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
The amended claim set filed 4/28/2023 is acknowledged. The response to election / restriction filed 3/18/2026 is acknowledged. The applicant elected Group I (claims 1, 4-5, 8, 12-14, 19-21, and 23-27), drawn to methods of treating polymicrobial biofilms comprising Haemophilus bacteria, related diseases thereto. The applicant elected the species of an anti-PilA antibody or fragment thereof. This election reads on claims 1, 4, 5, 8, 12-13, 19-21, and 23-27. Claim 14 is drawn to an unelected species.
Upon further consideration because the PilA polypeptide species was found during the search it has been rejoined.
The election was made without traverse.
Claims 14, 28, 29, 31, 37, and 39 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 4-5, 8, 12-14, 19-21, and 23-27 will be examined on the merits herein.
Claim Objections
Claim 21 is objected to as the claim omitted at least one conjunction following the last comma (e.g., “and” or “or”) in the list of bacterial species options.
Claim 27 is objected to as being unclear, the examiner recommends rewriting claim 27 as follows:
The method of claim 26, wherein the high level, low level, altered level, or altered expression is compared to the same bacteria but grown planktonically.
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.
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 19 and 26 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 26 is indefinite because it is not clear what the reference point is for comparing the altered protein or gene expression to. Is it compared to bacteria in the biofilm state, the planktonic state, or something else?
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 25-27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 25-27 recite inherent outcomes of the methods of treatment from which they depend and do not provide any further steps or limitations. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 25 is drawn to synergistic effects, this is an outcome of using both antibodies as disclosed in the specification par.20, 22, 23, 645-646. The synergistic effect would necessarily occur if following administration of the anti-DNABII and anti-PilA antibodies of claim 1. Therefore claim 25 does not further limit claim 1.
Regarding claim 26 alteration of gene expression of at least the gene artM is a result of the method of antibody treatment par.17 and fig.4. The altered gene expression of claim 26 would necessarily occur if following administration for the anti-DNABII and anti-PilA antibody of claim 1. Therefore claim 26 does not further limit claim 8.
Claim 27 is rejected as above in the rejection for claim 26 because the comparison in par.17 and fig.4 is to NTHI grown planktonically.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 5, 8, 12, 19, 20, 21, 23, 24, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Mokrzan et al (Reference A15 from IDS filed 2/08/2024). in view of National Children’s Hospital (US-20190000971-A1 published 2019-01-03) hereinafter NCH and further in view of Novotny et al. (Antibodies against the majority subunit of type IV Pili disperse nontypeable Haemophilus influenzae biofilms in a LuxS-dependent manner and confer therapeutic resolution of experimental otitis media. Mol Microbiol. 2015 Apr;96(2):276-92. doi: 10.1111/mmi.12934. Epub 2015 Feb 15. PMID: 25597921; PMCID: PMC4423401.)
Regarding claims 1, 5, 12, 20, and 21, Mokrzan teaches otitis media (OM) is often chronic and recurrent, due to the presence of highly antibiotic-resistant communities of bacteria (called biofilms) that persist within the middle ear space. To combat these recalcitrant infections, new and powerful biofilm directed approaches are needed p.1 par.2. Mokrzan teaches “Antibodies against the Majority Subunit (PilA) of the Type IV Pilus of Nontypeable Haemophilus influenzae Disperse Moraxella catarrhalis from a Dual-Species Biofilm” p.1 title. Mokrzan teaches anti-rsPilA induced the release of both NTHI and Mcat (Moraxella catarrhalis) from dual-species biofilms p.6 par.2 and fig 3A-B. A dual species biofilm is a polymicrobial biofilm. Therefore an anti-PilA antibody can disperse a polymicrobial biofilm of NTHI and Mcat in an in vitro assay.
Mokrzan does not teach an anti-DNABII antibody.
NCH teaches Fig.9B depicts the disruption of biofilms formed by Haemophilus influenzae NTHI strain # 1714 upon incubation with monoclonal anti - IHF and combinations thereof, par.200. FIG. 7D depicts similar results for biofilms formed by Moraxella catarrhalis 7169, par. 198. Therefore, an anti-DNABII antibody can disrupt both NTHI and Mcat biofilms in a single species in vitro assay.
It is noted that IHF is a DNABII protein, NCH par.176.
Mokrzan and NCH do not teach the use of the aforementioned antibodies as a treatment in vivo as both of their experiments are in vitro biofilms.
