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 .
Claim Status
Currently, claims 1-20 are pending in the instant application. Claims 1-16 are under examination and claims 17-20 are withdrawn. This action is written in response to applicant' s correspondence submitted 02/03/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is FINAL.
Priority
The certified translation of PCT/CN2020/096940 and foreign application CHINA CN202010205841.1 was submitted on 02/03/2026. The effective filing date of the instant application is 3/23/2020.
Withdrawn Rejections
The rejection of claims 1-16 under 35 USC 101 is withdrawn in view of the amendment to the claims.
The rejection of claims 1-16 under 35 USC 102(a)(1) as being anticipated by Dai et al. (CN111074011 B) is withdrawn in view of the certified English translations provided for the priority documents of PCT/CN2020/096940 and CN202010205841.1
The rejection of claims 1, 4, 7, 9-10, 13-14 under 35 U.S.C. 103 as being unpatentable over Chu (WO 2021/263101 A1) in view of Lim et al. (KR20200056831A) is withdrawn in view of the filing of a certified translation of the priority documents of PCT/CN2020/096940 and CN202010205841.1.
The rejection of claims 1, 3, 7, 9-10, 13-14 under 35 U.S.C. 103 as being unpatentable unpatentable over Chu (WO 2021/263101 A1) in view of Lu (US 8163474 B2) is withdrawn in view of the filing of a certified translation of the priority documents of PCT/CN2020/096940 and CN202010205841.1.
The rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over Chu (WO 2021/263101 A1) in view of Lu (US 8163474 B2) as applied to claims 1, 3, 7, 9-10, 13-14 above, and further in view of Lim et al. (KR20200056831A) is withdrawn in view of the filing of a certified translation of the priority documents of PCT/CN2020/096940 and CN202010205841.1.
The rejection of claims 1, 13-15 under 35 USC 103 as being unpatentable over NEB catalog in view of Rothstein and Hodgson is withdrawn in view of the amendment to the claims.
Specification
The amendment filed 02/03/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: 6-Carboxyfluorescein (FAM®), Rhodamine-derived fluorescent dye(VIC®), and 6-Carboxy-4',5'-dichloro-2',7'-dimethoxyfluorescein (JOE®) on page 7 of the specification filed 02/03/2026. The recitation of 6-Carboxyfluorescein, Rhodamine-derived fluorescent dye, and 6-Carboxy-4',5'-dichloro-2',7'-dimethoxyfluorescein are not the chemical or generic names for FAM, VIC, and JOE and therefore the added material is new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim is not grammatically correct. There should be a semicolon followed by “and” after SEQ ID NO: 12, such that the claim recites “SEQ ID NO: 12; and” . Appropriate correction is required.
Claims 10-12 are objected to because of the following informalities: the claims capitalize the fluorescent reporter groups recited in the claims however these terms should not be capitalized. For example 6-Carboxyfluorescein should be 6-carbodyfluorescein. Appropriate correction is required.
New Grounds of Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to require the coronavirus 2019-nCoV probe is labeled with a fluorescent reporter group at the 5’ end and a quencher group at the 3’ end, the influenza probe is labeled with a fluorescent reporter group at the 5’ end and a quencher group at the 3’ end; the influenza B virus probe is labeled with a fluorescent reporter group at the 5’ end and a quencher group at the 3’ end. This recitation is not supported by the instant disclosure and raises the issue of new matter.
Claims 10-12 has been amended to recite 6-carboxyfluorescein, rhodamine-derived fluorescent dye, and 6-carboxy-4’5’-dichloro-2’7’-dimethoxyfluorescein. The recitation of these reporter groups is not supported by the instant specification and raises the issues of new matter.
With respect to claim 1, the specification provides support for a reporter that is different from each other and do not interfere with each other (see pg. 3). The specification does provide support for fluorescent reporter groups (see pg. 10-11) however the specification does not provide support for the quencher group. The specification does not provide support for the genus of quenchers and the location of the genus of quenchers. The specification provides support for specific quenchers of BHQ1 and BHQ2 (see pg. 11) and demonstrates the location at the 3’ end, however the disclosure provides no support for any other quenchers other than BHQ1 and BHQ2. A quencher group of BHQ1 and BHQ2 is supported on pg. 11 and recited in the sequence of SEQ ID NO 18, 21, and 24, demonstrating these two quenchers are located at the 3’ end. The specification does not provide support for broad genus of a quencher group.
