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 .
Claims 1-2 have been cancelled. Claims 3-20 are pending and are under examination.
The information disclosure statements filed 11/6/24 and 06/17/26 have been considered and initialed copies are enclosed.
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 3-20 (in-part with respect to Prevotella intermedia and portions thereof) 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.
Claim 3 is drawn to a method of reducing one or more symptoms caused by bacterial pneumonia, the method comprising administering a therapeutically effective amount of a composition comprising cells, or portions thereof, of one or more strains of Prevotella, (claim 6) wherein the pneumonia-causing bacteria are one or more of Streptococcus pneumoniae and Staphylococcus aureus.
The prior art teaches that Prevotella intermedia induces severe bacteremia pneumococcal (S. pneumoniae) pneumonia in mice (See Nagaoka et al cite #CD IDS filed 6/17/2016) and Yamashita et al (cite #CF IDS filed 6/17/2016) disclose that mice administered supernatant of Prevotella intermedia administered with Staphylococcus aureus (S. aureus) exhibit significantly lower survival rate, higher bacterial loads in the lungs and higher alpha-hemolysins expression in the lungs.
Thus, it can be concluded that Prevotella intermedia is pathogenic and exacerbates bacteria pneumonia caused by S. pneumoniae and S. aureus.
For this reason, the claims when it comes to Prevotella intermedia are not enabled for reducing one or more symptoms of bacterial pneumonia included caused by S. pneumoniae and S. aureus, not enabled for Prevotella intermedia as an immunobiotic, not enabled for Prevotella intermedia for promoting neutrophil activation and not enabled for Prevotella intermedia for activating, enhancing and/or promoting immune response in a subject afflicted with a respiratory infection
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 3-6 and 14-20 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.
The method step of claims 3-6 and 14-20 recite administering a therapeutically effective amount of a composition comprising cells, or portions thereof, of one or more strains of Prevotella (claim 3); administering the composition comprising cells, or portions thereof, of one or more strains of claim 7 (claim 14); and administering a composition comprising cells, or portions thereof, of one or more strains of Prevotella (claim 17), respectively.
However, the method step of the claims do not disclose whom the composition is administered to, for example to a subject, therefore the claims are vague and indefinite.
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.
Claim(s) 3, 6, 7, 17, 14 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark et al. The Journal of Immunology, Volume 206, Issue 1_Supplement, May 2021, Page 16.24, https://doi.org/10.4049/jimmunol.206.Supp.16.24. Published: 01 May 2021 and cited in IDS.
Claim 3: Clark et al disclose a method of reducing one or more symptoms caused by bacterial pneumonia, the method comprising administering a therapeutically effective amount of a composition comprising cells of one or more strains of heat-killed (inactivated) Prevotella. See abstract.
Claim 6: Clark et al disclose the pneumonia-causing bacteria are one or more of Streptococcus pneumoniae. See abstract.
Claim 7: Clark et al disclose an immunobiotic composition comprising cells of one or more strains of Prevotella. See abstract.
Claim 14: Clark et al disclose a method of promoting neutrophil activation in a lung, the method comprising administering cells of one or more strains of Prevotella. See abstract.
Claim 17: Clark et al disclose a method of activating, enhancing, and/or promoting an innate immune response in a subject afflicted with a Streptococcus pneumoniae infection in the lung (respiratory infection), the method comprising administering by inhalation an immunobiotic composition comprising one or more strains of Prevotella bacteria. See abstract.
Claim 18: Clark et al disclose the same method steps thus the activating, enhancing, and/or promoting the innate immune response comprises increasing a presence of neutrophils in one or both lungs of the subject. See abstract.
Claim 19: Clark et al disclose the same method of claim 17 and 18, thus increasing the presence of neutrophils causes a lung-localized increase in TNFα production followed by IL-10 production. See abstract.
Claim 20: Clark et al disclose the same method as claims 17-19, thus activating, enhancing, and/or promoting the innate immune response comprises sub-clinical inflammation followed by inflammatory resolution. See abstract.
Claim(s) 3, 4, 6, 7, 8, 17, 14, 15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark et al. The Journal of Immunology, Volume 208, Issue 1_Supplement, May 1, 2022, cited in IDS.
Claim 3: Clark et al disclose a method of reducing one or more symptoms caused by bacterial pneumonia, the method comprising administering a therapeutically effective amount of a composition comprising cells of one or more strains of Prevotella. See abstract.
