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 .
Election/Restrictions and Status of the Claims
2. Applicant’s election of Group I in the reply filed on 25 February 2026 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Claims 15, 18-20, 22, 24-27, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 25 February 2026.
Claims 1-3, 6-8, and 11-14 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 15 September 2023 and 9 February 2024 are acknowledged and have 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.
Claim Objections
4. Claim 7 is objected to because of the following informalities: claim 7 recites “methacylate,” which appears to be a typographical error. Appropriate correction is required.
For the purposes of examination, the term is interpreted as “methacrylate.”
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 3 and 6-7 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 3 is indefinite in the recitation “an acrylic, an epoxy,” each of which is indicative of a single molecule rather than a polymer.
Claim 6 is indefinite in the recitation “a thiol/ene cross-linkable monomer mix,” which is indicative of a mix of monomers rather than a polymer.
Claim 7 is indefinite in the recitation “methacylate.” Although the term is interpreted as “methacrylate” as discussed above, it is unclear how “methacrylate” is a polymer, as “methacrylate” is indicative of a single molecule. Claim 7 is also indefinite in the recitation “isopropyl acrylamide,” which is indicative of a single molecule rather than a polymer.
For the purposes of examination, each of the terms is interpreted as being polymers of the listed molecules, as each of the other alternatives in the claims are clearly polymers.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. Claims 1-3, 6-8, 11-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Scholin et al. (U.S. Patent Application Publication No. US 2019/0290762 A1, published 26 September 2019) in combination with Gao et al. (U.S. Patent Application Publication No. US 2011/0008775 A1, published 13 January 2011).
Regarding claim 1, Scholin et al. teach a nanoparticle, in the form of a nano-architectured colloidosome (Abstract) comprising a first layer (i.e., core), a second layer (i.e., middle shell) and a third layer (i.e., outer shell), wherein each layer comprises active agents (Figure 4C and paragraphs 0049 and 0123). Scholin et al. further teach the active agents are attached to each shell/core (paragraph 0049), and the shells and cores each comprise polymers (paragraph 0009). Scholin et al. further teach the active agents attached to the shells are nucleic acids (paragraph 0011), and that attachment occurs via bonding (paragraph 0115). Thus, it would have been obvious to attach the nucleic acids to the second layer via accessory sites, in the form of moieties that can bind to the nucleic acids. In addition, because the third shell also has active agents attached, the third layer must also accessory sites, in the form of moieties that attach the active agents to the third shell.
With respect to binding a template nucleic acid, the nucleic acids attached to the second layer are template sites that can bind (via hybridization), to a template nucleic acid (which is not part of the claimed nanoparticle).
It is also noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claim (e.g., bonding to a template nucleic acid) fail to define additional structural elements of the claimed nanoparticle.
It is also noted that the courts have held that when a claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated (In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)). The phrase “for binding a template nucleic acid” clearly defines a use of the composition.
Thus, because the cited prior art teaches the structural elements of the claim, the claim is obvious, and the intended use does not further distinguish the composition over the prior art. See MPEP § 2114 and MPEP 2112.02.
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.
Scholin et al. also teach the nanoparticles have the added advantage of allowing release of the nucleic acids (i.e., active agents) in response to a stimulus (Abstract). Thus, Scholin et al. teach the known techniques discussed above.
Scholin et al. do not teach a single template site (i.e., single molecule).
However, Gao et al. teach nanoparticles (i.e., beads having nanometer diameters; paragraph 0054), wherein a particle has a capture sequence attached (paragraph 0103 and Figure 12), and that each nanoparticle has only a single molecule attached (paragraph 0062). Thus, there is only a single template site for bonding (i.e., capture molecule) on the nanoparticle. Gao et al. also teach the nanoparticles have the added advantage of enriching target sequences and deleting undesirable sequence templates from sequencing samples (Abstract). Thus, Gao 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 Scholin et al. and Gao 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 allowing release of nucleic acids in response to a stimulus as explicitly taught by Scholin et al. (Abstract) and enriching target sequences and deleting undesirable sequence templates from sequencing samples as explicitly taught by Gao et al. (Abstract). 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 nanoparticles useful for nucleic acid reactions.