Novotny teaches an experiment in which antigens to integration host factor and recombinant soluble PilA (rsPilA) are used as a post infection vaccine in a nontypeable Haemophilus influenzae (NTHI) chinchilla infection model of ear infections (otitis media). The vaccine produces antibodies to IHF and PilA which are found in the serum and middle ear fluids, p.8 par.2 and p.2 par.1. Novotny teaches that the combination of these 2 antigens when applied to chinchillas resulted in and additive effect greater than IHF alone, this effect resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7. Although the subject, the chinchilla, was not treated with antibodies, nonetheless anti-bodies to IHF and PilA were produced and found in the biofilms.
Novotny does not specifically teach that the biofilm is polymicrobial, however, Novotny does not use germ free chinchillas and thus the biofilm cannot be stated to be single species, it can be multispecies.
It is noted that IHF refers to DNABII protein, integration host factor (IHF) Novotny p.1 summary, and rsPilA is a biologically active fragment of PilA as it possesses functional qualities of the native pilin subunit, instant specification par.209.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Mokrzan of treatment of multispecies biofilms with an anti-PilA antibody with the teachings of NCH of treatment of NTHI or Mcat biofilms with an anti-DNABII antibody for the treatment of polymicrobial biofilms comprising an NTHI and Mcat polymicrobial biofilm in a subject in need thereof.
A person having ordinary skill in the art would have been motivated to treat NTHI infections because Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1, and OM are highly prevalent among children worldwide and present a tremendous socioeconomic challenge for health care systems which diminishes the quality of life of young children p.1 par.2.
There would have been reasonable expectation of success because Novotny teaches that both antibodies worked together to resolved OM in a chinchilla animal model p.12 par.3 and fig.7 and Mokrzan demonstrated a PilA antibody works against polymicrobial biofilms p.6 par.2 and fig 3A-B, and NCH demonstrated that an anti-DNABII antibody worked against the 2 common species found in these polymicrobial biofilms individually.
Regarding claims 4 and 23, As indicated above Novotny and Mokrzan teach claim 1, however the above rejection does not address the use of antibiotics.
Mokrzan teaches OM is often chronic and recurrent, due to the presence of highly antibiotic-resistant communities of bacteria (called biofilms) that persist within the middle ear space. To combat these recalcitrant infections, new and powerful biofilm directed approaches are needed p.1 par.2. Mokrzan teaches to evaluate the antibiotic sensitivity of newly released NTHI and Mcat, they exposed NTHI and Mcat biofilms to anti-rsPilA collected the newly released bacteria, and then incubated this subpopulation with antibiotics p.10 par.3. For amoxicillin-clavulanate in the newly released population, they observed NTHI killing of 28% at 37°C. These results indicated that newly released NTHI was significantly more sensitive to amoxicillin-clavulanate than biofilm resident NTHI p.10 par.4. Mokrzan teaches Mcat newly released from a dual-species biofilm by the action of anti-rsPilA was highly sensitive to amoxicillin-clavulanate, 68% killing at 37°C. The percent killing in the newly released population was significantly greater than that of biofilm-resident Mcat, and at least as sensitive as broth-suspended Mcat p.10 par.5 and Fig. 7B.
It is noted that amoxicillin is a β-lactam antibiotic. instant specification par.472.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Novotny with Mokrzan in order to arrive at administering an anti-DNABII antibody and an anti-PilA antibody to a subject who was previously treated with amoxicillin. A person having ordinary skill in the art would have been motivated to do this because Mokrzan teaches Amoxicillin is one of the most commonly prescribed antibiotics for OM p.10 par.3, and Mokrzan teaches OM is often chronic and recurrent, due to the presence of highly antibiotic-resistant communities of bacteria (called biofilms) that persist within the middle ear space. To combat these recalcitrant infections, new and powerful biofilm directed approaches are needed p.1 par.2.
There would have been reasonable expectation of success because Novotny teaches that both antibodies worked together to resolved OM in an animal model p.12 par.3 and fig.7 and Mokrzan demonstrated an anti-PilA antibody works against multispecies biofilms p.6 par.2 and fig 3A-B and an anti-PilA antibody treatment which induced newly NTHI and Mcat was significantly more sensitive to amoxicillin-clavulanate than biofilm resident cells as detailed above.
Regarding claim 8, the above rejection of claim 4 details inducing bacteria to a newly released state and sensitizing them to antibiotic therapy.
