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 1683) whose telephone number is (571) 272-1113.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 3 December 2025 has been entered.
Amendments and Status of the Claims
4. This action is in response to papers filed 3 December 2025 in which claims 1 and 13 were amended, claims 4 and 16 were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
Claims 1-3, 5-15, and 17-18 are under prosecution.
Information Disclosure Statement
5. The Information Disclosure Statement filed 3 December 2025 is acknowledged and has been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
6. The use of trade names or marks used in commerce (including but not necessarily limited to Tween and Gleevec), has been noted in this application. Any trade names or marks 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 Interpretation
7. 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 and 5-12 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 17-18 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.
Claim Rejections - 35 USC § 112
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
9. Claims 2-3, 6-7, 9, 13-15, and 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A. Claims 2 and 3 are each indefinite in the recitation “the target sequence,” which lacks antecedent basis in the previous recitation of a “template nucleic acid” in claim 1.
B. Claims 6 and 7 are each indefinite in the recitation the contiguous single stranded template,” which lacks antecedent basis because there is no previous recitation of a “contiguous single stranded template.”
C. Claim 9 is indefinite as it is unclear if the term “less than” applies only to 25 nm.
D. Claim 13 (upon which claims 14-15 and 17-18 depend) is indefinite in the phrase “and hybridize with multiple target segments.” It is unclear if this limitation required the surface to be hybridized with multiple target segments or merely describes an intended used of the surface.
Claim Rejections - 35 USC § 102
10. 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.
11. Claims 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwardson et al. (Nature Chemistry, vol. 8, pages 162-170 and Supplementary Information, pages 1-78, published 4 January 2016).
Regarding claim 13, Edwardson et al. teach a spherical nanoparticle 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.
Regarding claim 14, the surface of claim 13 is discussed above. The instant limitations refer to a target nucleic acid, which is not necessarily part of the claimed surface as discussed above in Section 9. Thus, in embodiments wherein the target nucleic acid is not present, the instant limitations do no further limit the claim.
Claim Rejections - 35 USC § 102/103
12. 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.
13. 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.
14. Claims 15 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, 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) as applied to claim 13 above.
Regarding claim 15, the surface of claim 13 is discussed above in Section 11.
Edwardson et al. teach the gold nanoparticles are patterned with numbers, geometry, and positioning of different unique strands. Thus, patterning the block nucleic acids is wither anticipated by, or obvious over, Edwardson et al.
Regarding claim 17, the surface 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 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)).
Claim Rejections - 35 USC § 103
15. 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) 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 surface 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), Edwardson et al. do not 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 surface taught by Edwardson et al. with the teachings of Stojanovic et al. to arrive at the instantly claimed surface 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 surface 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 surface of Edwardson et al. with predictable results because the known techniques of Stojanovic et al. predictably result in molecules useful for delivering agents to a subject.
Prior Art
15. The following prior art is hereby made of record, but not presently relied upon for any rejection, as it is considered pertinent to Applicant's disclosure.
Shieh et al. (U.S. Patent Application Publication No. US 2012/0123107 A1, published 17 May 2012) teach nanoparticles having multiple different nucleic acids attached thereto (paragraph 0014 and Figure 1C). However, these nucleic acids are hairpins, and thus are not “single stranded” as discussed in the “Claim Interpretation” section above.
Conclusion
16. Claims 1, 5, 8, and 10-12 are allowed subject to the interpretation discussed above.
Claims 2-3, 6-7, 9, 13-15, and 17-18 are rejected.
17. 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