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 .
The remarks and amendments filed 14 January 2026 have been entered. Claims 1-15 are pending and under examination.
Withdrawn Rejections
The rejection under 35 USC 112(a) is withdrawn in light of the amendment to claim 1.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The foreign priority document is not in English, therefore the examiner is unable to determine if it discloses the now-claimed invention. For the purposes of applying prior art, the effective filing date of the claimed invention is 27 September 2021, the date that PCT/KR2021/013152 was filed.
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.
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) 1-8 and 10-12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sokol 2008 (PNAS 105(43):16731-16736) in view of Kwak WO 2020/197362 and as is evidenced by Kwak US 2022/0008487.
Kwak WO ‘362 was published on 1 October 2020, which is before the effective filing date of the presently-claimed invention. As set forth above in the Priority section, the effective filing date of the presently-claimed invention is 27 September 2021.
Kwak WO’ 362 is the publication of PCT/KR2020/004363. While the document is not in English, US ‘487 is an English-language publication of the same underlying PCT and therefore serves as an accurate translation of the WO ‘362 document. While WO ‘362 is the being cited as prior art in this rejection, reference is made to US ‘487 as it is in English.
Sokol 2008 teaches that administration of a composition comprising Faecalibacterium was able to attenuate the symptoms of Crohn’s disease in mice. See abstract, as well as p. 16733, second column, first complete paragraph – p. 16734. This is on point to claims 1-3, 8, 12 – 13. However, Sokol does not teach an organism comprising the nucleic acid set forth in SEQ ID NO:1 or the particular strain recited in claim 11.
Kwak teaches a therapeutic strain of Faecalibacterium, deposited as KCTC 13783BP. See for example p. 4 paragraph 0048. The strain from Kwak is presumed to have characteristics identical to those recited in claims 4-6, and 10 as identical products cannot have mutually exclusive characteristics.
It would have been obvious to a person of ordinary skill in the art to modify the teachings of Sokol by administering the particular bacterial strain taught by Kwak, thereby arriving at the present invention. It is prima facie obvious to substitute known equivalents, and since both the bacteria from Sokol and from Kwak are from the same genus, it would be reasonable to expect they would function in a similar manner.
Claims 7-8 are included in this rejection as Sokol teaches administering live bacteria (see page 16736, paragraph spanning the two columns) and gives guidance as to the doses.
Claims 14-15 are included in this rejection as Kwok teaches that the bacteria is a probiotic, and a composition comprising the bacteria can also comprise prebiotics; see p. 5 paragraph 0061.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over over Sokol in view of Kwok as applied to claim 1 above, and further in view of Benmassaoud 2018 (Digestive Disease 63:1302-1310).
The reasons why the invention of claim 1 would have been obvious are set forth above. While both references teach administration of bacteria, neither reference teaches administration of TNF inhibitors as in claim 9.
Benmassaoud teaches that both infliximab and adalimumab are treatments for Crohn’s disease, and that they are known TNF-inhibitors, as in claim 9. See Introduction.
It would have been obvious to one of ordinary skill in the art to modify the invention suggested by Sokol and Kwok by including a TNF inhibitor as taught by Benmassaoud, as it is prima facie obvious to combine treatments which are each known to be useful for treating the same disease
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sokol in view of Kwok as applied to claim 1 above, and further in view of Yde WO 2019/043051, published 7 March 2019.
The reasons why the invention of claim 1 would have been obvious are set forth above. While Sokol teaches oral administration of bacteria, neither reference teaches capsules as set forth in claim 13.
Yde teaches capsules for holding bacteria; see abstract and claims. Yde particularly teaches that Faecalibacterium can be contained in the bacteria, see p. 9 lines 15 – 22.
It would have been obvious to one of ordinary skill in the art to modify the invention suggested by Sokol and Kwok by placing the bacteria in a capsule, thereby arriving at the invention of claim 13. The motivation to do so would be to provide the bacteria in a convenient, easy-to-swallow form.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL E KOLKER whose telephone number is (571)272-3181. The examiner can normally be reached Monday-Friday, 8:00am - 4:30pm.
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/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645