Regarding claim 13, The above rejections do not address the specific anti-DNABII peptides A-5 or mB4. NCH teaches FIG. 7A depicts the reduction of biofilms formed by B. cenocepacia K56 upon incubation with monoclonal anti-IHF and combinations thereof, as well as polyclonal anti-IHF. Specifically anti-IHF A-5 and anti-IHF mB-4 demonstrated robust disruption of biofilms either alone or in combination with one another. FIG. 7B depicts similar results for biofilms formed by Pseudomonas aeruginosa 28753. FIG. 7C depicts similar results for biofilms formed by Staphylococcus aureus 29213. FIG. 7D depicts similar results for biofilms formed by Moraxella catarrhalis 7169, par. 198. Taken together this demonstrates that anti-IHF antibodies to the A-5 and mB4 peptides disrupt biofilms of many species of bacteria including NTHI and Mcat.
It would have been obvious to a person having ordinary skill in the art to combine the teachings of Mokrzan with NCH and Novotny in order to arrive at anti-DNABII antibodies which recognize and bind to DNABII A5 and mB4 peptides. A person having ordinary skill in the art would have been motivated to select these because they exhibited good efficacy against multiple bacteria in addition to Moraxella catarrhalis.
There would have been reasonable expectation of success because NCH teaches, they were effective in disrupting biofilms in par. 198 and fig. 7A-D.
Regarding claim 14, Novotny teaches a recombinant soluble PilA (rsPilA) are used as a vaccine in a nontypeable Haemophilus influenzae (NTHI) chinchilla infection model of ear infections (otitis media) p.8 par.2.
It is noted that rsPilA is a biologically active fragment of PilA as it possesses functional qualities of the native pilin subunit, instant specification par.209.
It would have been obvious for a person having ordinary skill in the art to administer rsPilA as a vaccine because this effect resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7.
Regarding claim 19, the above rejection of claim 4 would make it obvious to carry out antibiotic treatment during or after step (i) or (ii) of claim 1 in order to kill the bacteria after they are sensitized to the antibiotic having been induced to the newly released state.
Regarding claim 25 the method of claim 1 entails all the steps of claim 25 and the limitation of an outcome being in a synergistic manner as compared to either antibody administered alone does not change the method or the obviousness of it as there are no additional steps or structures presented in claim 25 nor is anything inferred that a person having ordinary skill in the art would use to make obvious alterations to the method of claim 1.
Regarding claims 26-27 the method of claim 8 would inherently lead to the outcomes of claims 26 and 27 as detailed in the 112d rejection above.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Mokrzan NCH and Novotny in further view of AAAA ( AAAA 2019 Reactions to therapeutic monoclonal antibodies).
Mokrzan NCH and Novotny teach claim 1 as detailed above, however they do not specifically teach identification of the bacteria in a sample of the subject prior to administration.
AAAA teaches all monoclonal antibodies or receptors fused with heavy chains are macromolecules of sufficient size to serve as antigens, and thus can result in a variety of immunologic reactions. These agents also frequently bind to receptors on cell surfaces or in blood and could result in immunologic reactions directly as their mechanism of action p.2 par.3.
It would have been obvious to a person having ordinary skill in the art to identify the bacteria present in an infection prior to administration because if the bacteria are not identified they may be species which are not affected by the treatment, and it would be an unnecessary risk of allergic reaction to administer an antibody.
There would have been reasonable expectation of success because if no antibody is administered there would not be a possible allergic reaction to it.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US 12116614 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11, and 12 of U.S. Patent No. US-12116614-B2, hereinafter 614 in view of Novotny, NCH and Mokrzan.
Regarding claims 1, 5, 8, 12, 20, and 21: although the claims at issue are not identical, they are not patentably distinct from each other because 614 claims a method which comprises the same method of the instant application. 614 claim 1 is drawn to identifying antibiotic sensitivity of newly released bacteria which comprises administration of an anti-rsPilA antibody, an anti-DNABII antibody, or an antigen binding fragment thereof, 614 claim 8 is drawn to dual species. It would have been obvious to a person having ordinary skill in the art to execute the methods of the instant application by removing the extra steps of determining the antibiotic resistance of the bacteria in claim 1 and selecting NTHI and Mcat in a dual species biofilm because Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of these 2 antibodies effect resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the 103 rejections above.
