Prosecution Insights
Last updated: August 06, 2026
Application No. 18/418,223

T7 DNA Ligase Variants R129D with Increased Specificity for Cohesive End Polynucleotides

Non-Final OA §101§112
Filed
Jan 20, 2024
Priority
Jan 25, 2023 — provisional 63/441,013
Examiner
MEYERING, SHABANA SHABBEER
Art Unit
Tech Center
Assignee
Abclonal Science Inc.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allowance Rate
45 granted / 65 resolved
+9.2% vs TC avg
Strong +42% interview lift
Without
With
+41.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 12m
Avg Prosecution
61 currently pending
Career history
119
Total Applications
across all art units

Statute-Specific Performance

§101
7.7%
-32.3% vs TC avg
§103
34.6%
-5.4% vs TC avg
§102
10.8%
-29.2% vs TC avg
§112
32.4%
-7.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 65 resolved cases

Office Action

§101 §112
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 . Status of Claims Claims 1-17 are under consideration. Priority This application claims priority to provisional application 63/441,013. Therefore, it is entitled to the 25th Jan 20223 priority date of the provisional application. Specification The title of the invention is not grammatically correct. The title states: T7 DNA Ligase Variant It should state: T7 DNA Ligase Variant, R129D, with Increased Specificity for Cohesive End Polynucleotides, or something similar. The specification discloses SEQ ID NO: 2 on pg. 5 with the following subtitle and sequence: Amino acids sequence of T7 DNA Ligase R129D SEQ ID NO:2 001 MNIKTNPFKAVSFVESAIKKALDNAGYLIAEIKYDGVRGNICVDNTANSYWLSRVSKTIP 060 061 ALEHLNGFDVRWKRLLNDDRCFYKDGFMLDGELMVKGVDFNTGSGLLRTKWTDTKNQEFH 120 121 EELFVEPIDKKDKVPFKLHTGHLHIKLYAILPLHIVESGEDCDVMTLLMQEHVKNMLPLL 180 181 QEYFPEIEWQAAESYEVYDMVELQQLYEQKRAEGHEGLIVKDPMCIYKRGKKSGWWKMKP 240 241 ENEADGIIQGLVWGTKGLANEGKVIGFEVLLESGRLVNATNISRALMDEFTETVKEATLS 300 301 QWGFFSPYGIGDNDACTINPYDGWACQISYMEETPDGSLRHPSFVMFRGTEDNPQEKM 358 However, the sequence listing for SEQ ID NO: 2 is as follows – PNG media_image1.png 603 896 media_image1.png Greyscale Thus, there is discrepancy between the specification and the sequence listing. Either or both must be corrected. There is similar discrepancy between the nucleotide sequence encoding the mutant R129D. Therefore, similarly, either or both the specification and the sequence listing must be corrected. Abstract. The abstract states: Disclosed is a novel T7 DNA ligase mutant with the mutation R129D, that had higher specificity toward cohesive end-ligation even in the presence of polyethylene glycol. Controlling the composition of final ligation products is important and thus, a variant which improves the specificity of T7 DNA ligase to cohesive ends will generate more reliable results. Applicant is reminded of the proper content of an abstract of the disclosure. A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. If the patent is of a basic nature, such as instant, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives. Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text, in accordance with 37 CFR 1.72(b). See MPEP § 608.01(b). In addition, Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. In the instant case, the abstract: Lacks concordance with tense e.g., disclosed is…that had…will generate. Mentions the R129D has “higher specificity toward cohesive end-ligation even in the presence of polyethylene glycol”. However, no experiments with polyethylene glycol are disclosed. The title and abstract mention a mutant enzyme for “cohesive end-ligation”. However, the summary of the invention, on pg. 2 states: The invention relates to engineered T7 DNA Ligase mutants reduced unwanted ligation of blunt-ended DNA polynucleotides compared to the wild-type ligase. Further, the claims do not recite either of the words “cohesive” or “blunt” rather the claims are directed to “performing a ligation reaction”; i.e., a generic ligation reaction. See for e.g., claim 14. 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 1-17 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. Regarding claim 1, the phrase “the mutation R129D” renders the claim indefinite because the claim does not further recite a reference sequence pointing to where the R129D mutation lies. “the mutation R129D” is also indefinite because the claim also recites “a biologically active fragment thereof”. So, an N-terminal deletion fragment would have different numbering and there are several arginine residues in T7 enzymes. So without a reference SEQ ID NO, it is not clear which arginine should be an aspartic acid. The description in the specification makes clear that Inventors have discovered a hitherto improved function for a T7 mutant ligase, i.e., decreases spurious blunt-end ligation compared to WT T7 ligase. The specification also discloses a sequence that encodes the mutant and an amino acid sequence carrying the mutation. However, the specification has no disclosure on biologically active fragments thereof. An artisan would not be able to determine the metes and bounds of the term. Regarding claim 6, claim 6 recites the phrase “a mutant T7 DNA ligase …having identity to SEQ ID NO: 1” which renders the claim vague and indefinite because it is unclear how a ligase, an enzyme that is composed of amino acids, can have nucleotides, and therefore identity to a sequence of nucleotides as recited Those claims identified in the statement of rejection but not explicitly referenced in the rejection are also rejected for depending from a rejected claim but failing to remedy the indefiniteness therein. 