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 4 May 2026 in which the specification and claims 1, 3, and 5 were amended, no claims were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
Any previous rejections not reiterated below are withdrawn in view of the amendments.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 1-8 are under prosecution.
4. This Office Action includes new objections and rejections necessitated by the amendments.
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (U.S. Patent Application Publication No. US 2021/0024991 A1, published 28 January 2021), Pengo et al. (European Biophysics Journal, vol. 46. pages 749-771, published 19 September 2017), and Roesler et al. (U.S. Patent Application Publication No. US 2010/0248991 A1, published 30 September 2010) and, as applied to claim 4, as evidenced by Percebom et al. (Chem. Comm., vol. 52, pages 4278-4381, published 21 March 2016).
Regarding claim 1, Fisher et al. teach functionalized nanostructures, in the form of a bead comprising an attached primer set (paragraph 0024), wherein the bead is metal and on the nanoscale (paragraph 0156), as well as chemically different regions comprising thiols on metals (e.g., gold; paragraph 0231), and that the different regions are adjacent one another (paragraph 0139). Fisher et al. further teach a first region comprising a first primer set having a first primer including an uncleavable first primer and a cleavable second primer, and a second primer set having a cleavable first primer and a second uncleavable primer (Abstract). Fisher et al. also teach each primer set has a different linker (paragraph 0209), that the primers are attached to the ends of their respective linkers 24 and 24’ (e.g., Figure 1B and paragraph 0208), and primer sets have the added advantage of allowing either simultaneous or sequential paired-end reads (paragraph 0140). Thus, Fisher et al. teach the known techniques discussed above.
While Fisher et al. teach each primer site is attached to different regions of a substrate (Abstract) via different monomers (paragraph 00452), as well as attachment to beads (paragraph 0010) and thiol monolayers to attach nucleotides to gold (paragraph 0213), Fisher et al. do not teach the primer sets are on different regions of the same nanostructure (i.e., bead) or spatial separation.
However, Pengo et al. teach nanostructured surfaces, in the form of gold nanoparticles (Abstract), where the nanostructure has two different linkers having different polarities (i.e., immiscibility) which results in spatial separation of the linkers on the gold nanoparticle (Figure 1A). Pengo et al. further teach the linkers are thiolated and that the thiol termini are attached to the gold surface (e.g., Figure 3). Pengo et al. also teach a nucleic acids attached to gold particles vial thiols (page 756, column 1), and that the nanostructures have the added advantage of allowing predicted and determined surface characteristics (Abstract). Thus, Pengo et al. teach the known techniques discussed above.
In addition, Roesler et al. teach gold nanoparticles (i.e., beads) having thiolated oligonucleotides attached thereto (paragraphs 0090 and 0019), wherein the nanoparticle has two different primers each having a different linker attached thereto (Figure 1). Roesler et al. also teach the linkers are attached to surfaces at their ends (e.g., Figure 2), and that nanoparticles have the added advantage of detecting the presence of mutations (paragraph 0004). Thus, Roesler 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 cited prior art, thereby using the different regions of different linkers taught by Pengo et al. as the different monomers for attachment taught by Fischer et al. to attach the different sets of primers of Fischer et al. on the gold nanostructure of Pengo et al. and Roesler et al., thus arriving at the instantly claimed nanostructure 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 nanostructure having the added advantages of:
A. Allowing either simultaneous or sequential paired-end reads as explicitly taught by Fisher et al. (paragraph 0140);
B. Allowing predicted and determined surface characteristics as explicitly taught by Pengo et al. (Abstract); and
C. Detecting the presence of mutations as explicitly taught by Roesler et al. (paragraph 0004).
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 cited prior art predictably result in reliable attachment of different molecules to nanostructures.
Regarding claim 2, the nanostructure of claim 1 is discussed above. Fisher et al. teach gold (paragraph 0231), Roesler et al. teach gold particles (paragraph 0090), and Pengo et al. teach gold nanostructures (Abstract).
