NANOPARTICLES FOR SENSING USE AND PRODUCTION METHOD FOR SAME

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 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 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. Response to Restriction/Election Applicant’s response filed 08/13/2026 is acknowledged and entered. Status of the claims Claims 1-15 are examined on merits in this office action. 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al (Chem. Commun. 2018). In regards to claim 1, Takeuchi is directed to molecularly imprinted polymer (MIP) nanoparticles (Page 6344, lines 5-6 of 2nd col. and page 6245, lines 16-18 or 2nd col.). Takeuchi teaches molecularly imprinted polymer (page 6245, 1st para of 2nd col.) having a molecularly imprinted cavity (Fig 2 ) having sensing capability (page 6246, 2nd para of 2nd col.) for biological material (e.g. protein; page 6245, 2nd para of 2nd col.). Takeuchi discloses molecularly imprinted polymer particle having cavity wherein the molecularly imprinted polymer comprises a constituent unit derived from a functional monomer having a functional group comprising a group that interacts with the biological material and a signal binding group that is different from the group that interacts with the biological material: PNG media_image1.png 401 770 media_image1.png Greyscale (Fig. 9). In the above scheme, the functional monomer utilized is PNG media_image2.png 132 336 media_image2.png Greyscale , which comprises a functional group (carboxylic group) that interacts with biological material and the secondary amine group (PIM site shown by dotted circle) is considered a signal binding group (i.e. capable of binding to a fluorescent group) that is different from the carboxylic group, which interacts with the biological material. See the above scheme wherein the secondary amine is utilized for binding to fluorescent group FITC. Takeuchi teaches molecularly imprinted polymer (MIP) (Page 6344, lines 5-6 of 2nd col. and page 6245, lines 16-18 or 2nd col.) but, however, does not mention the MIP having the functional monomer PNG media_image2.png 132 336 media_image2.png Greyscale as nanoparticle. However, from the description of Takeuchi of MIP nanoparticles for use as drug-delivery system (page 6344, lines 5-6 of 2nd col.) and molecularly imprinted polymer nanoparticles for a bisphenol A (BPA)-sensing system (page 6245, lines 16-18 of 2nd col.) throughout the reference, one of ordinary skilled in the art can easily envisage the MIP having the PNG media_image2.png 132 336 media_image2.png Greyscale as nanoparticles for various sensing systems with a reasonable expectation of success because Takeuchi discloses MIP nanoparticles for BPA-sensing system. In regards to the recitation “for sensing use” in the preamble, it is an intended use language and Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In regards to claim 2, as described above, Takeuchi discloses functional group PNG media_image2.png 132 336 media_image2.png Greyscale , wherein the carboxylic group represents R1 that interacts with the biological material, PNG media_image3.png 45 64 media_image3.png Greyscale represents L1 and the PNG media_image4.png 91 162 media_image4.png Greyscale having the secondary amine group (drawn withing the circle) represents R2 comprising the signal substance binding group. In regards to claim 3, as disclosed above, Takeuchi discloses carboxyl group that binds with the biological materials. In regards to claim 4, as described above, the secondary amine group shown withing the dotted circle is the signal substance binding group. In regards to claim 5, as described above, Takeuchi discloses functional group PNG media_image5.png 92 193 media_image5.png Greyscale , which reads on chemical Formula 2 wherein R11 is carboxylaryl group, the CH2 group linking the aryl group to the secondary amine NH represents L11 as an alkylene. In regards to claim 6, Takeuchi discloses FITC (i.e. a signal group) bound to the signal substance binding group NH as disclosed in Fig. 9: PNG media_image6.png 125 136 media_image6.png Greyscale . In regards to claim 7, Takeuchi discloses functional group PNG media_image2.png 132 336 media_image2.png Greyscale (4-[2-(N-methacrylamido)ethylaminomethyl] benzoic acid (MABA)), which is considered as a constituent unit derived from N-substituted (meth)acrylamide. In regards to claims 8 and 9, Takeuchi discloses human serum albumin (HSA) interacting with COOH group in the binding cavity (Fig. 8). In regards to claims 10-13, the recitations “for sensing use of claim 1, which is used ..” recited in claim 