DETAILED ACTION
Notice of Pre-AIA or AIA Status
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. Please note that the examiner for this application has changed. Please address future correspondence to Robert T. Crow (Art Unit 1634) whose telephone number is (571) 272-1113.
Election/Restrictions
3. Applicant’s election of Group I in the reply filed on 22 October 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 October 2025.
Claims 1-12 are under prosecution.
Information Disclosure Statement
4. The Information Disclosure Statement filed 28 November 2022 is acknowledged and has been considered.
Specification
5. The use of trade names or marks used in commerce (including but not necessarily limited to AccuPrep and Triton X-100), has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
6. Claim 11 is objected to because of the following informalities: claim 11 contains the recitation “according to claims 1,” which appears to be a typographical error. Appropriate correction is required.
Claim Interpretation
7. The claims are subject to the following interpretation:
A. Claim 1 (upon which claims 2-12 depend) states that each microparticle comprises “sequences complementary to those of the target nucleic acids” and “reporter nucleic acids.” Each recitation is interpreted as encompassing multiple molecules of the same sequence (as opposed to being limited multiple different capture sequences and multiple different reporter nucleic acid sequences on a single microparticle). In addition, the ”[m]icroparticle probes” are broadly interpreted as encompassing a collection of the same type of microparticles (i.e., all having the same two sequences as described above thereon).
B. Claims 11-12 each recite a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
C. The recitations of “the microparticle” in each of claims 2-4 are interpreted as referring to each microparticle of claim 1.
Claim Rejections - 35 USC § 103
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, 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.
9. 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.
10. Claims 1-2, 5, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019).
Regarding claim 1, Dowell et al teach microparticle probes (paragraph 0155) wherein each microparticle comprises an analyte binding molecule (ABM) and a reporter molecule (i.e., detection ABM with a reporter group; Figure 5), wherein the target (i.e., analyte) is a nucleic acid (paragraph 0078) each analyte binding molecule (i.e., specific binding partner; paragraph 0081) is a complementary nucleic acid sequence (paragraph 0097).
In addition, regarding claims 1, 5, and 10, it is noted that the courts have held that when a claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated (In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)). The phrase “for the application of (i.e., claim 5)” and the phrase “to be cleaved (i.e., claim 10)” each clearly defines a use of the composition, and thus do not further distinguish the composition over the prior art. See MPEP 2112.02.
Regarding claim 2, the probes of claim 1 are discussed above. Dowell et al teach magnetic microparticles (paragraph 0072).
Regarding claim 9, the probes of claim 1 are discussed above. Dowell et al teach the reporter nucleic acids are labeled with a luminescent material (e.g., luminophores; paragraph 0092).
11. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019) as applied to claim 1 above, and further in view of Mooney et al (U.S. Patent Application Publication No. US 2018/0214385 A1, published 2 August 2018).
Regarding claim 3, the probes of claim 1 are discussed above in Section 10.
Dowell et al discuss coated and magnetic microparticles (paragraph 0115), and that the microparticles have the added advantage of expanding the range of accurately measurable analyte concentration (Abstract). Thus, Dowell et al teach the known techniques discussed above
Dowell et al do not explicitly teach core shell microparticles.
However, Mooney et al teach core shell microparticles having a uniform shell thickness and wherein the core is magnetic (paragraph 0032-0033). The microparticles also have nucleic acids linked thereto (paragraph 0047), and have the added advantage of a high degree of structural homogeneity (paragraph 0003). Thus, Mooney et al teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Dowell et al and Mooney et al to arrive at the instantly claimed probes with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in probes having the added advantage of expanding the range of accurately measurable analyte concentration as explicitly taught by Dowell et al (Abstract) and the added advantage of a high degree of structural homogeneity as explicitly taught by Mooney et al (paragraph 0003). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in microparticles useful in nucleic acid-based applications.
12. Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019) as applied to claim 1 above, and further in view of Kokoris et al (U.S. Patent Application Publication No. US 2009/0148847 A1, published 11 June 2009).
It is noted that while claim 10 has been rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claims 4 and 10, the method of probes of claim 1 are discussed above in Section 10.
