DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on June 1, 2026, has been received and entered.
Claim Disposition
3. Claims 1-143, 157, 159-160 and 165 has been canceled. Claims 144-156, 158, and 161-164 are pending and are under examination.
Drawing
4. The drawings filed on June 1, 2026, has been accepted by the examiner.
Claim objection
5. Claims 144-156, 158, and 161-164 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 144 is amended to recite “A composition comprising an isolated RNA encoding [[an amino acid sequence comprising]] a peptidoglycan hydrolase and a signal peptide, wherein the peptidoglycan hydrolase has the amino acid sequence set forth in SEQ ID NO: …. and wherein the peptidoglycan hydrolase breaks down…….”. The dependent claims hereto are also included.
For clarity it is suggested that claim 145 is amended to read, “A method of treating a bacterial infection in a subject comprising:
administering an isolated RNA encoding….”. The dependent claims hereto are also included.
For clarity it is suggested that claim 149 is amended to read, “….modifying group, and wherein the pharmacokinetic ….”.
For clarity it is suggested that claim 150 is amended to read, “……(m5U); and wherein the RNA comprises…..”.
For clarity it is suggested that claim 152 is amended to read, “……particles, and wherein the RNA…..”.
For clarity it is suggested that claim 153 is amended to read, “……[[which is]] wherein a pharmaceutical composition, further [[comprising]] comprises……”.
For clarity it is suggested that claim 156 is amended to read, “….particles, and wherein the RNA lipid……”.
For clarity it is suggested that claim 162 is amended to read, “….cell, and wherein …..”.
Appropriate correction is required.
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.
6. Claims 144-156, 158, and 161-164 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention is directed to “a composition comprising an RNA encoding an amino acid sequence comprising a peptidoglycan hydrolase and a signal peptide, wherein the peptidoglycan hydrolase breaks down peptidoglycan in bacterial cell wall”, and the claimed invention is devoid of any structure (see claim 144). No correlation is made between structure and function. The claimed invention is overly broad and does not provide a representative number of species to demonstrate possession of the entire genus (see claim 144 and the dependent claims hereto). The claimed invention is also directed to a method of treating a bacterial infection in a subject comprising administering an RNA encoding an amino acid sequence comprising a peptidoglycan hydrolase and a signal peptide to the subject, wherein the bacterial infection is caused by Staphylococcus aureus. The treatment method does not describe or define what bacterial infection is being treated in a human subject and no treatment regimen or modality, see claim 145, for example. It is noted that claim 144 has been amended to recite an activity for the hydrolase and a human subject, however, what specific disease is being treated and how much and is it an oral dose. The art generally recognizes that Staphylococcus aureus bacteria can cause many types of infections, most commonly skin and soft tissue infections, bloodstream infections and pneumonia (such as boils and abscesses, cellulitis, impetigo, folliculitis, bacteremia and sepsis, pneumonia, endocarditis, osteomyelitis, food poisoning, toxic shock syndrome, and scalded skin syndrome). What is applicant treating in a human subject, what specific RNA encoding what specific sequence (for the hydrolase) and what specific signal peptide. Will this treatment treat every type of bacterial infections in all humans with any sequence. In addition, the recitation of the medical preparation is not descriptive, because this could be viewed as a composition prepared for administration for pharmaceutical usage, however, there is no indicia as to a pharmaceutically acceptable carrier or it could be construed as a kit or vaccine (see claim 146). The claims are overly broad because the RNA encoding an amino acid is not clearly defined as being the peptidoglycan hydrolase and signal peptide but only as ‘comprising’ it, thus the ordinary skilled worker does not know what else the composition or preparation comprises, what it is being administered to, what infection is targeted and can this composition treat any and all bacterial infection, what bacteria is the treatment derived, how is the preparation made and administered. The claimed invention is not commensurate in scope with the disclosure in the specification which discloses bacteriophage-encoded peptidoglycan hydrolases or endolysins or enzybiotics (see pages 1-3 of the specification).
The claimed invention is also overly broad with respect to the peptidoglycan hydrolase being modified so as to reduce glycosylation. The specification discloses on page 3 a modification such as Ly26A, however, the claims encompass a vast amount of modifications that are not adequately described and provide a few that are deemed as optional. Additionally, the claimed invention encompasses a large variable genus of moieties, fragments and variants thereof (see claim 149). The art generally discloses that a single amino acid change can be detrimental to the structure-function of the protein as well as changes made to the gene structure and the modifications encompassed in the instant claims are far greater and exceeds the scope of the specification disclosure.
The claimed invention is not adequately described because it encompasses a large variable genus of enzymes and coding sequences, peptides, modifications, infection types, bacteria and subjects, for example. The claimed invention also encompasses any treatment of any bacterial infection in a human adult or child with any RNA encoding an amino acid (which includes fragments, analogs, derivatives and variants thereof) comprising any peptidoglycan hydrolase and signal peptide via any route of administration, which is overly broad. The claimed invention is not adequately described and is not commensurate in scope with the disclosure in the specification. The specification fails to provide a representative number of species for the claimed genus to show that 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. 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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "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. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
The following is a quotation of 35 U.S.C. 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.
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.
7. Claims 144-156, 158, and 161-164 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.
Claims 144 and 145 are indefinite for the recitation of “signal peptide” because it is unclear if native to the peptidoglycan hydrolase or a heterologous structure because it is well established in the art that many peptidoglycan hydrolases feature an N-terminal signal peptide, transmembrane domains, or specific cell wall-binding domains depending on their location and function. The dependent claims hereto are included.
Claim 146 lacks clear antecedent basis for the recitation of “or medical preparation”.
Response to Arguments
8. Applicant’s arguments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejections of record under 112 first and second paragraph remains but have been altered based on amendments made to the claims.
Applicant traverses the 112, first paragraph rejection stating that claim 144 has been amended to recite a signal peptide and activity and claim 145 has been amended to recite the organism. This argument is not persuasive because the claimed invention is still not adequately described as it is devoid of structural limitation. Note that claim 144 is directed to any structure for the products in the composition and the method of treatment has no specific disease or treatment regimen. Thus the claimed invention remains drawn to a large genus not adequately described, nor did applicant demonstrate possession of.
In addition, although the 112, second paragraph rejection was traversed applicant did not consistently amend the claim limitations, for example claim 146, thus a new rejection was needed to address that issue.
Conclusion
9. No claims are presently allowable.
10. Applicant’s amendment necessitated the new/modified 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 HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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