Claim 4: Clark et al disclose the Prevotella is Prevotella melaninogenica. See abstract.
Claim 6: Clark et al disclose the pneumonia-causing bacteria are one or more of Streptococcus pneumoniae. See abstract.
Claim 7: Clark et al disclose an immunobiotic composition comprising cells of one or more strains of Prevotella. See abstract.
Claim 8: Clark et al disclose the Prevotella is Prevotella melaninogenica. See abstract.
Claim 14: Clark et al disclose a method of promoting neutrophil activation in a lung, the method comprising administering cells of one or more strains of Prevotella. See abstract.
Claim 15: Clark et al disclose the Prevotella is Prevotella melaninogenica. See abstract.
Claim 17: Clark et al disclose a method of activating, enhancing, and/or promoting an innate immune response in a subject afflicted with a Streptococcus pneumoniae infection in the lung (respiratory infection), the method comprising administering by inhalation an immunobiotic composition comprising one or more strains of Prevotella bacteria. See abstract.
Claim 18: Clark et al disclose the same method steps thus the activating, enhancing, and/or promoting the innate immune response comprises increasing a presence of neutrophils in one or both lungs of the subject. See abstract.
Claim 19: Clark et al disclose the same method of claim 17 and 18, thus increasing the presence of neutrophils causes a lung-localized increase in TNFα production followed by IL-10 production. See abstract.
Claim 20: Clark et al disclose the same method as claims 17-19, thus activating, enhancing, and/or promoting the innate immune response comprises sub-clinical inflammation followed by inflammatory resolution. See abstract.
Claim(s) 7-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodman et al. WO 2020172492 8/27/2020.
Claim 7: Goodman et al disclose an immunobiotic composition comprising one or more strains of Prevotella bacteria and/or portions thereof (membrane preparations). See paragraph 2, 20-21, 34, 51, 54-56, .
Claim 8: Goodman et al disclose the one or more strains of
Prevotella comprise P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis etc. See paragraph 75.
Claim 9: Goodman et al disclose the membrane fractions which comprises lipoproteins. See paragraph 34.
Claim 10 and Claim 12: Goodman et al disclose the Prevotella are live or inactivated (killed). See paragraph 2.
Claim 11: Goodman et al disclose the composition comprises cells at about 105 to about 107 CFU. See paragraphs 97-100.
Claim 13: Goodman et al disclose the composition comprises cells or portions of cells are at about 105 to about 107 CFU equivalents. See paragraphs 97-100.
Claim 14: Goodman et al disclose a method of promoting neutrophil activation in a lung, the method comprising administering by inhalation an immunobiotic composition comprising one or more strains of Prevotella bacteria and/or portions thereof (membrane preparations). See paragraph 2, 14, 20-21, 34, 51, 54-56 .
Claim 15: Goodman et al disclose the one or more strains of
Prevotella comprise P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis etc. See paragraph 75. See paragraph 14.
Claim 16: Goodman et al disclose the method of claim 14, wherein the administering is by inhalation.
Claim 17: Goodman et al disclose a method of activating, enhancing, and/or promoting an innate immune response in a subject afflicted with a respiratory infection such as fulminating or disseminated pulmonary tuberculosis in a lung, the method comprising administering by inhalation an immunobiotic composition comprising one or more strains of Prevotella bacteria (one or more P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis) and/or portions thereof (membrane preparations). See paragraph 2, 14, 20-21, 34, 51, 54-56,75 .
Claim 18: Goodman et al disclose the same method steps thus the activating, enhancing, and/or promoting the innate immune response comprises increasing a presence of neutrophils in one or both lungs of the subject.
Claim 19: Goodman et al disclose the same method of claim 17 and 18, thus increasing the presence of neutrophils causes a lung-localized increase in TNFα production followed by IL-10 production.
Claim 20: Goodman et al disclose the same method as claims 17-19, thus activating, enhancing, and/or promoting the innate immune response comprises sub-clinical inflammation followed by inflammatory resolution.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 3-5 and 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable Clark et al. The Journal of Immunology, Volume 206, Issue 1_Supplement, May 2021, Page 16.24, https://doi.org/10.4049/jimmunol.206.Supp.16.24. Published: 01 May 2021 and cited in IDS in view of Goodman et al. WO 2020172492 8/27/2020.
