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
Amendment Entry
1. Applicant's amendment / response filed December 22, 2025 is acknowledged and has been entered. Applicant’s submission of replacement drawings is also acknowledged and has been entered. Claims 1, 2, 4, 7, 8, 11, and 16 have been amended. Claims 19-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Accordingly, claims 1-26 are pending. Claims 1-18 are under examination.
Withdrawn Rejections / Objections
2. Any objection or rejection not reiterated herein, has been withdrawn.
3. The rejection of claims 1-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-20 of U.S. Patent No. 17/777,599, is withdrawn in light of the abandonment of ASN 17/777,599.
Priority
4. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a). Based on the filing receipt, the effective filing date of this National Stage application, which is a 371 of PCT/KR2020/013024 filed 09/25/2020, is September 27, 2019 which is the filing date of Foreign Application REPUBLIC OF KOREA 10-2019-0119565 from which the benefit of foreign priority is claimed.
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.
5. Claims 1-18 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 1 in line 9 is indefinite in reciting an open-ended numerical range in reciting “15 nm or less” because it appears to encompass “0;” hence, excluding any surface roughness as a parameter of the shell layer in the claimed invention.
Claim 15 lacks antecedent basis in reciting “the biomarker.”
Claim 16, step (v) in line 4 is indefinite in reciting an open-ended numerical range in reciting “15 nm or less” because it appears to encompass “0;” hence, excluding any surface roughness as a parameter of the shell layer in the claimed invention.
Claim 17 has improper antecedent basis problem in reciting “a silane-based solution.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
6. Claims 4 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In this case, the recitations of “wherein the surface of the shell layer has 1 to 80 hydrophilic functional groups per unit area (nm2)” in claim 4 and “wherein the capture probes are linked to the hydrophilic functional groups on the surface of the shell layer” in claim 6 have been recited in amended claim 1. Accordingly, claims 4 and 6 are deemed to fail to further limit the subject matter of claim 1 from which they depend and/or ultimately depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
7. Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-14 of U.S. Patent No. 12,493,028 (formerly claims 1, 2, 6-15, and 18-20 of allowed copending Application No. 17/285,890) in view of De Palma et al. (US 2005/0255514). Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite and teach magnetic particles comprising a core which comprises a magnetically responsive metal that occupies 60% or more of the total volume of the magnetic particles; a shell layer surrounding the core having a uniform thickness; capture probes immobilized on a surface of the shell layer to capture biological materials; wherein the surface of the shell layer is made of glass and has surface hydrophilic functional groups which are silanol groups or carboxyl, amino, hydroxyl, thiol, or aldehyde groups derived from silanol groups; the shell layer having an average surface roughness (Ra) of 15 nm or less; the capture probes linked to the hydrophilic functional groups on the surface of the shell layer; and the magnetic particles having a limit of detection of greater than 0 and not more than 1 pg/ml (1 pg/ml or less). Although U.S. Patent No. 12,493,028 does not teach that the shell layer is treated with an acidic solution comprising a mixture of a strong acid and hydrogen peroxide in a volume ratio of 1:1 to 7:1; De Palma et al. teach that it is conventional practice to treat surfaces of shell layers on magnetic particles with an acidic solution (piranha solution) comprising a mixture of a strong acid which is sulfuric acid (H2SO4) and hydrogen peroxide (H2O2) in a volume ratio of 4:1 or 7:3 (encompassed within 1:1 to 7:1) to decontaminate and/or clean the magnetic particles prior to functionalizing shell layer surfaces with silanol groups ([0357]; Table 1) by depositing and immobilizing silane molecules (silanol groups: hydrophilic functional groups) onto the glass shell layer surface (coating) of the magnetic particles (Abstract; [0130, 0356, 0357]; Table 1; Table 2).
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:
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claims 1 and 3-18 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US 2020/0246866) in view of De Palma et al. (US 2005/0255547).
Park et al. disclose non-spherical asymmetric fine magnetic particles comprising magnetic particles obtained by cutting glass-coated metal micro-wires [0015, 0020, 0021, 0025, 0026]. The magnetic particles specifically comprise a core comprising a magnetically responsive metal (paramagnetic metal); a shell layer surrounding the core having a uniform thickness, the shell layer comprising glass; and capture probes linked onto the shell layer to capture biological materials (target); wherein each capture probe comprises an antibody against a biomarker (target) [0035, 0058, 0080, 0091, 0151-0153, 0157, 0162, 0165]. Park teach that the shell layer has a shell surface having 1-80 (multiple or greater than 1 encompassing up to 80) hydrophilic functional groups; the hydrophilic functional groups being silanol groups or carboxyl, amino, or hydroxyl groups derived from the silanol groups [0152, 0154, 0156, 0165]. The shell layer may have an average surface roughness (Ra) that alter reflectance of the exposed region (encompassing Ra= 15 nm or less) [0050, 01061, 0171, 0172].
