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 .
Claim Objections
2. The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered new claim 23 has been renumbered 22.
Amendments and Status of the Claims
3. This action is in response to papers filed 19 May 2026 in which the specification and claims 2-3, 6-7, 9, 13-15, and 17-18 were amended, no claims were canceled, and new claims 19-22 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All previous rejections not reiterated below are withdrawn in view of the amendments.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 rejections necessitated by the amendments.
3. Claims 1-3, 5-15, and 17-22 are under prosecution.
4. This Office Action includes new objections and rejections necessitated by the amendments.
Claim Interpretation
6. As noted in the previous Office Action, the claims are subject to the following interpretation:
A. The claims are drawn to “multiple single stranded block nucleic acids,” which are interpreted as being single stranded nucleic acids that do not self-hybridize; i.e., single stranded molecular beacons and other stem-loop/hairpin structures are excluded.
B. Claim 1 (upon which claims 2-3, 5-12, and 21-22 depend) states that the multiple second block segments comprise “an anchor.” Based on Figure 1C and the teachings of the specification, the claims are interpreted as requiring each second block segment to require its own anchor. Consequently, claim 10 is further interpreted as all anchors to be thiols; i.e., each second block segment comprises its own thiol.
C. Claims 2 and 3 each contain the language “wherein separating…is…”, which interpreted as closed claim language, and thus limits the claims to only those steps discussed therein.
D. Claim 11 (upon which claim 12 depends) is interpreted as requiring all of the steps of claim 1 as part of the claim.
E. Claim 13 (upon which claims 14-15 and 17-20 depend) recites first and second block segments. However, there is no further differentiation as to how many nucleotides each segment is or how long they are. Thus, the claimed block segments are interpreted as encompassing any linker and/or sequence length.
7. In addition, it is noted that while claim 9, claim 13 (as amended) and new claims 19-22 each recite a nanoparticle “core,” the claims do not further require a shell surrounding the core. Thus, the core is merely interpreted as the nanoparticle itself.
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. It is noted that a prior art reference is considered as a whole and for all it stands for. Thus, the rejections listed below merely present a modified interpretation of the teachings of Edwardson et al
11. Claims 13-15, 17, and 19-20 are rejected under 35 U.S.C. 103 as obvious over Edwardson et al. (Nature Chemistry, vol. 8, pages 162-170 and Supplementary Information, pages 1-78, published 4 January 2016) and Beattie et al. (U.S. Patent Application Publication No. US 2011/0105346 A1, published 5 May 2011).
Regarding claims 13 and 19-20, Edwardson et al. teach a spherical nanoparticle having a surface comprising multiple second block segments attached to a nanoparticle surface, each of the second block segments being part of multiple single strand block nucleic acids, wherein the first block segments are substantially variant, in the form of the structure of Step 2 of Figure 4, each of which binds different targets as depicted by structure E4 of Figure 4.
Further, as noted in the supplementary materials, each of the nucleic acids attached to the gold nanoparticle (i.e., Da-Dd) comprise oligoT segments (Supplementary Table ST1), which are interpreted as the second block segments attached to the nanoparticle surface. Each of these block nucleic acids further comprises an additional sequence (after the oligoT portions) which are the first blocks that are substantially variant. The table also shows the target nucleic acids EXT-A-EXT-D, which do not fully hybridize to the oligoT portions (as their A tails are too short). Thus, the sequences depicted in Supplementary Table ST1 meet the claimed limitations.
Edwardson et al. also teach the nanoparticles have a core diameter of 10 nm (page 166, column 1) which is in the range of claims 13 and 19-20, and that the nanoparticle surface has 8 binding sites, to which the block nucleic acids are attached (Figure 2).
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.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
Edwardson et al. also teach the nanoparticles have the added advantage of exhibiting site-specific addressability of DNA nanostructures and are promising components for biomedical applications (Abstract). Thus, Edwardson et al. teach the known techniques discussed above.
While Edwardson et al teach the single stranded block nucleic acids are patterned on the nanoparticle surface (Abstract), Edwardson et al. do not teach a tandem pattern.
However, Beattie et al. teach the attachment of nucleic acid probes to nanometer-sized particles (paragraph 0262), as well as tandem patterns, which have the added advantage of allowing fingerprinting to identify an organism’s identity (paragraphs 0289 and 0007). Thus, Beattie et al. teach the known techniques discussed above.
It is also noted that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04.
The courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). See MPEP 2144.04 IV B.
Thus, the tandem patterning merely represents rearrangement of the block nucleic acids and/or a change of the shape of their deposition on the nanoparticle surface.
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 Edwardson et al. and Beattie et al. to arrive at the instantly claimed nanoparticles with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in nanoparticles having the added advantages of exhibiting site-specific addressability of DNA nanostructures and are promising components for biomedical applications as explicitly taught by Edwardson et al. and allowing fingerprinting to identify an organism’s identity as explicitly taught by Beattie et al. (paragraph 0289 and 0007). 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 useful nanoparticles for DNA assays.
Regarding claim 14, the nanoparticle of claim 13 is discussed above. The instant limitations refer to a target nucleic acid, which is not necessarily part of the claimed nanoparticle. Thus, in embodiments wherein the target nucleic acid is not present, the instant limitations do not further limit the claim.
Regarding claim 15, the nanoparticle of claim 13 is discussed above.
Edwardson et al. teach the gold nanoparticles are patterned with numbers, geometry, and positioning of different unique strands. Thus, claimed patterning is obvious.
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device, and that changes in shape are obvious.
Thus, the tandem patterning merely represents rearrangement of the block nucleic acids and/or a change of the shape of their deposition on the nanoparticle surface.
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.
Regarding claim 17, the nanoparticle of claim 13 is discussed above. Supplementary Table ST1 show the single stranded multiple block nucleic acids Da-Db are less than 50 nucleotides in length.
Alternatively, 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.
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.
12. Claim 18 is rejected under 35 U.S.C. 103 as obvious over Edwardson et al. (Nature Chemistry, vol. 8, pages 162-170 and Supplementary Information, pages 1-78, published 4 January 2016) and Beattie et al. (U.S. Patent Application Publication No. US 2011/0105346 A1, published 5 May 2011) as applied to claim 13 above, and further in view of Stojanovic et al. (U.S. Patent Application Publication No. US 2012/0114558 A1, published 10 May 2012).
Regarding claim 18, the nanoparticle of claim 13 is discussed above in Section 11.
While Edwardson et al. teach the method is compatible with DNA/RNA aptamers, which can be targeted for cellular delivery (Conclusion), neither Edwardson et al. nor Beattie et al. teach therapeutic agents.
However, Stojanovic et al. teach aptamers having therapeutics (i.e., drugs) attached thereto, which have the added advantage of allowing release by an innocuous orally administrable trigger (Abstract). Thus, Stojanovic 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 modified the nanoparticle taught by Edwardson et al. and Beattie et al. with the teachings of Stojanovic 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 modification because said modification would have resulted in a nanoparticle having the added advantage of allowing release by an innocuous orally administrable trigger as explicitly taught by Stojanovic et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Stojanovic et al. could have been applied to the nanoparticle of Edwardson et al. and Beattie et al. with predictable results because the known techniques of Stojanovic et al. predictably result in molecules useful for delivering agents to a subject.
Response to Arguments
13. Applicant’s arguments have been considered but are moot in view of the new ejections necessitated by the amendments.
Conclusion
14. Claims 1-3, 5-12, and 21-22 are allowed subject to the interpretation discussed above.
15. Claims 13-15 and 17-20 are rejected.
16. 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).
17. 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.
18. 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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