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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because claims 1-10 claim the “Use of Bifidobacterium lactis”. This is not one of the four statutory categories that are eligible for a patent in the United States (process, machine, manufacture or composition of matter). Claiming the “use” of a composition of matter per se is not sufficient to determine if the claim is intended to be the method of making the composition of matter or if the claim is to the composition of matter itself. For the purposes of examination, claims 1-10 are construed as claiming the composition of matter CGMCC 15650 with the intended use of preventing or ameliorating gastritis (see rejection for indefiniteness below for detailed explanation).
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.
Biological Deposit
Claims 1-15 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. Therefor it is by definition, not possible to make what is construed to be the composition of claims 1-10 or practice the method of claims 13-15 without access to the specified strain of bacteria B. lactis BL-99. It is also by definition impossible to make the composition of claims 11 & 12 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.
• 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 CGMCCSearchNotes26JAN26.pdf. This is surprising, since all restrictions on the public availability of this strain should have been irrevocably removed on 12APR22.
• 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.
Indefiniteness
Claims 1-10 and 15 are 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.
Regarding claims 1-10, Applicant is claiming the use of a composition of matter (B. lactis) in another composition of matter for use in prevention and/or amelioration of gastritis. It is unclear whether applicant intends to claim the composition of matter or a method for the prevention or amelioration of gastritis. This failure to distinctly claim one or the other renders the independent claim 1, and all its dependent claims (2-10) indefinite. For the purposes of applying prior art, claims 1-10 are construed as claiming a composition of matter (B. lactis CGMCC No. 15650) with the intended use of preventing or ameliorating gastritis. This is the most reasonable construction based on the claim language since it lacks an active step required for a process claim (typically administering the probiotic).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8 and 15 recite the broad recitation 1.0 X 10 ^3 CFU/day to 1.0 X 10^12 CFU/day, and the claim also recites preferably 1.0 X 10^7 CFU/day to 1.0 X 10^ 11 CFU/day, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purpose of applying prior art the claims will be interpreted to being drawn to either amount.
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.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Hong et. al. (Bifidobacterium Lactis BL-99 Capable Of Adjusting Gastrointestinal Tract Bacteria Group And Application Thereof, CN 110964655 A, 07APR20, hereafter “Hong”). This is because Hong teaches the exact same composition (CGMCC 15650), and the intended use of “prevention and/or amelioration of gastritis” is construed as non-limiting for the purposes of examination since a subject in need of prevention of gastritis could encompass any subject under the broadest reasonable interpretation.
Regarding claims 1-12; A composition in solid or liquid form, comprising CGMCC 15650 in live or inactivated form, for use in the prevention or amelioration of gastritis, at a dose of between 1x 103-12 CFU per day. The composition further comprising, food, feed or pharmaceutical composition. Food further comprising: fermented dairy product, cheese, a dairy beverage, a solid beverage, a tableted candy, a milk tablet, ice cream, or milk powder and pharmaceutical further comprising pharmaceutically acceptable auxiliary material, and the auxiliary material comprises an excipient, a diluent, a filler, and/or an absorption enhancer.
Hong teaches that CGMCC 15650 can be used as live or inactivated bacteria in solid or liquid form (Summary of invention section 8th paragraph). Hong teaches the following embodiments of 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 the following embodiments for a pharmaceutical, “a proper amount of auxiliary material, the auxiliary material can be excipients, diluents, fillers, absorption promoters and the like” (Summary of the Invention paragraph 13). Hong teaches the inhibition of H. pylori (Summary of the Invention paragraph 2) with doses between 107-9 CFU per day (Example 3), which is squarely within the ranges recited in instant claims 8 and 15. The intended efficacies of the composition of claim 1 recited in claims 2 & 3, are inherent effects of administering the composition of claim 1 to any subject and therefore must have been present even if they were not measured in Hong, and thus are also anticipated.
Regarding claims 13-15, A method for prevention and/or amelioration of gastritis comprising administering and effective amount (between 1 x 103-12 CFU per day) of CGMCC 15650 and further comprising the efficacies of ameliorating the symptoms of dyspepsia, increasing the levels of PGI/II or indicators, regulating gastric acid secretion and or reducing the expression of inflammatory factors IL-6 and or TNF-alpha.
