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 .
Claims 1-20 are pending. Claims 1-3 are withdrawn. Claims 4-20 are under examination.
Election/Restrictions
Applicant’s election without traverse of invention II claims 4-20 and the species Lactobacillus, sunflower seed oil, glycerin fatty acid ester, peanuts, fructo-oligosaccharides, xanthan gum and constipation in the reply filed on 3/08/2026 is acknowledged.
Claims 1-3 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/08/2026.
Information Disclosure Statement
The information disclosure statements filed 3/21/2024, 05/19/2025 and 12/26/2025 have been considered and initialed copies are enclosed.
Claim Objections
Claim 4 is objected to because of the following informalities: In claim 4, “contains” should be “containing”. Appropriate correction is required.
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 4-20 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.
The metes and bounds of “gastric acid-stable” is not clear. What is encompassed by gastric-acid stability? This term is not defined in the specification.
Claims 5 and 11 recite the special character “~” for the weight part. Does this mean the ranges are approximate ranges?
Claim 5 recites “the inventive gastric acid-stable probiotic formulation”. The recitation of “inventive” is a subjective term subject to debate and is regarded as vague.
Regarding claims 12 and 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 20 recites the use of a composition comprising gastric acid-stable probiotic formulation according to claim 4, for manufacture of medicines employed for treating or preventing the disease caused by the proliferation of harmful bacteria in the intestine.
Claim 20 does not set forth any step for the manufacture of the composition of claim 4, thus the claim is vague and indefinite.
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.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is not a proper process because it does not provide process steps for the manufacture of the composition of claim 1.
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.
Claim(s) 4, 6-10 and 12-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pompejus et al. WO 2012/100991 8/2/2012.
Claim 4, 6-10 and 12-20: Pompejus et al disclose a gastric acid-stable probiotic formulation containing (a) Lactobacillus, (b) edible oils such as sunflower seed oil, and (c) emulsifiers such as glycerin fatty acid ester or sucrose fatty acid ester d) oil seed meals such as peanut meal (nuts), soybean meal, sunflower meal (corresponding to sunflower seed nut) or coconut meal as essential ingredients and further comprises dietary fiber such as xanthan gum or guar gum, prebiotics such as sucrose, fructose, galactose or glucose. See p. 4 lines 13-28, p. 5-6, p. 40-41, p. 42 lines 23-25, p. 43 first and second paragraph, p. 45 last paragraph, p. 46 second paragraph, p. 47 last paragraph lines 17-20.
Pompejus et al disclose the formulation comprises 0.025 wt.% to 2 wt-% of Lactobacillus. See p. 40 lines 3-6 and p. 40-41.
The composition of Pompejus is a health care food, a food additive and a pharmaceutical composition comprising the probiotic formulation as an active ingredient. See in addition abstract and claims
Regarding claim 16, Pompejus et al disclose the health functional food is a beverage, oral tablet, chewing tablet (oral tablet), granule, or capsule.
The recitation to treat or prevent the disease caused by the proliferation of harmful bacteria in the intestine including constipation and the recitation for promoting the proliferation of beneficial bacteria to improve or prevent the disease caused by the proliferation of harmful bacteria in the intestine or the prevention or alleviation of the disease caused by the proliferation of harmful bacteria in the intestine and the recitation for manufacture of medicines employed for treating or preventing the disease caused by the proliferation of harmful bacteria in the intestine are drawn to the intended uses of the probiotic formulation.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-5 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pompejus et al. WO 2012/100991 8/2/2012.
Pompejus et al disclose a gastric acid-stable probiotic formulation containing (a) Lactobacillus, (b) edible oils such as sunflower seed oil, and (c) emulsifiers such as glycerin fatty acid ester or sucrose fatty acid ester d) oil seed meals such as peanut meal (nuts), soybean meal, sunflower meal (corresponding to sunflower seed nut) or coconut meal as essential ingredients and further comprises dietary fiber such as xanthan gum or guar gum, prebiotics such as sucrose, fructose, galactose or glucose. See p. 4 lines 13-28, p. 5-6, p. 40-41, p. 42 lines 23-25, p. 43 first and second paragraph, p. 45 last paragraph, p. 46 second paragraph, p. 47 last paragraph lines 17-20.
Pompejus et al disclose the formulation comprises 0.025 wt.% to 2 wt-% of Lactobacillus. See p. 40 lines 3-6 and p. 40-41.
Pompejus et al does not disclose, claim 5, the probiotic formulation according to claim 4, wherein relative weight ratio of the individual components of the probiotic formulation consists of (a) lactic acid bacteria 1.0 weight part, (b) edible oil 1 ~ 90 weight part, and (c) emulsifier 0.1 ~ 5.0 weight part and nuts 5 ~ 90 .
Pompejus et al does not disclose claim 11, the probiotic formulation according to claim 10, Wherein said relative weight ratio of the individual components of a probiotic formulation for relieving hangovers consists of (a) lactic acid bacteria 1.0 weight part, (b) edible oil 1 ~ 60 weight part, (c) emulsifier 0.1 ~ 5.0 weight part, (d) nuts 5.0 ~ 90.0 weight part, (e) prebiotics 0.01 ~ 5.0 weight part, and (f) cohesive agents 0.1 ~ 5.0 weight part.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Pompejus et al teach that the components of the probiotic formulation comprise therapeutically effective amounts so as to provide the form for proper administration to the patient and disclose that the Lactobacillus is 0.025 wt.% to 2 wt-% relative to the total mass of the composition. See p. 40 lines 3-6 and p. 40-41.