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 1-17 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. Scope of the Invention #1. Claim 1 is indefinite for the reasons described above. For the purpose of compact prosecution, claim 1 will be interpreted as “a mutant T7 DNA ligase or biologically active fragment comprising SEQ ID NO 2 except for an R129D substitution”; and claim 1directed to a mutant T7 DNA ligase comprising the mutation R129D. #2. Claim 6 is indefinite for the reasons described above. For the purpose of compact prosecution, claim 6 will be interpreted as “a mutant T7 DNA ligase or biologically active fragment encoded by a nucleic acid sequence having at least 95% identity to SEQ ID NO 1”. Further, the 5% differences from WT comprise only conservative amino acid substitutions. SEQ ID NO: 1 is disclosed in the specification as carrying the R129D mutation. #3. Claim 14 is directed to a method for performing a ligation reaction with the mutant T7 DNA ligase of claim 1. The broadest reasonable interpretation of the claimed fragment: is a fragment of the T7 DNA ligase that is biologically active. Claim 1 further requires that it carries the R129D mutation. Claim 6 is ambiguous in its recitation of whether or not the R129D mutation must be present in the mutant with biological function. The specification states the following: PNG media_image2.png 200 400 media_image2.png Greyscale Therefore, the end-goal is to achieve: reduced blunt-end ligation as compared to the WT counterpart. Regarding a fragment that caries the R129D mutation: The term "biologically active fragment" is defined in the specification, pg. 6, 2nd para, as any fragment, derivative, homolog or analog of a T7 DNA ligase mutant that possesses in vivo or in vitro activity that is characteristic of that biomolecule; including, for example, ligase activity or repairing via ligation the mismatches that exist in nicked DNA. Disclosure of a Complete or Partial structure On pg. 4 Applicants provide the DNA sequence of T7 DNA Ligase comprising R129D called SEQ ID NO:1. On pg. 5 Applicants provide the amino acid sequence of T7 DNA Ligase comprising R129D called SEQ ID NO: 2. Regarding the end-goal: The specification and Figure 1 disclose results of the R129D mutant and compare with wild-type. Thus, Applicant provides written description for a nucleic acid encoding an amino acid sequence that comprises R129D. Applicant also provides written description for a method that utilizes such mutant in a ligation reaction. Species not Disclosed However, the claims recite more than the described species and the specification does not provide written support for the sequences as required by #1 or #2 above, and therefore does not provide written description for a method of using the fragments of #1 or #2 above. Specifically, i) No biologically active fragment is described and ii) No sequences that vary but still have at least 95% identity to SEQ ID NO:1 and having only conservative amino acid substitutions are described. Each of the instantly disclosed genus of biologically active fragments includes substantially different sequences. Given the breadth of sequences embraced in the instantly claimed genus, one could not envision the member agents that target such a broad genus. Knowledge from the art Regarding, having at least 95% identity to SEQ ID NO:1 and having only conservative amino acid substitutions: An important consideration is that structure is not necessarily a reliable indicator of function. In the disclosure, there is no discussion relating similarity of structure to conservation of function. General knowledge in the art included the knowledge that some amino acid variations are tolerated without losing a protein’s tertiary structure. The results of amino acid substitutions have been studied so extensively that amino acids are grouped in so-called “exchange groups” of similar properties because substituting within the exchange group is expected to conserve the overall structure. For example, the expectation from replacing leucine with isoleucine would be that the protein would likely retain its tertiary structure. On the other hand, when non-exchange group members are substituted, e.g., proline for tryptophan, the expectation would be that the substitution would not likely conserve the protein’s tertiary structure. Given what is known in the art about the likely outcome of substitutions on structure, those in the art would have likely expected the applicant to have been in possession of a genus of proteins having a tertiary structure similar to SEQ ID NO: 1 just as claim 6 is limited: having only conservative amino acid substitutions. However, conservation of structure is not necessarily a surrogate for conservation of function. In this case, there is a requirement for conservative amino acid substitutions but no disclosed correlation between structure and function. For the relationship between the sequence of a peptide and its tertiary structure (i.e. its activity) see Huang B et al., (Genomics, Proteomics & Bioinformatics, Volume 21, Issue 5, 2023, Pages 913-925, ISSN 1672-0229). Simply put, Huang conclude “structure prediction can be accomplished through minimizing an energy function or directly simulating the folding process It is a challenging task to design accurate energy functions for ab initio approaches. …Most of the widely used energy functions are hand-crafted and thus require considerable expertise from designers.”, bridging pgs. 915 and 916. Structure/Function Correlation The specification does not support the broad scope of the claims which encompass all modifications and fragments of i) any R129D mutant T7 DNA ligase or of ii) any mutant T7 DNA ligase with 95% identity to SEQ ID NO: 1 with or without R129D. The genus of T7 DNA ligase that comprise these protein molecules may be obtained with the aid of a computer by a skilled artisan. However, there is no teaching regarding i) which parts of the T7 mutant comprise the biologically active fragment or ii) which 5% of the sequence can be varied and still result in a protein having T7 DNA ligase activity. An important consideration is that structure is not necessarily a reliable indicator of function. The instant specification provides no disclosure relating similarity or identity