Park et al. teach that the core occupies 60% or more of the total volume of the magnetic particles [0091] and the shell layer (glass coat) has a thickness of 10 to 100 µm [0091]. Park et al. teach linking the capture probes to the hydrophilic functional groups on the surface of the shell layer [0152, 0154, 0156, 0165]. Park et al. teach that the magnetic particles comprise cut glass-coated metal micro-wires and formed into micro-rods having an average length of 400 µm (within the range of 10-1000 µm) [0145] with an inner diameter and thickness aspect ratio of 2 (encompassed within 2 to 15) [0113, 0128, 0141]. Figure 7A and Figure 8 show that the magnetic particles may have two or more different sizes or lengths for simultaneously testing two or more biomarkers (targets) ([0143, 0161]; Figure 7A; Figure 8).
Park et al differ from the instant invention in failing to teach that that the shell layer is treated with an acidic solution comprising a mixture of a strong acid.
De Palma et al. disclose depositing and immobilizing silane molecules (silanol groups: hydrophilic functional groups) into the surface of substrates including magnetic particles having a glass shell layer (coating) (Abstract; [0130, 0356]). De Palma et al. specifically teach treating the surface shell layer of the magnetic particles with an acidic solution comprising a mixture of a strong acid which is sulfuric acid (H2SO4) and hydrogen peroxide (H2O2) in a volume ratio of 4:1 or 7:3 (encompassed within 1:1 to 7:1) to decontaminate and/or clean the magnetic particles prior to functionalizing the surface with silanol groups ([0357]; Table 1). Thereafter, De Palma et al. teach immersing the surface-treated magnetic particles in a silane-based solution to bind the silanol groups (aminosilylation) so as to convert the terminal groups of the silane molecules to terminal groups capable of binding to probes or antibodies ([0130, 0356, 0357]; Table 1; Table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have incorporated the teaching of De Palma in treating magnetic particles with an acidic solution mixture of H2SO4 and H2O2 into the magnetic particle composition as taught by Park as part of functionalization process because De Palma taught that such treatment process is conventionally used in the art
to decontaminate and/or clean the magnetic particles prior to functionalizing shell layer surfaces with silanol groups which are comprised in the magnetic particles of Park. One of ordinary skill would have had reasonable expectation of success in incorporating the teaching of De Palma into the glass coated magnetic microrod particles taught by Park because both of Park and De Palma teach analogous art of fabricating magnetic particle compositions for use in methods of detecting biological materials.
With respect to the recitation of “the shell layer has an average surface roughness (Ra) of greater than 0 and not more than 15 nm” in claim 8; “the magnetic particles have a specific gravity of 5-30 such that they are not suspended in water” in claim 11; and immersing the magnetic microrods in silane-based solution for 6 to 24 hours” in claim 17; generally, differences in component parameters of a composition and process of making will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). Since Applicant has not disclosed that the specific limitations recited in instant claims 8, 11, and 17 are for any particular purpose or solve any stated problem and the prior art teaches that component parameters of the magnetic particles may often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well; absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the composition and method disclosed by the prior art by normal optimization procedures.
Response to Arguments
9. Applicant’s arguments with respect to 35 USC § 102(a)(1) and 102(a)(2) rejections of claims 1 and 3-15 have been considered but are moot in light of the new grounds of rejection necessitated by Applicant’s amendment and because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
10. Applicant's arguments filed December 22, 2025 have been fully considered but they are not persuasive.
A) Applicant argues that the obviousness double patenting rejection of claims 1-18 should be withdrawn because the claims have been substantially narrowed to include specific chemical treatment conditions resulting to surface properties that are not present in the claims of now U.S. Patent No. 12,493,028 (formerly claims 1, 2, 6-15, and 18-20 of allowed copending Application No. 17/285,890).
Applicant’s argument is not persuasive because as set forth herein supra, both the instant claims and those of U.S. Patent No. 12,493,028 recite and teach magnetic particles comprising a core which comprises a magnetically responsive metal that occupies 60% or more of the total volume of the magnetic particles; a shell layer surrounding the core having a uniform thickness; capture probes immobilized on a surface of the shell layer to capture biological materials; wherein the surface of the shell layer is made of glass and has surface hydrophilic functional groups which are silanol groups or carboxyl, amino, hydroxyl, thiol, or aldehyde groups derived from silanol groups; the shell layer having an average surface roughness (Ra) of 15 nm or less; the capture probes linked to the hydrophilic functional groups on the surface of the shell layer; and the magnetic particles having a limit of detection of greater than 0 and not more than 1 pg/ml (1 pg/ml or less). Although U.S. Patent No. 12,493,028 does not teach that the shell layer is treated with an acidic solution comprising a mixture of a strong acid and hydrogen peroxide in a volume ratio of 1:1 to 7:1; De Palma et al. teach that it is conventional practice to treat surfaces of shell layers on magnetic particles with an acidic solution (piranha solution) comprising a mixture of a strong acid which is H2SO4 and H2O2 in a volume ratio of 4:1 or 7:3 (encompassed within 1:1 to 7:1) to decontaminate and/or clean the magnetic particles prior to functionalizing shell layer surfaces with silanol groups ([0357]; Table 1) by depositing and immobilizing silane molecules (silanol groups: hydrophilic functional groups) onto the glass shell layer surface (coating) of the magnetic particles (Abstract; [0130, 0356, 0357]; Table 1; Table 2). Accordingly, the rejection is maintained for reasons of record.
11. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
February 4, 2026