DETAILED ACTION
Status of Application
The response filed 12/23/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 7 have been amended.
Claim 1-6, 8 has been cancelled.
Claim 14-20 has been added.
Applicant had previously elected Group I in response to restriction requirement and for the examination.
Due to restriction, based on election of Group I, claims 9-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 7, 9-20 are pending.
Claims 7, 14-20 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn are moot as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
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.
Claims 7, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (U.S. Pat. 2018/0009863) in view of Kopczynski et al. (U.S. Pat. Pub. 2014/0275161).
Rejection:
Luo et al. teaches a composition (the separation composition) comprising a magnetic particle coupled to lectins like lens culinaris agglutin (LCA) or concanavalin lectin or a combination thereof [49-50]. The magnetic particle can be coated with epoxy resin or agarose [57], including an embodiment of a lectin labeled magnetic particle that is agarose coated labeled with lens culinaris agglutin [40]. This is exemplified as magnetic particles with a size of 1 micron coated with an epoxy resin and lens culinaris agglutinin (LCA lectin with epoxy resin magnetic bead, [51] Example 1, falling within the claimed range and materials, coupling rate was also 98% [54]). The separation composition can also comprise a protective solution with phosphate buffer (PBS) and cleaning solution as exemplified with Tris-HCL and D-mannoside in Example 2 ([144-146, 149], Tris HCL solution is metal salt ion free solution as described by the instant specification [70], see full document specifically areas cited).
The amount of lectin coupled to the magnetic carrier naturally flows through from the size of the magnetic particle as addressed by the instant specification which states that the recited claimed size range allows for a greater number of lectins to be coupled to the magnetic bead from the decreased steric hinderance [56] (1-20mg lectin to 1ml of magnetic carrier); wherein as the exemplified magnetic particle is within the recited size of the magnetic particle (1-200um) coated with a recited epoxy resin and coupled with the instant claimed lectin like lens culinaris agglutin - it would naturally have the same amount of lectin coupling to magnetic carrier as claimed (i.e. 1-20mg lectin to 1ml of magnetic carrier) as the same components are present in the prior art in the lectin magnetic particle, and if the composition/particle is physically the same it must have the same properties as “products of identical chemical composition cannot have mutually exclusive properties: In re Spada, 911 F.2D 705, 709, 15 USPQ2D 1655, 1658 (Fed.Cir. 1990). When the structural magnetic particle recitations are met (the listed magnetic bead with recited lectins), the desired results and properties are met as it naturally flows from the structural components of the magnetic particle, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope.
Luo et al. does not expressly recite the presence of a borate buffer but does expressly teach the presence of buffers and exemplifies the magnetic particles with a size of 1 micron coated with an epoxy resin and lens culinaris agglutinin (LCA lectin, , coupling rate was also 98%, with a phosphate buffer (PBS, protective solution) and cleaning solution exemplified with Tris-HCL and D-mannoside in Example 2.
Kopczynski et al. teaches that know buffers include phosphate buffers, borate buffers, tris buffer, and combination buffers such as borate/phosphate buffer and the like; and one includes an amount of buffer to provide a suitable buffering capacity [245].
Wherein it would be obvious to one of ordinary skill in the art before the effective Ing filing date of the claimed invention to incorporate a borate buffer as suggested by Kopczynski et al. and produce the claimed invention, as the inclusion of borate to attain the known combination buffer of borate/phosphate buffer for its known purpose is prima facie obvious with a reasonable expectation of success. With regards to the future intended use for a clinical sample, the composition contains the same recited structural components of the composition, wherein the particle/composition of the prior art is capable of the recited future intended use of the composition to a clinical sample as they are composition claims (and are not the withdrawn method of use claims).
Response to Arguments:
Applicant’s arguments with respect to the prior art rejection of Luo et al. have been considered but are moot due to the claim amendments and the new rejection applied as a result of claim amendments.
Accordingly, the rejection stands.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (U.S. Pat. 2018/0009863) in view of Kopczynski et al. (U.S. Pat. Pub. 2014/0275161) as applied to claims 7, 16-20, further in view of expedeon (Nickel Magnetic Resin).
