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 .
Claim Status
2. This Office Action is in response to the amendment filed 09 July 2026, wherein claims 1-8, 15-16, and 18-19.
Claims 9-10 and 13-14 are withdrawn.
Claims 1-8, 11-12, and 15-20 are under consideration.
Priority
3. The Instant Application is a CON of PCT/CN2022/117972 filed 09 September 2022, which claims priority to foreign application CN202111356118.4 filed 16 November 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A certified English translation was filed on 09 July 2026. Claims 1-8, 11-12, and 15-20 are supported by the foreign priority document and thus the U.S. the effective filing date of these claims is 16 November 2021.
Objections Withdrawn
Drawings
4. The objection to the drawings because the lines in Figure 1 are indiscernible is withdrawn in view of Applicant’s amendments.
Specification
5. The objection to the abstract for improper language is withdrawn in view of Applicant’s amendments.
6. The objection to the specification for the use of trade names or marks used in commerce is withdrawn in view of Applicant’s amendments.
Claim Objections
7. The objections to claims 1-2, 4, 6-8, 15, and 18-19 for informalities are withdrawn in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112
8. The rejections of claims 2, 7, 8, and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the following issues:
Claims 2 and 7 for multiple structural interpretations;
Claim 8 for insufficient antecedent basis; and
Claim 18 for “second” implying an additional composition
are withdrawn in view of Applicant’s amendments.
9. The rejection of claim 7 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 103
10. Applicant’s arguments, see page 4, section 1.3, filed 09 July 2026, with respect to the rejection of claims 15-17 under 35 U.S.C. 103 as being unpatentable over Poetter (WO 2013049891 A1; published 11 April 2013) (See IDS filed 07 November 2024) in view of Lee (BioTechniques, August 1999, 27: 342-349) (See PTO-892 mailed 09 April 2026); NCBI reference sequence NC_007367.1 (13 August 2018) (See PTO-892 mailed 09 April 2026); GenBank CY018505.1 (29 December 2006) (See PTO-892 mailed 09 April 2026), OP342736.1 (13 December 2022), and KF543930.1 (01 December 2013) (See PTO-892 mailed 09 April 2026); Rychlik (Nucleic Acids Research, 1989, 17(21): 8543-8551) (See PTO-892 mailed 09 April 2026); and Buck (Biotechniques, 1999, 27: 528-536) (See PTO-892 mailed 09 April 2026) have been fully considered and are persuasive. The rejection of claims 15-17 has been withdrawn.
Rejections Maintained
11. 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 § 112
12. Claims 1-8, 11-12, and 15-20 remain/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, 3, 5-6, 15-16, and 18-19, it is unclear as to what “as shown in” means. Examiner is interpreting this limitation to be equivalent to “comprising” and thus the sequence could be the full sequence or a fragment thereof. Examiner suggests replacing this phrase with “comprising”.
Claims 2-8 and 11-12, which depend on claim 1, are similarly rejected.
Claims 16-17, which depend on claim 15, are similarly rejected.
Claims 19-20, which depend on claim 18, are similarly rejected.
Claim 4 still contains the trademark/trade name “JOE”.
Claim 8 recites the limitations “detection primers” and "detection probes". There is insufficient antecedent basis for the limitations in the claim.
New Objections
13. Claims 2 and 18 are objected to because of the following informalities:
Regarding claim 2, the comma after “probe” should be removed.
Regarding claim 18, “comprising” should be inserted after “the nucleic acid composition” in line 3.
Appropriate correction is required.
Claim Interpretation
14. The “R” in SEQ ID NO: 10 is being interpreted as a purine (guanine or adenine).
New Rejections
Claim Rejections - 35 USC § 112
15. 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.
16. In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 ¶ 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include: (1) the breadth of the claims, (2) the nature of the invention, (3) the relative skill of those in the art, (4) the presence or absence of working examples, (5) the amount of direction or guidance provided, (6) the state of the prior art, (7) the level of predictability in the art, and (8) the quantity of experimentation necessary.
17. Claims 1-8 and 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a composition wherein each virus’ probes has a different fluorescent group, does not reasonably provide enablement for a composition wherein the probes of multiple viruses have the same fluorescent group. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The claims are drawn to a composition made of two nucleic acid compositions, each with primers and probes to multiple viruses, and kits thereof.
The nature of the invention is a composition for detecting and identifying a pathogen made of two nucleic acid compositions of primers and probes.
The level of skill of one of ordinary skill in this art is high.
