DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claim 16 was previously cancelled, in the amendment filed 03/28/2023. Claims 1-15 are pending and will be examined on the merits.
Response to Amendment
The response to office action filed 04/27/2026 in response to the office action mailed 01/26/2026 is acknowledged. The rejections set forth under 35 USC 103 are withdrawn for the following reasons:
Applicant has submitted a certified translation of the foreign priority application KR10-2020-0126243, perfecting the priority date of 09/28/2020, and has submitted a Common Ownership Statement regarding WO 2020/197362, “Kwak”. As a result, Kwak is no longer prior art. As such, all 103 rejections based on a combination of references including Kwak are withdrawn.
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8 recites "wherein the bacterium is live or lyophilizate". The term 'live' is an adjective, and 'lyophilizate' is a noun. For proper consistency, Examiner requests 'lyophilizate' is amended to 'lyophilized'. Appropriate correction is required.
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 1-15 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 1 recites the limitation "the microorganism" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “a microbial cell”, which is interpreted to be ‘the’ microorganism of line 4. Examiner requests consistent terms are used – either microorganism or microbial cell, to provide appropriate clarity to the claim. Claims 2-15 inherit this rejection, as they do not rectify this issue.
Claim 1 recites “a composition comprising at least one selected from the group consisting of; a microbial cell of a bacterium comprising a 16S rRNA sequence having the nucleotide sequence of SEQ ID NO: 1; a culture of the microorganism; a lysate of the microorganism; and at least an extract selected from the group consisting of the microbial cell, culture and lysate into a subject.” This language is unclear, as one cannot be sure what is required in the composition based on the Markush group as recited. A proper Markush group should recite “selected from the group consisting of…” and the list should recite “and” at the end of the recited options (see MPEP §2117). It is unclear if the composition comprises one option from each group presented in the claim, or if the second group is a subset of options for the first list. Specifically, it is unclear if the composition must comprise only at least one of a microbial cell, a culture, a lysate, an extract of a microbial cell, an extract of a culture, or an extract of a lysate, or if the composition requires an option from both groups, i.e., a cell, culture, or lysate and an extract of a cell, culture, and lysate. If the first option is correct and only one group is intended, Examiner suggests removing “at least” from line 4 of the claim, so the claim reads “and an extract selected from…” so it is clear to one of ordinary skill in the art that the recited extracts are part of the Markush group listed in the claim. If the second option is correct and selections from both groups are required, Examiner suggests amending the claim to read “a culture of the microorganism; and a lysate of the microorganism, and at least an extract selected from…” on line 4 of Claim 1, so it is clear to one of ordinary skill in the art that the recited extract is also required and is not part of the first Markush group. Claims 2-15 inherit this rejection, as they do not rectify this issue.
Claim 5 recites “wherein the bacterium has an immunomodulatory activity by modulating cytokine.” A bacterium does not make cytokines and therefore cannot directly modulate cytokines. Examiner suggests clarifying how the bacterium can impact cytokines by amending the claim to read similar to “…by modulating cytokine expression” or the like.
Claim 10 is unclear regarding how the recited limitations are relevant to the claimed subject matter. Claim 10 is dependent from claim 1, which recites a method for treatment of inflammatory disease. The second, third, and fourth limitations of claim 10 are drawn to tumors, or cancers, which are not inflammatory diseases. Additionally, claim 10 recites “being cultured under a temperature…and anaerobic conditions”, which is not a bacterial characteristic, but a set of culturing conditions or a method of growing said bacteria. Finally, claim 10 recites the absence of a fatty acid as a bacterial characteristic, but it is unclear if the absence of this metabolite is a temporary metabolic state or a fundamental incapability of the bacterium.
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.
Claim 10 is 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. Claim 10 does not further modify the method of claim 1. Claim 10 is drawn to various properties of the claimed bacterium, but does not provide any insight into how these properties would impact the method of claim 1. Therefore, as these properties are considered inherent to the bacterium of claim 1, claim 10 does not further limit claim 1 as written. 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.
Allowable Subject Matter
Claims 1-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: A sequence search returned no 100% sequence identity matches in the prior at SEQ ID NO: 1, the sequence claimed in Claim 1 of the instant invention, apart from the applicant's own prior art, which has been overcome by Common Ownership Agreement and perfection of foreign priority. Therefore, the method of claim 1, which requires a microbial cell or a microorganism with the 16S rRNA sequence of SEQ ID NO: 1, is free of the prior art as of the effective filing date.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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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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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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