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
Applicant’s election without traverse of Group III, corresponding to claims 16-20, in the reply filed on 11/03/2025 is acknowledged.
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Specification
The use of the term LIPOFECTAMINE, 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.
Claim Objections
Claims 16 and 19 are objected to because of the following informalities:
Claim 16, line 3 should be amended to recite “introducing a single-stranded DNA comprising a nucleic into the cells”
Claim 19, line 2, the recitation of “Hela” should be amended to recite “HeLa”
Claim 19, line 3, the recitation of “Helf” should be amended to recite “HELF”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 20 is 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.
Instant claim 20 recites the “method according to claim 19, wherein the organism comprises the cells according to claim 19, or tissues or organs containing the cells.” There is insufficient antecedent basis for recitation of “the organism” in the claim. Moreover, instant claim 19 recites various cell lines, e.g., 293T cells, so it is unclear how these cells are present in the tissues or organs of an organism. It is unclear, e.g., if the claim requires administering, transplanting, etc. cancerous cells, e.g. MCF-7, into the organism.
For purposes of compact prosecution and applying prior art, claim 19 was interpreted herein to require an organism comprising the cells according to claim 19, or tissues or organs comprising the cells according to claim 19.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC §§ 102/103
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.
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.
Claims 16-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wolff et al. (WO 00/74635, IDS-FOR, hereinafter “Wolff”).
Regarding claim 16, Wolff discloses a method for expressing an exogenous protein in cells, comprising introducing a single-stranded DNA comprising a nucleic acid sequence encoding the exogenous protein (Abstract; page 19, lines 10-30).
Regarding claim 17, Wolff discloses that the cells are tumor (cancer) cells (page 1, lines 19-20; page 27, lines 6-8).
Regarding claim 18, Wolff discloses that the cells are 3T3 mouse embryonic fibroblast cells (page 39, Example 12).
Regarding claim 19, Wolff discloses that the cells are HeLa cells (page 42, E) Transfection of HeLa cells).
As such, Wolff discloses each and every element of the claimed method.
In the alternative, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ method they exemplify. As such, the claimed method is within the scope of Wolff, and thus Wolff renders the method prima facie obvious. The rationale to support this conclusion of obviousness is that Wolff provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Accordingly, Wolff anticipates the claimed method or, in the alternative, renders the claimed method prima facie obvious.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wolff as applied to claims 16-19 above, and further in view of Fais et al. (WO 2005/014637, hereinafter “Fais”).
As discussed above, claims 16-19 were anticipated or, in the alternative, rendered prima facie obvious by Wolff. As further discussed above, Wolff teaches expressing an exogenous protein in HeLa cells. Wolff further teaches delivery to cells within tissues or organs, i.e., to an organism (page 19, line 10 to page 20, line 14; page 32 lines 5-9).
The reference does not explicitly teach an organism comprising the HeLa cells, or tissues or organs comprising the HeLa cells. However, Fais teaches transplantation of transfected HeLa cells expressing an exogenous mutant ezrin protein into mice for cancer studies (pages 18-19, Growth of HeLa Cells in Mice). One of ordinary skill in the art would have motivated to combine the teachings of Wolff and Fais in order to advantageously and conveniently express exogenous mutant ezrin protein in the HeLa cells using single-stranded DNA according to Wolff for cancer studies according to Fais with a reasonable expectation of success.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chen et al., Intracellular production of DNA enzyme by a novel single-stranded DNA expression vector, Gene Therapy, 10:1776-1780 (2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Mallari can be reached at 571-272-4729. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672