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
Acknowledgement is hereby made of receipt and entry of the communication filed on July 30, 2026. Claims 2, 16-18, 20, 21, 23-26, 32, 34, 36, 39-44, 46-49, 52, 54-55, 57-59, 75, 76, 84, 88 and 89 are pending. Claims 43-44, 46, 48-49, 52, 54 and 57 are currently examined. Claims 2, 16-18, 20, 21, 23-26, 32, 34, 36, 39-42, 47, 55, 58-59, 75, 76, 84, 88 and 89 are withdrawn.
Election/Restrictions
Applicants’ election without traverse of Group III (claims 43-44, 46-49, 52, 54-55 and 57), in the reply filed on July 30, 2026, is acknowledged.
For species election requirements, applicant’s election with traverse and argument for claim 54 is considered through communication on 07/27/2026. Applicant’s Remarks referring to the examiner’s phone message are acknowledged. The applicant elected the method of administration of claim 46 and the subject in claim 57 without traverse is acknowledged.
Accordingly, claims 2, 16-18, 20, 21, 23-26, 32, 34, 36, 39-42, 58-59, 75, 76, 84, 88 and 89 are withdrawn as being directed to a non-elected group. Claims 47 and 55 are withdrawn as being directed to non-elected species.
Comments: Applicant elected Group III, where the administrating composition claimed in claim 43 of Group III is from claim 16 of Group II. Based on the restriction requirement filed on 06/05/2026 and for the purposes of compact prosecution and applying prior art, SEQ ID NO: 26 of Claim 16 is examined as the composition of claim 43.
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 43-44, 46, 48-49, 52, 54 and 57 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.
Claim 43 is directed to a method for treating a Pseudomonas aeruginosa infection, comprising administering the composition of claim 16 to a subject in need thereof, where the claim 16 recites a phrase “a bacteriophage composition comprising one or more bacteriophages that express one or more polynucleotide sequences…” that render the claims indefinite. It is not clear how the polynucleotide sequences can be expressed.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
For claim 48, Applicant recites a phrase “…the bacterial infection has become resistant to…” that renders the claim indefinite. It is unclear what the “has become” means.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
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 43-44, 46, 48-49, 52, 54 and 57 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.
Claim 43 is directed to a method for treating a Pseudomonas aeruginosa infection, comprising administering the composition comprising one or more bacteriophages that express one or more polynucleotide sequences with at least 90% identity to SEQ ID NO:26.
The written description rejection is made because the claims are interpreted as being drawn to method for treating a Pseudomonas aeruginosa infection by administering the composition bacteriophages with at least 90% identity to SEQ ID NO:26. This means that up to 10% nucleotide can vary. The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004).
The instant specification discloses that their invention provides a bacteriophage composition comprising one or more bacteriophages that express an exopolysaccharide (EPS) depolymerase, wherein the one or more bacteriophages comprise a “polynucleotide sequence selected from SEQ ID NO:26, SEQ ID NO:27… SEQ ID NO:71, SEQ ID NO:73, a polynucleotide sequence with at least 90% identity to SEQ ID NO: 26…” (See e.g., [0014]). However, the specification does not provide information disclosing which portions of the claimed SEQ ID NO: 26 is essential to retain the ability to treat a Pseudomonas aeruginosa infection or which portions of the SEQ ID NO: 26 can be modified or altered up to 10% and still retain being able to treat a Pseudomonas aeruginosa infection.
Peris et al. (Genetics. 2010 Jun;185(2):603-9) teaches the distribution of fitness effects caused by single-nucleotide substitutions in bacteriophage f1. Peris et al. discloses that they used site-directed mutagenesis to engineer single mutations and measure the fitness effect of 100 single-nucleotide substitutions in the bacteriophage f1, a filamentous single-strand DNA virus. They found that approximately one-fifth of all mutations are lethal. Viable ones reduced fitness by 11% on average and were accurately described by a log-normal distribution. More than 90% of synonymous substitutions were selectively neutral, while those affecting intergenic regions reduced fitness by 14% on average. Mutations leading to amino acid substitutions had an overall mean deleterious effect of 37%, which increased to 45% for those changing the amino acid polarity (See Title and Abstract).
Based on the teachings of Peris et al., it is reasonable to consider that the 10% variation as claimed can have a large impact on bacteriophage’s capability for treating a Pseudomonas aeruginosa infection and may contain the essential sequences to retain the ability to treat a Pseudomonas aeruginosa infection as well.
Accordingly, the specification does not provide written description to support that the applicant is in possession of the composition used for administration as claimed in claim 43.
Thus, claims 43 is therefore rejected as lacking adequate descriptive support for a method using the composition of Claim 16 to treat Pseudomonas aeruginosa infection as claimed, and not providing guidance on how such sequence changes should be made to up to 10% varies and still retain the composition’s function.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 43-44, 46, 49, 52, 54 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Sharp et al. (US 2006/0140911 A1, published on Jun. 29, 2006, submitted in the IDS on 08/19/2025, hereinafter, “Sharp”) in view of MN615700-2019 (https://www.ncbi.nlm.nih.gov/nuccore/MN615700.1).
