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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17NOV25 has been entered.
Applicant’s arguments, see applicant’s remarks pages 3-5, filed 21AUG25, with respect to claims 1, 2 & 13 have been fully considered and are persuasive. The previous rejections under 35 U.S.C 102/103 and non-statutory double patenting rejections of claims 1, 2 & 13 have been withdrawn.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claims 1, 2 & 13 are rejected under 35 U.S.C.§ 112, first paragraph, as containing 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.
• It is apparent that Bifidobacterium animalis subspecies lactis strain BL-99 (CGMCC 15650) is required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the aforementioned B. lactis BL-99.
• The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. Applicant claims the use of a specific strain of bacteria in the method of claim 1 and its dependent claims, 2 & 13. Therefor it is by definition, not possible to practice the method of claim 1 without access to the specified strain of bacteria B. lactis BL-99. It would be effectively impossible to reisolate that exact strain of bacteria from known sources of the same species, and would require an undue investment of time and resources for one skilled in the art to even attempt it. Since such an endeavor would require isolating and sequencing Bifidobacteria until one with the same sequence is found by chance. This would be a monumental and unnecessary effort that would be easily avoided by providing access to B. lactis BL-99 via an acceptable deposit of viable culture, that is made available to the public.
• It is noted that Applicants have provided evidence of deposited biological material, however a search of the CGMCC catalogue for CGMCC No. 15650 did not show evidence of B. lactis BL-99 being available to the public under that catalogue number to the contrary that search rendered Arthrobacter alkaliphilus strain JCM 21827 and Penicillium oxalicum strain DeltaPoxKu70 as the results. For further details see PDPSearchNotes17778587_08JAN26.pdf.
• If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
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 1, 2 & 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 155 of U.S. Patent Application No. 18/714,839 in view of Schindler (“Chronic Gastritis”, Bulletin of the New York Academy of Medicine, 1939 May;15(5):322-37, hereafter “Schindler”).
Claims 1 & 5 of 18/714,839 recite the use of B. lactis (CGMCC No. 15650) in the preparation of a composition for use in prevention and/or amelioration of gastritis, and the use of B. lactis (CGMCC 15650) in a solid or liquid form of bacterial preparation, respectively. The “bacterial preparation” of claim 5 is construed to include both live and dead bacteria since this is not specified in the claim and would be understood by an artisan of ordinary skill in the art to encompass both.
Claim 1 of 18/714,839 does not explicitly recite the amelioration of bloody stools.
Schindler teaches that it has been known to those who study gastritis that this condition can cause blood in the stool of patients that suffer from this affliction since at least 1939 (Schindler, pages 327 & 329). Thus, the scopes of claim 1 of 18/714,389 and claim 1 of the instant application are patentably indistinct under the broadest reasonable interpretation of both claims; since an amelioration of gastritis could also result in the suppression of bloody stools. Furthermore, the scopes claim 5 of 18/714,839 and claims 2 & 13 are also patentably indistinct from one another since they depend on patentably indistinct independent claims as well as claim 5 of ‘839 reciting that the bacterial preparation can be in solid or liquid form. Since a bacterial preparation encompasses both live and dead bacteria the scope of claim 5 encompasses both the solid or liquid bacterial preparation of viable bacteria of claim 2 and the solid or liquid bacterial preparation of dead bacteria in claim 13 of the instant application.
Discussion of the Closest Prior Art
Examiner did not find prior art that teaches the specific strain of Bifidobacterium animalis subspecies lactis strain BL-99 (CGMCC 15650) being administered to suppress the bloody stools caused by intestinal inflammation. The closest prior art references of note were: Wallace et. al., (“Proton Pump Inhibitors Exacerbate NSAID-Induced Small Intestinal Injury by Inducing Dysbiosis”, Gastroenterology 29 June 2011,141(4), hereafter “Wallace”), Leser et. al. (European Patent document EP 3194567 B1, hereafter “Leser”), Philippe et. al., (“Bifidobacterium lactis attenuates onset of inflammation in a murine model of colitis", World J Gastroenterol 2011 January 28; 17(4): 459-469; hereafter "Philippe") and Mogna et. al. (“Bacteria strains having a high anti-inflammatory activity”, U.S. Publication No. US 2015/0283185 Al, hereafter “Mogna”).
Wallace teaches the restoration of small intestinal Actinobacteria numbers through administration of selected (Bifidobacteria enriched) commensal bacteria during treatment with omeprazole and naproxen prevented intestinal ulceration/bleeding (results section of the abstract). Wallace further teaches that the lack of the naturally occurring Bifidobacteria is mechanistically linked to the intestinal damage caused by the NSAID induced intestinal inflammation (supplementary table 2 and figure 4). In short, the naturally occurring Bifidobacteria are sufficient in the subjects’ intestines were sufficient to stop intestinal bleeding due to inflammation. Thus, it is likely that all the Bifidobacterial species listed in the supplementary table 2 of Wallace contribute to the suppression of intestinal bleeding observed upon induced intestinal inflammation.
Wallace does not teach the administration of a single isolated strain of Bifidobacterium since it teaches the administration of a community of bacteria (known to contain Bifidobacteria) that had been enriched for multiple Bifidobacteria via culture conditions (methods section of Wallace). However, Leser teaches the administration of Bifidobacterium adolescentis BIF038 ( DSM 29103) for the treatment of subjects with intestinal inflammation, with a result of lowering fecal bleeding (page 23 lines 49-50). This is a single strain of Bifidobacterium being administered to relieve the bloody stools caused by intestinal inflammation.
Leser does not teach, the administration of a single strain of Bifidobacterium animalis subspecies lactis. However, Philippe teaches that specific doses (see page 460, 2nd col, 2nd para) reduce intestinal inflammation and the proinflammatory mediators IL-6 and TNF-a (see page 463, 1st col, para 2nd; and Fig 3 and Fig 4). Philippe describes a B. lactis strain which is NCC 2818 and does not describe the strain CGMCC 15650. While Philippe teaches a reduction in inflammation it does not make any observations of blood in stool which are taught in Wallace and Leser. Mogna teaches the administration of anti-inflammatory probiotics in the form of live (viable) bacteria (to include but not limited to B. lactis) or dead bacteria, in food products (solid), (page 5, paragraphs 25, 32-33).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY WILLKEEN whose telephone number is (571)272-6184. The examiner can normally be reached 9:00-5:00 Mon-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.W./Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651