With respect to claims 10-12, the specification does not provide support for the recitation of some of the generic fluorescent names recited in claims 10-12. The original specification discloses FAM, HEX, ROX, VIC, CY5, 5-TAMARA, TET, CY3, and JOE on page 5. The original disclosure does not provide generic names for the recited trademarks, however the chemical or generic names for the trademarks would not be new matter except that the recitation of 6-carboxyfluorescein is not the generic name for FAM, rhodamine-derived fluorescent dye is not the generic name for VIC, and 6-carboxy-4’5’-dichloro-2’7’-dimethoxyfluorescein is not the name for JOE. 6-carboxyfluorescein is the chemical name for 6-FAM and the specification does not have support for 6-FAM. The recitation of rhodamine-derived fluorescent dye is a large genus of different fluorescent dyes which the disclosure does not have support, the disclosure only recite VIC. The chemical name for VIC is 2′-chloro-7′-phenyl-1,4-dichloro-6-carboxyfluorescein, it is a fluorescein dye not a rhodamine dye. The specification does not provide any description or support for the large genus of rhodamine derived fluorescent dyes. The fluorescent label JOE chemical name is 4',5'-dichloro-2',7'-dimethoxy-5(6)-carboxyfluorescein not 6-carboxy-4’5’-dichloro-2’7’-dimethoxyfluorescein which is the chemical name for 6-JOE which is not disclosed in the instant disclosure.
Maintained Rejection
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 1-16 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. This rejection was previously presented and has been rewritten to address the amendment tot eh claims
Claims 1-6, 8, 11, 12 are indefinite for the recitation of “set forth in”. Each of the claims recite a primer or probe “set forth in” SEQ ID NO. It is not clear whether the claim consists, or encompasses fragments of each of the sequences. The metes and bounds of “set forth in” are unclear and indefinite. Set forth in may comprise a portion of the sequence not the entire sequence, for example. While applicant asserts in the remarks on page 1 mailed 02/03/2026 that set forth in are limited to the exact nucleic acid sequence disclosed in the corresponding SEQ ID Nos excluding any fragments or variants of the sequence, the specification does not define the phrase “set forth in” and this recitation could include the sequence or fragments thereof. This rejection could be overcome by reciting a primer comprising the nucleic acid sequence of SEQ ID NO 1, for example.
Claim 10 contains the trademark/trade name FAM, HEX, ROX, VIC, CY5, 5-TAMRA, TET, CY3, JOE. 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 fluorescent reporter and, accordingly, the identification/description is indefinite. While the claim recites a generic name followed by parenthesis of a trademark name, the recitation of a trademark name in a claim is indefinite. Additionally the recitation of the generic names recited in the claim do not necessarily correspond to the name within parenthesis. For example the recitation of 6-carboxyfluorescein is for 6-FAM not FAM, the recitation of rhodamine-derived fluorescent dye does not correspond to VIC. The chemical structure for VIC fluorescent dye is 2′-chloro-7′-phenyl-1,4-dichloro-6-carboxyfluorescein. The name for JOE is 4’, 5’-dichloro-2’, 7’-dimethoxy-5(6)-carboxyfluorescein and 6-carboxy-4’,5’-dichloro-2’7’-dimethoxyfluorescein does not correspond to JOE. Therefore the recitation in parenthesis is not equivalent to the terminology prior to the parenthesis and the recitation of trademarks in the claim renders the claim indefinite.
