FINAL ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Amendments and Status of the Claims
2. This action is in response to papers filed 21 September 2026 in which the specification and claims 49 and 53-55 were amended, no claims were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
Any previous objections and/or rejections not reiterated below are withdrawn in view of the amendments.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 49-56 are under prosecution.
Information Disclosure Statement
4. The Information Disclosure Statement filed 21 September 2025 is acknowledged and has been considered.
Claim Rejections - 35 USC § 103
5. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
7. Claims 49-50 and 52-54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011).
Regarding claim 49, Maglia et al. teach kits (paragraph 0174) including a transmembrane pore and a nucleic acid handling enzyme, as well as nucleotides and additional reagents and instruments (paragraphs 0173-0174). Maglia et al. further teach helicases (paragraph 0172), and nucleic acid sequences comprising modified nucleotides (paragraph 0071), and that the kits have the added advantage of allowing enhanced translation of the analyte through the nanopore (paragraph 0001). Thus, Maglia et al. teach the known techniques discussed above.
Maglia et al. do not explicitly teach the modified nucleotide is in a spacer.
However, Sorenson et al. teach systems (Abstract) comprising nanopores (paragraph 0222), helicases (paragraph 0217) and sequencing templates comprising internal spacers (i.e., linkers) comprising modified nucleotides (i.e., abasic sites; paragraph 0208), wherein the internal spacer (i.e., linker) interrupts a polynucleotide because it is in between the 3’ end of a first portion of a nucleic acid molecule and the 5’ end of a second portion of the nucleic acid molecule, and which has the added advantage of allowing either permanent or temporary blocking of the sequence process (paragraph 0033), which is a stated desire of Maglia et al. (paragraph 0190). Thus, Sorenson 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 Maglia et al. and Sorenson et al. to arrive at the instantly claimed kit 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 kit having the added advantages of allowing enhanced translation of an analyte through the nanopore as explicitly taught by Maglia et al. (paragraph 0001) and allowing either permanent or temporary blocking of the sequencing process next generation nucleic acids sequencing as explicitly taught by Sorenson et al. (paragraph 0033), which is a stated desire of Maglia et al. (paragraph 0190). 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 components useful for nanopore sequencing.
Regarding claims 50 and 52-54, the kit of claim 49 is discussed above.
Sorenson et al. teach one or more fluorophores (paragraph 0011), as well as one or more blocking agents in the linker (paragraph 0033). Maglia et al. teach nucleotides having fluorophores (i.e., fluorescent labels) attached thereto (paragraph 0071). Thus, it would have been obvious to have more than one fluorophore in the linker.
It is further 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.
Thus, placement of the fluorophores at any position along the oligonucleotide spacers is obvious.
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.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
In addition, further regarding claims 53-54, it is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04.
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).
It is 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)).
Therefore, the various uses recited in the claims (e.g., stalling in the presence of free nucleotides or cofactors or at specific salt concentrations) fail to define additional structural elements of the claimed kits. Because the cited prior art teaches the recited structural elements of the claim, the claims are obvious. See MPEP § 2114 and MPEP 2112.02.
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.
8. Claims 51 and 55 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011) as applied to claim 49 above, and further in view of Oliver (U.S. Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010).
Regarding claim 51, the kit of claim 49 is discussed above in Section 15.
None of the previously cited prior art teaches the claimed adaptors.
However, Oliver teaches molecules for use in nanopore translocation (Abstract), wherein the molecules are polynucleotides comprising a single stranded region 2100, a spacer (i.e., linker) region 2300, and a double stranded portion 2200 (Figure 22b and paragraph 0224). Oliver also teaches the molecules have the added advantage of improving the signal to noise ratio (Abstract). Thus, Oliver teaches 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 Oliver with the previously cited prior art to arrive at the instantly claimed kit 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 kit having the added advantages of improving signal to noise ratios as explicitly taught by Oliver (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Oliver could have been combined with the cited prior art with predictable results because the known techniques of the Oliver predictably result in adaptors useful for nanopore sequencing.
Regarding claim 555, the kit of claim 51 is discussed above. It is also reiterated that the courts have held that apparatus claims cover what a device is, not what a device does, and 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.
Therefore, the various uses recited in the claims (e.g., binding to only one or two helicases) fail to define additional structural elements of the claimed kits. Because the cited prior art teaches the recited structural elements of the claim, the claims are obvious.
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.
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claims 49-50 and 52-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,252,717 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011).
Both sets of claims are drawn to kits comprising a transmembrane pore and a helicase. Any additional limitations of the ‘717 claims are encompassed by the open clam language “comprising” found in the instant claims.
The ‘717 claims do not include the spacers.
However, the spacers and the additional limitations, as well as the rationale for combining, is taught by the cited prior art as discussed above.
11. Claims 51 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,252,717 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011) as applied to claim 49 above, and further in view of Oliver (U.S. Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010) based on the citations and rationale provided above.
12. Claims 49-50 and 52-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,258,591 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011).
Both sets of claims are drawn to kits comprising a transmembrane pore and a helicase. Any additional limitations of the ‘591 claims are encompassed by the open clam language “comprising” found in the instant claims.
The ‘591 claims do not include the spacers.
However, the spacers and the additional limitations, as well as the rationale for combining, is taught by the cited prior art as discussed above.
13. Claims 51 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,258,591 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011) as applied to claim 49 above, and further in view of Oliver (U.S. Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010) based on the citations and rationale provided above.
14. Claims 49-50 and 52-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 9,751,915 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011).
Both sets of claims are drawn to kits comprising a transmembrane pore and a helicase. Any additional limitations of the ‘915 claim is encompassed by the open clam language “comprising” found in the instant claims.
The ‘915 claim does not include the spacers.
However, the spacers and the additional limitations, as well as the rationale for combining, is taught by the cited prior art as discussed above.
15. Claims 51 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 9,751,915 B2 in view of Maglia et al. (U.S. Patent Application Publication No. US 2011/0311965 A1, published 22 December 2011) and Sorenson et al. (U.S. Patent Application Publication No. US 2011/0195406 A1, published 11 August 2011) as applied to claim 49 above, and further in view of Oliver (U.S. Patent Application Publication No. US 2010/0243449 A1, published 30 September 2010) based on the citations and rationale provided above.
Claim Objections
16. Claim 56 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims; specifically, because the claim requires the helicases are required to be stalled on the adapter while in the kit.
Response to Arguments
17. Applicant’s arguments filed 21 September 2026 have been considered. The previous objections and rejections under 35 U.S.C. 112(a) and (b) are withdrawn in view of the amendments. The previous art rejections are withdrawn in view of the amendments, and the arguments are moot in view of the new rejections necessitated by the amendments that are presented above.
Conclusion
18. No claim is allowed.
19. 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).
20. 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.
21. 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