Claim 3: Clark et al disclose a method of reducing one or more symptoms caused by bacterial pneumonia, the method comprising administering a therapeutically effective amount of a composition comprising cells of one or more strains of heat-killed (inactivated) Prevotella. Clark et al disclose the pneumonia-causing bacteria are one or more of Streptococcus pneumoniae.
Claim 7: Clark et al disclose an immunobiotic composition comprising cells of one or more strains of Prevotella.
Claim 14: Clark et al disclose a method of promoting neutrophil activation in a lung, the method comprising administering cells of one or more strains of Prevotella.
Regarding claims 4, 8 and 15: Clark et al does not disclose the one or more strains of Prevotella comprise P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis.
Regarding claim 8 and 16: Clark et al does not disclose the administering is by inhalation.
Regarding claim 9: Clark et al does not disclose the composition comprises portions of cells of Prevotella, wherein the portion of cells include lipoprotein.
Regarding claims 10-11: Clark et al does not disclose the cells of at least one of the one or more strains of Prevotella are live and the cells are present at about 105 to about 107 CFU.
Regarding claim 13: Clark et al does not disclose the inactivated Prevotella cells are present at about 107 CFU.
Goodman et al disclose a method of promoting neutrophil activation in a lung, the method comprising administering by inhalation an immunobiotic composition comprising one or more strains of Prevotella bacteria and/or portions thereof (membrane preparations). See paragraph 2, 14, 20-21, 34, 51, 54-56 .
Goodman et al disclose an immunobiotic composition comprising one or more strains of Prevotella bacteria and/or portions thereof (membrane preparations). See paragraph 2, 20-21, 34, 51 and 54-56 .
Claim 8: Goodman et al disclose the one or more strains of
Prevotella comprise P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis etc. See paragraph 75.
Claim 9: Goodman et al disclose the membrane fractions which comprises lipoproteins. See paragraph 34.
Claim 10 and Claim 12: Goodman et al disclose the Prevotella are live or inactivated (killed). See paragraph 2.
Claim 11: Goodman et al disclose the composition comprises cells at about 105 to about 107 CFU. See paragraphs 97-100.
Claim 13: Goodman et al disclose the composition comprises cells or portions of cells are at about 105 to about 107 CFU equivalents. See paragraphs 97-100.
Claim 15: Goodman et al disclose the one or more strains of
Prevotella comprise P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis etc. See paragraph 75. See paragraph 14.
Claim 16: Goodman et al disclose the method of claim 14, wherein the administering by inhalation.
Regarding claims 4, 8, 9 and 15, it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Clark et al so that the Prevotella species is one or more of P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis and/or portions thereof (membrane fractions which comprise membrane lipoproteins), thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Clark et al requires Prevotella species and Goodman et al disclose that Prevotella species such as P. melaninogenica, P. buccae, P. tannerae, and P. nanceiensis or portions thereof (membrane fractions which comprise membrane lipoproteins) can be used as therapeutic agents for the treatment and/or prevention of disease. See abstract and paragraph 2.
Regarding claims 5 and 16, furthermore Goodman et al disclose Prevotella species and/or portions thereof (membrane fractions) can be administered by inhalation. Thus administering the Prevotella species in the method of Clark et al by inhalation, would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention.
Regarding claims 10-11, furthermore Goodman et al disclose that the Prevotella can be administered as live bacteria and disclose amounts administered at about 105 to 107 CFU for therapeutic and/or prevention of disease, for this reason it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Clark et al to administer live Prevotella species instead of heat-killed Prevotella and wherein the live Prevotella is administered in amounts of about 105 to 107 CFU, thus resulting in the instant invention with a reasonable expectation of success.
Regarding claims 12 and 13, furthermore Goodman et al disclose that the Prevotella can be administered as inactivated bacteria and disclose amounts administered at about 105 to 107 CFU for therapeutic and/or prevention of disease, for this reason it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Clark et al to administer the heat killed (inactivated) Prevotella species at amounts of about 105 to 107 CFU, thus resulting in the instant invention with a reasonable expectation of success.
Claim(s) 3-5 and 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable Clark et al. The Journal of Immunology, Volume 208, Issue 1_Supplement, May 1, 2022, cited in IDS in view of Goodman et al. WO 2020172492 8/27/2020.