Regarding claims 4 and 23 see the 103 rejection of claims 4 and 23 above and 614 claim 11 which is drawn to β-lactam antibiotic.
Regarding claim 13 see the 103 rejection of claim 13 above and it would be obvious because 614 claim 12 is drawn to an anti-tip chimer antibody.
Regarding claim 19, 614 claim 1 administers antibiotics after antibody administration, and see the 103 rejection of claim 19 above.
Regarding claim 24 see the 103 rejection of claim 24 above.
Regarding claims 25 see the 103 rejection of claim 25 above.
Regarding claims 26 and 27 see the 103 rejection of claims 26 and 27 above.
US 11684673 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 15, 17, 18 of U.S. Patent No. US 11684673 B2, hereinafter 673 in view of Novotny, NCH and Mokrzan.
Regarding claims 1, 5, 12, 20, and 21, 673 claim 1 is drawn to a composition of a DNABII antibody, the antibody targets Haemophilus influenzae DNABII, 673 specification column 18 lines 46-57. 673 claim 12 is drawn to a method of treating a subject in need thereof with the antibody of 673 claim 1. 673 claim 15 is drawn to the method of claim 12 further comprising one or more of the following, (a) an antibody directed against rsPilA in addition to other choices. It would have been obvious to a person having ordinary skill in the art to select the aforementioned choice of 673 claim 15 for treating a subject with NTHI and Mcat in a dual species biofilm because Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of these 2 antibodies effect resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above. In addition, 673 teaches the use of the method of claim 12 with the specific bacterial choices of NTHI and Mcat biofilms in claim 18, and for otitis media in claim 17.
It is noted that the antibody of claim 1 is targeted to IHF A5 fragment as disclosed in the description of CDRL1 SEQ ID NO: 79, from the specification column 11 lines 6-7.
Regarding claims 4 and 23 see the 103 rejection of claims 4 and 23 above.
Regarding claim 8 see the 103 rejection of claim 8 above.
Regarding claim 13 see the 103 rejection of claim 13 above and it would be obvious because 673 claim 1 is drawn to an anti-IHF A5 antibody as noted above.
Regarding claim 19, 673 claim 15 step (b) is drawn to an antibiotics with antibody administration, and see the 103 rejection of claim 19 above.
Regarding claim 24 see the 103 rejection of claim 24 above.
Regarding claims 25 see the 103 rejection of claim 25 above.
Regarding claims 26 and 27 see the 103 rejection of claims 26 and 27 above.
US 12239763 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 15 of U.S. Patent No. US 12239763 B2 in view of Novotny, NCH, and Mokrzan as evidenced Li et al. (Li W, Joshi MD, Singhania S, Ramsey KH, Murthy AK. Peptide Vaccine: Progress and Challenges. Vaccines. 2014; 2(3):515-536. https://doi.org/10.3390/vaccines2030515)
US 12239763 B2 claims 1 is drawn to an isolated polypeptide and an adjuvant and this would generate antibodies to DNABII as evidenced by Li p.516 par.1. 182. Claim 9 is drawn to the composition of claim 1 and amoxicillin and/or an antibody directed against rsPilA.
The claims of US 12239763 B2 are not drawn to multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine the anti- DNABII antibody and the anti-rsPilA antibody of US 12239763 B2 claim 9 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 10940204 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6 and 8 of U.S. Patent No. US 10940204 B2, hereinafter 204 in view of Novotny, NCH and Mokrzan.
Regarding claims 1, 5, 12, 20, and 21, 204 claim 1 is drawn to a method of treating a subject having a biofilm consisting of Haemophilus influenza, Moraxella catarrhalis, and various other bacterial species. 204 claim 8 further limits the species list while retaining Haemophilus influenza, Moraxella catarrhalis, indicating these are preferred embodiments. The method comprises administration of a DNABII antibody, the antibody targets Haemophilus influenzae DNABII as evidenced by 204 specification column 15 lines 10-21. 204 claim 6 is drawn to treatment of otitis media.
The claims of 204 are not drawn to administration of an anti-PilA antibody.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art to select the aforementioned choice of 204 claim 1 and an anti-PilA antibody for treating a subject with NTHI and Mcat in a dual species biofilm.
It is noted that the antibody of claim 1 is targeted to IHF mB4 fragment as disclosed in the description of CDRH1 SEQ ID NO: 110, from the specification column 12 lines 52-53.
