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 .
DETAILED ACTION
Claims 1-2, 4-10, and 15 are pending.
Response to Amendment
Applicant amended claims 1-2, 4-10, and 15 to recite a method for treating dysregulation of gastric acid secretion. Applicant canceled claims 3 and 11-14.
The rejection of claims 1-10 under 35 U.S.C. 101 is withdrawn in view of the amendment.
The rejection of claims 1-15 under 35 U.S.C.§ 112 is withdrawn in view of the biological deposit statement filed on 05/12/2026.
The rejection of claims 1-10 and 15 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
The rejection of claims 1-15 under 35 U.S.C. 102(a)(1) is withdrawn in view of the amendment.
The rejection of claims 1-15 under 35 U.S.C. 103 is withdrawn in view of the amendment.
The rejection of claims 1-15 on the ground of nonstatutory double patenting is withdrawn in view of the amendment.
New Rejection Necessitated by the Amendment
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.
Claim 5 is 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 5 recites “wherein the Bifidobacterium lactis is used in the form of a solid or liquid bacterial”. The claim is indefinite because it is unclear how a bacterial cell can be in liquid form. Applicant may consider amending the claim to recite “wherein the composition is in the form of a solid or a liquid bacterial preparation”.
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 1-2, 4-10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hong (CN 110964655 A, of record in IDS) as evidenced by McColl (British Medical Bulletin 54.1 (1998): 121-138).
Regarding claims 1-2, Hong teaches the administration of Bifidobacterium lactis BL-99 with a deposit number of CGMCC No. 15650 to a subject to inhibit the growth of Helicobacter pylori (Title, Example 3, Table 13, Summary of the Invention paragraph 2, page 3). Evidentiary reference McColl reports that H. pylori gastritis alters gastric acid secretion (abstract). It is thus understood that the subject taught in Hong have a dysregulation of gastric acid secretion.
Hong does not teach measuring the gastric acid secretion. However, since Hong teaches the claimed composition and the same population, then the limitations of treating dysregulation of gastric acid secretion and bidirectionally regulating the amount of gastric acid secretion will also be present when the teachings of Hong are practiced. Regarding claims 4, 7, and 9-10, Hong teaches administering the strain Bifidobacterium lactis BL-99 CGMCC 15650 as a food or feed "fermented milk, cheese, milk-containing beverage, solid beverage, milk and other common food or healthcare food" (Example 4) and as a pharmaceutical comprising excipients, diluents, fillers, and absorption enhancers (Summary of the Invention paragraph 13, page 3).
Regarding claims 5-6, Hong teaches that Bifidobacterium lactis BL-99 is either a solid powder in live or inactivated form, or a liquid bacterial formulation in either live or inactivated form (page 3).
Regarding claims 8 and 15, Hong teaches a dose of 2.5x109 CFU/ml (Example 3).
Claims 1-2, 4-10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hong (CN 110964655 A, of record in IDS) in view of Barbuti (Gastroenterology (New York, N.Y. 1943), 2014-05, Vol.146 (5), p.S-854-S-854).
The limitation of a subject in need of treating dysregulation of gastric acid secretion is interpreted as comprising subject with functional dyspepsia as disclosed by Applicant in Figures 1-5.
Regrading claims 1-2, 4-10, and 15, Hong teaches the administration of Bifidobacterium lactis BL-99 with a deposit number of CGMCC No. 15650 in order to promote the growth of intestinal bifidobacteria and lactobacilli, inhibiting the growth of Vibrio desulfides and/or Enterobacteria in the intestines, and to regulate effect the gastrointestinal flora. Hong teaches that this bacterium has good resistance to stomach acid and intestinal juice. Hong does not teach administering the bacterium to a subject with functional dyspepsia.
However, Barbuti teaches administering a composition comprising Bifidobacterium lactis B420 to treat dyspepsia with significant clinical improvement and without side effects (para. Tu1846).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition taught by Hong to a subject with dyspepsia, as suggested by Barbuti. One of ordinary skill in the art would be motivated to do so in order to treat dyspepsia. MPEP 2144.06 II states it is obvious to substitute equivalents know for the same purpose. Since Hong teaches Bifidobacterium lactis BL-99 is a probiotic with effect on gastrointestinal flora and has good resistance to stomach acid and intestinal juice, and since Barbuti teaches a correlation between administering a probiotic Bifidobacterium lactis B420 and treating dyspepsia, there is a reasonable expectation of success.
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, 4-10, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-9, and 16 of copending Application No. 18/714852 in view of Hong as evidenced by McColl.
