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/Application
The amendment dated 06/25/2026 is acknowledged. Claims 1, 2, 4, 9, 11-12, and 39 are amended. Claims 22-38 and 40-60 are cancelled. No claims are newly added. Claims 1 – 21 and 39 are currently pending.
Priority
The instant application is a National Stage Application of PCT/CN2022/084601 filed 03/31/2022, and claims foreign priority to CN202110355785.4 filed on 04/01/2021. The certified copy has been filed in the instant application on 09/25/2023. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted in the instant application
on 12/14/2023, 02/24/2025, 07/03/2025, and 10/22/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, drawn to a compound or a kit containing a compound, and the election of species with traverse of Compound 7A in the reply filed on June 25, 2026, is acknowledged.
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The traversal is on the ground(s) that there is no serious burden to examine all of the claims together. This is not found persuasive, as this application is a national stage application, and the unity of invention standard applies. However, the amended claims have overcome the common technical feature cited in view of WO 2009/051807 (IDS 12/14/2023) by deleting -N3 as part of the linker group in the claimed compounds. The elected species is found to be free of the prior art, and thus, the search has been extended to include the full scope of claim 9.
Claim 9 is directed to an allowable product as it contains a disulfide attached to a benzoyl group as part of the linker and/or the reversible blocking group. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 12 – 19, Groups II – V, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 05/01/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1 – 21, and 39 are examined on the merits herein.
Objections to Specification
The use of the term iF100 which is abbreviated for iFluor 700, which is a trade name or a mark used in commerce, has been noted in this application. It is noted in pg. 70 and pg. 135 of the instant disclosure. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 1-8, 10, 12-13, 15, 18-21, and 39 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 claims 1-5, 7, and 21 the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 2-8, 20, and 39, the limitation "e.g." renders the claim indefinite because e.g. means "for example," and it is unclear whether the limitation(s) following "e.g." are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1-3, 5-6 and 39, the phrase “such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation of the variable L1, L2, R, and so on and the claim also recites "preferably, L1 is selected from," which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 1-8, 10, 12-13, 15, 18-20, and 39 recite "preferably," "more preferably," or "most preferably" multiple times (over 150 times in the claims that are being examined), so it is not feasible to list every instance of a broad limitation together with a narrow limitation in this rejection.
Claim 10 recites “if base1 is different, the additional detectable label carried by the compound of formula I varies; preferably, base2 is different, and the additional detectable label carried by the compound of formula II varies;”. This limitation is unclear because the claims do not state what base1 or base2 might be different from or what the detectable label varies from.
Claim 10 contains the trademark/trade name iF700, abbreviated for iFluor 700. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a fluorescent detectable label and, accordingly, the identification/description is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-11 and 14-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 10 and 20 depend from claim 1. Claims 10 and 20 each recite that the compound carries an additional detectable label. Detectable labels are not within the scope of formula I or formula II in claim 1 and are not present in the compounds recited in claim 9. So claims 10 and 20 fail to include all the limitations of the claim upon which they depend. In other words, claims 10 and 20 are broader than the claims upon which they depend. Claim 11 depends from claim 10 and includes all the limitations of claim 10. Claim 21 depends from claim 20 and includes all the limitations of claim 20.
Claims 14 and 15 each recite optional detectable label with a compound of claim 1, which is not within the scope of claim 1. Claims 16 – 18 require a compound of claim 10. Claim 19 depends from claim 18 and includes all the limitations of claim 18.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim recites a method for determining the sequence of a target single-stranded polynucleotide, which comprises 1) monitoring the incorporation of nucleotides complementary to the target single-stranded polynucleotide in a growing nucleic acid strand, wherein at least one complementary nucleotide incorporated is the compound or a salt thereof according to claim 1, and 2) determining the types of incorporated nucleotides.
Subject matter that is not patent eligible is determined by evaluating a claim for patentability based on the eligibility test set forth below:
(Step 1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter?
For the rejected claim, the answer is “Yes” because the claim is to a method (process).
(Step 2a) Prong 1: Does the claim recite or involve a judicial exception?
The answer is “Yes” because the claim recites the method steps 1) monitoring the incorporation of nucleotides and 2) determining the types of incorporated nucleotides, which fall under abstract ideas, specifically mental processes.
MPEP 2106.04(a)(2) states The "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.
(Step 2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The answer is “No” as there are no additional steps recited in the claim that integrate the judicial exceptions into a practical application. The claimed method ends with sequential or simultaneous removal of the reversible blocking group and the detectable label from the nucleotide. The claim does not further limit the determination with additional steps beyond the mental steps.
(Step 2b) Does the claim recite additional elements that amount to significantly more than the judicial exception?
The answer is “No” as the claim does not recite additional limitations amounting to significantly more than the judicial exception because sequential or simultaneous removal of the reversible blocking group and the detectable label from the nucleotide are considered to be well-understood, routine, and conventional in the field.
MPEP 2106.05(d) states Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry. If the additional element (or combination of elements) is a specific limitation other than what is well-understood, routine and conventional in the field, for instance because it is an unconventional step that confines the claim to a particular useful application of the judicial exception, then this consideration favors eligibility. If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.
As the instant claim recites judicial exceptions that are not integrated into a practical application and recite no elements that amount to significantly more than the judicial exceptions, the claim is found to not be drawn to eligible subject matter under 35 USC 101.
Allowable Subject Matter
Claim 9 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.
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This moiety in the reversible blocking group in the 3’-ribose and/or as part of the linker attached to the base is free of prior art.
The closest prior art is US 2018/0274024, design and synthesis of novel disulfide linked based nucleotides as reversible terminators for DNA sequencing by synthesis (title) which teaches a compound of formula
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Even though the prior art teaches a disulfide linker, it does not teach a disulfide attached to a benzoyl group as claimed in the instant application.
WO 2022/083686 A1, published on 04/28/2022 with a filing date of 10/21/2021 discloses compounds with the disulfide attached to a benzoyl group as the reversible blocking group similar to the compound of formula II recited in claim 1 of the instant application. However, WO’686 is not used as a prior art under 102(a)(2) as it has common inventors with the instant application and qualifies for the 102(b)(2)(A) exception.
Conclusion
Claims 1 – 8, 10– 21, and 39 are rejected. Claim 9 is objected to as depending from a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANAKI ANANTH MAHADEVAN whose telephone number is (571)272-0230. The examiner can normally be reached Monday-Friday 8-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 5712705241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.M./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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