The specification provides the fluorescent groups on each probe in Table 1 (¶ [0074]), wherein influenza A and human adenovirus uses FAM, influenza B and RSV use HEX, and human rhinovirus and mycoplasma pneumoniae use CY5.
A search of the art shows Lee (August 1999, BioTechniques, 27(2): 342-349) teaches “Fluorescent dyes can be obtained in a broad spectrum of colors, allowing the use of multiple probes in one tube.” (Page 342, Introduction). See Table 3 and Figure 3, respectively:
PNG
media_image1.png
559
560
media_image1.png
Greyscale
PNG
media_image2.png
869
554
media_image2.png
Greyscale
These show that each dye has its own fluorescence wavelength, allowing for up to seven samples to be run and distinguished simultaneously.
Therefore, one would not be able distinguish the results of the two nucleic acid compositions in a single composition for detecting and identifying a pathogen, as recited. The duplicate fluorescent groups would not allow for the identification of a single pathogen and will interfere with each other.
Claim Rejections - 35 USC § 103
18. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
19. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
20. Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Poetter (WO 2013049891 A1; published 11 April 2013) (See IDS filed 07 November 2024) in view of Lee (BioTechniques, August 1999, 27: 342-349) (See PTO-892 mailed 09 April 2026); NCBI reference sequence NC_007367.1 (13 August 2018) (See PTO-892 mailed 09 April 2026); GenBank CY018505.1 (29 December 2006) (See PTO-892 mailed 09 April 2026), FJ445119.1 (10 April 2009), and KF543930.1 (01 December 2013) (See PTO-892 mailed 09 April 2026); Rychlik (Nucleic Acids Research, 1989, 17(21): 8543-8551) (See PTO-892 mailed 09 April 2026); and Buck (Biotechniques, 1999, 27: 528-536) (See PTO-892 mailed 09 April 2026).
Regarding claims 15-16, Poetter teaches “a method of screening a sample for a multiplicity of respiratory pathogens” using PCR by “subjecting the nucleic acid to amplification, wherein an aqueous primer pair directs the amplification of a region of nucleic acid from a respiratory pathogen, the number of primer pairs being selected on the basis of the number of pathogens desired to be screened… wherein the amplicon is captured by hybridizing to an oligonucleotide probe that is complementary to a region of the amplicon…” (¶ [0009]). Poetter also includes a list of all the respiratory pathogens that can be detected, including Influenza A; Influenza B; and Human Rhinovirus; (¶ [0014]), as well as the specific nucleic acid targets (¶ [0015]). Poetter also teaches that the primer pairs and probes are selected from the SEQ ID NOs listed in Table 8 and that two or more primer pairs + probes are selected, up to 18
(¶ [0134J). In addition, Poetter also teaches “An oligonucleotide probe may be labeled with a detectable label, as herein described, using any convenient means, including those exemplified hereinbefore with respect to labeling of the strain-specific amplicon.” (¶ [0137J) and a huge list of potential fluorescent groups, including FAM, HEX, ROX, Cy5, TAMRA, TET, CY3, and JOE (¶ [0138]). In summary, Poetter teaches a method of detecting and identifying different respiratory pathogens by using a mix of primers and probes specific for each pathogen to be detected, as well as labeling the probes with a fluorescent group. Poetter does not teach the specific SEQ ID NOs nor that the fluorescent groups do not interfere with each other.
However, Lee teaches seven different dyes with different wavelengths, allowing them to be distinguished in PCR (Table 3 and Figure 3):
PNG
media_image1.png
559
560
media_image1.png
Greyscale
PNG
media_image2.png
869
554
media_image2.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the large list of fluorescent groups and further chose seven with different wavelengths in order for the different pathogens to be distinguishable. In this case, since only three different pathogens are being detected, only three different fluorescent groups need to be selected. One of ordinary skill would be motivated to choose FAM, HEX, and CY5 because FAM has an emission wavelength of 517 nm, HEX has an emission wavelength of 559 nm, and CY5 has an emission wavelength of 670 nm (AAT Bioquest, Accessed 28 September 2026). Therefore, FAM, HEX, and CY5 will not interfere with each other. A rationale to support a conclusion that a claim would have been obvious is that there is some teaching, suggestion, or motivation in the prior art or in the knowledge generally available to one of ordinary skill in the art to modify the reference or combine reference teachings, and the modification or combination would have a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, G. and 2143.02).