Thus, arriving at the claimed weight parts of lactic acid bacteria, approximate weight parts of edible oil and approximate weight parts of emulsifier and furthermore approximate weight parts of nuts, approximate weight parts of prebiotics and approximate weight parts of cohesive agents would have been achieved by one of ordinary skill in the art as of the effective filing date by routine optimization of the disclosed ingredients in order to arrive at therapeutic amounts of the components of the probiotic formulation so as to provide a proper form for proper administration to the patient.
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 4-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 and 18-19 of copending Application No. 18/611,944 (‘944). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 4. The ‘944 application discloses a probiotic formulation for relieving hangovers contains (a) lactic acid bacteria, (b) edible oils, and (c) emulsifiers and nuts as essential ingredients.
Claim 5. The ‘944 application discloses the probiotic formulation, Wherein relative weight ratio of the individual components of the probiotic formulation consists of (a) lactic acid bacteria 1.0 weight part, (b) edible oil 1~90 weight part, (c) emulsifier 0.1~5.0 weight part, and (d) nuts 5~90 weight part.
Claim 6. The ‘944 application discloses the probiotic formulation, Wherein said (a) lactic acid bacteria is characterized by one or more strains selected from microorganisms of the genus Lactobacillus, Bifidobacterium, Bacillus, Streptococcus, and Enterococcus.
Claim 7. The ‘944 application discloses the probiotic formulation, Wherein said (b) edible oils are characterized by one or more ingredients selected from a group of avocado oil, canola oil, evening primrose oil, coconut oil, Brazil nut oil, corn oil, cottonseed oil, flaxseed oil, grapeseed oil, hemp oil, olive oil, palm oil, safflower seed oil, soybean oil, peanut oil, sunflower seed oil, krill oil, anchovy oil, salmon oil, rice bran oil, brown rice oil, virgin coconut oil, rosehip oil, and tuna oil.
Claim 8. The ‘944 application discloses the probiotic formulation, wherein said (c) emulsifiers are characterized by one or more components selected from a group consisting of propylene glycol fatty acid esters, glycerin fatty acid esters, sucrose fatty acid esters, polyglycerin fatty acid esters, sorbitan fatty acid esters, organic acid monoglycerides, polyoxyethylene fatty acid esters, propylene glycol fatty acid esters, polyoxyethylene fatty acid esters, polysorbate, egg yolk lecithin, soybean lecithin, carboxymethylcellulose, glycerin, soy phospholipids, and stearyl calcium lactate.
Claim 10. The ‘944 application discloses the probiotic formulation, wherein said probiotic formulation comprises one or more additional ingredients selected from (d) nuts, (e) prebiotics, and (f) cohesive agents in addition to the essential ingredients consisting of (a) lactic acid bacteria, (b) edible oils, and (c) emulsifiers.
Claim 11. The ‘944 application discloses probiotic formulation, wherein said relative weight ratio of the individual components of a probiotic formulation for relieving hangovers consists of (a) lactic acid bacteria 1.0 weight part, (b) edible oil 1 ~ 60 weight part, (c) emulsifier 0.1 ~ 5.0 weight part, (d) nuts 5.0 ~ 90.0 weight part, (e) prebiotics 0.01 ~ 5.0 weight part, and (f) cohesive agents 0.1 ~ 5.0 weight part.
Claim 9. The ‘944 application discloses the probiotic formulation, wherein said (d) nuts is characterized by one or more components selected from a group of peanuts, almonds, walnuts, pine nuts, pistachios, pecans, macadamias, hazelnuts, cashews, Brazil nuts, chestnuts, soybeans, cacao nibs, coconuts, sunflower seeds, and pumpkin seeds.
Claim 12 . The ‘944 application discloses the probiotic formulation, wherein said (e) prebiotics is characterized by being one or more components selected from pentose such as xylose and arabinose, hexose such as glucose, mannose, fructose, and galactose; lactulose, lactitol, sucrose, lactose, maltose, trehalose; fructo-oligosaccharide, raffinose, stachyose, maltodextrin, amylose, amylopectin, starch, cellulose, and pectin.
Claim 13. The ‘944 claims disclose the probiotic formulation, wherein said cohesive agents is characterized by one or more components selected from a group consisting of sodium silico aluminate, xanthan gum, carrageenan, guar gum, diutan gum, cellulose gum, gellan gum, pectin, and carboxymethylcellulose.
Claim 16-18. The ‘944 claims disclose a health care food comprising the probiotic formulation for promoting the proliferation of beneficial bacteria to improve or prevent the disease caused by the proliferation of harmful bacteria in the intestine. This recitation is an intended use of the composition.
Claim 19. The ‘944 claims disclose a food additive comprising the probiotic formulation. The recitation of for the prevention or alleviation of the disease caused by the proliferation of harmful bacteria in the intestine. This is an intended use of the composition.
Claims 14-15. The ‘944 claims disclose a pharmaceutical composition comprising the probiotic formulation as an active ingredient to treat or prevent the disease caused by the proliferation of harmful bacteria in the intestine is an intended use of the composition.
Claim 20: The ‘944 claims disclose the composition comprising gastric acid-stable probiotic formulation as set forth above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Status of Claims
Claims 1-3 are withdrawn. Claims 4-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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