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.
Election/Restrictions
3. Applicant’s election of Group I in the reply filed on 27 October 2025 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Claims 9-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 27 October 2025.
Claims 1-8 are under prosecution.
Information Disclosure Statement
4. The Information Disclosure Statements filed 1 March 2023 and 21 June 2023 are acknowledged and have been considered.
Specification
5. The use of trade names or marks used in commerce (including but not necessarily limited to those listed on page 15 of the instant specification), 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 Rejections - 35 USC § 112
6. 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.
7. Claims 1-8 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.
Claim 1 (upon which claims 2-8 depend) is indefinite in the recitations “”respective first thiol linkages attached… the first polarity” and “respective second thiol linkages attached… the second polarity.” It is unclear a single primer is attached to multiple thiol linkages.
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. 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), Gethers et al. (U.S Patent Application Publication No. US 2015/0328616 A1, published 19 November 2015), and Roesler et al. (U.S. Patent Application Publication No. US 2010/0248991 A1, published 30 September 2010).
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). Fisher et al. further teach the primer sets comprise a firs primer including an uncleavable first primer and a cleavable second primer, and a second primer including a cleavable first primer and a second uncleavable primer (Abstract). Fisher et al. also teach chemically different regions comprising thiols on metals (e.g., gold; paragraph 0231), and that the different regions are adjacent one another (paragraph 0139) 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.
Fischer et al. also 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).
However, Gethers et al. teach nanostructured surfaces (paragraph 0041), in the form of nanoparticles and nanotubes comprising gold (paragraph 0070), where he nanostructure has two different monomers for binding polynucleotides (Abstract and paragraph 0006). Gethers et al. also teach the monomers have different polarities (i.e., dissimilar dipole moments; paragraph 0138), and that the nanostructures have the added advantage of creating a highly ordered surface for doing affinity assays (paragraph 0238). Thus, Gethers 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 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 monomers taught by Gethers 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 Gethers 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. Creating a highly ordered surface for doing affinity assays as explicitly taught by Gethers et al. (paragraph 0238); 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 Gethers 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). Gethers et al. teach attachment via a surface linking group, then a linker, then the monomer (Figure 8A and paragraph 0034), wherein the monomer is part of the nucleic acid (paragraph 0010). Roesler et al. teach the thiols are attached to the gold (paragraph 0027) followed by a linker (Figure 1). Thus, each primer is attached via a thio; at a first end of the monomer of the monolayer, and each primer is attached at the other end of the monomer of the monolayer.
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). Gethers et al. teach the linkers include polyethylene glycol (paragraph 0121) and styrene monomers (paragraph 0217), and that the thiols are on the monomers attached to the linkers (paragraph 0167).
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 Gethers 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.
11. 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), Gethers et al. (U.S Patent Application Publication No. US 2015/0328616 A1, published 19 November 2015), 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 10.
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), Roesler et al. do 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 pf 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.
Conclusion
12. No claim is allowed.
13. 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