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 .
Claim Status
Claims 1-2 and 15-16 were canceled.
Claims 3-14 are pending and under consideration.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically Bifidobacterium animalis subsp. lactis CNCM I-3446, Bifidobacterium animalis subsp. lactis B112, Bifidobacterium animalis subsp. lactis BLC1, Bifidobacterium animalis subsp. lactis DSM10140, Bifidobacterium animalis subsp. lactis V9, Bifidobacterium animalis subsp. lactis B1-04, Bifidobacterium animalis subsp. lactis Bi-07, Bifidobacterium animalis subsp. lactis B420, Bifidobacterium animalis subsp. lactis BB-12, Bifidobacterium animalis subsp. lactis AD011, Bifidobacterium animalis subsp. lactis HN019, Bifidobacterium animalis subsp. lactis DN-173 010, Bifidobacterium animalis subsp. lactis ATCC 27536, and Bifidobacterium animalis subsp. lactis VTT E-012010. Since the biological materials are essential to the claimed invention, they must be obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the biological materials and it is not apparent if the biological materials are readily available to the public. Instant specification disclosed that Bifidobacterium animalis subsp. lactis CNCM I-3446, also named NCC 2818, was deposited with the Collection Nationale de Cultures de Microorganismes (CNCM), Institut Pasteur, 25 rue du Docteur Roux, F-75724 PARIS Cedex 15, France, on 7th June 2005 and given the deposit number 1-3446 (page 10), but there is no indication in the specification as to public availability. Furthermore, instant specification did not disclose any deposit information about other cell lines recited by instant claim 4.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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.
Claim(s) 3-4 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benyacoub et al (US10501530; published 12/10/2019; PTO-892).
Regarding claim 3-4, and 13-14, 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) to a subject (claim 1 and 13). The composition of Benyacoub must contain Bifidobacterium lactis cells and supernatant. Therefore, administration of the composition of Benyacoub is also the administration of the supernatant. Because instant claim 3 does not recite that the supernatant is prepared from culture medium and Bifidobacterium lactis cells were removed by centrifugation or filtration, instant claim 3 is anticipated by Benyacoub. The limitation “for treating or preventing a gastrointestinal disease by enhancing the growth of bifidobacteria in the gastrointestinal tract of a subject” of instant claim 3 is the expected result of the active process step. Because Benyacoub teaches the same active process step “administering a Bifidobacterium lactis supernatant to the subject”, the method of Benyacoub will have same expected result.
Regarding claim 12, Benyacoub teaches “The composition of the present invention may also contain prebiotics.”
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.
Claims 3-4 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Benyacoub et al (US10501530; published 12/10/2019; PTO-892) in view of David et al (US2014/0294789; 2/5/2026 IDS).
Regarding claim 3-4 and 13-14, 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) to a subject (claim 1 and 13).
Regarding claim 12, Benyacoub teaches that the composition contains prebiotic (claim 6). Benyacoub teaches that the prebiotic is galacto-oligosaccharides (GOS) (claims 7-8).
The difference between prior art and the instant invention is that Benyacoub does not teach cell-free supernatant.
Regarding claim 3, 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].
Regarding claim 7, pasteurization and lyophilization are well known routine process in nutritional science. Therefore, it is obvious to one of ordinary skill in the art. Furthermore, David teaches “The culture supernatants are subsequently lyophilized. The lyophilized products are herein named the “postbiotic” fraction” [0129].
Regarding claim 8-9, it is well known in the art that probiotics are in the form of supplement or a nutritional composition and orally administered. Therefore, one of ordinary skill in the art would orally administer probiotic supernatant, too.
Regarding claim 10-11, wherein-clause of claim 10-11 describe the inherent characteristics of the Bifidobacterium lactis supernatant. Although David does not expressly teach this characteristics, Bifidobacterium lactis supernatant will have same characteristics because it is inherent characteristics of the supernatant.
In this case, the Office does not have the facilities for examining and comparing Applicant's products with the 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).
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.
Claims 3-14 are rejected under 35 U.S.C. 103 as being unpatentable over Benyacoub et al (US10501530; published 12/10/2019; PTO-892) in view of David et al (US2014/0294789; 2/5/2026 IDS) as applied to claims 3-4 and 7-14 above, and further in view of WO2020/063553 (hereinafter WO553; published 4/2/2020; see google patent for English translation; PTO-892).
