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 reply to the Restriction Requirement, dated May 11, 2026, has been received. By way of this submission, Applicant has elected, with traverse, the species of ID4310 (SEQ ID NO. 17), ID4428 (SEQ ID NO. 18), ID0785 (SEQ ID NO. 19), and ID3836 (SEQ ID NO. 20) as the enhancer sequences, SOX2 as the transcription factor that binds the ID4310, ID4428, ID0785, and ID3836 enhancer sequences, SSE-7 (SEQ ID NO. 70) as the super-enhancer sequence, a single cistron (via P2A) for combined expression of herpes simplex virus thymidine kinase (HSV-Tk) and IL-12 as the transgene, and a dual payload comprising the cytotoxic enzyme/prodrug payload (HSV-TK) together with the immunostimulatory cytokine IL-12 as the adverse payload.
Applicant's election with traverse in the reply filed on May 11, 2026 is acknowledged. The traversal is on the ground(s) that search and examination of all recited species can be made without serious burden. This is not found persuasive for reasons stated in the previous Restriction Requirement, mailed February 11, 2026.
Should Applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, Applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-19 are pending in the application and under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at pages 34, 35, 43, and 52. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 2 and 19 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.
Claims 2 and 19 recite preferential nested ranges of narrow and broader range. Use of a narrow numerical range that falls within a broader range in the same claim may render the claim indefinite when the boundaries of the claim are not discernible. Description of examples and preferences is properly set forth in the specification rather than in a single claim. A narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. MPEP 2173.05(c)(I).
Claim 7 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.
Claim 7 impermissibly refers to a table. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). MPEP 2173.05(s).
Claim 16 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.
Claim 16 recites an intended use for the claimed product. The claim is directed to the product itself, not a method of using the product. Additionally, the claim recites an example of a cancer to be treated with the product. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. MPEP 2173.05(d).
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.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 9-11, 16-19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hnisz (US20140287932A1, cited in IDS).
Hnisz teaches a super-enhancer, comprising a genomic region of DNA that contains at least two enhancers (para. 0005). Hnisz further teaches that each enhancer may be a different enhancer (i.e., from a different genomic loci), and that each enhancer comprises a binding site for a cognate transcription factor that interacts with the transcriptional coactivator to stimulate transcription of the gene associated with the super-enhancer, and that one of these transcription factors may be Sox2 (para. 0242).
Hnisz further teaches that the super-enhancer may be between 500 and 4,000 base pairs in length (para. 0239), which is pertinent to claim 2. Hnisz also teaches that the transcription factor may comprise its known DNA sequence motif (para. 0019). Applicant's specification at page 12 teaches that the SOX motif comprises 21 base pairs. Hnisz therefore inherently teaches the subject matter of claim 2.
Hnisz further teaches that the super-enhancer may comprise a concatemer (i.e., two or more copies) of a Sox2 binding motif (para. 0250), which is pertinent to claim 4.
Hnisz further teaches that the super-enhancer may contribute to increased expression of the associated gene (para. 0006). Hnisz also teaches that the super-enhancer may be operatively linked to a gene of interest to stimulate high levels of expression of the target gene within a cell (para. 0056), which is pertinent to claims 10 and 11.
Hnisz further teaches compositions of the above super-enhancer for the treatment of cancer (para. 0054, 0249, and 0430), which is pertinent to claim 16.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hnisz (US20140287932A1, cited in IDS) in view of Hao (Oncol Lett. 2018 May;15(5):6503-651).
The teachings of Hnisz have been discussed supra. Hnisz further taches that enhancer elements are useful to recruit RNA polymerase to promoters of target genes (para. 0468). However, Hnisz does not teach an adverse payload.
Hao teaches a fusion transgene comprising herpes simplex virus-thymidine kinase and interleukin-12, under the control of a promoter (abstract). According to Applicant's specification at pages 20-21, IL-12 is a protein that stimulates an immune response that leads to the activation of cytotoxic immune cells, and HSV-TK is a suicide gene which encodes a protein capable of converting an inactive prodrug into a cytotoxic drug. Hao therefore teaches the subject matter of claims 14-15.
Hao further teaches that this fusion gene may be expressed under a tumor-specific promoter for expression in cancer cells (i.e., aberrant cells) and treatment of cancer (page 6504, left column, third through fifth paragraphs), which is pertinent to claims 12-13 and 16.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Hnisz and Hao to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Hnisz and Hao are concerned with gene expression in cancer cells. Hao teaches a method of expressing HSV-TK and IL-12 in a cancer cell. Hnisz teaches that super-enhancers are useful for enhancing expression of operably linked genes of interest in target cells. One of ordinary skill could apply that super-enhancer of Hnisz to the HSV-TK/IL-12 system of Hao by known methods to arrive at the claimed invention, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Allowable Subject Matter
Claims 5-6 and 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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