DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-5, 10-12, 14, and 17-26 are currently pending.
Election/Restrictions
3. Applicant’s election without traverse of Bifidobacterium animalis subs. lactis CNCM I-3446 for species A and inflammatory bowel disease (IBD) for species B in the reply filed on March 25, 2026 is acknowledged.
4. Claims 1-5, 10-12, 14, and 17-26 are examined on the merits in regards to the elected species.
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 1-5, 10-12 and 17-26 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.
5. Claim 1 is indefinite because it is unclear what are considered the risk factors for having an overactive immune system disorder; thus, it is unclear which subjects are considered to be “at risk” as recited in the claim.
6. Claim 2 is indefinite because it is unclear what diseases are considered to be an “IL-10 mediated disease”. In addition, it is unclear what are considered the risk factors for having an IL-10 mediated disease; thus, it is unclear which subjects are considered to be “at risk” as recited in the claim.
7. Claim 3 is indefinite because it is unclear what diseases are considered to be an “IL-10 mediated disease”.
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.
8. Claim(s) 1-4, 12, 14, 17, 18, 25, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benyacoub (US 10,501,530).
Benyacoub teaches a method for reducing the severity of inflammatory bowel disease, the method comprising administering a therapeutically-effective amount of a composition comprising Bifidobacterium lactis (CNCM I-3446) (synonymous with B. animals subsp. lactis) to a subject (see claims 1 and 13). The reference also teaches that the composition comprises a prebiotic ingredient (see claim 6).
The reference does not explicitly state that the composition comprises a B. lactis supernatant. However, the reference teaches that the bacteria are viable and are combined with ingredients to promote their growth (see column 4, lines 59-64). Thus, the growing, viable bacteria would naturally produce a supernatant ingredient.
The reference also does not specifically state that the administration of the composition enhances the expression of IL-10 or reduces the expression of pro-inflammatory chemokines. However, this mechanism of action would be inherent in the prior art method because the prior art teaches administering the same composition as claimed to the same subject as claimed.
Claim Rejections - 35 USC § 103
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.
9. Claim(s) 1-4, 10, 11, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benyacoub (US 10,501,530) in view of David (US 2014/0294789).
The teachings of Benyacoub are discussed above. Benyacoub teaches that the composition contains prebiotic (claim 6). Benyacoub teaches that the prebiotic is galacto-oligosaccharides (GOS) (claims 7-8).
The reference does not specifically teach does not teach cell-free supernatant. However, David teaches "incubation of probiotic Bifidobacterium lactis with GOS results in production of a supernatant "postbiotic" that induces the expression of genes that can promote gastrointestinal healing" [0126].
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have substituted the composition of Benyacoub
with cell-free supernatant "postbiotic" taught by David because David teaches that the supernatant postbiotic promotes gastrointestinal healing. Because probiotics need to be
kept alive, limiting their application, the preparation of supernatant "postbiotic" that
promotes gastrointestinal healing is beneficial because supernatant has same
gastrointestinal healing effect as probiotic itself. Furthermore, the composition of
Benyacoub also contain same prebiotic galacto-oligosaccharides (GOS) as David and
David teaches that incubation of probiotic Bifidobacterium lactis with GOS results in
production of a supernatant "postbiotic" that promote gastrointestinal healing.
Therefore, one of ordinary skill in the art would be motivated to remove bacterial cell
Bifidobacterium lactis from the composition of Benyacoub by centrifugation or filtration
and to prepare supernatant to administer cell-free supernatant instead of cell-containing
composition because cell-free supernatant has an advantage because probiotics need
to be kept alive, limiting their application. Therefore, the invention as a whole would
have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in
the art would have had a reasonable expectation of success because David teaches that the supernatant postbiotic promotes gastrointestinal healing. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding claims 10-11 and 21-24, these claims describe intrinsic characteristics of the Bifidobacterium lactis supernatant. Although David does not expressly teach this characteristics, Bifidobacterium lactis supernatant will have same characteristics because it is an intrinsic characteristics of the supernatant. Furthermore, the Office does not have the facilities for examining and comparing the claimed products of the prior art in order to establish that the
products of the prior art possess the same material, structural, and functional characteristics as applicant's products. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the products to which the claims are directed are different than that taught by the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA, 1977) and Ex parte Gray, 10 USPQ2d 1922 1923 (PTO Board of Patent Appeals and Interferences, 1988 and 1989).
10. Claims 5, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over
Benyacoub (US 10,501,530) in view of David (US 2014/0294789) as applied to claims 1-4, 10, 11, and 21-24 above, and further in view of Liu (WO 2020/063553 – English translation).
The teachings of Benyacoub and David are discussed above. The references do not teach culture media comprising sugar and yeast extract.
However, Liu teaches culturing Bifidobacterium lactis in a culture medium composition yeast powder 2.0, glucose (a sugar) 5.0 (example 5). It is well known in the art that yeast powder and yeast extract is alternative term.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have cultured Bifidobacterium lactis in culture
media comprising sugar and yeast extract because it is well known in the art that Bifidobacterium lactis is cultured in this type of media as taught by Liu. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
11. Claims 1-5, 10-12, 14, and 17-26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3-14 of copending Application No. 18/683,538 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating gastrointestinal diseases such as inflammatory bowel disease using a culture supernatant from B. lactis (with B. animalis subsp. lactis CNCM I-3446 claimed). The reference application teaches culturing the bacteria using the same media as claimed and that the supernatant has the same compositional make up as claimed. Thus, the claims are not patentably distinct despite a difference in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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, Anand Desai can be reached at 571-272-0947. 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.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Prosecution Insights