Claim 3: Clark et al disclose a method of reducing one or more symptoms caused by bacterial pneumonia, the method comprising administering a therapeutically effective amount of a composition comprising cells of one or more strains of Prevotella melaninogenica. Clark et al disclose the pneumonia-causing bacteria are one or more of Streptococcus pneumoniae.
Claim 7: Clark et al disclose an immunobiotic composition comprising cells of one or more strains of Prevotella.
Claim 14: Clark et al disclose a method of promoting neutrophil activation in a lung, the method comprising administering cells of one or more strains of Prevotella.
Regarding claims 4, 8 and 15: Clark et al does not disclose the one or more strains of Prevotella comprise P. buccae, P. tannerae, or P. nanceiensis.
Regarding claim 8 and 16: Clark et al does not disclose the administering is by inhalation.
Regarding claim 9: Clark et al does not disclose the composition comprises portions of cells of Prevotella, wherein the portion of cells include lipoprotein.
Regarding claims 10-11: Clark et al does not disclose the cells of at least one of the one or more strains of Prevotella are live and the cells are present at about 105 to about 107 CFU.
Regarding claim 13: Clark et al does not disclose the inactivated Prevotella cells are present at about 107 CFU.
Goodman et al disclose a method of promoting neutrophil activation in a lung, the method comprising administering by inhalation an immunobiotic composition comprising one or more strains of Prevotella bacteria and/or portions thereof (membrane preparations). See paragraph 2, 14, 20-21, 34, 51, 54-56 .
Goodman et al disclose an immunobiotic composition comprising one or more strains of Prevotella bacteria and/or portions thereof (membrane preparations). See paragraph 2, 20-21, 34, 51 and 54-56 .
Claim 8: Goodman et al disclose the one or more strains of
Prevotella comprise P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis etc. See paragraph 75.
Claim 9: Goodman et al disclose the membrane fractions which comprises lipoproteins. See paragraph 34.
Claim 10 and Claim 12: Goodman et al disclose the Prevotella are live or inactivated (killed). See paragraph 2.
Claim 11: Goodman et al disclose the composition comprises cells at about 105 to about 107 CFU. See paragraphs 97-100.
Claim 13: Goodman et al disclose the composition comprises cells or portions of cells are at about 105 to about 107 CFU equivalents. See paragraphs 97-100.
Claim 15: Goodman et al disclose the one or more strains of
Prevotella comprise P. melaninogenica, P. buccae, P. tannerae, or P. nanceiensis etc. See paragraph 75. See paragraph 14.
Claim 16: Goodman et al disclose the method of claim 14, wherein the administering by inhalation.
Regarding claims 4, 8, 9 and 15, it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Clark et al so that the Prevotella species is one or more of P. buccae, P. tannerae, or P. nanceiensis and/or portions thereof (membrane fractions which comprise membrane lipoproteins), thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Clark et al requires Prevotella species and Goodman et al disclose that Prevotella species such as P. melaninogenica, P. buccae, P. tannerae, and P. nanceiensis or portions thereof (membrane fractions which comprise membrane lipoproteins) can be used as therapeutic agents for the treatment and/or prevention of disease. See abstract and paragraph 2.
Regarding claims 5 and 16, furthermore Goodman et al disclose Prevotella species and/or portions thereof (membrane fractions) can be administered by inhalation. Thus administering the Prevotella species in the method of Clark et al by inhalation, would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention.
Regarding claims 10-11, furthermore Goodman et al disclose that the Prevotella can be administered as live bacteria and disclose amounts administered at about 105 to 107 CFU for therapeutic and/or prevention of disease, for this reason it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Clark et al to administer live Prevotella species instead of heat-killed Prevotella and wherein the live Prevotella is administered in amounts of about 105 to 107 CFU, thus resulting in the instant invention with a reasonable expectation of success.
Regarding claims 12 and 13, furthermore Goodman et al disclose that the Prevotella can be administered as inactivated bacteria and disclose amounts administered at about 105 to 107 CFU for therapeutic and/or prevention of disease, for this reason it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Clark et al to administer heat killed (inactivated) Prevotella species at amounts of about 105 to 107 CFU, thus resulting in the instant invention with a reasonable expectation of success.
Status of Claims
Claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 5712703497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
Prosecution Insights