Regarding the specific sequences for the primers and probes being used, the following sequences were found on NCBI BLAST:
NCBI Reference Sequence NC_007367.1, which contains SEQ ID NOs: 1-3, note that SEQ ID NO: 3 is found between the two primers:
PNG
media_image3.png
183
704
media_image3.png
Greyscale
PNG
media_image4.png
38
629
media_image4.png
Greyscale
GenBank CY018505.1, which contains SEQ ID NOs 4-6, note that SEQ ID NO: 6 is found between the two primers:
PNG
media_image5.png
190
658
media_image5.png
Greyscale
PNG
media_image6.png
41
624
media_image6.png
Greyscale
GenBank FJ445119.1, which contains SEQ ID NOs: 7-9, note that SEQ ID NO: 9 is found between the two primers:
PNG
media_image7.png
158
443
media_image7.png
Greyscale
PNG
media_image8.png
48
502
media_image8.png
Greyscale
SEQ ID NO: 9
GenBank KF543930.1, which contains SEQ ID NO: 10:
PNG
media_image9.png
198
678
media_image9.png
Greyscale
Although SEQ ID NO: 10 is not found in the same sequence as SEQ ID NOs: 7-9, it would be obvious to screen for the additional human rhinovirus strain disclosed in KF543930.1, using primers that flank either side of SEQ ID NO: 10 (which would be used as a probe).
Rychlik teaches it is routine and predictable to make primers for DNA amplification wherein primers are designed to a known oligonucleotide sequence. Rychlik teaches criteria to design/choose suitable primers for DNA amplification (see whole document and Abstract). Buck expressly provides evidence of the equivalence of primers. Specifically, Buck invited primer submissions from a number of labs (39) (Page 532, Column 3), with 69 different primers being submitted (Page 530, Column 1). Buck also tested 95 primers spaced at 3 nucleotide intervals along the entire sequence at issue, thereby testing more than 1/3 of all possible 18 met primers on the 300 base pair sequence (Page 530, Column 1). When Buck tested each of the primers selected by the methods of the different labs, Buck found that every single primer worked (Page 533, Column 1). Further, every single control primer functioned as well (Page 533, Column 1). Buck expressly states "The results of the empirical sequencing analysis were surprising in that nearly all of the primers yielded data of extremely high quality (Page 535, Column 2)." Therefore, Buck provides direct evidence that all primers would be expected to function, and in particular, all primers selected according to the ordinary criteria. This clearly shows that every primer would have a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the method of Poetter and further replace their primers and probes with the ones as claimed.
Taken together, it would have been obvious to make a composition using the method of Poetter to detect and identify Influenza A, B, and two Human Rhinovirus strains using the primers and probes made obvious above, in PCR. It would have further been obvious to add fluorescent groups that do not interfere with each other so that the different viruses can be distinguished from each other, as discussed by Lee.
Regarding claim 17, Poetter further teaches “Table 8 provides a list of primers and capture probes used in the assay method and kit for respiratory pathogens. At least two primer pairs and corresponding probes are used in the kit. By "at least two" means 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1, 12, 13, 14, 15, 16, 17 or 18.” (¶ [0182]). Therefore, it would be obvious to one of ordinary skill before the effective filing date to take the composition of claim 15 and further add it to a kit. See In re Venezia 189 USPQ 49 (CCPA 1976), where kits are drawn to the structural attributes of interrelated component parts and not to activities that may or may not occur.
Response to Traversal
21. Applicant argues that Poetter does not disclose the claimed rhinovirus dual-probe design, nor do the additional references provide a teaching or motivation for such a dual-probe design. Applicant further argues that their probes (SEQ ID NOs: 9-10) are specifically designed to cover different rhinovirus mutation types and avoid cross-reactivity with enterovirus and that one of ordinary skill would not be motivated to choose SEQ ID NOs: 1-10 simply due to the existing of GenBank sequences. Applicant also argues unexpected results of their dual-probe design.
The argument that Poetter does not each a rhinovirus dual-probe design specifically for distinguishing rhinovirus from enterovirus is not commensurate in scope with the claims. The claims merely require SEQ ID NOs: 1-10, which are made obvious through their template sequences. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The motivation for using their template sequences is made by the desire of one of ordinary skill to screen for those specific viruses and strains. As taught by Rychlik and Buck supra, selecting any primer and probe on the template sequence would be obvious. There is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004).
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding Applicant’s argument of unexpected results, there is no comparison to the closest prior art nor statistical significance presented.
22. Applicant’s arguments regarding claims 1 and 18-20 have been fully considered but are rendered moot as the claims in question have no applied art rejections.
Conclusion
23. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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, Michael Allen can be reached at (571) 270-3497. The fax phone number for the 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.
/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
