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 .
Applicant’s response to restriction requirement of 6/5/26 is acknowledged. Applicant elected species 13, drawn to an attenuated Salmonella gallinarum strain with deletion of relA, spot, ssrAB and Gifsy 2 prophage genes for initial examination.
Claims 1, 3-5, 7-8, 10 and 12-17 are under examination on the merits.
Claims 2, 6, 9, 11 and all species beyond species 13 are hereby withdrawn as drawn to non-elected invention.
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, 3-4, 10, 12-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being attenuation of specific strains of Salmonella gallinarum (S. gallinarum) with Gifsy-2 gene, it does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to attenuation of any generic strain of S. gallinarum resulting in instant claim 1 (and its dependent claims 3-4, 10 ( and methods of use thereof (see claims 12-17).
The criteria for undue experimentation, summarized in re Wands, 8, USPQ2n 1400 (Fed. Cir. 1988) are: 1) the quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breadth of the claims.
A thorough search of Gifsy-2 gene and S. gallinarum in public databases online, suggests that while some strains of S. gallinarum have said gene, there are other strains thereof with no Gifsy-2 prophage gene whatsoever. However, apart from a couple of examples, neither applicant nor the prior art specifies which strains comprise said specific prophage gene and fail to teach which specific characteristics of strains reveal the presence of said Gifsy-2 gene.
Therefore, before preparing the attenuated strain of instant claim 1 which has a broad scope, one of skill in the art has to go through the burden of undue experimentation in order to identify specific strains of S. gallinarum carrying Gifsy-2 gene among thousands and thousands of species of said S. Gallinarum, before conducting deletion thereof.
In conclusion, in the absence of identification of specific strain(s) of S. gallinarum which carry Gifsy-2 gene, instant claim 1 and its dependent claims 3-4 and 10, are not fully enabled.
Since the attenuated strain of claim 1 is not fully enabled, methods of use thereof (see claims 12-17) are not fully enabled either.
Claims 5, 7 and 8 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 claim 5 and 7-8, it is noted that the applicants have deposited the organisms but there is no indication in the specification as to the public availability. Since the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
during the pendency of this application, access to the invention will be afforded to the commissioner upon request;
all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent whichever is longer; and
the deposit will be replaced if it should ever become inviable.
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, 3-5, 7-8, 10 and 12-17 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. In claims 1, 3-5, 7-8 and 10, it is unclear which function of the claimed Salmonella gallinarum strain is “attenuated”. In other words, it is unknown if the claimed strain is less/more infectious, less potent, or its ability for binding a specific tumor cell is reduced or enhanced etc. Applicant is required to clarify the specific function of the claimed “attenuated” strain. Claims 12-17 are merely rejected for depending from base claim 1.
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)(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.
Claim(s) 1, 3, 5, 10, 12-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by “Choy” (Choy et al., US2024/0108664, 4/2024).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Choy in [0013], discloses the development of a Salmonella strain with targeting and viability excellent for cancer cells, but poor for normal organs.
In [0016-0017], said publication mentions
“[0016] As used herein, the term “attenuated” refers to modified to lower pathogenicity of a strain. Attenuation makes it possible to prevent the pathogenicity of the strain from causing cytotoxicity and other adverse effects in normal cells other than tumor cells. Attenuated strains can be constructed using various methods known in the art. By way of example, the attenuation is made by deletion or destruction of a virulence factor so that the strain can be viable in host cells. In this regard, relA, spoA, and spoT genes, and the genes, encoded by Salmonella Pathogenicity Islands, including ssaV, sseBCD, ssrAB, sopB, sseF, and sseG, can be deleted to achieve the attenuation.
[0017] According to an embodiment of the present disclosure, the strain is a variant of the Salmonella gallinarum SG4021 strain (microorganism accession number: KCTC13985BP) as a result of deleting guanosine tetraphosphate production capability therefrom.”
Said strain of S. Gallinarum, according to a search in public databases, does not carry Gifsy-2 gene by inherency, anticipating claim 1, 3, 5.
In [0077], Cho discloses about the lux operon (luxCADABE) which was inserted into a plasmid utilized for transfecting its S. Gallinarum cells, anticipating claim 10.
In claims 11-19, Choy claims a pharmaceutical composition of said S. gallinarum strains for prevention and treatment of a tumor, including an adenocarcinoma tumor.
In claim 14, the target cancers are claimed to be colorectal cancer, pancreatic cancer, skin cancer, and breast cancer.
Claim 15 of said publication recites:
“15. A method for providing information about tumor analysis, the method comprising the steps of: administering the Salmonella gallinarum strain to a subject; detecting bioluminescence of the strain; and determining the presence of tumor in the subject if the bioluminescence is detected”, anticipating claims 12-17.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651
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