Claim 43 is directed to a method for treating a Pseudomonas aeruginosa infection, comprising administering the composition of claim 16 to a subject in need.
Sharp teaches that their invention provides a composition for treating a lung biofilm in a CFpatient, preferably a biofilm comprising Pseudomonas aeruginosa and/or Burkholderia cepacia. The composition according to this embodiment preferably comprises a bacteriophage that encodes a polysaccharide lyase, preferably an alginate lyase enzyme. Alternatively, the enzyme may be provided exogenously (See [0060]). However, Sharp does not point out sequence information of the bacteriophage.
MN615700-2019 teaches the Pseudomonas phage vB_PaeM_SMS12, complete genome that contains 98% sequence identity to SEQ ID NO: 26 as claimed (See Table A below).
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It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the known sequence of MN615700-2019 into Sharp’s invention. One of skill in the art would be motivated to substitute one sequence for another (See MPEP 2144.06: Substituting equivalents known for the same purpose). There would be a reasonable expectation of success to develop a method for treating Pseudomonas aeruginosa infection by administering the SEQ ID NO: 26 in claim 16.
Regarding claim 44, Sharp teaches that the administered bacteriophages can be at 1x10^10 pfu (See e.g., [0158]).
Regarding claim 46, Sharp teaches that the composition may further comprise one or more pharmaceutically acceptable antimicrobial agents (eg. antibiotics, and/or defensins) (See [0019]), where the antibiotics can be ciprofloxacin, ceftazidime and tobramycin (See [0058]; [0054]).
Regarding claims 49 and 54, Sharp teaches that the observation that phage infection and cell lysis was not inhibited in the presence of sputum or by the process of aerosolization demonstrates that the inhalation conveyance system of phage aerosols would ensure delivery of viable lytic phage into the sputum rich lung alveoli of CF patients (See [0171]) (teaches claim 49), Here the patients teaches that the subject is human (claim 54).
Regarding claim 52, Sharp teaches that preferably the medicament is administered in more than one dose, more preferably in at least 3 separate doses ( eg. per day) (See [0063]).
Regarding claim 57, it requires that the subject was previously treated with one or more antibiotics. Sharp teaches that antibiotic, a DNase and/or a defensin, either at the same time, prior to, or subsequently to administration of the bacteriophage (See [0095]).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Sharp in view of MN615700-2019 as applied to claims 43-44, 46, 49, 52, 54 and 57 above and further evidenced by Vancomycin-Medline (https://medlineplus.gov/druginfo/meds/a604038.html) and in view of Pang et al. (Biotechnol Adv. 2019 Jan-Feb;37(1):177-192. Epub 2018 Nov 27).
Claim 48 is directed to a method wherein the bacterial infection has become resistant to one or antibiotics as claimed.
Sharp teaches that Biswas et al. (2002) have recently reported the successful bacteriophage mediated rescue of bacteremic mice infected with vancomycin resistant Enterococcus faecium (See [0014]), where Vancomycin belongs to the family of glycopeptide antibiotics as claimed. This can be evidenced by the Vancomycin-Medline. It teaches that Vancomycin is in a class of medications called glycopeptide antibiotics. It works by killing bacteria in the intestines. Vancomycin will not kill bacteria in any other part of the body when taken by mouth (See page 1). Therefore, although Sharp does not specifically point out the “glycopeptide”, one of skilled in the art can test any antibiotics including the Vancomycin for the bacteria resistance.
In addition, Sharp teaches that the present invention preferably relates to specific bacteriophage, which offer the potential to control Ps. aeruginosa induced biofilm formation and, in particular, biofilms involving the more aggressive drug-resistant bacterial species that contribute significantly to morbidity and mortality in CF patients (See [0106]).
Nevertheless, Pang studies the antibiotic resistance in Pseudomonas aeruginosa: mechanisms and alternative therapeutic strategies and teaches that a deficiency in OprD in P. aeruginosa confers a high level of resistance to carbapenems, especially to imipenem (See page 180, right column, paragraph 4), which teaches the claim 48. Pang also teaches that one of the advantages of phage therapy over antibiotic treatment is its activity against P. aeruginosa biofilms (See page 186, right column).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce Pang’s study into Sharp’s invention to arrive at an invention as claimed. One of skill in the art would be motivated to do so based on the teachings of Pang for using phage to treat the P. aeruginosa infection to overcome the antibiotics resistant such as carbapenem-resistant P. aeruginosa. There would be a reasonable expectation of success to develop a method for treating a Pseudomonas aeruginosa infection that is resistant to the claimed antibiotics.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:30 pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached on (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUIXUE WANG/ Examiner, Art Unit 1672