Regarding claim 3, the nanostructure of claim 1 is discussed above. Fischer et al. teach the gold has a thio monolayer thereon (paragraph 0231), and that the primers are attached via groups at their 5’ ends (paragraph 0205). Pengo et al. teach attachment of the linker to the gold surface via a terminal thiol (Figure 3A) and the use oligonucleotides attached via their termini to a thiol (pages 756, column 1). Roesler et al. teach the thiols are attached to the gold (paragraph 0027) followed by a linker (Figure 1). Thus, it would have been obvious for each primer to be attached via its end to the end of its respective linker, wherein the linker is in turn attached to the gold surface via terminal thiol.
Regarding claim 4, the nanostructure of claim 3 is discussed above. Fisher et al. teach the use of polyethylene glycol chains as linkers (paragraph 0208). Pengo et al. teach the linkers include polyethylene glycol and polystyrene as taught by Percebom et al. (page 755, column 2), which are separate molecules as shown in Percebom et al. (page 4278, column 1).
Regarding claim 5, the nanostructure of claim 1 is discussed above. Roesler et al. teach branched linkers that are attached to a solid support and having two different functional groups attached thereto, wherein one functional group is bound to one primer and the other functional group is bound to a second primer (paragraphs 0102-0104). Thus, it would have been obvious to attach each set of the two primers taught by Fisher et al. with its own linker-monomer as taught by Pengo et al., wherein each linker monomer is a branched linker, wherein the branches are the claimed side chains, having the two primers of each set thereon.
8. Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (U.S. Patent Application Publication No. US 2021/0024991 A1, published 28 January 2021), Pengo et al. (European Biophysics Journal, vol. 46. pages 749-771, published 19 September 2017), and Roesler et al. (U.S. Patent Application Publication No. US 2010/0248991 A1, published 30 September 2010) as applied to claim 1 above, and further in combination with Drmanac et al. (U.S. Patent Application Publication No. US 2017/01525554 A1, published 1 June 2017), alternatively further in combination with Oldham et al. (U.S. Patent Application Publication No. US 2019/0169684 A1, published 6 June 2019).
It is noted that while claim 5 has been rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claims 5-8, the nanostructure of claim 1 is discussed above in Section 7.
While Roesler et al. teach. branched linkers that are attached to a solid support and having two different functional groups attached thereto, wherein one functional group is bound to one primer and the other functional group is bound to a second primer (paragraphs 0102-0104), the cited prior art does not teach the specific embodiments encompassed by claims 6-8, which also encompass claim 5.
However, Drmanac et al. teach the use of dendrimeric or branched structures having a thiol linkage with attachment points R on regions opposite the thiol end (i.e., claim 6; Figure 1G and paragraph 0046). The dendrimer structures include polymer chain backbone 1406, which is free of the respective side chains 1408 and 1410 (i.e., claim 7) which results in the respective side chains distributed along a backbone of polymer chain backbone 1406 (i.e., claim 8; Figure 1G). Drmanac et al. also teach the structures have the added advantage of allowing attachment to a surface as well as the capping of unreactive functionalities (paragraph 0046). Thus, Drmanac et al. teach the known techniques discussed above.
In addition, Oldham et al. teach dendrimers having different sequence of nucleic acid that are part of a monolayer (I.e., SAM), and which have the added advantage of allowing encoding of different binding regions (paragraph 0151). Thus, Oldham 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 cited prior art with the teachings of Drmanac et al., and alternatively further combine with the teachings of Oldham et al. The combination would result in the substitution of different dendrimeric structures in place of the different branched structures of Roesler et al. (i.e., claim 5), for each different pair of primers, thus arriving at the instantly claimed nanostructure 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 nanostructure having the added advantage of:
A. Allowing attachment to a surface as well as the capping of unreactive functionalities as explicitly taught by Drmanac et al. (paragraph 0046); and alternatively, the further advantage of
B. Allowing encoding of different binding regions as explicitly taught by Oldham et al. (paragraph 0151).
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 cited prior art predictably result in reliable attachment of different molecules to nanostructures.
Response to Arguments
8. Applicant’s arguments have been considered but are moot in view of the amendments and the new rejections necessitated by the amendments.
Conclusion
9. No claim is allowed.
10. 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).
11. 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.
12. 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
Prosecution Insights