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. The previous Requirement for Species Election is withdrawn.
Claims 31-32 and 37-56 are under prosecution.
Specification
3. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
4. The abstract of the disclosure is objected to.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
5. The drawings were received on 27 January 2023, and the replacement sheets were received on 4 May 2026. These drawings are accepted.
Information Disclosure Statement
6. The Information Disclosure Statements filed 14 June 2023 and 7 May 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 Interpretation
6. The claims are subject to the following interpretation:
Claim 31 (upon which claims 32 and 37-56 depend) contains the limitation “the hybridization region of a probe of the panel comprises one or more non-natural nucleotides.” Thus, only one probe of the panel requires one or more non-natural nucleotides.
Claim Objections
7. Claim 51 is objected to because of the following informalities:
Claim 51 contains the text “a siRNA,” which appears to be a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 31-32 and 37-56 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.
A. Claim 31 (upon which claims 32 and 37-56 depend) is indefinite in each of the following:
I. The multiple recitations of “the target polynucleotides”, which lacks antecedent basis in the previous recitation of “two or more target polynucleotides.”
This limitation is also present in claims 37 and 41.
II. The multiple recitations of “the probes,” which lacks antecedent basis in the previous recitation of a “panel of two or more probes.”
This recitation is also present in claim 50.
III. The multiple recitations of “the pore,” which lacks antecedent basis in the previous recitation of a “transmembrane pore.”
This recitation is also present in claim 47.
IV. The recitations of “the hybridised probes” in (ii) (iii)(a),and , as there is no previous recitation of “hybridised probes.” In addition, the recitation in (iii)(a) is confusing and (iii)(a) only discusses one hybridized probe.
The recitation is also present in claim 47.
V. The recitation “the probe” in (iii)(a), which lacks antecedent basis in the previous recitation of a “probe of the panel.”
This recitation is also present in claim 44.
VI. The recitation “the window,” which lacks antecedent basis in the previous recitation of a “dwell time window.”
This recitation is also resent in each of claims 47-49.
VI. The recitation “ the current blockade,” which lacks antecedent basis in the previous recitation of current “blockades.”
VII. The recitation “each hybridized probe,” due to confusion with the previously noted confusing recitations of singular and plural probes.
B. Claims 39 and 40 are each indefinite in the recitation “the non-natural nucleotide,” each of which lacks antecedent basis in the previous recitation of current “one or more non-natural nucleotides.”
C. The term “short” in claim 48 is a relative term which renders the claim indefinite. The term “short” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
D. Claim 51 is indefinite in the recitation “the polynucleotides,” which lacks antecedent basis in the previous recitation of current “two or more target polynucleotides.”
Double Patenting
10. 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.
11. Claims 31-32 and 37-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,390,910 B2 in view of Gu et al. (U.S. Patent Application Publication No. US 2013/0220809 A1, published 29 August 2013)..
Instant claims 31 37-53 claim s1-20 of the ‘910 Patent and are drawn to probes having the instantly claimed regions, current blockades, anchors, polymers, etc. etc. Any additional limitations of the ‘910 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘910 claims do not diagnose a disease (i.e., claims 31-32) in a human (i.e., claim 54) using plasma (i.e., claims 55-56).
However, Gu et al. teach methods of using nanopores for diagnosing (i.e., detecting) cancer (i.e., claims 31-32; Abstract) using plasma samples from human (i.e., claims 54-56), and that the methods have the added advantage of being non-invasive and cost-effective (Abstract). Thus, Gu 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 modified the ‘910 claims with the teachings of Gu et al. to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in methods having the added advantage of being non-invasive and cost-effective as explicitly taught by Gu et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Gu et al. could have been applied to the ‘910 claims with predictable results because the known techniques of Gu et al. predictably result in useful techniques for detecting human disease.
Prior Art
12. The following prior art is hereby made of record, but not presently relied upon for any rejection, as it is considered pertinent to Applicant's disclosure.
Oliver et al. (U.S. Patent Application Publication No. US 2014/0212874 A1, published 31 July 2014) teach methods comprising providing two or more target polynucleotides, in the form of a plurality of DNA biomolecules (paragraph 0057), which are hybridized simultaneously with a panel (e.g., an entire universe) of probes (paragraphs 0061-0062). Oliver et al. also teach the probes comprise a non-hybridization region (e.g., a tag) and a hybridization region (Figures 8a-b and paragraphs 0087-0088l Figure 7a and paragraph 0086). Because Oliver et al. do not teach quadruplexes, the probes do not comprise a quadruplex.
However, Oliver et al. do not teach the nanopore is such that double-stranded polynucleotides cannot pass while a single stranded one can pass, nor do Oliver et al. teach the non-nucleotides in the hybridization regions increase the dwell time.
Conclusion
13. No claim is allowed.
14. 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
Prosecution Insights