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 .
Election/Restrictions
Upon further review and consideration, all species elections still remaining from those made of record on October 10th, 2024 are hereby withdrawn.
All organisms are being considered, as well as all SEQ IDs.
Response to Amendment
The amendment filed October 9th, 2025 is acknowledged. Regarding the Office Action mailed April 9th, 2025:
The rejections set forth under 35 U.S.C. 103 are withdrawn in view of the arguments.
The double patenting rejections are withdrawn in view of the arguments.
New grounds of rejection are set forth below, as necessitated by further considerations.
Claim Summary
Claims 10-18 have been canceled. Claims 1-9 are pending. Claims 1-9 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 112(a) – New – Necessitated by Further Considerations
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 1-9 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.
In making a determination of whether the application complies with the written description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). See MPEP § 2163.
Claims 1 and 2 recite options for forward primers, reverse primers, and probes for each bacteria species claimed. Claim 6 similarly recites options for forward primers, reverse primers, and probes for each yeast species claimed. As written, these claims appear to embrace methods wherein, for each bacteria and yeast species, any of the claimed forward primers specific for a species are interchangeable with each other, any of the claimed reverse primers specific for a species are interchangeable with each other, and any of the claimed probes specific for a species are interchangeable with each other. However, this aspect of the primers and probes being interchangeable is not further defined or described in the claims.
Regarding the primers and probes, the specification does not clearly define or describe that all forward primers, all reverse primers, and all probes for a particular species are necessarily interchangeable for each other.
When turning to the specification, there are several sections (see pages 42-46 of the instant specification) and tables (see pages 21-27) dedicated to the bacteria and yeast species that indicate particular genes are targeted by particular primers and probes. For example, Table 1 details primers and probes for Gardnerella vaginalis, indicating that SEQ ID NOs 1-4 are for the tuf gene, SEQ ID NOs 5-10 are for 23s rRNA, and SEQ ID NOs 11-13 are for 16s rRNA. Another example is Table 7, which details primers and probes for Candida krusei and Candida glabrata. This table indicates that SEQ ID NOs 60-62 are for the Candida krusei rRNA ITS and SEQ ID NOs 79-83 are for Candida krusei 18s rRNA. Within these primers and probes for specific genes, it also appears that, where there is more than one option for the primers and probes, specific combos of primers and probes are intended to be used together. For example, for Gardnerella vaginalis, while SEQ ID NOs 5-10 are all for 23s rRNA, SEQ ID NOs 5-7 are indicated for one 23s rRNA assay, and therefore for use together, and SEQ ID NOs 8-10 are indicated for another 23s rRNA assay, and therefore for use together (see Page 43, Example 3). There is no description where, for instance, SEQ ID NO 5, a forward primer, is interchangeable with SEQ ID NO 8, a different forward primer.
There are also bacteria species that appear to only have one gene target, but particular primers and probes are described for use together. One example is BVAB-2, where the only target is 16s rRNA. When looking at Example 4 (Page 43), SEQ ID NOs 30-32 appear to be for exclusive use with each other, while SEQ ID NO 33 can be used with either SEQ ID NOs 34 and 35 or SEQ ID NOs 36 and 37, indicating SEQ ID NOs 34-35 and 36-37 are interchangeable. However, while SEQ ID NO 33, a forward primer, can be used with two different sets of reverse primers and probes, it is not described as interchangeable with SEQ ID NO 30, a different forward primer, for BVAB-2 16s rRNA.
The examples presented above are non-exhaustive, but similar descriptions are noted for the other bacteria and yeast species claimed. These descriptions indicate that particular primers and probes are intended to work together, and all forward primers, all reverse primers, and all probes for a particular species are not necessarily interchangeable as currently claimed. Therefore, the Applicant does not have possession of the method as currently claimed. Claims 3-5 and 7-9 suffer from the same issue due to their dependence from claims 1 and 6 respectively, and not further detailing which specific primers and probes are intended to be used together. It is noted by the Examiner that claims 3 and 7 do appear to more narrowly claim one specific option for each primer and probe that are intended to work together on the same target in the same bacteria or yeast species, and these options have support for use together in the specification. For instance, claim 6 recites “the set of primers to produce an amplification product from Candida krusei comprises a forward primer of SEQ ID NO: 79, and a reverse primer of SEQ ID NO: 80, and the one or more detectable probes is SEQ ID NO:81”, all of which are described as targeting C. krusei 18s rRNA in Table 7. However, it is further noted that this does not solve the issues noted for the claims that they depend from given all the bacteria and yeast species claimed, and therefore, they are rejected as indicated above.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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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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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683