of structure to conservation of function. Method of Ligation Regarding the method: There is no essential structure of record required for biologically active fragments to function in a ligation reaction that would support written description for the genus of biologically active fragments. It is not sufficient to define the mutant T7 DNA ligase fragment solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. The skilled artisan cannot envision the min or max length of a mutant having the desired biological activity based on the nucleic acid/amino acid sequence described in the specification. Other than generically contemplating these molecules, the specification does not provide adequate written description of the biologically active fragments themselves. See MPEP 2163, Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). While it is acknowledged that it is routine and conventional to prepare these molecules, in view of MPEP 2163, adequate written description of biologically active fragments requires more than just generically contemplating the species of biologically active fragments. To demonstrate possession of a method of treatment that requires a compound and the compound belongs to a broad genus of compounds, one must provide substantially more than the description of compounds having said activity, in combination with a hypothesis that the use of any compound having that activity in a ligation reaction might produce a beneficial effect. What is required is an established nexus between the genus of such compounds and a beneficial result consequent thereto. As stated in MPEP 2163(II)(A)(3), a specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) (“[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim.”); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) (“[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose.”); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves). The instant specification, however, fails to describe the product adequately. If the product is not described, a method of using that product cannot be adequately described. In addition, the prior art and the as-filed specification do not provide written description for biologically active fragments that a skilled artisan may extrapolate from given the description of one species. Conclusion of Written Description The written description requirement for the claimed genus of sequences is not satisfied through sufficient description of a representative number of species. A representative number of species are not adequately described to be considered representative of the entire genus. There is substantial variation within the genus of agents that are T7 mutants carrying the R129D mutation or synonymous mutations, and the applicant does not describe a sufficient variety of species to reflect the variation within the genus. See Enzo Biochem., 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). See also MPEP §2163. Accordingly, one of skill in the art would not accept the disclosure of SEQ ID NO: 1 and a single mutant as representative of all proteins having T7 DNA ligase activity. The specification, taken with the pre-existing knowledge in the art of amino acid substitution and the genetic code, fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph. Dependent claims 2-5, 10-17 and 7-9, are also rejected because they depend on Claim 1 and 6 respectively and do not remedy the issues of lack of written description as discussed above. Examiner Suggestion: Amend the claims to comprise limitations which are adequately supported in the disclosure or prior art. For e.g., Delete “biologically active fragments” and merge claims 1 and 6. Scope of Enablement Claims 14-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a thermostable blunt-end DNA ligase comprising the amino acid sequence of SEQ ID NO: 2; does not reasonably provide enablement for any other embodiment as recited in the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. MPEP §2164.01(c) recites, “When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (claiming a chimeric gene capable of being expressed in any cyanobacterium and thus defining the claimed gene by its use).”. Here, the method claim recited in claim 14 requires the mutant of claim 1. Further the mutant of claim 1 has not been disclosed to be used in any other method other than the method of performing a ligation reaction. Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states that “Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue.’ Not ‘experimentation;” (Wands, 8 USPQ2d 104). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighting many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation required is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure Furthermore, the USPTO does not have laboratory facilities to test if an invention will function as claimed when working examples are not disclosed in the specification. Therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention. And thus, skepticism raised in the enablement rejections are those raised in the art by artisans of expertise. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. The Nature of the Invention: The invention is drawn to T7 ligase which is an essential component in a ligation reaction. The Breadth of the Claims: The breadth of the claims is excessive with regards to making and using the mutants in a generic ligation reaction. Thus the nature and breadth of the claims encompass any T7 DNA ligase having any amino acid sequence and structure including any homologs, mutants, and/or derivatives thereof suitable for use in any, blunt-ended or cohesive, DNA ligation reaction performed using generic reaction components and conditions. The state of the prior art: The reference of Chica et al. (Curr Opin Biotechnol. 