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 Status
The original claim set filed 5 Mar 2026 is acknowledged. Claims 1-26 are currently pending. No claims are cancelled. Claims 1-26 will be examined on the merits herein.
Priority
The application claims priority to provisional application 63/033,442 (filed 2 June 2020) and is a continuation of 17/337,052 (filed 2 June 2021). The effective filing date for claims 1-26 is 2 June 2020.
Information Disclosure Statement
information disclosure statement (IDS) submitted on 1 Aug 2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action. Copies of the cited NPL were made of record in application 17/337,052.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. This paragraph is only a notice to the applicant and is not a requirement that all references listed in the specification be submitted in an IDS.
Claim Objections
Applicant is advised that should claim 9 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Both claims 9 and 10 require that the bacterial infection be caused by Haemophilus influenzae, claim 1 already limits the bacterial infection to being in the respiratory tract as explicitly stated in claim 10. Therefore, it appears that the scope of the two claims is identical despite being phrased differently.
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 11 and 25-26 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 11 recites the limitation "the Haemophilus influenzae". There is insufficient antecedent basis for this limitation in the claim because claim 11 depends from claim 1, which does not recite any Haemophilus influenzae. Perhaps this claim should depend from claim 10, or could use similar language to claim 10.
Claim 25 recites the limitation "the bacterial respiratory infection". There is insufficient antecedent basis for this limitation in the claim because parent claim 21 does not recite a bacterial respiratory infection, only otitis media. Claim 26 is also rejected as indefinite because it depends from claim 25 and does not obviate this grounds of rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3-5, 7-12, 14-15, 21, and 23-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Granland et al. (12 Jan 2020; hereafter Granland; IDS filed 1 Aug 2024). It is noted that a declaration was filed in 17/337,052 (filed 26 Dec 2023) to claim the 102(b)(1)(A) exception. Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of the prior application do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
Regarding claim 1, Granland teaches a method for preventing a bacterial infection (nontypeable Haemophilus influenzae; NTHi) and a viral infection (influenza A; IAV) comprising administering to the respiratory tract (intranasal inoculation) Muribacter muris (Abstract). “Only 1/12 M. muris-pretreated mice developed otitis media on day 5 compared to 8/15 mice with no pretreatment” (Abstract). The clinical outcomes were improved in the days following IAV + NTHi co-infection (Figure 3 on pg. 6).
Regarding claim 12, Granland teaches a method of inducing an innate immune stimulation in the respiratory tract of a subject in need thereof, “The initial increases in IL-6 and KC on day 0 (24 h after M. muris treatment) in both the middle ear and nasal washes of the mice suggest that despite not seeing an increase in the commensal density, an innate immune response was elicited.” (pg. 9 par. 3). The method comprised administering to the respiratory tract (intranasal inoculation) Muribacter muris (Abstract).
Regarding claim 21, Granland teaches a method of preventing otitis media in a subject, comprising administering to the respiratory tract (intranasal inoculation) Muribacter muris (Abstract). “Only 1/12 M. muris-pretreated mice developed otitis media on day 5 compared to 8/15 mice with no pretreatment” (Abstract).
Regarding claims 3, 14, and 23, the bacteria was Muribacter muris (Abstract).
Regarding claims 4, 15, and 24, the bacteria were administered to the nasal cavity via intranasal inoculation (Abstract).
Regarding claim 5, the bacterial infection was subsequent to the viral infection; “BALB/c mice were inoculated intranasally with 1 × 104.5 PFU IAV in a volume of 10 μl. At 72 h after IAV challenge, mice were intranasally administered 5 × 107 CFU of NTHi” (par. bridging pg. 10-11).
Regarding claims 7-8, the viral respiratory infection was influenza A (Abstract).
Regarding claims 9-11 and 25-26, the bacterial respiratory infection used to model otitis media was nontypeable Haemophilus influenzae (NTHi) (Abstract).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Granland et al. (12 Jan 2020; hereafter Granland; IDS filed 1 Aug 2024) in view of Pickering et al. (2016; hereafter Pickering; IDS filed 1 Aug 2024).
The teachings of Granland are laid out above. Additionally, Granland teaches “Some H. haemolyticus isolates have been found to produce a bacteriocin-like substance that specifically inhibits NTHi growth (24), further supporting a role for H. haemolyticus as a bacterial therapy to prevent NTHi disease. H. haemolyticus does not colonize mice (our unpublished data); therefore, we sought alternatives to further investigate microbial interference of NTHi in vivo. In this study, we have used Muribacter muris, a closely related rodent equivalent of H. haemolyticus from the Pasteurellaceae family (25), in a murine model of NTHi acute otitis media.” (pg. 2 par. 5).In the Granland experiment, mice were pretreated with M. muris 24 hours before co-infection with influenza A and three days before co-infection with NTHi (Abstract and Figure 3). Granland teaches that like in the previous study, “Intranasal treatment of mice with M. muris can temporarily reduce NTHi colonization and prevent development of NTHi otitis media” (pg. 2 par. 6).
Granland does not teach a method comprising administering to the respiratory tract of the subject an effective amount of Haemophilus haemolyticus, as in claims 2, 13, and 22. Also, Granland does not teach the one or more bacteria are administered during or after the viral infection and during or before the bacterial infection, as in claim 6, or that the subject is suffering from a viral and/or a bacterial respiratory infection, as in claim 16 and dependent claims 17-20.