Hong teaches the administration of the previously recited composition to mice at doses between 1 x 107-9 CFU per day, with the efficacy of inhibiting H. pylori (Summary of the invention paragraph 6). The efficacies claimed in the instant application are inherent effects of administering the composition of claim 1, at the range of doses prescribed in the method of claim 15, to any subject and therefore must have been present even if they were not measured in Hong, and thus are also anticipated.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et. al. (Bifidobacterium Lactis BL-99 Capable Of Adjusting Gastrointestinal Tract Bacteria Group And Application Thereof, CN 110964655 A, 07APR20, hereafter “Hong”) and Patel et. al. (Clinical application of probiotics in the treatment of Helicobacter pylori infection—A brief review, Journal of Microbiology, Immunology and Infection(47), 429-437, 10JUN13, hereafter “Patel”).
Hong teaches that Bifidobacterium animalis subspecies lactis strain BL-99 (CGMCC 15650) has the effect of inhibiting Helicobacter pylori. Hong also teaches the following additional compositions that can include CGMCC 15650, and still be effective embodiments for the inhibition of H. pylori: “food, feed or pharmaceutical use. the food can be, for example, fermented milk, cheese, milk-containing beverage, solid beverage, milk and other common food or healthcare food. Bifidobacterium lactis BL-99 can be present in the food, feed or medicine in viable bacteria or inactivated form”; “for a pharmaceutical composition, which may comprise proper amount of auxiliary material, the auxiliary material can be excipients, diluents, fillers, absorption promoters and the like”. Hong further teaches doses of between 107-9 CFU per day of CGMCC 15650.
Hong does not explicitly teach a method of ameliorating gastritis comprising administering to a subject an effective amount of Bifidobacterium lactis having the deposit number CGMCC No. 15650.
Patel, however, teaches probiotics for the treatment of gastritis (to include B. lactis) caused by H. pylori. Patel teaches that “H. pylori colonizes the stomach and induces chronic gastritis, a long-lasting inflammation of the stomach”. Patel also teaches that probiotic strains are immunomodulatory i.e. controlling the balance of proinflammatory and anti-inflammatory cytokines and chemokines, to include IL-6. Patel further teaches probiotics for the amelioration of dyspepsia and the increase of serum pepsinogen in subjects with H. pylori infections treated with probiotics (Clinical studies on humans, paragraphs 4 & 6 and tables 2 & 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the particular B. lactis strain taught by Hong (CGMCC No. 15650) to a subject to prevent or ameliorate gastritis.
Based on the teachings of Hong and Patel, one of ordinary skill in the art would have recognized that inhibiting H. pylori would also prevent or ameliorate chronic gastritis since it was known in the art that H. pylori causes gastritis. One would have been motivated to combine the compositions of Hong with the treatments taught in Patel since Patel demonstrates that probiotics are useful as treatments for gastritis caused by H. pylori infections and Hong teaches a composition of a single probiotic strain of B. lactis, in various commercially useful forms, that can inhibit H. pylori as live bacteria or the more shelf stable inactivated bacteria.
Regarding claims 1 & 4-12; A composition in solid or liquid form, comprising CGMCC 15650 in live or inactivated form, for use in the prevention or amelioration of gastritis, at a dose of between 1x 103-12 CFU per day. The composition further comprising, food, feed or pharmaceutical composition. Food further comprising: fermented dairy product, cheese, a dairy beverage, a solid beverage, a tableted candy, a milk tablet, ice cream, or milk powder and pharmaceutical further comprising pharmaceutically acceptable auxiliary material, and the auxiliary material comprises an excipient, a diluent, a filler, and/or an absorption enhancer. Hong teaches that CGMCC 15650 can be used as live or inactivated bacteria in solid or liquid form (Summary of invention section 8th paragraph). Hong teaches the following embodiments of 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 the following embodiments for a pharmaceutical, “a proper amount of auxiliary material, the auxiliary material can be excipients, diluents, fillers, absorption promoters and the like” (Summary of the Invention paragraph 13). Hong teaches the inhibition of H. pylori (Summary of the Invention paragraph 2) with doses between 107-9 CFU per day (Example 3), but does not directly teach amelioration of gastritis. Patel however teaches that “H. pylori colonizes the stomach and induces chronic gastritis, a long lasting inflammation of the stomach”.
