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 Group I – claims 1-7 and 9-16 in the reply filed on 9/23/25 is acknowledged.
Claims 8 and 17-20 are withdrawn from consideration;
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
JP 2020-053635 has been received.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 2, 10, 11, and 13 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 2 is vague because it is not clear as to what the “magnetic separability is 40% or more” is relative to. 40% or more of the particles are separable relative to what?
In response to this rejection, Applicants argue that magnetic separability is clearly defined in the specification, including how it is measured and calculated, and thus readily understood by one of ordinary skill in the art.
Applicant’s arguments have been considered but are not convincing. While the claims are read in light of the specification, the claims must also clearly set forth the limitations of the claimed invention. The recitation of “40% or more” lacks any units or reference point so it is not clear what this percentage represents. Applicants have noted that the “40% or more” expresses reduction in absorbance under a defined magnetic separation condition. Examiner suggests by doing something the lines of adding “reduction in absorbance under a defined magnetic separation condition” after “more” to clarify claim 2.
Claim Rejections - 35 USC § 102
6. The rejection of claim(s) 1, 2, 4, 9, and 11 as being anticipated by Mizoguchi et al (JP2019082356A; herein referred to as Mizoguchi) is withdrawn in view of Applicant’s arguments.
Claim Rejections - 35 USC § 103
7. The rejection of claims 6, 7, 13, and 15 as being unpatentable over Mizoguchi et al (JP2019082356A; herein referred to as Mizoguchi) is withdrawn in view of Applicant’s arguments.
8. The rejection of claims 3, 5, 10, and 12-16 as being unpatentable over Mizoguchi et al (JP2019082356A; herein referred to as Mizoguchi) in view of Suetsuna et al. (CN 101299365 B; hereinafter Suetsuna) is withdrawn in view of Applicant’s arguments.
9. The rejection of claims 1, 2, 4, 6, 9, 11, 13, and 15 as being unpatentable over Lundberg et al. (WO 2018/134374 A2; herein referred to as Lundberg) is withdrawn in view of Applicant’s arguments.
10. The rejection of claims 3, 5, 10, 12, 14, and 16 as being unpatentable over Lundberg et al. (WO 2018/134374 A2; herein referred to as Lundberg) in view of Suetsuna et al. (CN 101299365 B; hereinafter Suetsuna) is withdrawn in view of Applicant’s arguments.
11. The rejection of claim 7 as being unpatentable over Lundberg et al. (WO 2018/134374 A2; herein referred to as Lundberg) as applied to claims 1 and 6 above, and further in view of Masuda et al (WO 2017204209; hereinafter Masuda) is withdrawn in view of Applicant’s arguments.
Double Patenting
12. 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.
13. Claims 1-7 and 9-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7, 9, and 23 of copending Application No. 17/598,015 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending ‘015 claims a sensitized magnetic responsive particle that anticipates or make obvious the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending ‘015 claims:
1. Sensitized magnetic responsive particles comprising
magnetic responsive particles having a core particle and at least one magnetic layer disposed on the core particle, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof; and
a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles,
wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles is 15% or less,
the average particle size of the magnetic responsive particles being 1 µm to 10 µm,
further comprising a nonmagnetic layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte.
2. The sensitized magnetic responsive particles according to claim 1, wherein the coefficient of variation in a volume-average particle size of the magnetic responsive particles is 20% or less.
3. Sensitized magnetic responsive particles comprising:
magnetic responsive particles having a core particle and at least one magnetic layer disposed on the core particle, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof; and
a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles,
wherein a coefficient of variation in a weight-average particle size of the sensitized magnetic responsive particles is 15% or less,
the average particle size of the magnetic responsive particles being 1 µm to 10 µm,
further comprising a nonmagnetic layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte.
4. The sensitized magnetic responsive particles according to claim 1, wherein the coefficient of variation in a volume-average particle size of the magnetic responsive particles is 20% or less.
6. The sensitized magnetic responsive particle according to claim 1, wherein the substance interacting specifically with the analyte is chemically bonded onto the magnetic layer through a one-step or multi-step reaction.
7. The sensitized magnetic responsive particles according to claim 1, wherein the substance interacting specifically with the analyte is bonded onto the nonmagnetic layer via one or multiple chemical bonds.
9. An immunoassay reagent comprising the sensitized magnetic responsive particles according to claim 1.
23. Sensitized magnetic responsive particles comprising:
magnetic responsive particles having a core particle, wherein the core particles have an average particle size of 0.5 to 10 µm and at least one magnetic layer disposed on the core particles, the magnetic layer comprising microparticles of a magnetic metal and/or an oxide thereof wherein the magnetic layer has a thickness of from 10 to 200 nm; and
a substance that specifically interacts with an analyte, the substance being supported on the magnetic responsive particles,
wherein a coefficient of variation in a weight-average particle size of the magnetic responsive particles is 15% or less,
further comprising a nonmagnetic layer comprising a nonmagnetic metal oxide and/or an organic metal compound between the magnetic layer and the substance interacting specifically with the analyte.
Copending ‘015 claims a particle that anticipates the physical limitations of the instant invention and thus will satisfy Expression 1 in instant claim 1.
With respect to claim 2, the magnetic particles of copending ‘015 comprise the same materials as the instant particles, with the same properties, and thus will exhibit the same claimed magnetic separability.
Conclusion
14. 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.
15. 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.
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, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
7/15/2026
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