Claims 3-6 are indefinite for the recitation of a composition comprising. Claims 2 and 7 are indefinite for the recitation of a composition further comprising. Claim 1 recites a composition consisting of forward and reverse primers and probe set forth in SEQ ID NO 1-3 and at least one of the two groups of an influenza A virus primer and probe set forth in SEQ ID NO 7-8 and influenza B virus primer and probe set forth in SEQ ID NO 10-12. Claim 1 is a composition with closed language and does not allow for additional items within the composition. Claims 3-6 depend from claim 1 and recite composition comprising primers and probes of SEQ ID NO1-3 and 7-9, SEQ ID NO 1-3 and 10-12, SEQ ID NO 1-3, 7-9 and 10-12. It is unclear the metes and bounds of claims 2-7 because claim 1 requires that the composition only encompasses the primers and probes of SEQ ID NO 1-3, 7-9, 10-12 whereas claims 3-6 include additional items by the recitation of comprises. Further the limitation of claims 2 and 7 require additional items that are not recited in claim 1. It is unclear the metes and bounds of the claim as it is unclear if the composition of claim 1 only includes the recited elements of the claim or if the claim is intended to include additional elements in the composition. Because the scope of the claims is unclear and it would not be readily apparent if one was infringing on the claimed invention, the claims are therefore indefinite.
Claims 2-16 depend from claim 1 and are indefinite for the reasons applied to claim 1.
Response to Arguments
The response traverses the rejection on pages 1-3 of the remarks mailed 02/03/2026. The response asserts replacing as shown in with set forth in clearly defines the primers and probes are limited to the exact nucleic acid sequence disclosed in the corresponding SEQ ID NO, excluding any fragments or variants of the sequence. This response has been thoroughly reviewed but not found persuasive. The recitation of set forth in is not equivalent to consisting of SEQ ID NO, the recitation of set forth in does not require entire sequence, a sequence that is set forth in a sequence, does not require the entire sequence only a portion of the sequence. While the remarks assert that it is clearly defined and excludes any fragments or variants, the specification does not provide an explicit definition for “set forth in” and there is no clear and explicit statement in the specification to redefine set forth in to exclude fragments of the sequence. As such the claims have been given their broadest reasonable interpretation to include fragments.
The response asserts that applicant has supplemented the generic terminology corresponding to the trademarks recited in the claims. This response has been reviewed but not found persuasive. The recitation of a trademark in a claim is indefinite. Furthermore the terminology recited in claim 10 and 11 does not correspond to the claimed trademarks. For example there are two different FAM dyes, 5-FAM and 6-FAM and the claims recites 6-FAM, 6-carboxyfluorescein which is the generic name for 6-FAM not FAM. The amendment tot eh claims renders the claims indefinite for the reasons stated above.
For these reasons and reasons of record the rejection is maintained.
Claim Rejections - 35 USC § 112(d)
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 2-7 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. This rejection was previously presented and has been rewritten to address the amendment to the claims.
Claim 2-7 depends from claim 1. Claim 1 recites a compositions consisting of primers and probes of SEQ ID NO 1-3, 7-9 and 10-12. Claim 1 is consisting of transitional language and therefore the composition does not have any other elements within the composition other than what is recited in claim 1. Claims 2 and 7 depend from claim 1 and recite the composition of claim 1 comprises and recites the composition comprises additional elements. Claims 2-6 recite the composition comprises primers and probes of SEQ ID NO1-3, 7-9, and/or 10-12 however claim 1 does not recite a composition that comprises the recited primers or probes but consists of these the recited primer and probes. Because claim 1 is a composition that consists of the recited elements and therefore closed transitional language not allowing for additional components, claims 2-7 do not further limit the compositions that consists of SEQ ID NO 1-3, 7-9 and/or 10-12.
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.
Response to Arguments
The rejection with regard to claim 11 has been withdrawn due to the amendment tot eh claims. However the amendment to claims 2-7 render the claims as improper dependent claims from claim 1 for the reasons stated above.
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.
Claims 2-10, 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reeve et al (U.S. Patent No. 6,399,364; 04 June 2002). This rejection was previously presented and has been rewritten to address the amendment to the claims.
