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 .
The amendment filed 6/23/2026 has been entered. Claims 4-5,10-12, 15, 17, 19 and 20 have been amended. Claims 1-20 are pending. Claims 1-3 and 20 are withdrawn. Claims 4-19 are under examination.
Election/Restrictions
Claim 20 has been amended from a use claim i.e. a 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 is now drawn to a method for treating or preventing a disease caused by the proliferation of harmful bacteria in the intestine, the method comprising administering the gastric acid-stable probiotic formulation according to claim 4 to a subject in need of treatment.
Accordingly, claim 20 is not drawn to the gastric acid stable formulation of invention II as set forth in the restriction requirement.
Newly amended claim 20 is directed at an invention that is independent or distinct from the invention examined originally claimed for the following reasons:
The invention of claims 4-19 (invention II) and the invention of claim 20 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method for treating or preventing a disease caused by the proliferation of harmful bacteria in the intestine can be practiced with another materially different product such as an antibiotic.
Invention I (drawn to a method for preparing a gastric acid stable probiotic formulation) and the invention of claim 20 drawn to a method for treating or preventing a disease caused by the proliferation of harmful bacteria in the intestine are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design wherein the step of administering the gastric acid stable probiotic formulation to a subject in need thereof is not found in the method of preparing the gastric acid stable probiotic formulation. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicants have received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 20 is withdrawn from consideration as being directed at a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicants traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections/Rejections Withdrawn
The objection to claim 4 is withdrawn in view of the amendment to the claims.
The rejection of claims 4-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
The rejection of claim 20 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 4, 6-10 and 12-20 under 35 U.S.C. 102(a)(1) as being anticipated by Pompejus et al. WO 2012/100991 8/2/2012 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 4-5 and 10-11 under 35 U.S.C. 103 as being unpatentable over Pompejus et al. WO 2012/100991 8/2/2012 is withdrawn in view of the amendment to the claims.
The rejection of claims 4-20 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) is withdrawn in view of the amendment to the claims.
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 12-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wassell, Paul. US 20070207133 2007-09-06 cited in IDS.
Claim 4: Wassell et al disclose a gastric acid-stable probiotic formulation, containing (a) lactic acid bacteria (paragraph 171 and 174) (b) edible oil (paragraph 105-107), (c) emulsifier (paragraph 204, 207) such as a triglyceride that comprises a fatty acid monoester, for example GRINDSTED (paragraph 140, 144) and nuts such as peanut butter as essential ingredient (paragraph 24, 39, 43, 68, 131-135 and 185 ), wherein the lactic acid bacteria are wrapped withing a gel-like flocculating mixture of edible oils and the emulsifiers – see paragraph 312 disclosing mixing the oil and the triglyceride that comprises a fatty acid monoester, for example GRINDSTED forms a gel which is broken by agitation/mixing action to which probiotic added and dispersed into oil and mixed resulting in probiotic staying in suspension (corresponding to gel-like flocculating mixture of edible oil and the emulsifier).
Claim 6: Wassell discloses the lactic acid bacteria is Streptococcus, Enterococcus, L Bifidobacterium and Lactobacillus or combinations thereof. See paragraph 174.
Claim 7: Wassell discloses the edible oils are sunflower oil, palm oil, palm kernel oil, coconut oil, olive oil, sesame oil, peanut oil, corn oil or mixtures thereof. See paragraphs 105 and 107.
Claim 8: Wassell disclose the GRINDSTED PS 209 is characterized by triglyceride that comprises a fatty acid monoester corresponding to a glycerin fatty acid ester (paragraph 140, 144, 312).
Claim 9: Wassell disclose the nut is characterized by a peanut component i.e. peanut butter as an essential ingredient (paragraph 24, 39, 43, 68, 131-135 and 185 ).
Claim 10: Wassell disclose the gastric acid-stable formulation further comprises a prebiotic and cohesive agents. See paragraphs 199 and 223-224.
Claim 12: Wassell disclose the prebiotic is maltodextrin, galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), lactosucrose, soybean oligosaccharides, palatinose, isomalto-oligosaccharides, gluco-oligosaccharides and xylo-oligosaccharides. See paragraph 223-224.
Claim 13: Wassell disclose the gastric acid-stable formulation comprises cohesive agents such as alginate, xanthan, pectin, locust bean gum (LBG), guar gum. See paragraph 199, 223.