Regarding claims 4 and 23 see the 103 rejection of claims 4 and 23 above.
Regarding claim 8 see the 103 rejection of claim 8 above.
Regarding claim 13 see the 103 rejection of claim 13 above and it would be obvious because 204 claim 1 is drawn to an anti-IHF mB4 antibody as noted above.
Regarding claim 19, 204 claim 3 is drawn to administration of antimicrobials, and see the 103 rejection of claim 19 above.
Regarding claim 24 see the 103 rejection of claim 24 above.
Regarding claims 25 see the 103 rejection of claim 25 above.
Regarding claims 26 and 27 see the 103 rejection of claims 26 and 27 above.
US 11629182 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, and 11-15 of U.S. Patent No. US 11629182 B2, hereinafter 182 in view of Novotny, NCH, and Mokrzan Li.
182 claim 1 is drawn to a method to prevent formation of a biofilm comprising administration of a polypeptide that is Haemophilus influenzae IhfA fragment A5 (SEQ ID NO. 352) 182 specification par.102. 182 claim 8 is drawn to subcutaneous, intramuscular and direct injection. This form of administration would be a vaccine that generates antibodies to IHF as evidenced by Li p.516 par.1. 182. Claim 6 is drawn to treatment of Haemophilus influenza, Moraxella catarrhalis, and various other bacterial species.
The claims of 182 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of 182 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections for the remaining claims.
US 12098188 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 6 of U.S. Patent No. US 12098188 B2 in view of Novotny, NCH, and Mokrzan.
US 12098188 B2 claims 1 drawn to a method to prevent formation of a biofilm comprising administration of an anti-DNABII antibody as evidenced by specification p.51 table 2, example SEQ ID NO: 112 IHFmb4 fragment. Claim 3 is drawn to administration with antibiotics. Claim 6 is drawn to treatment of Haemophilus influenza, Moraxella catarrhalis, and various other bacterial species.
The claims of US 12098188 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of US 12098188 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 12152068 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6 of U.S. Patent No. US 12152068 B2 in view of Novotny, NCH, and Mokrzan.
US 12152068 B2 claims 1 drawn to an anti-DNABII antibody. Claim 6 is drawn to binding at least 3 different bacterial species. Claim 7 is drawn to the antibody having greater affinity to DNABII than DNABII has to a component of the biofilm. Claim 9 is drawn to addition of antibiotics to a composition with the anti-DNABII antibody.
The claims of US 12098188 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of US 12152068 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 10233234 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. US 10233234 B2 in view of Novotny, NCH, and Mokrzan.
US 10233234 B2 claim 1 is drawn to an anti-DNABII antibody.
The claims of US 10233234 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody US 10233234 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 8999291 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, and 12 of U.S. Patent No. US 8999291 B2 in view of Novotny, NCH, and Mokrzan.
US 8999291 B2 claim 1 is drawn to a method of breaking down a microbial biofilm in a subject by administering an anti-DNABII antibody, see parts (a) and (i).
The claims of US 8999291 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of US 8999291 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 11104723 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21, and 30 of U.S. Patent No. US 11104723 B2 in view of Novotny and Mokrzan, NCH.
US 11104723 B2 claims 1 drawn to a method to prevent formation of a biofilm comprising administration an anti-tip antibody as evidenced by specification p.32 col.3 last paragraph, col.4 first paragraph. Claim 21 is drawn to disruption of a biofilm. Claim 30 is drawn to the antibody binding the tip region of DNABII.
The claims of US 11104723 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of US 11104723 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 11564982 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US 11564982 B2 in view of Novotny, NCH, and Mokrzan.
US 11564982 B2 claims 1 drawn to a method to prevent formation of a biofilm comprising administration an DNABII polypeptide fragment as evidenced by specification p.27 col.21 fig.1 description, SEQ ID NO: 50 is a Haemophilus influenzae mIHFB4 fragment. Claim 2 is drawn to use of this in a vaccine. Claim 3 is drawn to administration with antibiotics. Claim 4 is drawn to disruption of biofilms with a vaccine and claim 5 is drawn to disruption of biofilms with the polypeptide of claim 1.
The claims of US 11564982 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of US 11564982 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 12419944 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, and 8 of U.S. Patent No. US 12419944 B2 in view of Novotny, NCH, and Mokrzan.