Regarding claims 2-3 and 6, the nanoparticle of claim 1 is discussed above. Scholin et al. teach the first polymer (i.e., core) includes the hydrophilic polymer polyvinyl alcohol (i.e., paragraph 0009), and the third polymer (i.e., outer shell) is N-isopropylacrylamide (paragraph 0117).
Regarding claim 7, the nanoparticle of claim 1 is discussed above. Scholin et al. tech the use of polyacrylamide (paragraph 0009), and Gao et al teach the bead is polyacrylamide (paragraph 0104). Thus, it would have been obvious to have the first polymer (i.e., the core nanoparticle) be polyacrylamide. Scholin et al. further teach the third polymer (i.e., outer shell) is N-isopropylacrylamide (paragraph 0117).
With respect to the second polymer (i.e., middle shell), Scholin et al. teach shells made of polyacrylic acid (paragraph 0009). The courts have stated:
similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
The courts have also stated:
[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious) (see MPEP 2144.09).
Therefore, the claimed methacrylate (i.e., a polymer of methacrylic acid) is an obvious variant of the polyacrylic acid of the prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 8, the nanoparticle of claim 1 is discussed above. Scholin et al. teach the shells are copolymers of polyvinyl alcohol and N-isopropyl acrylamide (paragraph 0009), which are the core (i.e., first layer) and outer shell (i.e., third layer) as discussed above in the rejection of claims 2-3 and 6.
Regarding claims 11-12, the nanoparticle of claim 1 is discussed above.
It is noted that claim 11 recites “one or both;” thus, the claim does not require accessory oligonucleotides to be attached to the first plurality of accessory sties.
Gao et al. teach each nanoparticle has multiple copies of forward primers, or forward and reverse primers (paragraph 0100). Thus, it would have been obvious to have the primers of Gao et al. as the accessory oligonucleotides attached to the third shell via the second accessory sites.
In addition, with respect to claims 12 and 14, it is reiterated that recitations of intended use does not further limit the structure of an apparatus or composition. The phrase “sequences…permit amplifying…by a polymerase” in claim 12 and “for a template anchor oligonucleotide…” each clearly indicates an intended use, and does not further limit the structure of the claimed nanoparticle.
Further regarding claim 14, it is reiterated that the nucleic acid attached to the second layer is a template sites that can bind to a template nucleic acid, which is not part of the claimed nanoparticle, via hybridization.
10. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Scholin et al. (U.S. Patent Application Publication No. US 2019/0290762 A1, published 26 September 2019) in combination with Gao et al. (U.S. Patent Application Publication No. US 2011/0008775 A1, published 13 January 2011) as applied to claim 12 above, and further in view of Li et al (U.S. Patent Application Publication No. US 2014/0080717 A1, published 20 March 2014).
Regarding claim 13, the method of claim 12 is discussed above in Section 9.
While Gao et al. teach cleavage of synthesis products (paragraph 0071), neither Scholin et al. nor Gao et al. teach a mixture of cleavable primers.
However, Li et al. teach primers attached to nanoparticles (i.e., beads; paragraph 0779), wherein the primers are a mixture of cleavable and uncleavable primers, which have the added advantage of allowing release of the complementary portion of a polynucleotide from a surface while maintaining the attachment of the rest of the polynucleotide (paragraph 0187). Thus, Li 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 Li et al. with Scholin et al. and Gao 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 advantage of allowing release of the complementary portion of a polynucleotide from a surface while maintaining the attachment of the rest of the polynucleotide as explicitly taught by Li et al. (paragraph 0187). In addition, it would have been obvious to the ordinary artisan that the known techniques of Li et al. could have been combined with the cited prior art with predictable results because the known techniques of Li et al. predictably result in primers useful for nucleic acid reactions on bead surfaces.
Conclusion
11. No claim is allowed.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683