The claims are directed to a composition or a kit comprising a collection of primer and probe of SEQ ID NO 1-15. The claim contains additional language that includes intended use of the primers and probes for detecting or typing Coronavirus. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
The claim recites “primer …set forth in SEQ ID NO 1…primer…set forth in SEQ ID NO 2…probe..set forth in SEQ ID NO 3”, for example. As addressed above in the 112 section, “set forth in” broadly encompasses fragments from within the recited sequences.
Reeve et al teach compositions comprising all possible "N mer" oligonucleotides or subsets thereof "where N is preferably from 5 to 10, particularly 8 or 9" (see, e.g., col. 2, lines 62-67; claims 11 and 12; quotation from col 2, lines 63-65). Reeve et al teach that each of the 5 to 10 N-mers is labeled with a detectable moiety that is a detected by fluorescence and particularly detectable moieties that are fluorophores, including Cy3 and teaches composition comprises a buffer (see, e.g., col. 2, lines 62-67; col. 3, lines 18-21; col. 10, line 1) (claim 10). Reeves teaches a composition that comprises buffer (claim 14). Given that Reeve teaches compositions comprising all possible 5-10mers, it is a property of at least one of the nucleic acids in the composition that it comprises primers and probes encompassed by the claimed recitation.
While claim 1 recites a composition that consists of primers set forth in SEQ ID NO 1-3 and primers set forth in SEQ ID NO 7-9 and/or SEQ ID NO 10-12, dependent claims 2-10 recite a composition that comprises the primers. Because claims 2-10 include an embodiment that comprises additional components in the composition these claims are anticipated by Reeve. Claim 2 requires a primer as set forth in SEQ ID NO 1, a primer as set forth in SEQ ID NO 2, a probe as set forth in SEQ ID NO 3, a primer as set forth in SEQ ID NO 7, a primer as set forth in SEQ ID NO 8, and a probe as set forth in SEQ ID NO 9. Here Reeve teaches every possible 10mer, the composition of Reeve will inherently comprise a primer as set forth in SEQ ID NO 1-2, 4-5, 7-8, 10-11, 13-14 and a probe as set forth in SEQ ID NO 3, 6, 9, 12, 15 (claims 2-8). Reeves teaches every possible 10 mer in a composition as such Reeve teaches a components of the composition are in the same package (claim 9 and 13). Reeve additionally teaches fluorescently labeled oligomers, as such Reeve teaches fluorescent reporter groups.
Further, it is noted that the claims recite the open claim language of “comprising” and thereby the recited compositions may include any number of nucleic acid probes in addition to the claimed primers and probes.
Response to Arguments
The response traverses the rejection on pages 4-5 of the remarks mailed 02/03/2026. The response asserts that Reeve’s random oligonucleotide mixture is fundamentally different from the present application specific sequence combination for the precise targeting of three respiratory viruses. The response asserts the application explicitly limits specific sequence combination for SEQ ID NO 1-3, 7-9 and 10-12. This response has been reviewed but not found persuasive. The claims are not limited to a composition consisting of a forward primer consisting of the sequence of SEQ ID NO 1, a reverse primer consisting of the sequence of SEQ ID NO 2, and a probe consisting of the sequence of SEQ ID NO 3 and at least one of a primer pair and probes for Influenza A and Influenza B, wherein the primers consist of the sequence of SEQ ID NO 7 and SEQ ID NO 8 or SEQ ID NO 10 and SEQ ID NO 11 and the probes consist of the sequence of SEQ ID NO 9 and SEQ ID NO 12. Claims 2-10 recite a composition further comprises or a composition comprises, as such the claims have been given their broadest reasonable interpretation to include a composition that includes additional components, including additional sequences. Reeves teaches a composition that comprises every possible ten mer, the composition of Reeves includes oligomers that include sequences set forth in SEQ ID NO 1-3, 7-9 and 10-12. Therefore because the claims are not limited to primers that consist of the sequence of SEQ ID NO 1-3, 7-9, 10-12, Reeve anticipate the claims. If the claims were amended to clearly requite a composition that consists of primers and probe that consist of the sequence of SEQ ID NO 1-3, and 7-9 and/or 10-12 this rejection would be withdrawn.
Conclusion
No claims are allowable.
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).
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 SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
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