US 12419944 B2 claims 1 drawn to a method to prevent formation of a biofilm comprising administration an DNABII polypeptide fragment as evidenced by specification p.22 col.11 lines 12-15, SEQ ID NO: 50 is a Haemophilus influenzae IHFA5 and mIHFB4 fragment chimer. Claim 4 is drawn to use of this in a vaccine. Claim 5 is drawn to administration with antibiotics. Claim 8 is drawn to disruption of biofilms with a vaccine and claim 5 is drawn to disruption of biofilms with the polypeptide of claim 1.
The claims of US 12419944 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of US 12419944 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 11274144 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, and 12, of U.S. Patent No. US 11274144 B2 in view of Novotny, NCH, and Mokrzan.
US 11274144 B2 claims 1 drawn to a method to prevent formation of a biofilm comprising administration an DNABII polypeptide fragment as evidenced by specification p.41 col.5 lines 44-65, SEQ ID NO: 352 is a Haemophilus influenzae IHFa fragment. Claim 2 is drawn to prevention of biofilms in subjects. Claim 3 is drawn to human and chinchilla subjects. Claim 6 is drawn to one or more of NTHI and Mcat. Claim 7 is drawn to administration with antibiotics. Claim 4 is drawn to disruption of biofilms with a vaccine and claim 5 is drawn to disruption of biofilms with the polypeptide of claim 1. Claim 12 is drawn antibodies which bind the polypeptide of claim 1.
The claims of US 11274144 B2 are not drawn to administration of an anti-PilA antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of US 11274144 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 7811591 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. US 7811591 B2 in view of Novotny and Mokrzan as evidenced by Li.
US 7811591 B2 claims 1 is eliciting an immune response to NTHI with a chimeric polypeptide containing PilA as evidenced by specification p.6 col.4 lines 59-63. Claim 7 is drawn to an NTHI infection including otitis media. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182.
The claims of US 7811591 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 7811591 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 8263363 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 8263363 B2 in view of Novotny, NCH, and Mokrzan as evidenced Li.
US 8263363 B2 claims 1 is eliciting an immune response to NTHI with a chimeric polypeptide containing PilA as evidenced by specification p.6 col.4 lines 65-66. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182.
The claims of US 8263363 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 8263363 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 8741304 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 3 of U.S. Patent No. US 8741304 B2 in view of Novotny and Mokrzan as evidenced by Li.
US 8741304 B2 claims 1 is eliciting an immune response to NTHI with a chimeric polypeptide containing PilA as evidenced by specification p.7 col.5 line 1. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182. Claim 2 is drawn to a treating an NTHI middle ear infection. Claim 3 is drawn to treating otitis media.
The claims of US 8741304 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 8741304 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 7501131 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, and 15 of U.S. Patent No. US 7501131 B2 in view of Novotny, NCH, and Mokrzan as evidenced by Li.
US 7501131 B2 claims 1 is drawn to a polypeptide PilA. Claim 6 is drawn to an antibody to PilA. Claim 15 is drawn to eliciting an immune response to NTHI comprising administration of the PilA peptide. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182. Claim 8 is drawn to an NTHI infection of the middle ear.
The claims of US 7501131 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 7501131 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 7893237 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 15 of U.S. Patent No. US 7893237 B2 in view of Novotny and Mokrzan as evidenced by Li.
US 7893237 B2 claims 1 and 5 are drawn to eliciting an immune response to NTHI comprising administration of the PilA peptide. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182.
It is noted that SEQ ID NO: 2 of US 7893237 B2 claim 1 is PilA, specification p.6 col.4 line 27.
The claims of US 7893237 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 7893237 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 8399000 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 10, 11, 12, 14, and 15 of U.S. Patent No. US 8399000 B2 in view of Novotny, NCH, and Mokrzan as evidenced by Li.
US 8399000 B2 claims 1 and 3 are drawn to eliciting an immune response to NTHI comprising administration of the PilA peptide. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182. Claim 11 is drawn to a middle ear infection.
It is noted that SEQ ID NO: 2 of US 8399000 B2 claim 1 is PilA, specification p.6 col.4 line 26.
The claims of US 8399000 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 8399000 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 9309294 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 7 of U.S. Patent No. US 9309294 B2 in view of Novotny and Mokrzan as evidenced by Li.
US 9309294 B2 claims 1 and 6 are drawn to eliciting an immune response to NTHI comprising administration of the PilA peptide. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182. Claim 7 is drawn to a middle ear infection.