Regarding claims 2 & 3, A composition comprising CGMCC 15650 with the intended use of prevention or amelioration of gastritis wherein gastritis further comprises one or more of the following: ameliorating the symptoms of functional dyspepsia, increasing levels of pepsinogen I and or PGI/PGII indicators, regulating the amount of gastric acid secretions, reducing the expression of inflammatory factors IL-6 and or TNF-alpha, preventing or ameliorating chronic gastritis and/or preventing and or ameliorating gastric mucosal atrophy. Patel further teaches that probiotics used in the treatment of gastritis have immunomodulatory effects to include “controlling the balance of proinflammatory and anti-inflammatory cytokines and chemokines, which in turn would reduce gastric activity and inflammation” then further specifies that H. pylori infection causes “activated monocytes and dendritic cells stimulate production of various cytokines together with IL-4, IL-5, IL-6, and interferon-gamma” (Mechanism of probiotic action on H. pylori). Patel also teaches the increase in serum pepsinogen I/II after treatment of H. pylori induced gastritis with probiotics (Clinical studies on human, paragraph 6, and Table 3). Patel further teaches the use of probiotics as increasing the eradication rate of H. pylori during treatment of dyspepsia and alleviating the adverse effects of the treatment (Clinical studies on humans, paragraph 4 and table 2).
This suggests that one of ordinary skill in the art would be able to combine the composition of Hong with the demonstrations of probiotic efficacy in treating the “chronic gastritis” induced by H. pylori infection of Patel with the expectation of success. One would have been motivated to do so since the composition of Hong already demonstrated the ability to inhibit H. pylori and that is the main mechanism of chronic gastritis, in need of being addressed in Patel, and the composition of Hong has the added benefit of being effective in inactivated form which is more shelf stable and other commercially important forms such as foods, feeds or pharmaceutical compositions.
Regarding claims 13-15, A method for prevention and/or amelioration of gastritis comprising administering and effective amount (between 1 x 103-12 CFU per day) of CGMCC 15650 and further comprising the efficacies of ameliorating the symptoms of dyspepsia, increasing the levels of PGI/II or indicators, regulating gastric acid secretion and or reducing the expression of inflammatory factors IL-6 and or TNF-alpha.
Hong teaches the administration of the previously recited composition to mice at doses between 1 x 107-9 CFU per day, with the efficacy of inhibiting H. pylori. Hong does not teach the administration of their composition with the efficacies listed above. However, Patel teaches the administration of probiotics to humans for ameliorating dyspepsia, increasing pepsinogen I/II and reducing controlling the balance of proinflammatory and anti-inflammatory cytokines and chemokines to include IL-6 (Tables 2-3 and mechanisms of probiotic action on H. pylori). This suggests that a person of ordinary skill in the art would be able to treat H. pylori induced gastritis using the composition of Hong while expecting the efficacies seen in the administration of probiotics in Patel. This is because H. pylori is the main cause of all the symptoms being addressed by the treatments in Patel and Hong demonstrates that CGMCC 15650 inhibits H. pylori. Thus, one would expect success in combining the composition of Hong with the process of Patel, and would be motivated to do so because the composition of Hong is effective as living or inactivated bacteria in many commercially important forms, inactivated bacteria are more stable for long term storage.
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 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 -14 of U.S. Patent Application No. 18/714,852.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of instant application claim or are construed to claim the composition of CGMCC 15650 with the intended use of prevention of amelioration of gastritis and claim 1 of ‘852 also claims the exact same composition. The intended use of “prevention and/or amelioration of gastritis” is construed as non-limiting for the purposes of examination since a subject in need of prevention of gastritis could encompass any subject under the broadest reasonable interpretation. Claims 5-9 of ‘852 are construed to claim compositions comprising: CGMCC 15650 in solid, liquid, live or inactivated forms, with the inclusion of prebiotics, a food composition further comprising: fermented dairy, cheese, dairy beverage, solid beverages or milk powder administered in the amount of between 1x103 to 1x 1012 CFU per day. Thus, claims 1-12 (claims to the composition of CGMCC 15650 also comprising a food composition) are anticipated by claims 1, & 5-9 of ‘852.