Regarding instant claims 1-2, 4-10, and 15, copending claim 1 recites a method for protecting cartilage, comprising administering an effective amount of Bifidobacterium lactis having the deposit number of CGMCC No. 15650 to a subject in need thereof.
copending claim 4 recites wherein the Bifidobacterium lactis is used in the form of a composition comprises a food composition, a feed composition or a pharmaceutical composition. Copending claim 5 recites wherein the Bifidobacterium lactis is used in the form of a solid or liquid bacterial composition and/or the Bifidobacterium lactis is used in the form of live bacteria or inactivated bacteria. Copending claim 6 recites wherein the Bifidobacterium lactis is combined with one or more of prebiotics. Copending claim 7 recites wherein the composition is a food composition. Copending claim 8 recites wherein the food is a fermented dairy product, cheese, a dairy beverage, a solid beverage, or milk powder. Copending claim 9 recites wherein the Bifidobacterium lactis is taken in an amount of 1.0 x 103 CFU/day to 1.0 x 1012 CFU/day. Copending claim 16 recites wherein the Bifidobacterium lactis is taken in an amount of 1.0 x 107 CFU/day to 1.0 x 1011 CFU/day. Copending claims 1, 4-9, and 16 do not recite administering the composition to a subject with dysregulation of gastric acid secretion.
However, Hong teaches the administration of Bifidobacterium lactis BL-99 with a deposit number of CGMCC No. 15650 to a subject to inhibit the growth of Helicobacter pylori (Title, Example 3, Table 13, Summary of the Invention paragraph 2, page 3). Evidentiary reference McColl reports that H. pylori gastritis alters gastric acid secretion (abstract). It is thus understood that the subject taught in Hong have a dysregulation of gastric acid secretion. Hong teaches the composition is a pharmaceutical composition comprising excipients, diluents, fillers, and absorption enhancers (Summary of the Invention paragraph 13, page 3). Hong does not teach measuring the gastric acid secretion. However, since Hong teaches the claimed composition and the same population, then the limitations of treating dysregulation of gastric acid secretion and bidirectionally regulating the amount of gastric acid secretion will also be present when the teachings of Hong are practiced.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method recited in copending claims 1, 4-9, and 16 by administering the composition to a subject with H. pylori, as suggested by Hong. One of ordinary skill in the art would be motivated to do so in order to treat H. pylori infection and its related diseases.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4-10, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 13 of copending Application No. 17/778587 in view of Hong as evidenced by McColl.
Regarding instant claims 1-2, 4-10, and 15, copending claim 1 recites a method for suppressing bloody stools caused by intestinal inflammation, comprising administering to a subject having bloody stools caused by intestinal inflammation, an effective amount of Bifidobacterium lactis to suppress the bloody stools, wherein the Bifidobacterium lactis has the deposit number CGMCC 15650. Copending claim 2 recites wherein the Bifidobacterium lactis is in a form of solid or liquid bacterial preparation of viable bacteria. Copending claim 13 recites wherein the Bifidobacterium
lactis is in a form of solid or liquid bacterial preparation of dead bacteria. Copending claims 1-2 and 13 do not recite administering the composition to a subject with dysregulation of gastric acid secretion.
However, Hong teaches the administration of Bifidobacterium lactis BL-99 with a deposit number of CGMCC No. 15650 to a subject to inhibit the growth of Helicobacter pylori (Title, Example 3, Table 13, Summary of the Invention paragraph 2, page 3). Evidentiary reference McColl reports that H. pylori gastritis alters gastric acid secretion (abstract). It is thus understood that the subject taught by Hong have a dysregulation of gastric acid secretion. Hong teaches the composition is a pharmaceutical composition comprising excipients, diluents, fillers, and absorption enhancers (Summary of the Invention paragraph 13, page 3). Hong teaches administering the strain Bifidobacterium lactis BL-99 CGMCC 15650 as a food or feed "fermented milk, cheese, milk-containing beverage, solid beverage, milk and other common food or healthcare food" (Example 4) and as a pharmaceutical comprising excipients, diluents, fillers, and absorption enhancers (Summary of the Invention paragraph 13, page 3). Hong teaches a dose of 2.5x109 CFU/ml (Example 3). Hong does not teach measuring the gastric acid secretion. However, since Hong teaches the claimed composition and the same population, then the limitations of treating dysregulation of gastric acid secretion and bidirectionally regulating the amount of gastric acid secretion will also be present when the teachings of Hong as practiced.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method recited in copending claims 1-2 and 13 by administering the composition to a subject with H. pylori, as suggested by Hong. One of ordinary skill in the art would be motivated to do so in order to treat H. pylori infection and its related diseases.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments with respect to claims 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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