FINAL 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 .
Amendments and Status of the Claims
2. This action is in response to papers filed 13 August 2026 in which claim 1 was amended, claims 2 and 5-11 were canceled, and new claims 12-13 were added. All of the amendments have been thoroughly reviewed and entered.
All previous rejections not reiterated below are withdrawn in view of the amendments.
Applicant’s arguments have been thoroughly reviewed and are addressed following the new rejections necessitated by the amendments.
3. Claims 1, 3-4, and 12-13 are under prosecution.
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, 4, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng (U.S. Patent Application Publication No. US 2019/0091162 A1, published 28 March 2019) in combination with Li et al. (U.S. Patent Application Publication No. US 2014/0080717 A1, published 20 March 2014), alternatively further in combination with Barnard et al. (U.S. Patent Application Publication No. US 2019/0046943 A1, published 14 February 2019).
Regarding claim 1, Cheng teach a method of generating a nanoparticle having a positively charged outer layer, to which nucleic acids are attached (i.e., condensed; paragraph 0092), wherein the particles have a diameter of hundreds of nanometers (paragraph 0136). The method further comprises applying multiple layers of alternating charges (paragraph 0122) on a negatively charged core (paragraph 0012), wherein the first layer is one of PLA, PLGA, PCL or PGA (paragraph 0075).
The open claim language “comprising” allows for the cores to include phospholipids (paragraph 0075) as well as the additional step of providing an outermost layer of PEG (paragraph 0122).
Cheng also teaches the nanoparticles are dried (paragraphs 0016 and 0113) and have the added advantage of having well-controlled physicochemical properties (paragraph 0067). Thus, Cheng teaches the known techniques discussed above.
While Cheng discusses polyacrylamide (paragraph 0091) and the attachment of nucleic acids (paragraph 00787), Cheng does not teach the nucleic acids are primers.
However, Li et al. teach polymeric nanoparticles comprising polyacrylamide (paragraph 0014), wherein the gel comprises polyacrylamide having nucleic acids attached thereto (paragraph 0776), wherein the nucleic acids are primer sets (paragraph 0004). Li et al. further teach the particles have diameters of 500 nanometers (paragraph 0778) and the added advantage of being suitable for nucleic acid amplification (Abstract). Thus, Li 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.
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, counsel’s mere arguments cannot take the place of evidence in the record.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
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 Cheng and Li 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:
Having well-controlled physicochemical properties as explicitly taught by Cheng (paragraph 0067);
Being suitable for nucleic acid amplification multiple PCR cycles as explicitly taught by Li et al. (Abstract); 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. Li et al. teach the polyacrylamide comprises positively charged quaternary amine groups (paragraph 0718), as does Cheng (paragraph 0091).
Regarding claim 12, the method of claim 1 is discussed above. LI et al. teach washing step the particles (paragraph 0777), including frequent wash steps during multi-step reactions (paragraph 0926).
With respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
7. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng (U.S. Patent Application Publication No. US 2019/0091162 A1, published 28 March 2019) in combination with Li et al. (U.S. Patent Application Publication No. US 2014/0080717 A1, published 20 March 2014), alternatively further in combination with Barnard et al. (U.S. Patent Application Publication No. US 2019/0046943 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 6.
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.
8. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng (U.S. Patent Application Publication No. US 2019/0091162 A1, published 28 March 2019) in combination with Li et al. (U.S. Patent Application Publication No. US 2014/0080717 A1, published 20 March 2014), alternatively further in combination with Barnard et al. (U.S. Patent Application Publication No. US 2019/0046943 A1, published 14 February 2019) as applied to claim 1 above, and further in combination with Rashba-Step et al. (U.S. Patent Application Publication No. US 2006/0260777 A1 published 23 November 2006).
It is noted that while claim 12 is rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claim 12, the method of claim 1 is discussed above in Section 6.
Rashba-Step et al. teach methods of forming particles wherein multiple alternatingly charged monolayers are formed thereon (paragraph 0129), and further wherein washing is repeated (paragraph 0136), and that washing has the added advantage of removing any excess polyions (paragraph 0173). Thus, Rashba-Step et al. teach the known techniques discussed above.
It is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
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 Rashba-Step 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 removing any excess polyions as explicitly taught by Rashba-Step et al. (paragraph 0173). In addition, it would have been obvious to the ordinary artisan that the known techniques of Rashba-Step et al. could have been combined the cited prior art with predictable results because the known techniques of Rashba-step et al. predictably result in nanoparticle layers ready for introduction of subsequent layers.
9. Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng (U.S. Patent Application Publication No. US 2019/0091162 A1, published 28 March 2019) in combination with Li et al. (U.S. Patent Application Publication No. US 2014/0080717 A1, published 20 March 2014), alternatively further in combination with Barnard et al. (U.S. Patent Application Publication No. US 2019/0046943 A1, published 14 February 2019) as applied to claim 1 above, and further in combination with Chen et al. (Journal of Agricultural and Food Chemistry, vol. 66, pages 8246-8252 and Supplementary Material, pages 1-4 , published 17 July 2018).
It is noted that while claim 3 is rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claims 3 and 13, the method of claim 1 is discussed above in Section 6.
None of the previously cited prior art teaches flash nanoprecipitation.
However, Chen et al. teach formation of polylactic acid (i.e., polylactide/o PDLLA) or policy-e-caprolactone nanoparticles using flash nanoprecipitation (i.e., claim 3; parge 8246), using solvent rations in the range of 1:2 and 1:4 (i.e., claim 13; Table S2, which has the added advantage of optimizing particle size as ratios higher that 1:4 showed a decline in particle size (page 8248). Thus, Chen et al. teach the known techniques discussed above.
It is reiterated 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, and 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
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 Chen 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 optimized particle diameters as taught by Chen et al. (paragraph 0090). In addition, it would have been obvious to the ordinary artisan that the known techniques of Chen et al. could have been combined the cited prior art with predictable results because the known techniques of Chen et al. predictably result in stable nanoparticles.
Response to Arguments
10. Applicant’s arguments filed 13 August 2026 merely refer to the response to the Notice of Non-compliant Amendment, and do not contain any arguments regarding the previous rejections.
11. Applicant’s arguments filed 30 June 2026 have been considered but are moot because the new ground of rejection necessitated by the amendments.
Conclusion
12. No claim is allowed
13. 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).
14. 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.
15. 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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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