10, “for sensing use of claim 1, wherein the biological material is a substance……” recited in claim 11, “the sensing use of claim 11, wherein the membrane structure is a cell, ………” recited in claim 12 and “for sensing use of claim 1, wherein the biological material is ……….”, are all directed to intended use language of utilizing the nanoparticle and are not a part of the claimed nanoparticle structures. Applicant is reminded that a recitation of the intended use of the claimed invention, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. See Bell Communications, 55 F.3d at 620; Kropa v. Robie, 38 C.C.P.A. 858, 187 F.2d 150, 152, 88 USPQ 478, 481 (1951). “Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation". Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997. In regards to claim 14, Takeuchi teaches immobilized MIP nanoparticle having fluorescent group and interacting carboxylic group on sensor chip substrate (page 6246, 1st para of 2nd col.) and thus various disclosed MIP nanoparticles including the MIP nanoparticle having FITC and arylcarboxylic group as described above, on a chip substrate surface or on various other substrate surface for detection would be obvious to one of ordinary skilled in the art. In regards to claim 15, the claimed reagent only comprises the nanoparticle of claim 1 and thus the disclosed nanoparticle of Takeuchi reads on the claim. Response to Argument Applicants’ arguments filed 08/13/2026 have been fully considered but are not found persuasive to overcome the 35 USC 103 rejection over Takeuchi et al. Applicant argued that Takeuchi contains no description whatsoever regarding particles possessing sensing capability. The above arguments have fully been considered but are not found persuasive because contrary to Applicant’s assertion, Takeuchi clearly teaches molecularly imprinted polymer nanoparticles for a bisphenol A (BPA) -sensing system (page 6245, lines 16-18 of 2nd col.). Takeuchi teaches MIPs for various target molecules such as sugars, amino acids and derivatives, agrichemicals (herbicides), peptides, proteins, and viruses have been reported. Recently, MIP nanoparticles have been developed for use as a drug-delivery system (page 6244, 2nd para of 2nd col.). Therefore, contrary to Applicant’s assertion, Takeuchi teaches particles possessing sensing capability. Applicant argued that Takeuchi in the Office Action relies on experimental results from specific working examples (Figs. 7 and 8) that utilized highly specialized functional monomers (FM1/FM2) to target a specific protein, the tumor marker AFP (alpha-fetoprotein). Applicant argued that Takeuchi does not actually describe or fairly suggest any link between the molecularly imprinted cavity shown in Fig. 2 and such sensing capability. The above arguments are not found persuasive because contrary to Applicant’s arguments, Takeuchi actually described a link between the molecularly imprinted cavity and such sensing ability. Takeuchi teaches that since the interacting group and the fluorophore were located only within the cavity, highly sensitive and selective detection of AFP is expected without the high background fluorescence and noise signal resulting from non-specific binding and this teaching is contradictory to what Applicant is asserting to. Applicant argued that the claimed functional monomer provides two different functions within the molecularly imprinted cavity and Takeuchi does not describe or suggest providing particular functional arrangement in the nanoparticle relied upon by the office action. The above arguments have fully been considered but are not found persuasive. Claim 1 as claimed, is directed to a molecularly imprinted polymer (product) and the final product (MIP) have a functional group that interact with a biological molecule and a signal substance binding group that is different from the functional group and wherein the functional groups are present on the surface of the molecularly imprinted polymer. Takeuchi teaches the concept and clear discloses MIP particles comprising a functional group on the surface that interact with a biological molecule and a signal substance binding group that is different from the functional group PNG media_image7.png 103 140 media_image7.png Greyscale , PNG media_image8.png 146 240 media_image8.png Greyscale and PNG media_image9.png 144 195 media_image9.png Greyscale . Conclusion 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30. 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Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SHAFIQUL HAQ/Primary Examiner, Art Unit 1678