2005 Aug;16(4):378-84) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships (whole paper). The reference of Sen et al. (Appl Biochem Biotechnol (2007) 143:212–223) teaches in vitro recombination techniques such as DNA shuffling, staggered extension process (StEP), random chimeragenesis on transient templates (RACHITT), iterative truncation for the creation of hybrid enzymes (ITCHY), recombined extension on truncated templates (RETT), and so on have been developed to mimic and accelerate nature's recombination strategy (abstract). However, such rational design and directed evolution techniques only provide guidance for searching and screening for the claimed ligase which is not guidance for making and/or using the claimed invention. The written description provided a contemporary view on determining function from structure, and that reference too expressed uncertainty in extrapolating from structure to function. Amount of Direction Provided by Inventor/Working Examples: Relevant to the claimed invention, the written description section above, in the section Disclosure of a Complete or Partial Structure, discusses examples provided by the Applicant. Particularly, Fig. 1 shows results of the R129D mutant present in SEQ ID NO: 2 enhances ligation of cohesive end substrates (Fig. 1B) and decreases ligation of blunt-ended substrates (Fig. 1A). At issue for the purpose of instant rejection is that none of these sequences can be reasonably considered to be biologically active fragments or variants of the full-length sequences described in detail or sequences recited but not described in detail. This is problematic. The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The specification does not support the broad scope of the claims which encompass all modifications and fragments of i) any R129D mutant T7 DNA ligase or of ii) any mutant T7 DNA ligase with 95% identity to SEQ ID NO: 1 with or without R129D because the specification does not establish: (A) regions of the protein structure which may be modified without effecting ligase activity; (B) the general tolerance of ligases to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying amino acid residues of the T7 DNA ligase with an expectation of retaining the desired biological activity; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful. Thus, the references teach the unpredictability in extrapolating from structure to function and the specification does not provide the missing link. This is reasonably interpreted as requiring demonstrating the biologically active fragments of mutants indeed have the efficacy they are claimed to purport. All of this underscores the criticality of providing workable examples which are not disclosed in the specification for biologically active fragments or variants of the full-length sequences. Therefore, in view the knowledge in the field, quantity of experimentation necessary, the breadth of the claims, lack of guidance in the specification, and the absence of working examples for biologically active fragments, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed. Dependent Claims Claims 15-17 do not further limit the genus of nucleic acid or amino acid molecules so as to resolve the issues above, and are therefore, not sufficiently enabled for at least the reasons above. Conclusion of Scope of Enablement While none of the Wands factors alone are specifically required to fulfill the Enablement criteria, in combination their lack means that one skilled in the art at the time of filing would conclude that the invention was not adequately enabled for a mutant other than R129D of T7 ligase, or biologically active variants thereof having 95% identity to the recited sequences, or any combination thereof. Therefore, the examiner concludes there is insufficient enablement support for the instantly claimed genera of mutants other than R129D of T7 ligase, or biologically active fragments, and combinations with each other as stated. Only SEQ ID NO: 1 as the DNA sequence encoding SEQ ID NO: 2, both sequences as disclosed in the specification, but not the full breadth of the claims is supported by Applicant’s disclosure. 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. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim 12 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 12 recites a cell. The claim is interpreted to read on a human organism because “a cell transformed with and expressing a polynucleotide of claim 10” could be encompassed within a human. The specification does not provide a limiting definition of a cell, and does not expressly exclude cells within a human organism In fact, the Spec in pg. 14 states: The mutant T7DNA ligase of the invention can be expressed in any suitable host system, including a bacterial, yeast, fungal, baculovirus, plant or mammalian host cell. Thus, the term “cell” could reasonably be interpreted as encompassing cells within a human organism, which is non-statutory subject matter. This rejection may be overcome by amending above claims to recite “an isolated cell” or “non-human cell”. Conclusion No claims are allowed. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHABANA MEYERING, Ph.D. whose telephone number is (703)756-4603. The examiner can normally be reached M - F: 9am to 5pm EST. 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, Ram Shukla can be reached at (571) 272-0735. 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. SHABANA S. MEYERING, Ph.D. Examiner Art Unit 1635 /SHABANA S MEYERING/Examiner, Art Unit 1635 /CATHERINE KONOPKA/Primary Examiner, Art Unit 1635
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Prosecution Timeline

Jan 20, 2024
Application Filed
Jul 13, 2026
Non-Final Rejection mailed — §101, §112
Jul 23, 2026
Response after Non-Final Action
Jul 23, 2026
Response Filed

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Prosecution Projections

1-2
Expected OA Rounds
69%
Grant Probability
99%
With Interview (+41.6%)
2y 12m (~5m remaining)
Median Time to Grant
Low
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