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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 5/11/26. Claims 19-21, and 24-36 are pending. Claims 32-36 are withdrawn. Claims 19-21 and 24-32 are considered on the merits.
Election/Restriction Requirement
Applicant’s election without traverse of Group I, claims 19-21, and 24-36, in the reply filed on 5/11/26 is acknowledged. Claims 33-36 are withdrawn.
Previously Proposed Amendments
The Examiner and Mr. Hyunseok Park attempted to negotiation the claims into allowance prior to the office action. However while writing the reasons for allowance, the current 35 USC 112 issues were found. At the end of this action you will find proposed claims to overcome these issues. The Applicant is encouraged to contact the Examiner if they have any questions or if they are willing to accept these amendments.
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 19-21, and 24-36 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.
PNG
media_image1.png
200
400
media_image1.png
Greyscale
The phrase “TetR-inducible promoter” is not described in the Specification. The Specification discloses a Ptet promoter which allows transcription using a tetA and tetR promoters (pg. 3, 1st full paragraph). However the Ptet promotor is induced by doxycycline (dox), not the TetR protein. The Specification states the TetR protein inhibits the activity of the Ptet by binding to the regulatory region (pg. 10, 1st full paragraph). This mechanism is supported by Das et al. who show in Fig. 1A (reproduced below) the TetR protein binding to the tetO1 and tetO2 operator binding sites. Once dox is added, the TetR protein releases from the tetO sites and expression may occur at both the tetA and tetR promoters. The Applicant has not clearly described how TetR protein induces either promoter since it acts as a repressor until dox is present.
The phrase “preventing or treating cancer” in claims 28 and 32 do not have adequate written description since no description is provide on how the composition prevents any cancer. And while the Specification provides some in vitro tests on colon cancer cell lines, this is not representative of all the possible cancers. It is unclear the Applicant’s composition will be effective against the numerous cancers known in the art.
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 19-21, and 24-36 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.
The phrase “TetR-inducible promoter” is confusing because Specification discloses the TetR protein inhibits the activity of the tet promoter by binding to the regulatory region (pg. 10, 1st full paragraph). This is counter to inducing a promoter and makes the claims indefinite.
Proposed Claim Amendments
The Examiner is proposing the following claims to place this application in condition for allowance. The Applicant is encouraged to contact the Examiner prior to responding to this office Action. These claims were modeled after US 12637688 that disclose the OBX1/Tet expression system.
19. (currently amended) A DNA construct comprising:
a nucleic acid sequence encoding a TetR protein operably linked downstream of a OXB1 promoter;
a nucleic acid sequence encoding a first promoter and a second promoter, the expression of each promotor is inhibited by the TetR protein and induced by tetracycline;
a nucleic acid sequence encoding a flagellin operably linked downstream of the first promoter;
a nucleic acid sequence encoding a toxin protein operably linked downstream of the second promoter;
24. (currently amended) The DNA construct of claim 19, wherein the first
28. (previously presented) A pharmaceutical composition for colon cancer comprising the strain of claim 26 as an active ingredient.
31. ( currently amended) A strain into which a recombinant vector has been introduced, the recombinant vector comprising:
a first DNA construct comprising a nucleic acid sequence encoding a TetR protein operably linked downstream of a OXB1 promoter, and a nucleic acid sequence encoding a
flagellin operably linked downstream of a first induced by the TetR protein; and
a second DNA construct comprising a nucleic acid sequence encoding the TetR protein operably linked downstream of the OXB1 promoter, and a nucleic acid sequence
encoding a toxin protein operably linked downstream of a second
promoter induced by the TetR protein.
32. (Amended) A pharmaceutical composition for colon cancer
comprising the strain of claim 31 as an active ingredient.
33. (Rejoined-Amended) A pharmaceutical composition for colon cancer comprising the strain of claim 27 as an active ingredient .
34. (Rejoined-Amended) A method for colon cancer by administering an effective amount of the strain of claim 26 to a target subject.
35. (Rejoined-Amended) A method for colon cancer by administering an effective amount of the strain of claim 31 to a target subject.
36. (Cancelled)
Closest Prior Art
Claims 19-21 and 24-32 appear free of the prior art. The closest prior art is US 12637688 which shares common inventors with the current Application. US’688 discloses a DNA construct with a OXB1 promoter that controls expression of TetR protein combined tetA and tetR promoters each of which can simultaneously express different genes. US’688 does not disclose or suggest encoding a flagellin as one of those genes.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
Prosecution Insights