Rejection:
The teachings of Luo et al in view of Kopczynski et al. are addressed above.
Luo et al in view of Kopczynski et al. does not recite the same exact particle size of the magnetic carrier but does teach the magnetic bead carrier that can be coated with epoxy or agarose, with a preferred embodiment of agarose coated magnetic particle.
expedeon teaches that magnetic agarose beads are commerically available from 50-150microns (Nickel Magnetic Resin-1st paragraph).
Wherein it would be obvious to one of ordinary skill in the art before the effective Ing filing date of the claimed invention to utilize the 50-150microns size for agarose magnetic beads as suggested by expedeon and produce the claimed invention; as it is prima facie obvious to utilize a known commercial size for agarose magnetic beads with a reasonable expectation of success.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (U.S. Pat. 2018/0009863) in view of Kopczynski et al. (U.S. Pat. Pub. 2014/0275161) as applied to claims 7, 16-20, further in view of Philippova et al. (Magnetic polymer beads: Recent trends and developments in synthetic design and applications).
Rejection:
The teachings of the Luo et al. in view of Kopczynski et al. are addressed above.
The Luo et al. in view of Kopczynski et al. do not recite the size of the magnetic particles but does recite the inclusion of magnetic particles with a polymer.
Philippova et al. teaches that one of the most widespread means to produce magnetic beads is emulsion polymerization where the iron oxide particles are encapsulated by the polymer and the particle size can range from 10-200um by adjusting the stirring speed (3.2.3 Magnetic beads with homogeneously dispersed magnetic particles – 2nd and 3rd paragraph).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjust the magnetic particle size such as 10-200um as suggested by Philippova et al. and produce the claimed invention; as it is prima facie obvious to utilize a known range for magnetic particles (10-200um falling within the instant claimed range) produced by one of the most common methods with a reasonable expectation of success.
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 7, 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 10329335 in view of Kopczynski et al. (U.S. Pat. Pub. 2014/0275161) and Philippova et al. (Magnetic polymer beads: Recent trends and developments in synthetic design and applications).
The patented claims recite a magnetic particle covered with an epoxy resin coupled with the lectin that is lens culinaris agglutin (LCA) or concanavalin lectin falling within the claimed structural composition for the magnetic particle.
The patented claim does not expressly recite the presence of a borate buffer or the magnetic particle size but does recite teach the presence of buffers like a phosphate buffer (PBS, has purified water) and D-mannoside, and the inclusion of magnetic particles with a polymer.
Philippova et al. teaches that one of the most widespread means to produce magnetic beads is emulsion polymerization where the iron oxide particles are encapsulated by the polymer and the particle size can range from 10-200um by adjusting the stirring speed (3.2.3 Magnetic beads with homogeneously dispersed magnetic particles – 2nd and 3rd paragraph).
Kopczynski et al. teaches that know buffers include phosphate buffers, borate buffers, tris buffer, and combination buffers such as borate/phosphate buffer and the like; and a one includes an amount of buffer to provide a suitable buffering capacity [245].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjust the magnetic particle size such as 10-200um as suggested by Philippova et al. and incorporate a borate and tris buffer as suggested by Kopczynski et al. and produce the claimed invention; as it is prima facie obvious to utilize a known range for magnetic particles (10-200um falling within the instant claimed range) produced by one of the most common methods with a reasonable expectation of success. As the amount of lectin coupled to the magnetic carrier naturally flows through from the size of the magnetic particle as addressed by the instant specification stating that the range allows for a greater number of lectins to be coupled to the magnetic bead from the decreased steric hinderance [56] (1-20mg lectin to 1ml of magnetic carrier); wherein the taught particle size of 10-200um for the magnetic particle with the recited resin and coupled with the lens culinaris agglutin lectin would be expected to have the same amount of lectin coupling to magnetic carrier (1-20mg lectin to 1ml of magnetic carrier) as it naturally flows from the particle size and the deceased steric hinderance with the lectin as disclosed by the instant specification. The inclusion of additional buffers for its additive effect for their known purpose is also prima facie obvious with a reasonable expectation of success. With regards to the future intended use for a clinical sample, the composition contains the same recited structural components of the composition, wherein the particle/composition of the prior art is capable of the recited future intended use of the composition to a clinical sample as they are composition claims (and are not the withdrawn method of use claims).
