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
Application Status
This application is a DIV of US patent application 16/340,476, filed on 09/27/2022, which was a 371 of PCT/EP2017/076140, filed on10/13/2017.
Claims 14-25 and 26 are currently pending in the instant patent application.
The preliminary amendment filed on 09/27/2022, canceling claims 1-13 and adding new claims 14-25 and 26 is acknowledged.
Election/Restriction
Applicant's election with traverse of Group I, Claims 14-21 and 22-23, drawn to a polynucleotide encoding a modified Methanosarcina mazei pyrrolysyl tRNA synthetase sequence or a Methanosarcina barkeri pyrrolysyl tRNA synthetase sequence wherein the modified pyrrolysyl tRNA synthetases are modified by introduction of a nuclear export signal, while retaining pyrrolysyl tRNA synthetase activity, and a eukaryotic cell comprising said polynucleotide, and species of polypeptide sequence of SEQ ID NO: 1, and nucleic acid sequence encoding SEQ ID NO: 1 in the response filed on 10/15/2025 is acknowledged.
Since, elected species of sequence is SEQ ID NO: 1, claims 16, and 17 are withdrawn further consideration as a non-elected inventions
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants request for rejoinder is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
Claims 14-15, 18-21 and 22-26 are present for examination.
Priority
Acknowledgement is made of applicants claim for domestic priority US patent application 16/340,476, filed on 04/09/2019, now US patent US11492608, which was a 371 of PCT/EP2017/076140, filed on 10/13/2017, and foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application EPO 16194038.2, (Germany), filed on 10/13/2017. with English translation.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/27/2022 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner. The signed copy of 1449 is enclosed herewith.
Drawings
Drawings submitted on 05/10/2023 are accepted by the Examiner.
Specification Objections
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code (see, pg 9). See MPEP § 608.01.
Claim Rejections - 35 USC § 112(b)
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.
Claim 20 is rejected under 35 U.S.C. 112 (b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 20 recites “a reverse complement” which is unclear as to whether it is limited to the full-length complement or includes partial complements, rendering the metes and bounds of the term unclear and confusing..
Claim Rejections - 35 USC § 112, First Paragraph
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.
A. Written Description
Claims 14-15, 19-21, 22-23 and 24-26 are rejected under 35 U.S.C. 112(a), 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.
Claims 22, and 23 are directed to a polynucleotide encoding a modified Methanosarcina mazei pyrrolysyl tRNA synthetase sequence or a Methanosarcina barkeri pyrrolysyl tRNA synthetase sequence wherein the modified pyrrolysyl tRNA synthetases are modified by introduction of a nuclear export signal, while retaining pyrrolysyl tRNA synthetase activity, and a eukaryotic cell comprising said polynucleotide.
The Court of Appeals for the Federal Circuit has held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).
Thus, Claims are drawn to any polynucleotide encoding a modified Methanosarcina mazei pyrrolysyl tRNA synthetase sequence or a Methanosarcina barkeri pyrrolysyl tRNA synthetase sequence wherein the modified pyrrolysyl tRNA synthetases are modified by introduction of any or all nuclear export signal polypeptide derived from many unknown sources having no structural feature, while retaining pyrrolysyl tRNA synthetase activity of the fusion protein , and a eukaryotic cell comprising said polynucleotide, i.e., the claims encompass many fusion proteins of Methanosarcina mazei pyrrolysyl tRNA synthetase proteins or Methanosarcina barkeri pyrrolysyl tRNA synthetase, and many nuclear export signal polypeptide, as well as many mutants, variants and fragments thereof, which can have wide verities of unknown structures, i.e. No Structure-Function correlation, which is required to fulfill the Written Description requirement.
As discussed in the written description guidelines 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, reduction to drawings, 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. 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.
Furthermore, the genus of genes encoding polypeptides and functional homologs or variants required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of genes encoding polypeptides are adequately described by the disclosure of the structures of prior art. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is a vague concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and completely eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Claims are drawn to very broadly any polynucleotide encoding a modified Methanosarcina mazei pyrrolysyl tRNA synthetase sequence or a Methanosarcina barkeri pyrrolysyl tRNA synthetase sequence wherein the modified pyrrolysyl tRNA synthetases are modified by introduction of any or all nuclear export signal polypeptide derived from many unknown sources having no structural feature, while retaining pyrrolysyl tRNA synthetase activity of the fusion protein , and a eukaryotic cell comprising said polynucleotide, i.e., the claims encompass many fusion proteins of Methanosarcina mazei pyrrolysyl tRNA synthetase proteins or Methanosarcina barkeri pyrrolysyl tRNA synthetase, and many nuclear export signal polypeptide, as well as many mutants, variants and fragments thereof, which can have wide verities of unknown structures, i.e. No Structure-Function correlation, whose structures are not fully described in the specification. No information, beyond the characterization of few genes encoding pyrrolysyl tRNA synthetase enzymes and nuclear export signal polypeptide, has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the pyrrolysyl tRNA synthetase fusion protein, or enzymes and any or all nuclear export signal polypeptide or proteins within the scope of the claimed genus. The genus of fusion protein pyrrolysyl tRNA synthetase enzymes and nuclear export signal polypeptide polypeptides fusion protein claimed is a large variable genus including many mutants, variants and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated fusion proteins having any or all nuclear export signal polypeptides are encompassed within the scope of these claims. The specification discloses the structure of only few representative species of the claimed genus, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus. Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Conclusion
Status of the claims:
Claims 14-15, 19-21, 22-23 and 24-26 are rejected.
Claim 18 is 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F from 9:00 AM-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, Ph.D.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office (USPTO)
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656