Dowell et al teach the microparticles have the added advantage of expanding the range of accurately measurable analyte concentration (Abstract). Thus, Dowell et al teach the known techniques discussed above
Dowell et al do not explicitly teach the density of cleavable reporters.
However, Kokoris et al teach microparticles (paragraph 0102) having labeled nucleic acid probes (paragraph 0051), and cleavage of the labeled probes (i.e., claim 10; paragraph 0097). Kokoris et al also teach a preference for microparticles (i.e., beads) that having a higher specific gravity (i.e.,. density) that aqueous solutions (paragraph 0172), and thus would not be suspended in water (i.e., claim 4). Kokoris et al also teach the microparticles have the added advantage of being readily visually detected (paragraph 0172). Thus, Kokoris et al teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Dowell et al and Kokoris et al to arrive at the instantly claimed probes with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in probes having the added advantage of expanding the range of accurately measurable analyte concentration as explicitly taught by Dowell et al (Abstract) and the added advantage of being readily visually detected as explicitly taught by Kokoris et al (paragraph 0172). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in microparticles useful in nucleic acid-based applications.
13. Claims 5-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019) as applied to claim 1 above, and further in view of Zheng et al (U.S. Patent Application Publication No. US 2018/0312873 A1, published 1 November 2018).
It is noted that while claims 5 and 10 have been rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claims 5-8 and 10-12, the probes of claim 1 are discussed above in Section 11.
Dowell et al teach kits and reagents for nucleic acid amplification (e.g., PCR; (i.e., claims 11-12; Abstract), as well as restriction sites (paragraph 0198), which allow for cleavage of nucleic acids by enzymes (i.e., claim 11), and that the microparticles have the added advantage of expanding the range of accurately measurable analyte concentration (Abstract). Thus, Dowell et al teach the known techniques discussed above.
Dowell et al do not teach the reporter nucleic acids are guide RNAs.
However, Zheng et al teach kits (paragraph 0121) comprising nucleic acid manipulating reagents and particles (i.e., beads; paragraph 0121), wherein the reagents include Cas9 (paragraph 0032), which is a restriction endonuclease as discussed on page 14 of the instant specification (i.e., claims 11-12). The guideRNA reporter can therefore be cleaved from the particle (i.e., claim 10). Zheng et al also teach guide RNA molecules are attached to the beads (i.e., claim 6; paragraph 0082), which includes a crRNA in combination with tracrRNA (i.e., claim 7; paragraph 0076).
It is reiterated that the courts have held that when a claim recites using an old composition or structure and the use is directed to a result or property of that composition or structure, then the claim is anticipated. The phrases “for the application of (i.e., claim 5),” “bind to the target…and can cleave…when they encounter (i.e.,, claim 8), “to be cleaved (i.e., claim 10),” “for nucleic acid isolation and detection (i.e., claim 11),” and “for nucleic acid amplification (i.e., claim 11)” each clearly defines a use of the composition, and thus do not further distinguish the composition over the prior art.
It is also noted that Zheng et al teach target nucleic acid editing (paragraph 0095) and cleavage with an RNA guided nuclease (i.e., claim 8; paragraph 0022).
Zheng et al further teach the probes have the added advantage of allowing delivery into and manipulation of single cells (Abstract). Thus, Zheng et al teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Dowell et al and Zheng et al to arrive at the instantly claimed probes with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in probes having the added advantage of expanding the range of accurately measurable analyte concentration as explicitly taught by Dowell et al (Abstract) and the added advantage of allowing delivery into and manipulation of single cells as explicitly taught by Zheng et al (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in microparticles useful in nucleic acid-based applications.
Double Patenting
14. 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.
15. Claims 1-5 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,493,028 B2 in view of Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019).
Both sets of claims are drawn to microparticles having capture probes, magnetic particles, shells with uniform thicknesses, and the claimed specific gravities. Any additional limitations of the ‘028 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘028 claims do not include the reporter nucleic acids.