Response to Arguments:
Applicant’s arguments with respect to the prior double patenting rejection have been considered but are moot due to the claim amendments and the new rejection applied as a result of claim amendments.
Accordingly, the rejection stands.
Claims 7, 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-7 of U.S. Patent No. 10329335 in view of Khien et al. (Clinical evaluation of lentil lectin-reactive alpha-fetoprotein-L3 in histology-proven hepatocellular carcinoma-Abstract) and Philippova et al. (Magnetic polymer beads: Recent trends and developments in synthetic design and applications) and of Kopczynski et al. (U.S. Pat. Pub. 2014/0275161).
The patented claims recite a magnetic particle covered with an epoxy resin coupled with the lectin that binds to an alpha-fetoprotein variant AFP-L3, and that the separation reagent can further comprise a cleaning solution which contain Tris-HCL and D-mannoside.
The patented claims do not expressly recite which lectin is coupled on the magnetic particle, the size of the particle, and the recited buffers, but does expressly recite that the lectin binds to an alpha-fetoprotein variant AFP-L3, with magnetic particle being coated with a polymer, and the inclusion of buffers (has purified water) such as phosphate buffer (PBS has purified water) and Tris.
Khien et al. teaches that lentil lectins like Lens culinaris agglutinin has an affinity/binds to alpha-fetoprotein for AFP-L3 (abstract).
Philippova et al. teaches that one of the most widespread means to produce magnetic beads is emulsion polymerization where the iron oxide particles are encapsulated by the polymer and the particle size can range from 10-200um by adjusting the stirring speed (3.2.3 Magnetic beads with homogeneously dispersed magnetic particles – 2nd and 3rd paragraph).
Kopczynski et al. teaches that known buffers include phosphate buffers, borate buffers, tris buffer, and combination buffers such as borate/phosphate buffer and the like; and a one includes an amount of buffer to provide a suitable buffering capacity [245].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Lens culinaris agglutinin as suggested by Khien et al., adjust the magnetic particle size such as 10-200um as suggested by Philippova et al., and incorporate a borate buffer as suggested by Kopczynski et al. and produce the claimed invention; as it is prima facie obvious to incorporate a lectin that is known to have an affinity/binds to alpha-fetoprotein for AFP-L3, which what the patented claims recites for the lectin on the magnetic particle and for the composition comprising the magnetic particle (i.e. Tris HCl) with a reasonable expectation of success. It is prima facie obvious to utilize a known range for magnetic particles (10-200um falling within the instant claimed range) produced by one of the most common methods with a reasonable expectation of success. As the amount of lectin coupled to the magnetic carrier naturally flows through from the size of the magnetic particle as addressed by the instant specification stating that the range allows for a greater number of lectins to be coupled to the magnetic bead from the decreased steric hinderance [56] (1-20mg lectin to 1ml of magnetic carrier); wherein the taught particle size of 10-200um for the magnetic particle with the recited resin and coupled with the lens culinaris agglutin lectin would be expected to have the same amount of lectin coupling to magnetic carrier (1-20mg lectin to 1ml of magnetic carrier) as it naturally flows from the particle size and the deceased steric hinderance with the lectin as disclosed by the instant specification. It is also prima facie obvious to incorporate known buffers and combination of buffers for their additive effect with a reasonable expectation of success. With regards to the future intended use, as the composition contains the same recited structural components of the composition, the composition is capable of the recited future intended use of the composition to a clinical sample as they are composition claims (and are not the withdrawn method of use claims).
Response to Arguments:
Applicant’s arguments with respect to the prior double patenting rejection have been considered but are moot due to the claim amendments and the new rejection applied as a result of claim amendments.
Accordingly, the rejection stands.
Conclusion
Claims 7, 14-20 are rejected.
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 GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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