DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and remarks filed on 4/24/2026 are acknowledged. Claims 24-25 and 42 are amended. New claim 45 id added. Claims 16-25 and 35-45 are pending.
Claim Rejections Withdrawn
The rejection of claims 24 and 42 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of applicant’s amendment thereto.
The rejection of claim 25 under 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of applicant’s amendment thereto.
Claim Rejections Maintained
35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-25, 35-44, and newly submitted claim 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Finlay et al (WO2016/141454; IDS filed 2/3/2023).
The instant claims are drawn to methods of treating inflammation comprising administering a bacterial composition or combination comprising at least two species from the genus Rothia or various combinations of Rothia, Gemella, and Roseomonas.
Finlay et al disclose treatment of asthma in humans (an inflammatory respiratory disorder) by administration of a “bacterial composition including two or more bacteria of the genera Faecalibacterium, Lachnospira, Veillonella or Rothia” (see paragraph 0004 and 00128). The compositions can comprise “one or more bacteria of the genera Rothia” (see paragraph 0063). Finlay et al state that some embodiments may include four or more bacteria of the genera Faecalibacterium, Lachnospira, Veillonella and Rothia” (see paragraph 0066). This language makes clear that combinations of more than one species within just one genus (such as Rothia) are encompassed. Finlay et al disclose that the bacteria from the genus Rothia include, among others, R. mucilaginosa and R. dentocariosa (see paragraph 0097). The composition can be administered in dermal, inhalation, aerosol, topical, gavage, or oral forms including nasal spray and as liquid suspensions or dry powders (see paragraphs 00140-00141). The composition can include live bacteria, which would require at least 1 CFU to be present (see paragraph 00150). Administration of live bacteria to the respiratory system (such as through inhalation or nasal spray) would necessarily increase the microbiota where administered. With regard to the outcomes recited in claim 42, administration of the same composition to the same subjects would necessarily result in the same outcome.
Applicant argues:
1. That Finlay does not disclose a composition comprising at least two species within the genus Rothia. Applicant argues that Finlay consistently presents multiple alternative genera and optional identification of individual species within those genera without any teaching or direction toward selecting multiple species from within a single genus. Applicant argues that Finlay is directed to combinations across different genera, not intra-genus multi-species combinations.
2. That Finlay requires impermissible picking and choosing from multiple alternatives. Applicant argues that the Examiner’s assertion that Finlay's disclosure "makes clear" that combinations of more than one species within a genus are encompassed is unsupported and that Finlay provides multiple alternative genera and multiple alternative species, without any teaching or suggestion to select multiple species from within a single genus, such as Rothia. To arrive at the claimed invention, one would need to (1) select Rothia from a list of alternative genera; (2) select multiple species within that genus; and (3) combine those species into a single composition.
3. That Finlay does not necessarily result in the claimed combination. Applicant argues that Finlay does not require the selection of multiple Rothia species or the formation of a composition containing such species together instead disclosing a broad range of optional combinations across multiple genera, without any requirement or preference for intra-genus multi-species compositions.
4. That Finlay does not disclose the claimed functional limitation of claim 42. Applicant argues that claim 42 requires a specific comparative functional evaluation that Finlay does not disclose.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
Regarding argument 1, while Finlay does disclose combinations across different genera, they also disclose combinations within a single genus. This is made clear in several places. For example, paragraph 0066 states that the compositions may include “four or more bacteria of the genera Faecalibacterium, Lachnospira, Veillonella, and Rothia.” There are four genera listed. The sentence states “four or more bacteria”. In order to have more than four, one would have to choose more than one species from one of the listed genera. Therefore, clearly, multiple bacteria from single genus are disclosed. This includes more than one species from the genus Rothia. Paragraph 0063 specifically states that the compositions may include “one or more bacteria of the genera Faecalibacterium, one or more bacteria of the genera Lachnospira, one or more bacteria of the genera Veillonella, or one or more bacteria of the genera Rothia.” This is a very clear and direct statement that one or more bacteria from the genus Rothia can be included in the composition. “One or more” clearly encompasses at least two.
Regarding argument 2, when a reference discloses many alternatives, all of those alternatives are disclosed. As discussed above, the reference clearly states that the compositions can include one or more bacteria from the genus Rothia. The reference clearly states that the bacteria from the genus Rothia include Rothia mucilaginosa and Rothia dentocariosa.
Regarding argument 3, when a reference discloses many alternatives, all of those alternatives are disclosed. As discussed above, the reference clearly states that the compositions can include one or more bacteria from the genus Rothia. The reference clearly states that the bacteria from the genus Rothia include Rothia mucilaginosa and Rothia dentocariosa.
3. That Finlay does not necessarily result in the claimed combination. Applicant argues that Finlay does not require the selection of multiple Rothia species or the formation of a composition containing such species together instead disclosing a broad range of optional combinations across multiple genera, without any requirement or preference for intra-genus multi-species compositions.
Regarding argument 4, as discussed in the rejection set forth below, it is not clear that claim 42 requires a specific functional evaluation step versus simply setting forth a functional characteristic that will occur upon administration of the composition. If the claim is amended so that a method step measuring and comparing the activity of various species and combinations is clearly required, then the art rejection over this claim may be withdrawn. However, as the claim currently reads, there appears only to be a requirement that the composition have the characteristic of inhibiting production of cytokines, chemokines, and NF-KB, which is an outcome that will necessarily occur upon administration of the composition
New Claim Rejections
35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 42 is 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 pre-AIA the applicant regards as the invention.
Claim 42 is indefinite because it is not clear what is intended by the phrase “at a highest single agent an equivalent total CFUs CFU”. Further, while claim 42 requires that the composition inhibit production of inflammatory cytokines and/or chemokines and/or NF-KB in comparison to other compositions, it is not clear if the claim requires a method step where these are measured and compared or whether this is simply a statement of the outcome of administration.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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