It is noted that SEQ ID NO: 2 of US 9309294 B2 claim 1 is PilA, specification p.6 col.4 line 30.
The claims of US 9309294 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 9309294 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 9533033 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 9533033 B2 in view of Novotny, NCH, and Mokrzan as evidenced by Li.
US 9533033 B2 claims 1 is drawn to eliciting an immune response to NTHI comprising administration of the PilA peptide. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182.
It is noted that SEQ ID NO: 2 of US 9533033 B2 claim 1 is PilA, specification p.6 col.4 line 40.
The claims of US 9533033 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 9533033 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
US 9987343 B2 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 2 of U.S. Patent No. US 9987343 B2 in view of Novotny, NCH, and Mokrzan as evidenced by Li.
US 9987343 B2 claims 1 and 2 are drawn to eliciting an immune response to H. influenzae comprising administration of the PilA peptide. Eliciting an immune response with a polypeptide will form antibodies as evidenced by Li p.516 par.1. 182.
It is noted that SEQ ID NO: 2 of US 9987343 B2 claim 1 is PilA, specification p.6 col.4 line 43.
The claims of US 9987343 B2 are not drawn to administration of an anti-DNABII antibody or multispecies biofilms.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
It would have been obvious to a person having ordinary skill in the art combine an anti- DNABII antibody with the anti-PilA antibody of US 9987343 B2 claim 1 for treating a subject with NTHI and Mcat in a dual species biofilm. See the above 103 rejections above for the remaining claims.
Provisional Double Patenting
18824806 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 25, 26, 27, of copending U.S. Application No. 18824806, hereinafter 806 in view of Novotny, NCH, and Mokrzan.
Regarding claims 1, 5, 8, 12, 20, and 21: Although the claims at issue are not identical, they are not patentably distinct from each other because 806 claims a method which comprises the same method of the instant application. 806 claim 21 is drawn to a method of treating a biofilm associated disease in a subject, 806 claim 21 step (b)(i) is drawn to comprising administration of an anti-rsPilA antibody, an anti-DNABII antibody, or an antigen binding fragment thereof, 806 claim 25 is drawn to dual species. It would have been obvious to a person having ordinary skill in the art to execute the methods of the instant application by removing the extra steps of determining the antibiotic resistance of the bacteria in 806 claim 21 step (a) and selecting NTHI and Mcat in a dual species biofilm because Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of these 2 antibodies effect resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7, further details and definitions or equivalents have been detailed in the rejection of instant claim 1 above.
Regarding claims 4 and 23 see the 103 rejections of claims 4 and 23 above and 806 claim 26 which is drawn to β-lactam antibiotic.
Regarding claim 13 see the 103 rejection of claim 13 above and it would be obvious because 806 claim 27 is drawn to an anti-tip chimer antibody.
Regarding claim 19, 806 claim 21 administers antibiotics after antibody administration, and see the 103 rejection of claim 19 above.
Regarding claim 24 see the 103 rejection of claim 24 above.
Regarding claims 25 see the 103 rejection of claim 25 above.
Regarding claims 26 and 27 see the 103 rejections for claims 26 and 27 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18984652 Double Patenting
Claims 1, 4, 5, 8, 12, 13, 19, 20, 21, 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41, 60, and 61 of copending U.S. Application No. 18984652, in view of Novotny, NCH, and Mokrzan.
Claim 41 is drawn to a humanized DNABII tip antibody as noted for SEQ ID NO: 1 and 7 par.56, and 186. Claim 60 and 61 are drawn to treatment of biofilms with these antibodies.
18984652 does not teach the use of an anti-PilA antibody or multispecies biofilm.
Mokrzan teaches Otitis media (OM) is often polymicrobial, with NTHI and Mcat frequently cocultured from clinical specimens p.1 par.1 and Novotny teaches that the combination of an anti-DNABII antibody and an anti-PilA antibody resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7. Novotny teaches that the combination of these 2 antibodies effect resolved otitis media, and improved clinical outcomes of NTHI, middle ear fluids, and reduced NTHI biofilms p.12 par.3 and fig.7
It would have been obvious to a person having ordinary skill in the art combine an anti-PilA antibody with the anti-DNABII antibody of 18984652 for treating a subject with NTHI and Mcat in a dual species biofilm. Further details and definitions or equivalents have been detailed in the rejection of instant 103 rejections above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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