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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
DETAILED ACTION
Claims 1-16 and 18-25 are canceled. Claims 17 and 26 are pending and under consideration in this action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The English translation of CN202010427735.8 was received on 05/14/2025.
The instant claims are entitled to an effective filing date of 05/14/2025.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites “an bio-vector” in line 6, which should be “a bio-vector”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 17 and 26 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.
Claim 17 recites “wherein the generic bio-vector Salmonella sp. is derived from a continuous in-vitro culture of a bio-vector bacterium Salmonella sp. S9…for passage to the fortieth generation and above, the strain derived from the passage 40th to 60th generation is named as a generic bio-vector S9H”, which renders the claim indefinite because, in one interpretation, the claim requires the generic bio-vector to be any strain from the fortieth generation and above, and under an alternative interpretation, the generic bio-vector is required to be from the 40th-60th generation and named S9H.
Claim 26 depends from claim 1 and is rejected for the reason set forth above.
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.
Claims 17 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product, which is a judicial exception, without significantly more. Each step described below is in reference to the subject matter eligibility test for products and processes (MPEP 2106).
Claim 17 recites a “generic bio-vector indirect agglutination test detection system” in line 1. Therefore, claim 17 and dependent claim 26 are drawn to a composition of matter, which is one of the statutory categories (Step 1:Yes).
Claim 17 recites: the generic bio-vector Salmonella sp. is derived from a continuous in-vitro culture of an bio-vector bacterium Salmonella sp. S9 by using Luria broth (LB) solid and liquid culture media for passage to the fortieth generation and above, the strain derived from passage 40th to 60th generation is named as a generic bio-vector S9H, and the deposit number of the bio-vector bacterium S9 is CGMCC No. 17340 (lines 5-9). According to MPEP 2113(I), even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Evidentiary reference Zhu (CN110218668, translation provided 08/13/2024) teaches Salmonella sp. S9 CGMCC 17340. See p. 2 the “Brief Description of the Drawings” section. Zhu discloses that the S9 strain can be isolated from hens at a poultry farm. See the first paragraph of example 1 spanning p. 2-3. Thus, Salmonella sp. S9 (CGMCC 17340) is considered a natural product. Consequently, all strains obtained via the natural reproduction of Salmonella sp. S9, such as S9H, are natural products. Furthermore, claim 17 recites “a complex that displays, expresses and carries a specific antigen factor of a surface of the generic bio-vector Salmonella sp…wherein the specific antigen factor is one or more from a group consisting of a K88ac antigen factor of porcine Escherichia coli, a K99 antigen factor of bovine Escherichia coli and an I antigen factor of human Salmonella sp.” (lines 3-4 and 10-13). The instant specification discloses that I antigen factor is type I fimbriae. See [0013]. As evidenced by Zhang (Current microbiology, 2014 69(4), 429-435; as provided 10/16/2024) type I fimbria is widely distributed in various Salmonellas. See p. 430, left column, last full sentence. The instant specification is silent as to whether the Salmonella sp. S9 CGMCC 17340 expresses type I fimbriae. Although the instant specification discloses that the type-I fimbriae seemed to not be found on the surface of the S9H (see [0086]), it is unclear whether this characteristic is common for all S9 progeny at the fortieth generation and above. As such, there is no indication of record that the instantly claimed Salmonella sp S9H has a marked difference in structure, function, or other properties as compared to its natural counterpart (i.e. other natural progeny from S9). Therefore, the instant claims are directed to a natural-product, which is a judicial exception (Step 2A Prong 1: Yes).
The additional claimed elements separately and accumulatively fail to integrate the product of nature into practical application. Claim 17 does not require any additional elements besides the natural product that could integrate the natural product into a practical application. Claim 26 is drawn to a detection kit comprising the detection system according to claim 17. The term “kit” is recited at a high level of generality, such that it encompasses any organization or packaging of the S9H. This provides insufficient specificity to add anything of significance to the judicial exception. Therefore, the claim as a whole, does not integrate the judicial exception into a practical application (Step 2A Prong 2: No).
The additional element kit element fails to amount to an inventive concept. Kits were well-understood and conventional in the art at the time of filing, as evidenced by Weiner (BioTechniques, 44(5), 701–704, 2008, as provided 10/16/2024). Weiner teaches that kits can be found not only in the lab, but everywhere from the medical practice to the home medicine cabinet. See lines 1-4 in the left column on page 703. Thus, the claims 17 and 26 do not amount to an inventive concept (Step 2B: No).
For all of these reasons, claims 17 and 26 are not patent eligible.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered, but they are unpersuasive.
Rejection of claims 17 and 26 under 35 USC §101
Applicant argues that the amendment overcame the previous rejection, because the claims no longer recite “a P factor of poultry Salmonella sp” as one of the selections for the specific antigen factor. Applicant asserts that the following antigen factors are not natural products: K88ac of porcine E. coli, K99 of bovine E. coli and I antigen of human Salmonella sp. See p. 5 of the remarks, second to last paragraph.
This argument is not persuasive because under the broadest interpretation claims 17 and 26 encompass any S9 progeny strain derived from the 40th generation and above. Based on the evidence of record, such Salmonella progeny could reasonably express I antigen factor (i.e. type I fimbriae) on their surface without additional genetic modifications. The instant specification discloses in example 6 that the S9H cell does not express type-I fimbriae (see [0080]). However, the instantly claimed generic bio-vector is not limited to the specific S9H cell of example 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/K.C.B./Examiner, Art Unit 1657
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