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 10/8/2025 are acknowledged. Claims 22 and 24 are amended. Claims 26-34 are cancelled. New claims 35-44 are added. Claims 16-25 and 35-44 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 10/8/2025 is acknowledged. Applicant's election with traverse of the species combination R. mucilaginosa and R. dentocariosa in the reply filed on 10/8/2025 is acknowledged. The traversal is on the ground(s) that searching additional species would not pose an undue burden. This is not found persuasive because burden is not part of determining the propriety of restriction in an application filed as a national stage application.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements filed on 2/3/2023 and 10/6/2025 have been considered. Signed copies are enclosed.
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.
Claims 24 and 42 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 pre-AIA the applicant regards as the invention.
Claim 24 is rendered indefinite by the phrase “at least about 100 colony forming units”. It is not clear whether applicant actually intended to recite that the composition must contain at least 1 CFU or if this was a typographical error.
Claim 42 is indefinite because it is not clear what is intended by the phrase “in comparison to a highest single agent at equivalent total CFUs”.
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.
Claim 25 is rejected 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. The parent claim requires the composition contain bacteria. Claim 25 recites that the composition comprises fermentation broths, extracts or cell culture supernatants of the bacteria. This does not appear to require the actual bacteria. 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. If applicant intends for these components to be in addition to the bacteria, the claim should be amended to read “the composition or combination further comprises”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-25 and 35-44 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.
Conclusion
No claim is allowed.
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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/BRIAN GANGLE/Primary Examiner, Art Unit 1645