CTFR 18/398,165 CTFR 77456 DETAILED ACTION 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 31-50 are pending in the instant application. Claims 43-50 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Claims 31-42 are under consideration in this Office Action. The previous objection to the title has been withdrawn in view of the amendment to the title filed 03/01/2026. The terminal disclaimer filed on 03/01/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of the previously cited patents has been reviewed and is accepted. The terminal disclaimer has been recorded. The previous rejection of the claims on the ground of nonstatutory obviousness-type double patenting have been withdrawn. In view of the claim amendments filed 03/01/2026 all previous claim rejections have been withdrawn in favor of the instant rejections of the amended claims. Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA) 2 nd Paragraph 07-30-02 AIA 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. 07-34-01 AIA Claim s 31-42 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 pre-AIA the applicant regards as the invention. The amended claims recite the limitation “wherein the enzyme comprises a means for catalyzing template-independent covalent addition of the nucleotide to the end of a polynucleotide; and wherein the linker comprises a means for selective cleavage after the covalent addition of the nucleotide to the end of a polynucleotide” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the specification fails to disclose the corresponding structure, material, or acts of each of the enzyme and linker for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not provide adequate structure of any enzyme to perform the claimed function for catalyzing covalent addition of the nucleotide to the end of a polynucleotide. The specification does not provide adequate structure of the linker to perform the claimed function for selective cleavage after the covalent addition of the nucleotide to the end of a polynucleotide. The phrase “catalyzing covalent addition” is not adequate structure for performing the maintaining function because it does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand the catalyzing structure or structures perform(s) the claimed function. The phrase “selective cleavage” is not adequate structure for performing the maintaining function because it does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand the selective cleavage structure or structures perform(s) the claimed function. The specification disclosed a terminal deoxynucleotidyl Transferase (TdT) referred to as TdTcys302 having a single surface cysteine and comprising the amino acid sequence of SEQ ID NO: 1 with OPSS-PEG4-amino-allyl-dUTP or BP-23354-propargylamino-dCTP covalently linked to the single surface cysteine. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Dependent claims 32-42 are also rejected because they do not correct the defect. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation 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 35 U.S.C. 112 (pre-AIA), first paragraph: 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. 07-31-01 AIA Claim s 31-42 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended claims are drawn to a broad genus of compositions comprising a genus of nucleotides, a genus of linkers, and a genus of enzymes, wherein wherein the enzyme comprises a means for catalyzing template-independent covalent addition of the nucleotide to the end of a polynucleotide, wherein the linker comprises a means for selective cleavage after the covalent addition of the nucleotide to the end of a polynucleotide, and wherein the enzyme bound to the nucleotide further comprises a means for shielding the nucleotide from subsequent nucleotide addition after the covalent addition of the nucleotide to the end of the polynucleotide. The genus of enzymes are widely varying with different amino acid sequences, structures, biological properties, and are from any biological source. The genus of inkers are widely varying with different chemical compositions, structures, and biological properties. According to MPEP 2163: “For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly , 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc ., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…” According to MPEP 2163.02: “The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar , 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc ., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow , 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).” The specification as originally filed does not disclose a representative number of species of the genus of enzymes capable of catalyzing the covalent addition of the nucleotide onto the end of a polynucleotide and species of the genus of linkers encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures correlate with the activity of any enzymes catalyzing the covalent addition of the nucleotide onto the end of a nucleic acid. The specification discloses a composition comprising a terminal deoxynucleotidyl Transferase (TdT) referred to as TdTcys302 having a single surface cysteine and comprising the amino acid sequence of SEQ ID NO: 1 with OPSS-PEG4-amino-allyl-dUTP or BP-23354-propargylamino-dCTP covalently linked to the single surface cysteine. While MPEP 2163 acknowledges that a single species can describe a genus, it also acknowledges that for a genus that encompasses widely variant species, disclosure of a single species within the genus fails to adequately describe all members of the genus. Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed broad genus of compositions comprising a genus of nucleotides, a genus of linkers, and a genus of enzymes, wherein the enzyme comprises a means for catalyzing template-independent covalent addition of the nucleotide to the end of a polynucleotide, wherein the linker comprises a means for selective cleavage after the covalent addition of the nucleotide to the end of a polynucleotide, and wherein the enzyme bound to the nucleotide further comprises a means for shielding the nucleotide from subsequent nucleotide addition after the covalent addition of the nucleotide to the end of the polynucleotide . Conclusion No claim is allowed. 07-40 AIA Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL . See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408)918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652 Application/Control Number: 18/398,165 Page 2 Art Unit: 1652 18398165-200 Application/Control Number: 18/398,165 Page 3 Art Unit: 1652 18398165-200 Application/Control Number: 18/398,165 Page 4 Art Unit: 1652 18398165-200 Application/Control Number: 18/398,165 Page 5 Art Unit: 1652 18398165-200 Application/Control Number: 18/398,165 Page 6 Art Unit: 1652 18398165-200
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