Claim 14-15: Wassell disclose a pharmaceutical composition comprising the gastric-acid stable formulation. See paragraphs 290-298.
The recitation as an active ingredient to treat or prevent the disease caused by the proliferation of harmful bacteria in the intestine is drawn to the intended use of the composition.
Claim 16-17: Wassell disclose a health functional food comprising the gastric-acid stable formulation such as powders, tablet, granule, capsules and beverage .
Claim 18-19: Wassell disclose a health care food and a food additive comprising the gastric-acid stable formulation. See paragraph 299-305.
The recitation “as an active ingredient to treat or prevent the disease caused by the proliferation of harmful bacteria in the intestine” is drawn to the intended use of the composition.
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 Wassell, Paul. US 20070207133 2007-09-06 cited in IDS.
Wassell et al disclose a gastric acid-stable probiotic formulation, containing (a) lactic acid bacteria (paragraph 171 and 174) (b) edible oil (paragraph 105-107), (c) emulsifier (paragraph 204, 207) such as a triglyceride that comprises a fatty acid monoester, for example GRINDSTED (paragraph 140, 144) and nuts such as peanut butter as essential ingredient (paragraph 24, 39, 43, 68, 131-135 and 185 ), wherein the lactic acid bacteria are wrapped withing a gel-like flocculating mixture of edible oils and the emulsifiers – see paragraph 312 disclosing mixing the oil and the triglyceride that comprises a fatty acid monoester, for example GRINDSTED forms a gel which is broken by agitation/mixing action to which probiotic added and dispersed into oil and mixed resulting in probiotic staying in suspension (corresponding to gel-like flocculating mixture of edible oil and the emulsifier).
Wassell disclose the lactic acid bacteria is Streptococcus, Enterococcus, L Bifidobacterium and Lactobacillus or combinations thereof. See paragraph 174.
Wassell disclose the edible oils are sunflower oil, palm oil, palm kernel oil, coconut oil, olive oil, sesame oil, peanut oil, corn oil or mixtures thereof. See paragraph 105 and 107.
Wassell disclose the GRINDSTED PS 209 is characterized by triglyceride that comprises a fatty acid monoester corresponding to a glycerin fatty acid ester (paragraph 140, 144, 312) .
Wassell disclose the nut is characterized by a peanut component i.e. peanut butter. and nuts such as peanut butter as essential ingredient (paragraph 24, 39, 43, 68, 131-135 and 185 ).
Wassell disclose the gastric acid-stable formulation further comprises a prebiotic. See paragraph 223-224.
Wassell disclose the prebiotic is maltodextrin, galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), lactosucrose, soybean oligosaccharides, palatinose, isomalto-oligosaccharides, gluco-oligosaccharides and xylo-oligosaccharides. See paragraph 223-224.
Wassell disclose the gastric acid-stable formulation comprises cohesive agents such as alginate, xanthan, pectin, locust bean gum (LBG), guar gum. See paragraph 199, 223.
Wassell disclose a pharmaceutical composition comprising the gastric-acid stable formulation. See paragraphs 290-298. Wassell disclose a health functional food comprising the gastric-acid stable formulation such as powders, tablet, granule, capsules and beverage. Wassell disclose a health care food and a food additive comprising the gastric-acid stable formulation. See paragraph 299-305.
Wassell 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 to 90 weight part, and (c) emulsifier 0.1 to 5.0 weight part and nuts 5 to 90 weight part.
Wassell 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 to 60 weight part, (c) emulsifier 0.1 to 5.0 weight part, (d) nuts 5.0 to 90.0 weight part, (e) prebiotics 0.01 to 5.0 weight part, and (f) cohesive agents 0.1 to 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).
Wassell et al teach the components of the gastric acid-probiotic formulation and arriving at the claimed weight parts of the components of the claimed gastric acid-stable probiotic formulation would have been achieved by one of ordinary skill in the art as of the effective filing date of the instant invention by routine optimization of the disclosed ingredients in order to arrive at a pharmaceutical composition comprising the gastric acid-stable probiotic formulation.
Status of Claims
Claims 1-3 and 20 are withdrawn. Claims 4-19 are rejected.
Applicants’ 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 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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