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 .
Specification
2. The use of the terms ‘TPOXX’, DNA/RNA Shield on page 4; ‘Kingfisher’ on pages 4 and 28; ‘FAM, HEX, and Cy5’ on page 5; ‘Quantstudio’ on pages 5 and 28; and ‘Integra Voyager’ on page 28; on which is a trade name or a mark used in commerce, has been noted in this application. 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.
Note that ‘TPOXX’, DNA/RNA Shield, ‘Kingfisher’, ‘FAM, HEX, and Cy5’, ‘Quantstudio’, and ‘Integra Voyager’ are merely examples and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
4. The disclosure is objected to because of the following informalities: paragraph [00153] seems to be internal notes for editing the document. Appropriate correction is required.
Claim Rejections - 35 USC § 102
5. 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.
6. 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.
7. Claim(s) 1-3 and 8-10 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Andreyev (US 2019/0169677 A1; 6 June 2019).
Regarding claims 1 and 8, Andreyev teaches a reverse transcription PCR assay (¶ [0061]) that converts viral messenger RNA to produce DNA and amplifies the produced DNA in the presence of viral DN (¶ [0062]).
Regarding claims 2-3 and 9-10, Andreyev teaches that any of the devices and methods described can be utilized to detect a member of the Orthopoxvirus genus, specifically including Monkeypox (¶ [0257]).
Claim Rejections - 35 USC § 103
8. 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.
9. 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 non-obviousness.
10. Claims 4-5 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Andreyev (US 2019/0169677 A1; 6 June 2019) in view of Neubauer (J. Virol. Methods, Oct. 1998, 74(2), 201-207) and Li (J. Clin. Virol, Oct. 2010, 169(1), 223-227).
Andreyev teaches the reverse transcription PCR for detecting Monkeypox of claims 1 and 8, as seen above in paragraph 10. Andreyev fails to teach a generic orthopox virus primer set and clade-specific primer sets for detecting West African or Congo Basin Monkeypox virus.
However, Li teaches a PCR that is MPXV West African strain-specific and a PCR that is MPVX Congo Basin strain-specific (see Li, last ¶). Neubauer teaches the existence of previously published orthopoxvirus PCR assays, as well as a rationale to combine those generic assays with the MPXV assays to “allow for rapid and reliable identification of generalized poxvirus infections.” (See section
4. Discussion, last ¶).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to take the reverse transcriptase PCR for detecting Monkeypox of Andreyev and further including capabilities for detecting West African monkeypox strain, Congo Basin monkeypox strain, as well as a generic othropox virus. 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).
11. Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Andreyev (US 2019/0169677 A1; 6 Jun. 2019) in view of Luscher (WO 2019/218093 A1; 21 Nov. 2019).
Andreyev teaches the reverse transcription PCR for detecting Monkeypox of claims 1 and 8, as seen above in paragraph 10, as well as the two targets being conservative regions (¶ [00219]). Andreyev fails to teach a control targeting the human RNase P gene area.
However, Luscher teaches the usage of primers to amplify human housekeeping genes in assays, including RNase P, to help determine the integrity of the reagents, equipment function, and the presence of inhibitor in the samples (¶ [0009]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to take the reverse transcription PCR and two targets for monkeypox conservative areas of Andreyev and further including the human RNase P control of Luscher to result in a reverse transcription PCR with a control to indicate test result reliability. A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
12. Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Andreyev (US 2019/0169677 A1; 6 Jun. 2019) and Luscher (WO 2019/218093 A1; 21 Nov. 2019) in view of Shchelkunov (Virology, 28 Feb. 2002, 297, 172-194).
Andreyev and Luscher teach the reverse transcription PCR for detecting Monkeypox as well as the two targets being conservative regions and a human RNase P control in claims 6 and 13, as seen above in paragraph 14. Andreyev and Luscher fail to teach that the virus-specific targeting probes are allocated within DNA-binding phosphoprotein (2) (I3L) and Protein F11 (F11L) genes of the monkeypox virus.
However, Shchelkunov teaches that “all genes known to be essential in other orthopoxviruses are present in MPV and occupy the central region of the genome (ORFs C10L to A25R).” (Coding Region, ¶ 1). Additionally, Table 1 shows that I3L and C17L (which is the F11L VAC isolog), are both within this central region.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to take the combination of Andreyev and Luscher and targeting two genes in the conserved central region of monkeypox, as seen in Shchelkunov. The Supreme Court decided that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.).
Conclusion
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, Janet Andres can be reached at (571)-272-0867. 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
/JANET L ANDRES/Supervisory Patent Examiner, Art Unit 1671