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 claims 1-5 with species election of gKphe and HzAla in the reply filed on August 12, 2026 is acknowledged.
Status of Claims
Claims 1-24 are currently pending in the instant application. Claims 5-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Accordingly, claims 1-4 are under examination on the merits in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 4, 2023 have been considered by the examiner. Note that all of the non-English language foreign patent documents are considered only insofar as the English language title and abstract as submitted by applicant.
Specification
The title of the invention is not descriptive. Note that the word “novel” is not descriptive of an invention. A new title is required that is clearly indicative of the invention to which the claims are directed.
The abstract of the disclosure is objected to because it is not descriptive of the claimed subject matter. Note that the word “novel” is not descriptive of an invention in a patent application. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to because they contain Figures that are not in black colored font, thereby rendering the non-black color structures/texts not clearly legible. Note that almost all Figures contain non-black color structures/texts. Note that the patent application content should be in black font for legibility. That is, all application papers must be clearly legible using black colored font text and black lines. See MPEP §608.01. Applicant is required to review the entire drawings and make appropriate corrections.
In addition, “Figure” should be abbreviated “FIG.”. See 37 CFR 1.84.
The drawings are also objected to because they fail to describe the features, in particular, colors (e.g., “pink”, “orange”) as described in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 1-4 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.
In the instant case, claim 1 recites parenthetical limitations such as “(e.g., methyl, ethyl)” and “(e.g., methyl).” The parenthetical limitations with “e.g.” render the claim indefinite because it is unclear whether the limitation(s) following the “e.g.” are part of the claimed invention. See MPEP § 2173.05(d). Since claims 2-4 depend from claim 1, claims 2-4 are rejected for the same reasons by virtue of claim dependency.
Claim Rejections - 35 USC § 112
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 1-4 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.
The factors to be considered when analyzing claims for compliance with the written description requirement include, but are not limited to: (A) actual reduction to practice; (B) disclosure of drawings or structural chemical formulas; (C) sufficient relevant identifying characteristics (e.g., complete structure, partial structure, physical and/or chemical properties, structure/function correlation); (D) level of skill and knowledge in the art; and (E) predictability in the art. See MPEP §2163.
Each factor is analyzed below.
(A) actual reduction to practice
The instant claims are broadly drawn to a combination composition comprising two acylated tRNA molecules having Formula I(a) and Formula II(a), wherein claims 2-4 each define either of the two Formulas. In contrast to the generically claimed combination composition requiring the generic Formula I(a) and Formula II(a), the instant specification appears to describe only a few combination compositions comprising two specific acyl-tRNA species for each of Formula I(a) and Formula II(a) that together form a pyridazinone bond, wherein four specific species of Formula I(a), which are monomers 1, 2, 3, and 4, and two specific species of Formula II(a), which are monomers 5 and 6 with (S) chirality, are combined, thereby resulting in eight combination compositions of 1:5, 1:6, 2:5, 2:6, 3:5, 3:6, 4:5, and 4:6. It appears that the specification also discloses an actual synthesis of a combination product comprising monomer 7 (cyanomethyl 2-amino-4-oxo-4-phenylbutanoate) and monomer 6. Hence, the specification discloses actual synthesis of a total of nine combination compositions within the claimed genus.
(B) disclosure of drawings or structural chemical formulas
The instant application discloses five specific structures of monomers 1, 2, 3, 4, and 7 for Formula I(a) and two specific structures of monomers 5 and 6 with (S) configuration for Formula II(a) for a combination composition.
(C) sufficient relevant identifying characteristics
The instant specification describes the intended function/utility for two acylated tRNA molecules forming a ribosome-mediated pyridazinone bond when the two acylated tRNA molecules have the specified structures as described in factor (A) above. As such, the instant specification is insufficient to adequately describe the requisite structure-function correlation for the entire genus as now claimed.
(D) level of skill and knowledge in the art
As evidenced by the improper title and abstract (see the objections above), the instantly claimed subject matter pertains to acylated tRNAs having “novel” chemistries, which form pyridazinone bonds catalyzed by the ribosome. The specification also discloses “this is to our knowledge the first example of intramolecular cyclic structure formation catalyzed by the ribosome in vitro” by monomer “1” and monomer “5”, wherein the percent yield of pyridazinone formation by the two monomers was deemed “inefficient”. See paragraph 0286. Hence, the instant application in and of itself expressly acknowledges on the record that there is no relevant prior art knowledge/technical skill pertaining to the claimed subject matter, which was deemed “novel” and “the first”, as of the filing date sought in the instant case.
(E) predictability in the art
As noted in factor (D) above, the instant specification expressly discloses an “inefficient” result by the combination of monomer “1” and monomer “5”, wherein the specification further discloses “higher efficiencies” with about 4-fold increase when monomer “5” is replaced with monomer “6”. See paragraph 0287. Hence, it remains unknown and undisclosed whether species not actually synthesized and tested in the instant application would confer the intended function/activity in the instantly claimed combination composition, thereby suggesting a lack of predictability pertaining to the claimed subject matter especially in view of the complete lack of pertinent prior art knowledge.
In view of the totality of factors (A)-(E) analyzed above, it is concluded that the instant specification fails to describe a sufficient number of structural variants representing the combination of “Formula I(a)” and “Formula II(a)” thus the instant specification fails to reasonably convey that the instant co-inventors had possession of the entire genus as of the filing date sought in the instant case.
Relevant Art/Application
It is noted that Application No. 18/796,506 (US 2025/0074944 A1) having at least one common inventor discloses and claims the same acylated tRNA molecule claimed in the instant application including applicant’s elected “HzAla”; however, the ‘506 application fails to disclose the instantly claimed first acylated tRNA molecule having Formula I(a).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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