Regarding claims 13-15 of the instant application claim methods of preventing or ameliorating gastritis comprising administering CGMCC 15650 at a dose between 1x103 to 1x 1012 CFU per day. Claim 12 of ‘852 claims a method of protecting cartilage, comprising administering CGMCC 15650. Claims 13-15 of the instant application are obvious over claims 9 & 12 of ‘852 because the methods both claim the exact same active step of administering CGMCC 15650, and the broadest reasonable interpretation of the prevention of “preventing gastritis” would include administering CGMCC 15650 to any subject. Claim 12 of ‘852 also has a broadest reasonable interpretation of administering CGMCC 15650 to any subject since the claim simply recites a method for protecting cartilage, this could apply to any subject since no antecedent cartilage damage is specified. The intended efficacies of the composition of claim 1 recited in claims 2-3 & 14, are inherent effects of administering the composition of claim 1 to any subject.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 & 13 of U.S. Patent Application No. 17/778,587 and further in view of Hong.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of instant application claim or are construed to claim the composition of CGMCC 15650 with the intended use of prevention of amelioration of gastritis and claims 13-15 recite the method of administering that composition. Claims 1-2 & 13 of ‘587 recites the administration of the exact same composition (CGMCC 15650). The intended use of “prevention and/or amelioration of gastritis” is construed as non-limiting for the purposes of examination since a subject in need of prevention of gastritis could encompass any subject under the broadest reasonable interpretation.
Hong teaches that CGMCC 15650 can be used as live or inactivated bacteria in solid or liquid form (Summary of invention section 8th paragraph). Hong teaches the following embodiments of 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 the following embodiments for a pharmaceutical, “a proper amount of auxiliary material, the auxiliary material can be excipients, diluents, fillers, absorption promoters and the like” (Summary of the Invention paragraph 13). Hong teaches the inhibition of H. pylori (Summary of the Invention paragraph 2) with doses between 107-9 CFU per day (Example 3).
Regarding claims 1-12; A composition in solid or liquid form, comprising CGMCC 15650 in live or inactivated form, for use in the prevention or amelioration of gastritis, at a dose of between 1x 103-12 CFU per day. The composition further comprising, food, feed or pharmaceutical composition. Food further comprising: fermented dairy product, cheese, a dairy beverage, a solid beverage, a tableted candy, a milk tablet, ice cream, or milk powder and pharmaceutical further comprising pharmaceutically acceptable auxiliary material, and the auxiliary material comprises an excipient, a diluent, a filler, and/or an absorption enhancer.
Claims 1-2 & 13 of ‘587 recite the administration of CGMCC 15650 in solid of liquid form of viable or dead bacteria for the purpose of suppressing bloody stools caused by intestinal inflammation. Thus, it would be obvious to one of ordinary skill in the art to combine the teachings of Hong (inclusion of CGMCC in foods, beverages and pharmaceuticals) at the dose specified in Hong with the methods of ‘587 and expect nothing but success, since this reference teaches the administration of the exact same strain to an overlapping subject group. The subject groups overlap since the claims of instant application recite prevention of gastritis which under the broadest reasonable interpretation includes any subject, and a subject with bloody stools caused by intestinal inflammation from ‘587 could also be in need of preventing gastritis. Thus, claims 1-12 of the instant application are rendered obvious over claims 1-2 & 13 of ‘587 in view of Hong. Regarding claims 13-15 methods of preventing or ameliorating gastritis comprising administering CGMCC 15650 at a dose between 1x103 to 1x 1012 CFU per day, with the one or more of the following intended efficacies: ameliorating the symptoms of functional dyspepsia, increasing PGI and or PGI/PGII indicators, regulating the amount of gastric acid secretion and or reducing the expression of IL-6 and or TNF-alpha.
It would be obvious to one of ordinary skill in the art to combine the teachings of Hong with the methods of ‘587 to achieve the prevention or amelioration of gastritis or at least one of the intended efficacies above, and at the doses taught in Hong, with the expectation of success. This is because ‘587 teaches the administration of CGMCC 15650 to a subject for the suppression of bloody stools caused by intestinal inflammation. The methods of claims 13-15 of the instant application recite a method of preventing gastritis, under the broadest reasonable interpretation this would include any subject, even a subject with bloody stools caused by intestinal inflammation since that subject could also be in need of preventing gastritis. The intended efficacies of the method of claim 14 are inherent effects of administering the composition of CGMCC 15650 to any subject. Thus, claims 13-15 of the instant application are rendered obvious over claims 1-2 & 13 of ‘587 in view of Hong.
Conclusion
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/G.A.W./Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651