However, Dowell et al teach the reporter nucleic acids and the additional limitans as discussed above, as well as the added advantage of expanding the range of accurately measurable analyte concentration (Abstract). Thus, Dowell et al teach the known techniques discussed above, and the combination nis obvious for the reasons discussed in the rejections above.
16. Claims 5-8 and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,493,028 B2 in view of Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019) as applied to claim 1 above, and further in view of Zheng et al (U.S. Patent Application Publication No. US 2018/0312873 A1, published 1 November 2018) based on the citations and rationale provided above.
17. Claims 1-5 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-20 of copending Application No. 17/285,890 in view of Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019).
Both sets of claims are drawn to microparticles having capture probes, magnetic particles, shells with uniform thicknesses, the claimed specific gravities, and luminescence. Any additional limitations of the ‘890 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘890 claims do not include the reporter nucleic acids.
However, Dowell et al teach the reporter nucleic acids and the additional limitans as discussed above, as well as the added advantage of expanding the range of accurately measurable analyte concentration (Abstract). Thus, Dowell et al teach the known techniques discussed above, and the combination nis obvious for the reasons discussed in the rejections above.
This is a provisional nonstatutory double patenting rejection.
18. Claims 5-8 and 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-20 of copending Application No. 17/285,890 in view of Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019) as applied to claim 1 above, and further in view of Zheng et al (U.S. Patent Application Publication No. US 2018/0312873 A1, published 1 November 2018) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
19. Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/858,662.
Both sets of claims are drawn to microparticles having capture probes, magnetic particles, shells with uniform thicknesses, the claimed specific gravities, luminescence, etc.. Any additional limitations of the ‘662 claims are encompassed by the open claim language “comprising” found in the instant claims.
While the ‘662 claims teach require only one particle, the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 VI.B.
This is a provisional nonstatutory double patenting rejection.
20. Claims 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/858,662 as applied to claim 1 above, and further in view of Zheng et al (U.S. Patent Application Publication No. US 2018/0312873 A1, published 1 November 2018) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
21. Claims 1-5 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/874,143 in view of Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019).
Both sets of claims are drawn to microparticles having capture probes, magnetic particles, shells with uniform thicknesses, and the claimed specific gravities. Any additional limitations of the ‘143 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘143 claims do not include the inactivated genetic scissors is the instantly claimed reporter nucleic acids.
However, Dowell et al teach the reporter nucleic acids and the additional limitans as discussed above, as well as the added advantage of expanding the range of accurately measurable analyte concentration (Abstract). Thus, Dowell et al teach the known techniques discussed above, and the combination nis obvious for the reasons discussed in the rejections above.
This is a provisional nonstatutory double patenting rejection.
22. Claims 5-8 and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/874,143 in view of Dowell et al (U.S. Patent Application Publication No. US 2019/0004041 A1, published 3 January 2019) as applied to claim 1 above, and further in view of Zheng et al (U.S. Patent Application Publication No. US 2018/0312873 A1, published 1 November 2018) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
Notice to Comply with Requirements for Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosure.
23. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below.
Specifically, the application fails to comply with CFR 1.821(e), which states:
(e) A copy of the “Sequence Listing” referred to in paragraph (c) of this section must also be submitted in computer readable form (CRF) in accordance with the requirements of § 1.824. The computer readable form must be a copy of the “Sequence Listing” and may not be retained as a part of the patent application file. If the computer readable form of a new application is to be identical with the computer readable form of another application of the applicant on file in the Office, reference may be made to the other application and computer readable form in lieu of filing a duplicate computer readable form in the new application if the computer readable form in the other application was compliant with all of the requirements of this subpart. The new application must be accompanied by a letter making such reference to the other application and computer readable form, both of which shall be completely identified. In the new application, applicant must also request the use of the compliant computer readable “Sequence Listing” that is already on file for the other application and must state that the paper or compact disc copy of the “Sequence Listing” in the new application is identical to the computer readable copy filed for the other application.
24. Please see the attached documents regarding the deficiencies of the CRF.
25. For the response to this Office Action to be complete, Applicant is REQUIRED to comply with the Requirements for Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Failure to comply with the Requirements will be considered nonresponsive.
Conclusion
26. No claim is allowed.
27. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683