feed 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 Non-Final Office Action is responsive to the communication received 10/25/2025. Election/Restrictions Applicant’s election without traverse in the Reply filed on 10/25/2025 of Group I, Claim(s) 1-15 is acknowledged. Applicant has elected without traverse in the Reply filed on 10/25/2025 the following species: A. the viral vector is a lentivirus (claim 11) The Restriction/Election Requirements are deemed proper and are made FINAL. Claims 1-20 are pending. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 10/25/2025. Claims 1-15 are under examination in this Office Action. 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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. Claims 2-15 depend directly or indirectly from claim 1. The claim 1 limitations directed to an abstract idea are determining whether the DNA fragment contains a silencer element and to identify a sequence of a silencer element. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community. The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are obtaining or having obtained a DNA fragment; inserting the DNA fragment into an expression construct comprising a promoter operatively linked with a gene, wherein the fragment is proximal to the promoter, and wherein the gene produces a suicide protein; introducing the expression construct into a biological cell; inducing toxicity of the suicide protein; and sequencing the DNA fragment within the biological cell. Otte et al. (06/07/2007) US Patent Application Publication 2007/0128717 A1 (hereinafter known as "Otte") teaches obtaining or having obtained a DNA fragment; inserting the DNA fragment into an expression construct comprising a promoter operatively linked with a gene, wherein the fragment is proximal to the promoter, and wherein the gene produces a suicide protein; introducing the expression construct into a biological cell; inducing toxicity of the suicide protein; and sequencing the DNA fragment within the biological cell (see [0003] to [0110]). 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. Claims 1-3, 8-10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otte et al. (06/07/2007) US Patent Application Publication 2007/0128717 A1 (hereinafter known as "Otte"). With regards to claims 1-3, 8-10 and 13-15, Otte teaches: a) as in claims 1-3, 8-10 and 13-15, a method to identify genetic silencer from a biological source comprising: obtaining or having obtained a DNA fragment; inserting the DNA fragment into an expression construct comprising a promoter operatively linked with a gene, wherein the fragment is proximal to the promoter, and wherein the gene produces a suicide protein; introducing the expression construct into a biological cell; determining whether the DNA fragment contains a silencer element by inducing toxicity of the suicide protein; and sequencing the DNA fragment within the biological cell to identify a sequence of a silencer element; wherein obtaining or having obtained the DNA fragment comprises: obtaining or having obtained DNA from a biological source; and fragmenting the DNA to a desired size; wherein the biological source is animal cells; wherein the expression construct further comprises a selectable marker or a fluorescent marker; wherein the expression construct includes a selectable marker, and wherein the biological cell is grown in the presence of puromycin, hygromycin, neomycin, or bleomycin; wherein introducing the expression construct into a biological cell comprises a viral vector transformation, transfection, or electroporation; further comprising synthesizing a DNA molecule comprising the sequence of the identified genetic silencer (see [0003] to [0110]). Thus, Otte anticipates the present claims. Claim Rejections - 35 USC § 103(a) The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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. 5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying. Common Ownership of Claimed Invention Presumed This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the Examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the Examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a). Claims 1-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Otte et al. (06/07/2007) US Patent Application Publication 2007/0128717 A1 (hereinafter known as "Otte") in view of Bayle et al. (06/15/2017) US Patent Application Publication 2017/0166877 A1 cited in the 11/17/2025 IDS (hereinafter known as "Bayle"). The limitations of claims 1-3, 8-10 and 13, and the corresponding teachings in Otte are presented above, and are hereby incorporated into the instant rejection. Otte does not explicitly teach: a) as in claims 4-7, 11-12 and 12-15, the suicide protein is a fusion protein comprising a binding protein and an apoptotic protein; wherein the suicide protein is a fusion protein comprising FK506 binding protein fused with caspase 9; wherein inducing toxicity of the suicide protein involves introducing a dimerizer molecule to the biological cell; wherein the dimerizer molecule is AP20187; wherein the expression cassette is introduced into the biological cell via a viral vector and the viral vector is a lentivirus; wherein the viral vector is transduced at a low multiplicity of infection; further comprising modifying a genetic silencer in a genome of a second biological cell, wherein the genetic silencer has a matching sequence to the silencer element identified via sequencing; wherein modifying the genetic silencer is accomplished via CRISPR/Cas9. With regards to claims 4-7, 11-12 and 12-15, Bayle teaches: a) as in claims 4-7, 11-12 and 12-15, the suicide protein is a fusion protein comprising a binding protein and an apoptotic protein; wherein the suicide protein is a fusion protein comprising FK506 binding protein fused with caspase 9; wherein inducing toxicity of the suicide protein involves introducing a dimerizer molecule to the biological cell; wherein the dimerizer molecule is AP20187; wherein the expression cassette is introduced into the biological cell via a viral vector and the viral vector is a lentivirus; wherein the viral vector is transduced at a low multiplicity of infection; further comprising modifying a genetic silencer in a genome of a second biological cell, wherein the genetic silencer has a matching sequence to the silencer element identified via sequencing; wherein modifying the genetic silencer is accomplished via CRISPR/Cas9 (see Figures 2 and 11A and [0008] to [0185] and [0322] to [0490]). One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. Bayle teaches the advantages of suicide genes that can be activated following the appearance of therapeutic cell-induced adverse events (see [0005]). One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of combining Bayle's suicide genes with Otte's fusion protein because suicide genes that can be activated following the appearance of therapeutic cell-induced adverse events. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice . /CHRISTIAN C BOESEN/ Primary Examiner, Art Unit 1684