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 .
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 8, 11 and 12 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. It is apparent that Dolosigranulum pigrum LMG P-31124 and LMG P-31154, Corynebacterium pseudodiphtheriticum JCM 1320 and ATCC 10700,are required to practice the claimed invention. As such, the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the strain Dolosigranulum pigrum LMG P-31124 and LMG P-31154.
The process disclosed in the specification does not appear to be repeatable. It is not clear that the invention will work with commonly available material and it is not apparent if the biological material(s) considered necessary to make and use the invention is both known and readily available to the public.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirements made herein.
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.
Claim 8,11, and 12 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.
It is unclear if applicant is attempting to state that the D. pigrum is deposited strain LMG P-31154. It is unclear what “D. pigrum comprises LMP-31154” means since it is unclear if applicant is claiming a recombinant strain in which one strain comprises another how a strain can comprise another strain.
Applicant is suggested to amend the names to state “ Dolosigranulum pigrum is deposited strain LMG P-31124…”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8, 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boeck et al., (WO2020128022; published 2020-06-25).
Regarding claims 1-3, Boeck et al., discloses two beneficial Dolosigranulum pigrum LMG P-31124 and LMG P-31154, for the treatment of acute and chronic otitis media (OM), in humans (Page 7,Lines 28-32; page 28, Claims 1 and 7 ).
Regarding claims 4 and 5,
Boeck et al., teaches that a concentration of 103 and 104 CFU D. pigrum LMG P-31124 demonstrated microcidal effects (Page 12, Figure 12d; Pages 23-25, Lines 36-39 and 1-7). The specification of the instant application discloses that a range of 102 - 1015 CFU is sufficient for providing the claimed reductions (Specification, Page 21, Paragraph 00042-00043). Since, the prior art teaches the same strain as claimed in the same sufficient amount as taught by the Specification (Page 21, Paragraph 00042-00043) to the same populations, the claimed reductions would inherently occur.
Regarding claims 6 and 7
Boeck discloses isolated Dolosigranulum pigrum strains from the nose and/or nasopharynx can also have probiotic potential (page 2, line 23-31). Boeck further discloses, experimental evaluation of pathogen inhibition by D.pigrum LMG15126 and D. pigrum LMG P-31124at a concentration of +/- 5 x 107 CFU/ml. (page 22, Lines 26-28; Page 23, Line 3-6;). The prior art presents the stains as “antipathogenic agent, more in particular antibacterial agents”. In a particular embodiment, said antipathogenic/antibacterial agents are effective against one or more bacteria selected from the list comprising: … Staphylococcus aureus, Haemophilus influenzae, … Pseudomonas aeruginosa, Moraxella catarrhalis, Streptococcus pneumoniae…” ( page 3, Claim 10, Lines 10-16).
Since the reference teaches the same method of treatment with said composition and at a same sufficient amount, OM reduction in cohorts of human patients, along with additional data/results from nasopharyngeal microbiome analysis (samples collected from nasal swabs), and in vitro studies on antipathogenic and probiotic effects of the instant composition to said pathogens -- the prior art anticipates the claims.
Regarding claim 8, wherein the plurality of strains of Dolosigranulum pigrum comprises LMG P-31124 or LMG P-31154, Boeck et al., discloses: “novel isolated bacterial strains of the Dolosigranulum pigrum species having at least 99% sequence identity in its 16S rRNA with a strain selected from the strains deposited under accession number LMG P-31124 or LMG P-31154.” (page 2, Lines 35-37).
Regarding claims 18-20, Boeck et al. teaches a purified population of bacteria at 103 and 104 CFU D. pigrum LMG P-31124 demonstrated microcidal effects (Page 12, Figure 12d; Pages 23-25, Lines 36-39 and 1-7). Brock further discloses, experimental evaluation of pathogen inhibition by D. pigrum LMG15126 and D. pigrum LMG P-31124 at a concentration of +/- 5 x 107 CFU/ml. (page 22, Lines 26-28; Page 23, Line 3-6;). Therefore, the reference teaches a total amount of Dolosigranulum pigrum within the range(s) of CFU described in the claims of the instant application.
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.
Claim(s) 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Boeck et al., ((WO2020128022; published 2020-06-25) in view of Lappan,R. and Peacock, C.S., “Corynebacterium and Dolosigranulum: future probiotic candidates for upper respiratory tract infections” Microbiology Australia. November 2019, (10.1071/MA19051), pages (172-177) [henceforth, referred to as Lappan et al.].
The teachings of Boeck et al., have been disclosed above.
Regarding claims 9-17 Boeck et al., does not teach the administration of Corynebacterium pseudodiphtheriticum JCM 1320 or ATCC 10700, and the administration of an intranasal spray , wherein the subjects are an infant, child or adult.
However, Lappen et al., teaches, a nasal spray probiotic therapy for children with recurrent acute OM, restores healthy flora of Corynebacterium and Dolosigranulum populations which prevents reemergence of pathogenic agents. (Lappen et al., page 175, paragraph 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to have modified Boeck et al., with Lappen et al, and add Corynebacterium to treat OM . One would have been motivated to combine Corynebacterium and Dolosigranulum , as a probiotic nasal spray for intranasal administration to improve treatment of OM and prevent the re-emergence of OM causing pathogens in infants, children, and adults. Since Lappen teaches the combination of D. pigrum and C. pseudodiphtheriticum, inhibits OM and restores a healthy microbiota within the nasopharynx. A skilled artisan would have reasonably expected success in the combination since the combination of both beneficial strains are solving the same problem and address the same concerns.
Conclusion
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653