DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-19 are pending upon entry of amendment filed on 1/10/24.
3. The information disclosure statement (IDS) submitted on 1/10/24 has been considered.
4. The oath filed on 1/10/24 has been entered.
5. 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.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1- 19 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by U.S. Pat. 8,382,987 as is evidenced by the specification of the instant application p.9.
The ‘987 patent teaches methods of capturing conjugated analyte using multimodal media comprising acrylamide and polysaccharides serving size exclusion and capture (claims 1-4).
The harvested analyte includes protein, antibody and nanoparticles are conjugated (col. 14-15) and the capture particles and molecular sieves (e.g. size exclusion) include various resins including acrylamide, hydrogels and baits for positively and negatively charged moieties (col. 27-29).
The ‘987 patent further discloses the capture particles and purification methods (col. 22).
As is evidenced in the instant specification in p. 9, multimodal modes comprise acrylamide and dye based affinity ligands include hydrogels and captocore, the reference teachings anticipate the claimed invention.
8. 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 of this title, 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.
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.
9. Claims 1 -19 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub 2013/0034854 (IDS reference) in view of U.S. Pub. 2010/0204455 (IDS reference) and U.S, Pat. 8,382,987 (IDS reference).
The ‘854 publication teaches conjugation of nanoparticles with antibodies and the nanaoparticles including polymer dot (p. 6-10). The claimed polymer dot is readable upon semiconducting colloidal polymers with fluorescence (p. 8-9, [109-111]) with the diameter 5-100nm as is evidenced in claims 13-14.
The disclosure of the ‘854 publication differs from the instant claimed invention in that it does not teach the purification methods with multimodal of SEC and capture and/or surfactant as in claims 1-8 of the instant application.
The teachings of the ‘987 patent have been discussed, supra.
The ‘455 publication teaches use of PEG surfactants in phosphate buffer in antibody purification for using SEC in preparation comprises impurities and discloses further optimization of antibody purification (p. 8-12).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to isolate nanoparticle conjugated antibodies as taught by the ‘854 publication and '455 publication with the nanoparticle conjugate antibodies generated by the ‘987 patent with the known method and conditions.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the isolation of the nanoparticle conjugated antibody improves purity and the known method with known concentrations will initiate purification method for further optimization.
From the teachings of references, it would have been obvious to one of ordinary skill in the art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
10. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
11. Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Pat 12,409,441.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘515 application recites methods of purifying protein comprising polymer filled chromatography (e.g. column) of resins of agarose and hydroxyapatite. The method further comprising use of surfactants. Given that two mixed resins that are identical to the claimed medium and it acts as multimodal and meets the limitations.
12. Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Pat. 10,934,366.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘366 patent teaches methods of purifying protein conjugated nanoparticles by mixed modal size exclusion and hydroxyapatite resins and column.
13. Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Pat. 10,814,305.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘305 patent recites methods of purifying protein comprising polymer filled chromatography (e.g. column) of resins of agarose and hydroxyapatite. The method further comprising use of surfactants. Given that two mixed resins that are identical to the claimed medium and it acts as multimodal and meets the limitations.
14. No claims are allowable.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
July 24, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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