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 .
The claims dated 10/25/2024 are under consideration.
Election/Restrictions
Applicant’s election of Group I, claims 1, 2, 3, 5-7, 9-10, 12, 14, 15, 17, 19, 20, 22, 23, 25, 27 and 29 in the reply filed on 6/29/2026 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)).
Claim 30 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/29/2026.
Priority
The present application is a 371 national stage entry of PCT/EP2022/077537 (filed 10/4/2022), and claims benefit of UNITED KINGDOM 2114183.3 (filed 10/4/2021).
Priority is recognized.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout 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 or cited on a submitted IDS, they have not been considered.
Drawings
High resolution copies of the drawings may be accessed via PAIR/Patent Center Retrieval using the Supplemental Content tab.
Claim Interpretation
It is noted the claims introduce elements with the term “optional” or “optionally”. Claim scope is not limited by claim language that makes optional but does not require steps to be performed. MPEP 2111.04.
Claim 12 is interpreted as further limiting the elements that are “optionally” included in claim 10.
Claim Rejections - 35 USC § 112
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.
Claims 2, 5 and 14 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.
Regarding claim 2, the claim recites a result or property of the method of claim 1. It is unclear whether any additional elements or steps are required in order to achieve the recited result or confer the recited property.
Regarding claim 6, it is unclear based on the use of the passive voice whether the claim requires a further additional active method step of “observing the electrical or current effect associated with the target polymer before and/or after the electrical current or current effect associated with the polymer-guided effector protein”.
Regarding claim 14, the claim depends from claim 7 and recites “the polynucleotide-guided effector protein”. The recitation lacks proper antecedent basis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 3, 5-7, 9-10, 12, 14, 15, 17, 19, 20, 22, 23, 25, 27 and 29 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Heron (US 2020/0024654 A1).
Regarding claims 1, 3, 7 and 9, Heron teaches contacting a sample with a guide polynucleotide as a “guide polymer” that binds to: 1) a sequence in a target polynucleotide; and 2) a polynucleotide-guided effector protein. Heron further teaches the guide polynucleotide and polynucleotide-guided effector protein form a complex with any target polynucleotide present in the sample. See para. 8.
Heron further teaches contacting the sample with a membrane comprising a transmembrane pore (para. 8). The transmembrane pore is a biological pore (para. 319).
Heron further teaches applying a potential difference across the membrane (para. 8). Heron teaches measuring current as “one or more electrical measurements” (para. 368-369).
Heron further teaches monitoring for the presence or absence of an effect resulting from the interaction of the complex with the transmembrane pore to determine the presence or absence of the complex, thereby detecting the target polynucleotide in the sample.
Regarding claim 2, the claim does not specify any further limitations of claim 1 but rather recites a property or intended result. Heron anticipates claim 2 because it teaches all of the positively recited, active method steps of claims 1 and 2.
Alternatively, Heron measures “more complex” current levels in the form of current deflections (para. 66, 67 and 429). See also Figs. 39 and 40.
Regarding claim 5, the claim does not specify any further limitations of claims 1 and 2 but rather recites a property or intended result. Heron anticipates claim 5 because it teaches all of the positively recited, active method steps of claims 1, 2 and 5.
Alternatively, Heron measures “more complex” current levels in the form of current deflections (para. 66, 67 and 429), which are “inconsistent effects”. See also Figs. 39 and 40.
Regarding claim 6, the claim does not specify any further limitations of claims 1 and 2 but rather recites a property or intended result. Heron anticipates claim 6 because it teaches all of the positively recited, active method steps of claims 1, 2 and 6.
Alternatively, Heron measures multiple electrical or current effects before and after the electrical or current effect associated with the polymer-guided effector protein (Fig. 22 and 32; para. 50, 60 and 399, 406).
Regarding claim 10, Heron teaches the “guide polynucleotide” is a guide RNA and the “polynucleotide-guided effector protein” is an RNA-guided effector protein (para. 5).
Regarding claim 12, the claim further limits elements that are “optionally” included in claim 10. Heron anticipates claim 12 because it teaches all of the positively recited, active method steps of claims 1, 10 and 12.
Alternatively, Heron teaches the RNA-guided effector endonuclease is Cas or C2c2 or Cas9 (para. 147).
Regarding claims 14 and 15, Heron teaches the “guide polynucleotide” is a guide RNA comprising a crRNA that binds to a sequence in the target polynucleotide and a tracrRNA (para. 159).
Regarding claim 17, Heron teaches one or more anchors are present on the guide polynucleotide or the polynucleotide-guided effector protein (para. 211). Heron teaches the anchor may be cholesterol (para. 212).
Regarding claims 19, 20 and 22, Heron teaches the claimed method elements as described in paragraph 429 and depicted in Figs. 39 and 40. See also paras. 90 and 91.
Regarding claim 23, Heron further teaches the method comprises determining the amount of the target polypeptide or one or more characteristics of the target polynucleotide (para. 101).
Regarding claim 25, Heron teaches the biological pore may be natural or derived from a transmembrane pore (para. 323-324).
Regarding claim 27, Heron teaches the biological pore may be artificial, such as a DNA origami pore (para. 319).
Regarding claim 29, Heron teaches membrane is preferably a solid state layer (para. 284) or a triblock copolymer (para. 285-286).
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 1, 2, 5-7, 9-10, 12, 14, 15, 17, 19, 20, 22, 23 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,739,379 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are sufficient broad so as to encompass the narrower embodiments of the ‘379 claims.
Claims 3, 25 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,739,379 B2 in view of Heron (US 2020/0024654 A1).
The present claims differ from the ‘379 claims based on the limitations of claims 3, 25 and 29.
However, as noted in the 102 rejections above, these features are taught by Heron.
It would have been prima facie obvious to have included the elements of Heron in the methods of the ‘379 claims in order achieve the results of Heron.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
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