Regarding claims 3-4 and 7-14, teachings of Benyacoub and David were discussed above.
However, Benyacoub and David do not teach culture media comprising sugar and yeast extract.
Regarding claims 5-6, WO553 teaches “Referring to the fermentation process shown in FIG. 6, the Bifidobacterium lactis BL-99 (that is, the Bifidobacterium lactis with a deposit number of CGMCC No. 15650) provided by the present invention is anaerobic cultured in a TPY liquid medium. TPY liquid culture medium (g / L): hydrolyzed casein 10.0, soybean mash 5.0, yeast powder 2.0, glucose 5.0 …” (example 5). Instant specification defined sugar as follows at page 3: “In some embodiments, the sugar is glucose, dextrose and/or glucose syrup.” It is well known in the art that yeast powder and yeast extract is alternative term. Furthermore, it is well known in the art that bacterial cells are usually cultured until stationary phase is reached.
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 under anaerobic condition until stationary phase is reached because it is well known in the art that Bifidobacterium lactis is cultured in this condition as taught by WO553. 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 WO553 teaches that Bifidobacterium lactis is cultured in culture media comprising sugar and yeast extract under anaerobic condition. 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.
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.
Claims 3-5, 10-12 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-12, 14, and 17-26 of copending Application No. 18/294358 (hereinafter application’358; US2024/0335484; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 3, claim 1 of application’358 claims “A method for enhancing expression of anti-inflammatory cytokines and/or reducing expression of protein-inflammatory chemokines in the gastrointestinal tract of a subject having or at risk of an overactive immune system disorder comprising administering a Bifidobacterium lactis supernatant to the subject.” Furthermore, claim 3 of application’358 claims “A method for use in treating or preventing an IL-10 mediated disease by enhancing expression of IL-10 in the gastrointestinal tract of a subject comprising administering a Bifidobacterium lactis supernatant to the subject.”
The limitation “for treating or preventing a gastrointestinal disease by enhancing the growth of bifidobacteria in the gastrointestinal tract of a subject” of instant claim 3 is the expected result of the active process step. Because application’358 claims the same active process step “administering a Bifidobacterium lactis supernatant to the subject”, the application’358 will have same expected result.
Regarding claim 4, claim 4 of application’358 claims that the Bifidobacterium lactis is selected from the group consisting of: Bifidobacterium animalis subsp. lactis CNCM I-3446, Bifidobacterium animalis subsp. lactis B112, Bifidobacterium animalis subsp. lactis BLC1, Bifidobacterium animalis subsp. lactis DSM10140, Bifidobacterium animalis subsp. lactis V9, Bifidobacterium animalis subsp. lactis B1-04, Bifidobacterium animalis subsp. lactis Bi-07, Bifidobacterium animalis subsp. lactis B420, Bifidobacterium animalis subsp. lactis BB-12, Bifidobacterium animalis subsp. lactis ADO11, Bifidobacterium animalis subsp. lactis HNO19, Bifidobacterium animalis subsp. lactis DN-173 010, Bifidobacterium animalis subsp. lactis ATCC 27536, and Bifidobacterium animalis subsp. lactis VTT E-012010.
Regarding claim 5, claim 5 of application’358 claims that the Bifidobacterium lactis supernatant is obtained or obtainable by culturing Bifidobacterium lactis in a culture media comprising sugar and yeast extract.
Regarding claim 10, claim 10 of application’358 claims that compared to Bifidobacterium lactis culture media the Bifidobacterium lactis supernatant has: (i) a decreased concentration of total sugar; (ii) an increased concentration of total acids; and (iii) a decreased concentration of total amino acids.
Regarding claim 11, claim 11 of application’358 claims that the Bifidobacterium lactis supernatant comprises: (i) about 4 wt% or less total sugars; (ii) about 0.5 wt% or more total acids; and (iii) about 3.5 wt% or less total amino acids.
Regarding claim 12, claim 12 of application’358 claims that the Bifidobacterium lactis supernatant is used in combination with one or more probiotics, prebiotics, or synbiotics.
Regarding claim 14, claim 14 of application’358 claims that the IL-10 mediated disease is inflammatory bowel disease (IBD) or colorectal cancer. Therefore, claim 14 of application’358 claims treating same disease (i.e. inflammatory bowel disease (IBD) or colorectal cancer) by same active process step (i.e. administering a Bifidobacterium lactis supernatant to the subject) as instant claim 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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