Pickering teaches that “Haemophilus haemolyticus is a respiratory tract commensal” (Abstract) and that ”in vitro pre-treatment of epithelial cells with H. haemolyticus significantly reduced NTHi attachment, suggesting interference or competition between the two species is possible and warrants further investigation. In conclusion, H. haemolyticus interacts differently with host cells compared to NTHi, with different immunostimulatory and cytotoxic properties.” (Abstract). Therefore, “We propose that H. haemolyticus may interfere with NTHi colonization of the respiratory tract and could therefore be exploited as a probiotic to reduce the burden of NTHi disease.” (pg. 2 col. 2 par. 2).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Granland method by administering Haemophilus haemolyticus in humans, thereby arriving at the claimed invention for claims 2, 13, and 22, because Pickering teaches that administering H. haemolyticus may have a beneficial effect on NTHi infection and Granland confirms the beneficial effect occurs using a bacteria, M. muris, that was chosen to model the effect of H. haemolyticus. Therefore the modification would be desirable because H. haemolyticus can be used in humans. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). Results using a well-established mouse model of a human disease (NTHi infection, otitis media) would have reasonably suggested to one of ordinary skill in the art that the method could also be useful for that human disease.
Alternately or in addition to the above, one of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Granland method by administering bacteria after influenza A virus infection and before NTHi infection, thereby arriving at the claimed invention for claims 6 and 16-20, because both Pickering and Granland teach that the mechanism of action is that M. muris and H. haemolyticus prevent NTHi colonization and it would be obvious to administer the bacteria at all times before the NTHi colonization when the bacteria can perform its well characterized mechanism of action.
KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp and if these options lead to the anticipated success, then the product was not of innovation but of ordinary skill and common sense. In the instant case, Granland teaches that there are three times when the probiotic could be administered: (1) before both IAV and NTHi infection, (2) after IAV infection but before NTHi infection, and (3) after both IAV and NTHi infection. These possibilities were already identified and constitute a finite number of solutions. Also, the outcome when choosing the second solution (administering after IAV infection but before NTHi infection) would predictably have the same benefits disclosed in Granland for pre-treatment because the bacteria can predictably still perform their known mechanism of action of preventing NTHi colonization. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
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.
Claims 1-3, 5, 7-14, 16-23, 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 12029767 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 12, and 21, ’767 claims 1, 13, 16, and 19 (and dependent claims) are methods comprising administering to the respiratory tract of the subject an effective amount of one or more bacteria selected from Haemophilus haemolyticus and Muribacter muris. ‘767 claims 1, 13, and 16 teach preventing or reducing the titer of a bacterial infection, and ‘767 claim 19 teaches treating or preventing otitis media. For “inducing an innate immune stimulation in the respiratory tract”, this will inherently occur when the same active agent (“an effective amount of one or more bacteria selected from Haemophilus haemolyticus and Muribacter muris”) is administered in the same way (“to the respiratory tract”) of the same subject (healthy subjects in need of preventative treatments or those with infections in need of treatment). See MPEP 2112.01: "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See also MPEP 2163.07(a) for a discussion of inherency.
Regarding claims 2, 13, and 22, ‘797 claims 1-2, 13, 16, and 19 teach the one or more bacteria is Haemophilus haemolyticus.
Regarding claims 3, 14, and 23, ‘797 claims 1, 3, 13, 16, and 19 teach the one or more bacteria is Muribacter muris.
Regarding claims 5 and 16, ’797 claim 7 teaches the one or more bacteria is administered to the subject when (i.e. simultaneous with) the subject is infected with a viral and/or bacterial respiratory infection.
Regarding claims 7-8, and 17-18, ‘797 claims 8-10 teach the viral infection is influenza or influenza A virus.
Regarding claims 9-11, 19-20, and 25-26, ‘797 claims 11-12, 14-15, and 17-18 teach the bacterial respiratory infection is a Haemophilus influenzae infection or nontypeable Haemophilus influenzae (NTHi).
Claims 1-5, and 7-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 12029767 B2 in view of Véras de Araujo et al. (2015; hereafter Veras; PTO-892).
The teachings of the claims of ‘797 are laid out above. In particular, the method claims of ‘797 teach “administering to the respiratory tract of the subject” the composition.
‘797 does not teach the one or more bacteria are administered to the mouth, oropharynx, larynx, nasal cavity, and/or fauces as in claims 4, 15, and 24.
Veras is a review of probiotics for the treatment of upper and lower respiratory-tract infections (Title) and teaches that administration of probiotics to the mouth (eg. administered in milk) or as a nasal spray are common approaches used by multiple studies in the field (Table 1).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the respiratory tract administration of the claims of ‘797 by specifically administering to the mouth or nasal cavity as taught by Veras, thereby arriving at the claimed invention, because Veras teaches that these are both common methods used to deliver probiotics to the respiratory tract by the art at the time of filing. The modification can be performed with a reasonable expectation of success because it is only performing the method step already claimed in ‘797 by using routine administration protocols.
KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the use of known techniques to improve similar devices, methods or products in the same way is obvious because enhancing a particular class of devices, methods, or products has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. In the instant case, the claims of ‘797 teach a “base” method for administering probiotics to the respiratory tract comprising no details about how to perform this step, and Veras teaches a comparable method for administering probiotics to the respiratory tract wherein the use of administering the probiotics to the mouth or nasal cavity is taught as routine. One of ordinary skill in the art would recognize the specific protocols of Veras as having an advantage because it teaches the methodological details required to perform the step disclosed generally in the claims of ‘797. Thus, one of ordinary skill in the art could have applied the known technique of Veras to the base method taught by the claims of ‘797 to yield predictable results (i.e. the same advantages). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645