DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Currently, claims 1-20 are pending in the instant application. Claims 1-10 are withdrawn from consideration as being drawn to a non-elected invention. Claims 11-20 are currently under examination.
All the arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections constitute the complete set being presently applied to the instant Application. Response to Applicant's arguments follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
Claims 11-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moon (Moon, John, WO 2020/005557, January 2, 2020; cited in the IDS dated 2/4/2025).
With regard to claims 11-15, and 17-20, Moon teaches a method for sequencing nucleic acids (see figure 3) comprising:
adding, by a polymerase (fig 3: 38), nucleotides to a first polynucleotide using at least a sequence of a second polynucleotide (fig 3: 50 and 48 respectively); hybridizing labels (base pairing) respectively coupled to the nucleotides (fig 3: 28, 40, 32) to a gap region (fig 3: 22; terminal end) of a polymer (DNA polymer, third and fourth polynucleotide) chain (fig 3: 18, 20) of a bridge spanning a space between first and second electrodes (fig 3: 12, 15), the gap region (gap region includes stabilizing region, see figure 3) comprising first and second universal monomer (“the polynucleotide chains 18, 20, may include any nucleic acid analogs”, including “universal bases”; non naturally occurring DNA); and
detecting a sequence in which the polymerase adds the nucleotides to the first polynucleotide using at least changes in an electrical signal through the bridge that are responsive to respective hybridizations between the universal monomers and the labels corresponding to those nucleotides, wherein the universal monomers hybridize to any monomers within the labels (para 0037).
Response to Arguments
The response traverses the rejection and asserts that the office action does not explain why the disclosure of Moon, that chains 18, 20 may include any nucleic acid analogs including “universal bases” should be interpreted as specifically meaning that Moon’s gap region should be equated with “a gap region comprising first and second universal monomers”. This argument has been thoroughly reviewed but was not found persuasive because the gap region on strand 20, for example, is comprised within strand 20. The arguments that Moon’s paragraphs 0045 and 0067-0072 merely disclose that gap 22 includes G, A, C, T, and/or U is not found persuasive because this ignores the teachings of Moon that chain 20 can comprise nucleic acid analogs, such as universal bases. The rejection is maintained.
Claim Rejections - 35 USC § 103
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Moon in view of Oldham (Oldham et al; WO 2017/189930; cited in the IDS dated 2/4/2025).
The teachings of Moon are set forth above and incorporated herein. Moon does not teach a universal base that is inosine, however Oldham teaches methods of sequencing nucleic acids
Oldham teaches a similar biosensor wherein the sensor detects a change in conductance upon addition of tunneling labels, which can comprise nucleotides that hybridize to nucleic acid polymers bound to an electrode (para 0086) and also teaches the universal base can include inosine (para 0103). Therefore it would have been prima facie obvious to one of ordinary skill in the art to have used inosine in the method of Moon in view of the teachings of Oldham.
Response to Arguments
The response traverses this rejection for the reason set forth above regarding the reference of Moon. This is not found persuasive for the reason made of record above.
Double Patenting
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.
Claims 11 -20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-19 of U.S. Patent No. 11,332,786 in view of Oldham.
The claims of the ‘786 patent teach a polynucleotide sequencing method comprising adding, by a polymerase, nucleotides to a first polynucleotide using at least a sequence of a second polynucleotide; hybridizing labels respectively coupled to the nucleotides to a gap region of a polymer chain of a bridge spanning a space between first and second electrodes, and detecting a sequence in which the polymerase adds the nucleotides to the first polynucleotide using at least changes in an electrical signal through the bridge that are responsive to respective hybridizations between the the labels corresponding to those nucleotides. However, the claims of the ‘786 patent do not teach the gap region comprises universal monomers. However, Oldham teaches a similar biosensor based method of nucleic acid analysis that utilizes tunneling nucleotide labels which hybridize to a gap region of a monolayer (para 0086-0103), including universal bases in the monolayer. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have modified the method of the ‘786 claims with the universal bases taught by Oldham for the expected result of nucleic acid sequencing using tunneling nucleic acid labels.
This rejection is maintained from the previous office action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Merriman et al; US 2019/0094175 teaches molecular sensors that comprise double stranded DNA bridge attached to electrodes separated by a gap. Merriman teaches (see figure 51) a polymerase in contact with the nucleic acid bridge, capable of adding nucleotides to a first nucleic acid using a sequence of the second nucleic acid. However, Merriman does not teach a gap region in the DNA bridge, let alone a gap region that comprises universal monomers (universal base). Furthermore, the signals generated by the addition of specific nucleotides is effected by a cleavable linker, not by hybridization of a nucleotide label to a gap region in the polymer bridge.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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, Winston Shen, can be reached on (571) 272-3157. The fax phone number for 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.
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
Prosecution Insights