising:
a cartridge housing comprising a base;
a sample chamber comprising a sample inlet for receiving a sample;
a conduit in fluidic communication with the sample chamber;
a sensor chip located within the conduit and formed on the base of the cartridge housing, wherein the sensor chip comprises a single sensing electrode comprising: a) a silicon wafer, b) a single trench formed in the silicon wafer, wherein the single trench has a length of from 10 to 500 μm, c) an insulating oxide layer formed on the silicon wafer, d) metal layers formed on the insulating oxide layer, e) a photodefinable polyimide formed on the metal layers, and f) electrode openings formed into the photodefinable polyimide exposing portions of the metal layers and forming a two-dimensional array of microfabricated electrodes formed at a bottom of a single trench;
a dissolvable dry matrix comprising magnetically susceptible beads, wherein the matrix is configured to dissolve in the sample fluid and wherein the dissolvable dry matrix is located in the sample chamber or the conduit; and
a permanent high-field magnet for retaining at least a portion of said beads in said trench, wherein the permanent high-field magnet is formed in the base abutting a bottom of the sensor chip; and
a pump for moving the sample from the sample chamber through the conduit to the sensing electrode, wherein the two-dimensional array of microfabricated electrodes comprises a line of microelectrodes in the single trench.
2. The device of claim 1, wherein the beads have an average particle size of from about 0.01 μm to about 20 μm.
3. The device of claim 1, wherein the beads comprise ferrite.
4. The device of claim 1, wherein the beads comprise magnetite (Fe.sub.3O.sub.4).
5. The device of claim 1, wherein the beads comprise a magnetically susceptible core with a polymer coating.
6. The device of claim 1, wherein the beads are coupled to an antibody in the dissolvable dry matrix.
7. The device of claim 6, wherein the antibody is to an analyte selected from the group consisting of cardiac troponin I, troponin T, a troponin complex, human chorionic gonadotropin, BNP, creatine kinase, creatine kinase subunit M, creatine kinase subunit B, creatine kinase MB (CK-MB), proBNP, NT-proBNP, myoglobin, and myosin light chain thereof.
8. The device of claim 6, wherein the antibody is to an analyte selected from the group consisting of beta-HCG, TSH, ultra hTSH II, TT3, TT4, FT3, FT4, myeloperoxidase, D-dimer, CRP, NGAL, PSA, LH, FSH, prolactin, progesterone, estradiol, DHEA-S, AFP, CA 125 II, CA 125, CA 15-3, CA 19-9, CA 19-9XR, CEA, thyroxine (T4), triiodothyronine (T3), T-uptake, Tg, anti-Tg, anti-TPO, ferritin, cortisol, insulin, HBsAg, HCV Ag/Ab combo, HCV core Ag, anti-HCV, AUSAB (anti-HBs), CORE, CORE-M, SHBG, iPTH, theophylline, sirolimus, tacrolimus, anti-HAV, anti-HAV IgM, HAVAB, HAVAB-M, HAVAB-M2.0, HAVAB-G, HAVAB 2.0, HAVAB 2.0 Quant, IgM, CMV IgM, CMV IgG, â-2-microglobulin, digitoxin, HBe, anti-HBe, HBeAg, HIV 1/2gO, HIV Ag/Ab combo, testosterone, SCC, vitamin B12, folate, syphilis, anti-HBc, rubella IgG, rubella IgM, homocysteine, MPO, cytomegalovirus (CMV) IgG Avidity, toxo IgG avidity, toxo IgG, toxo IgM, C-peptide, vitamin D, HTLV I/II, total âhCG, progesterone, estradrogen, prolactin, myoglobin, tPSA, fPSA, carbamazepine (CBZ), digoxin, gentamicin, NAPA, phenytoin, phenobarbital, valproic acid, vancomycin, procaine, quinidine, tobramycin, methamphetamine (METH), amphetamine (AMPH), barbiturates, benzodiazepine, cannabis, cocaine, methadone, opiates, PCP, acetaminophen, ethanol, salicylates, tricyclics, holoTc, anti-CCP, HbA1c, and barbs-U.
9. The device of claim 1, wherein the beads are mobile within the trough of the single trench.
10. The device of claim 1, wherein the ratio of beads within the trough of the single trench to electrodes of the electrode array is about 1.
11. The device of claim 1, wherein the sample is amended with an anticoagulant.
12. The device of claim 1, wherein the width to height ratio of the single trench is in the range of about 0.1 to about 5.
13. The device of claim 1, wherein the magnet is positioned in a non-coplanar position relative to said electrode array.
14. The device of claim 1, wherein the magnet is positioned below said electrode array.
15. The device of claim 1, wherein the magnet comprises a neodymium iron boron (NdFeB) alloy.
16. The device of claim 1, wherein the magnet comprises a Nd2Fe14B alloy.
17. The device of claim 1, wherein the magnet provides a magnetic field of greater than about 0.1 Tesla.
18. The device of claim 1, wherein the magnet is a bulk magnet.
19. The device of claim 1, wherein the magnet is a substantially cylindrical bulk magnet.
20. The device of claim 1, wherein the magnet is a substantially cylindrical bulk magnet, having a diameter in the range of about 0.1 mm to about 5 mm and a length of about 0.1 mm to about 5 mm.
21. The device of claim 1, wherein the magnet is positioned to yield an event horizon in the range of less than about 200 μm in the region of the electrode array.
22. The device of claim 1, wherein the electrode array is amperometric.
23. The device of claim 1, wherein the electrode array is a gold microarray.
24. The device of claim 1, wherein the average width, height and length of the single trench are each at least twice the mean average particle size of the beads.
25. The device of claim 1, wherein the conduit is coated with the dissolvable dry matrix.
26. The device of claim 1, wherein the device comprises the sample chamber coated within the dissolvable dry matrix, wherein the sample chamber is connected to the conduit between the sample inlet and the two-dimensional array.
27. The device of claim 1, wherein: the width of the single trench is from 0.1 μm to 50 μm, the height of the single trench is from 0.1 μm to 50 μm.
Allowable Subject Matter
Claims 35-54 are free of the prior art of record because the prior art does not teach magnetic immunosensing device with a sensor chip in a conduit with a high-field magnet and pump as recited in the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
2/7/2026