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 .
Election/Restrictions
2. Applicant’s election of Group I in the reply filed on 5 March 2026 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Claims 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 5 March 2026.
Claims 1-4 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 29 June 2023, 30 June 2023, and 2 November 2023 are acknowledged and have been considered.
The Kong et al. reference is lined through because the cited Patent Number is actually that of Oxley et al, which is cited on the same Information Disclosure Statement.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Scholin et al. (U.S. Patent Application Publication No. US 2019/0290762 A1, published 26 September 2019) in combination with Chetverin et al. (U.S. Patent Application Publication No. US 2009/0105082 A1, published 23 April 2009), alternatively further in combination with Barnard et al. (U.S. Patent Application Publication No. US 2019, 46943 A1, published 14 February 2019).
Regarding claims 1-2, Scholin et al. teach a method of providing a negatively charged nanoparticle with a negatively chargeable hydrophobic polymer, in the form of a colloidosome having a core/shell structure (paragraph 0009), wherein the core is polylactic acid (i.e., claim 2; paragraph 0088), and the shell is polyacrylamide, and the shell and core are attached to one another via electrostatic interactions (paragraph 0009). Scholin et al. also teach the core is formed by combinations of polymer emulsions, including poly-e-caprolactone and polylactic acid (paragraph 0088), that the nanoparticle (i.e., colloidosome) is formed using layer-by-layer deposition (paragraph 0109), and that the nanoparticles (i.e., colloidosomes) have multiple layers or shells (paragraph 0068), which is interpreted as the cores also having multiple layers (as shells are separately identified as different multi-layered structures). Thus, it would have been obvious to form a polylactic acid layer on the poly-e-caprolactone layer to form the core.
It is also noted that paragraph 0080 states that nanomaterial layers are the same or different materials; thus, it would have alternatively been obvious to have a core having either two layers of polylactic acid or a layer of poly-e-caprolactone with an outer layer of polylactic acid.
In addition, it is noted that the claim does not specify how many layers of each material is on the nanoparticle. Thus, the claimed “forming layers of a positively charged acrylamide hydrogel and of the negatively chargeable, hydrophobic polymer” encompasses only one layer of each on the nanoparticle, as depicted in Figure 1B of the instant specification.
Scholin et al. also teach the shell has active agents attached thereto (paragraph 0109), where the active agents are nucleic acids (paragraph 0011). Scholin et al. also teach diameters of 350 nm (paragraph 0073) the methods have the added advantage of allowing release of the nucleic acids (i.e., active agents) in response to a stimulus (Abstract). Thus, Scholin et al. teach the known techniques discussed above.
Scholin et al. do not teach the nucleic acids are primers.
However, Chetverin et al. teach nanoparticles of merged gels (paragraph 0014), wherein the gel comprises polyacrylamide having primers attached (paragraph 0055). Chetverin et al. further teach the polyacrylamide gel is in a dried form, and that the polyacrylamide has the added advantage of resisting multiple PCR cycles (paragraph 0055). Thus, Chetverin et al. teach the known techniques discussed above.
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where 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). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
With respect to the claimed “grafting,” a review of the instant specification yields no limiting definition of the claimed “grafting.” Therefore, any attachment of the primers to the polyacrylamide meets the claimed limitation, and the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding “grafting” (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Alternatively, Barnard et al. teach methods wherein primers are attached to acrylamide using the functionally equivalent method of grafting (paragraph 0103), which has the added advantage of allowing target nucleic acids to be seeded within the gel for the creation of nucleic acid clusters (paragraph 0111). Thus, Barnard et al. teach the know 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 Scholin et al. and Chetverin et al., alternatively further combining with Barnard et al., to arrive at the instantly claimed nanoparticle with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a nanoparticle having the added advantages of:
Allowing release of the nucleic acids (i.e., active agents) in response to a stimulus as explicitly taught by Scholin et al. (Abstract);
Resisting multiple PCR cycles as explicitly taught by Chetverin et al. (paragraph 0055); and, alternatively the further advantage of
Allowing target nucleic acids to be seeded within the gel for the creation of nucleic acid cluster as explicitly taught by Barnard et al. (paragraph 0111).
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 particles useful for nucleic acid assays.
Regarding claim 4, the method of claim 1 is discussed above. Chetverin et al. teach the polyacrylamide matrix (paragraph 0019) comprise positively charged quarternary amine groups (paragraph 0055).
9. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Scholin et al. (U.S. Patent Application Publication No. US 2019/0290762 A1, published 26 September 2019) in combination with Chetverin et al. (U.S. Patent Application Publication No. US 2009/0105082 A1, published 23 April 2009), alternatively further in combination with Barnard et al. (U.S. Patent Application Publication No. US 201946943 A1, published 14 February 2019) as applied to claim 1 above, and further in combination with Prud’homme et al. (U.S. Patent Application Publication No. US 2017/0037234 A1, published 9 February 2017).
Regarding claim 3, the method of claim 1 is discussed above in Section 8.
None of the previously cited prior art teaches flash nanoprecipitation.
However, Prud’homme et al. teach formation of polylactic acid (i.e., polylactide) nanoparticles using flash nanoprecipitation, which has the added advantage of providing stabilized particles (paragraph 0090). Thus, Prud’homme 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 Prud’homme et al. with the previously cited prior art to arrive at the instantly claimed nanoparticle with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a nanoparticle having the added advantage of providing stabilized particles as explicitly taught by Prud’homme et al. (paragraph 0090). In addition, it would have been obvious to the ordinary artisan that the known techniques of Prud’homme et al. could have been combined the cited prior art with predictable results because the known techniques of Prud’homme et al. predictably result in stabilized particles.
Conclusion
10. No claim is allowed.
11. 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.
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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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights